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MEDICAL CHRONICLE Est 1965 | Circ 15 000 The Doctor’s Newspaper June 2011 Telephonic Consultation Initiatives the ‘Wrong Medicine’ for Patient Care? The legality of several private health care initiatives using modern technology to consult and advise patients has come under severe fire from the Health Professions Council of SA (HPCSA) and the South African Medical Association (Sama). However, providers of these services argue that legislation and regulations governing telemedicine in SA haven’t yet caught up with the times and that barring providers from using it prevents patients from quick access to medical services which they will otherwise not have access to. The HPCSA has urged the public not to use the services of Hello Doctor, a company that uses telephone consultations to diagnose patients, prescribe medicine and even supply sick notes, or that of MTN/ Sanlam’s Care Connect telephonic health information offering, until its Committee for Undesirable Business Practices has had time to review their business models. The body has also warned doctors to not use the Hello Doctor platform to offer their services because it will constitute a breach of the ethical rules that govern its members. The committee will make a ruling once the two services have submitted their business models for review. Sama too has slammed the launch of Hello Doctor describing it as a breach of patients’ rights such as practitioner-patient relationship, patient confiden tiality and informed consent, as well as being ‘disastrous and unethical’. Hello Doctor CEO, Andy Milné, countered the allegations saying that the 350 practitioners that form part of their network are subject to the regulatory guidelines of the HPCSA and subscribe to the Hippocratic Oath. Andy Milné, In terms of in- Hello Doctor CEO formed consent, he said each doctor is obliged to ensure that there is informed consent and this has become even more relevant with the advent of the Consumer Protection Act (CPA), which requires that Earlier ARV Treatment Key to Turning SA’s AIDS Epidemic Around Initiating HIV-positive patients on antiretroviral (ARV) therapy at CD4 counts of between 350 and 550 could potentially avert between 300 000 and 400 000 new infections per year in SA and significantly decrease positive patients’ risks of contracting opportunistic infections, particularly tuberculosis (TB). If introduced in conjunction with other proven HIV transmission prevention interventions, it could put the country firmly on course to reverse the spread of the epidemic within the next decade. These are the key messages from a landmark study conducted in SA and various other countries that showed a 96% reduction of HIV transmission in serodiscordant couples when the infected partner received early ARV treatment. Conducted by the Prof Ian Sanne HIV Prevention Trials from the Clinical HIV Network (HPTN) Research Unit at Wits and funded by the and MD of Right to Care US National Institutes of Health AIDS division, the HPTN 052 trial started in April 2005 and was due to end in 2015. However, it was halted in May last year after an interim review by the study’s data and safety monitoring board concluded that ‘it was clear that the use of ARVs by HIV-infected individuals with relatively healthier immune systems substantially reduced transmission to their partners’. The results of the randomised clinical trial involving almost 1800 couples in Africa (100 in SA), Asia and North and South America, support the findings of several observational studies showing the effectiveness of ARVs in reducing the infectiousness of HIV-infected individuals. Last year, epidemiologist Dr Brian Williams from the SA Centre for Epidemiological Modelling and Analysis told a meeting of the American Association for the Advancement of Science that earlier ARV treatment could make HIV-infected people virtually noninfectious, stopping the spread of HIV within five years resulting in the elimination of HIV/AIDS in the next 40 years. SA guideline review urged Commenting on the findings of the HPTN 052 trial, one of the principal investigators, Prof Ian Sanne from the Clinical HIV Research Unit of the University of the Witwatersrand and managing director of Right to Care, said the results supported the view that SA should urgently review its ARV treatment guidelines to allow for therapy initiation at CD4 <350 for everybody. Serious consideration should also be given to increase it to 500 in the near future. According to Prof Sanne, starting treatment at CD4 <350 would add an estimated R1bn to the cost of the current ARV programme in SA, but would significantly reduce the costs associated with new infections and the treatment of patients who now have to wait until their CD4 counts drop to 200 and who are already sick when they access treatment. The cost of increasing it to 500 or less has not been calculated yet, but the benefits of ‘test and treat immediately’ are significant, as has been proven by the study. Of the 28 cases of HIV transmission that occurred during the trial and linked to the infected partner, 27 infections were among the 877 couples in which the HIV-infected partner delayed ARV treatment. Only one case of HIV infection occurred among the 886 couples in which the HIV-infected partner began immediate treatment. There were 105 morbidity and mortality events 65 events in the delayed treatment arm and 40 in the immediate treatment arm. Seventeen cases of extra pulmonary TB were found among HIV-infected participants in the delayed treatment group compared with three cases in the immediate treatment arm. ... to page 2 consumers be given the whole story or all the details. “We do not understand where there is a breach of patients’ rights and are seeking further information on the matter. Our confidentiality processes are stringent as only authorised medical personnel have access to the information, with each access obviously having a record of entry, each call is recorded and password protected.” He added that their process of confidentiality is, in fact, much better than most face-to-face consultations because the medical information is only available to the medical practitioner concerned. He acknowledged that this ‘relationship’ is not the same as a patient-GP relationship, but added that it is a relationship not dissimilar to a hospital or ... to page 2 // Highlights // Specialist Managed Shortage Care HIV/AIDS The link Training alone To the benefit between HIV of patients or and preterm won’t fill the profits? gaps births P6 P41 P69 Psychiatry Depression during pregnancy undertreated P77 page 2 | medical chronicle | June 2011 // News Capsules Paediatric surgeon shortage a crisis The severe shortage of paediatric surgeons in SA is reaching critical proportions impacting particularly on the health of children who need elective surgery in the state sector. According to the SA Association of Paediatric Surgeons, there are currently only 27 registered paediatric surgeons in the country, meaning that there is only one for every two million people in SA compared to one for every 300 000 people in the UK and one for every 400 000 in the US. The majority of these surgeons (10) work in the Western Cape, six in Gauteng, five in KwaZuluNatal, three in the Eastern Cape and one in the Free State, while the other two work in the private sector only. MCC pulls Avandia The Medicines Control Council (MCC) has withdrawn registration for the former blockbuster diabetes drug rosiglitazone (Avandia). It follows a decision last year to withdraw the drug in Europe after research showed it increased the risk for heart attacks and bone fractures. The manufacturer of the drug, GlaxoSmithKline has indicated that it did not intend to appeal the MCC’s decision. Adcock acquires Bioswiss South African pharmaceutical company, Adcock Ingram Healthcare has acquired a controlling stake in Bioswiss, a specialised diabetes pharmaceutical company that distributes a range of human biosimilar insulins and a range of diabetic diagnostic products (Glucometer and test strips). Commenting on the acquisition, Adcock Ingram CEO, Dr Jonathan Louw, said Bioswiss would provide Adcock Ingram immediate entry into the growing diabetes market. He said the introduction of a biosimilar insulin range would allow the company to provide a cost-effective alternative for people living with diabetes. Currently, there are approximately six million people in SA living with diabetes. J&J to retain CT plant Johnson & Johnson (J&J) has decided to retain its manufacturing facility in Cape Town. The company earlier announced that the facility would be closed at the end of last year, but according to J&J regional vice president: supply chain, Filip de Keersmaecker, it was recommended that the facility be retained within the company’s internal manufacturing network. The facility manufactures a range of over-thecounter products and employs approximately 200 people. J&J has two manufacturing operations in SA - in East London and in Cape Town. UTi to build R530m warehouse Pharmaceutical distributor UTi Pharma has begun with the construction of a R530m warehouse and distribution centre in Meadowview, Johannesburg that is to be completed in October 2013. UTi’s associate company, Chronic Medicine Dispensary, will also be located in the facility. Company CEO, Holger Eckholt, said the centre will triple UTi’s distribution capability. Med-e-Mass boosts software offering Med-e-Mass, part of Bytes Healthcare Solutions, recently added HEALTHone, (electronic patient record software) to their wide range of practice management solutions. The software is an interactive clinical record system that improves practice efficiency and profitability and allows for smooth interoperability and exchange of information, said Med-e-Mass MD, Gideon Brits. The product can be customised and refined to meet the needs of GPs and specialists as well as to comply with a variety of requirements such as those set for occupational health, ARV treatment and injuries on duty. Telephonic Consultation Initiatives the ‘Wrong Medicine’ for Patient Care? ... from page 1 clinic environment where patients do not get to see the same doctor each time. Sama chairperson, Dr Norman Mabasa, said his organisation does not support any initiative that discouraged face-to-face consultation between patient and doctor. Hello Doctor has since stopped its services, not because it believes it is wrong, said Milné, but out of respect for their patients, clients, the doctors and the HPCSA. “This has had a massive financial impact on our business, but until we have the support of the HPCSA, we will not proceed with this area of the business.” HPCSA and Hello Doctor was held at the end of last month to discuss a way forward. It was during this meeting that the HPCSA requested Hello Doctor to submit its business model. In regard to the HPCSA’s call on the public to not use these services, Milné said they were extremely disappointed that the powers that be have chosen to say this before understanding what it is that Hello Doctor does. “If they had spoken to us first and found out what we’re about and then still were of the opinion that our services were as they have portrayed to the media, then I would have applauded their proactive approach.” He added that he was shocked that the HPCSA issued what he described as a ‘precipitous and irresponsible’ press release before knowing the facts. “It’s like finding a person guilty before even charging him,” he said. Services not approved by the HPCSA In response to the question of whether or not Hello Doctor has been approved or registered by the HPCSA, Milné said this aspect has been beset with inaccuracy. Hello Doctor is not a practice and that means it does not have to register with the HPCSA. In addition, they don’t employ any doctors nor do they undertake medical services. The initial doctor group, ER Consulting Inc, however, is a registered medical practice and all the doctors in their network are registered with the HPCSA. The doctors have developed a set of clinical protocols, procedures and processes, which forms the basis of the clinical governance of the Hello Doctor system. This system has been developed over many years in clinical practice, is based on international standards and is refined to cater for the local South African environment, Milné added. “Doctors using the Hello Doctor platform will not attend to just anything or any ailment. The clinical governance rules and triage system means that only the appropriate group of primary health care problems will be addressed.” If a patient is not suitable for the system, then he/ she is encouraged to consult with his/her doctor or go to an emergency department. “We are not trying to take work away from other doctors. In fact, we believe that this process, if embraced by doctors, will compliment their practices and grow the referral base of patients. Unethical medicine The HPCSA also accused Hello Doctor of practising unethical medicine and called on health care practitioners to continue ‘upholding the general ethical rules and regulations and to refrain from offering services that contravene these rules and regulations, including offering or participating in unethical telemedicine practises’. Milné strongly denied that they were practising unethical medicine and said they hope to dissuade the HPCSA of this notion. A meeting between the Earlier ARV Treatment Key to Turning SA’s AIDS Epidemic Around ... from page 1 “It is not only easier to bring down patients’ viral load to undetectable when they are well than when they are sick, but it will also help to reduce the number of patients that are diagnosed but don’t return for follow-up and monitoring. Many of them only come back when they become ill and already have TB, adding significantly to the cost of treatment,” said Prof Sanne. Treatment alone not enough However, he stressed that earlier treatment is not enough to turn the tide on the epidemic. It will have to be implemented in conjunction with other interventions that have been proven in recent years to reduce the risk of transmission, such as male circumcision, the use of tenofovir gel before or after sex and the impact of ‘knowing your status’ to ensure that those who are negative remain negative and those who are positive get treatment. system aimed at facilitating access to health care for millions of South Africans,” said Pienaar. Telemedicine not ‘illegal’ According to Milné, there is currently no legislation that prohibits telemedicine or ehealth in SA. He acknowledged that the HPCSA did issue ‘some’ draft guidelines, but added that these ‘have not yet seen the light of day’. The only reference to the HPCSA’s views on telemedicine is what appears to be an executive committee comment, which states that consultations cannot be done by telephone, he added. “Despite Milné’s contention to the contrary, the HPCSA does indeed have rules that clearly prohibit the type of services offered by Hello Doctor. This is encapsulated in Ethical Rule 23 (5): “A practitioner may prescribe or supply medicine or a medical device: Provided that such practitioner has ascertained the diagnosis of the patient concerned through a personal examination of the patient or the report of a practitioner who has.” According to Milné this rule does not specifically mention telemedicine and, more importantly, the HPCSA cannot put in place any guideline or rule which is in conflict with its enabling legislation and the national health policy - which just happens to have telemedicine as one of its stated priorities. He suggested that those who believe that telemedicine was contrary to the guidelines should ask why the government has set up a special task team to implement telemedicine. Telemedicine is the future Karel Pienaar, managing director of MTN SA, stressed that their service is a mobile health information and education service and not telemedicine. One of their first offerings, the Nurses Advisory Helpline, does not provide telephonic diagnosis, prescriptions or sick notes, he added. The purpose of the helpline is to facilitate access to basic health care information and education. This is done through utilising the reach of the cell phone to provide medical education and information to callers, he explained. “The product offerings focus on health information and education and comply with all relevant legislation governing the provision of health care,” said Pienaar. He added that the provision of such educational and information services is undertaken by professional nurses. The information provided is not to be used as a substitute for a medical practitioner’s diagnosis or treatment relative to the specific medical condition or query. “Under no circumstances is this helpline a conclusive diagnosis (or treatment) of the alleged ailment and not a substitute for conventional medical care, but a complementary service to the health care Milné accused the HPCSA and Sama of procrastination, saying that while the rest of the country has transformed over the years, it seems as though these two bodies have stagnated. He added that the concept of telemedicine has been embraced by a number of countries including the US, Canada, India, Mexico and Australia. “Telemedicine is huge and will continue to develop as a way to provide health care,” said Milné. In addition, technology (and times) has changed, and he believes that the doctors that are utilising the Hello Doctor platform should be seen as progressive and hailed as champions of better patient care for all. When time, technology and needs change, rules and ethics need to be changed too, to accommodate the best interest of the patient, he added. “It must also be remembered that the Health Professions Act came about in 1974, long before our Constitution, and the guidelines and various ethical practice directives are based on the then old order interpretation of the legislation and do not and have not taken into account the technological advances of the past 15 years let alone the Competition Act, the Consumer Protection Act and the Electronic Communications Transactions Act.” Milné said they will continue to engage and consult with the HPCSA with a view to ironing out whatever misunderstandings were communicated or inferred to ensure that common ground is reached, which will be in the best interest of the health care sector and the public, he concluded. “All these findings feed together into a body of interventions that we need to consider when we make decisions on what should be prioritised for funding at a public health level. The concept is similar to a jigsaw puzzle that has to be put together for different populations,” Prof Sanne explained. “For instance, the use of tenofivir gel may be considered predominantly for prevention of transmission to young heterosexual women where you have a serodiscordant couple and the partner doesn’t qualify yet for ARV treatment.” In addition, the circumcision campaign should be accelerated. Studies conducted in recent years have shown that circumcision could reduce the HIV transmission rate to men by between 50% and 60%, but to have a major impact in SA, it will have to reach at least six million men between the ages of 15 and 49, Prof Sanne noted. However, the gateway to ensure that these interventions succeed in reducing infections is to continue government’s HIV Counselling and Testing (HCT) campaign. “We are still far away from having identified all those who are infected in the country and from developing a treatment plan for all those who are positive. The HTC campaign needs to be sustained with the same target of testing 15 million per year for at least another 10 years and a culture needs to develop where people want to know their status and are willing to test on an ongoing basis,” Prof Sanne added. Currently, SA only has around 1.2 million people of the estimated five to six million who are infected on treatment, with government preparing to increase its ARV rollout to three million people in 2016. Based on data from the Wits HIV Research Group at the Helen Joseph Hospital in Johannesburg, raising the CD-4 count to 500 would translate in an estimated increase of 30% in the number of patients who would be eligible for treatment. Although the expected surge in demand for treatment would put increased pressure on government to obtain more funding, train more health workers, improve the clinic system and increase the procurement and distribution of ARVs, Prof Sanne said this is achievable. “It is not an insurmountable task. We have already gone a third of the way and we can go the remaining two-thirds.” Care Connect medical chronicle | June 2011 | page 3 News // Health System Not Fit for NHI But we’re Getting There: Minister Health minister Dr Aaron Motsoaledi has urged South Africans who are concerned about the establishment of the National Health Insurance (NHI) to be patient, as government is working around the clock to finalise the Dr Aaron long-awaited docu- Motsoaledi, ment to be released for health minister public comment. “The problem is that many believe that NHI is just the release of a document. For us in health, we know that it also involves an extensive preparation of the health care system, while at the same time preparing a policy document and, in this case, the re-engineering of the health care system is vital,” Dr Motsoaledi said in his budget vote speech at the end of last month. Announcing an increase in his department’s budget from R21.7bn in the 2010/11 financial year to R25.7bn in the 2011/12 financial year, he said an additional R16.1bn has been allocated at provincial level for preparatory work for the NHI. Current system not fit for NHI But the minister stressed that no NHI can ever survive in the current health system. “I know that at face value, problems in the health system are said to be existing only in the public sector and the private sector must be left alone to some wayward phenomena called market forces, even though these market forces dismally failed to stop or, more appropriately, caused the most recent global economic collapse,” Dr Motsoaledi said. He said while it is true that the public health care system is ‘bedevilled’ by very poor management and a dire shortage of resources that have resulted in poor quality of care, the overall health care system, both public and private, will be completely re-engineered. “The present health care system is characterised by four very clearly identified negatives. It is unsustainable, very destructive, extremely costly and very hospicentric or curative in nature. For any intervention dealing with the cost of health care, such as the NHI, to make any sense, a complete re-engineering of the current health system is essential and it is an obligation placed upon our shoulders.” Ringing in the changes Elaborating on the changes envisaged for the health care system, Dr Motsoaledi said it will involve three main interventions: the first being the establishment of a district-based model that will start with the deployment of a team consisting of a principal obstetrician, paediatrician, family physician, advanced midwife and senior primary care nurse in each district. The team’s main focus will be on the reduction of maternal and child mortality in the country. Dr Motsoaledi said he had consulted all the deans of the eight medical schools in the country, the professional associations of paediatricians, obstetricians, family physicians, the Colleges of Medicines and the nursing fraternity, and that they have given their support to the initiative. The intention is to have the plan in place by the end of this year, which, he said, will, for the first time, require the creation of these posts at district level. “We are absolutely determined to make sure that this model is implemented. Once appointed, these teams will deal with guidelines and protocols at antenatal care clinics, labour wards, postnatal health care and paediatrics, and child health clinics.” In addition, the teams will be responsible for the training of interns, community service doctors and medical officers. The second stream will include a school health programme, which will be instituted with the assistance of the Ministers of Basic Education and Social Development. The third stream will be a ward-based primary health care model, which will deploy at least 10 well-trained health workers per ward. Such a model has already been implemented in Brazil, where 30 000 community health care workers have been deployed to various communities. It will also be employed in India soon. According to Dr Motsoaledi, a total of 251 teams have been deployed in SA in the past three months and have reached 41 000 families. At least 18% of the people that have been tested in the process were found to have TB. He pointed out that in the past, most of these cases would not have been picked up with many of them only presenting at health facilities ‘when it was already too late’. Kidney Scandal Surgeons Allegedly Paid to Perform Transplants The state has proceeded with charges against the surgeons and transplant unit staffers accused of performing illegal kidney transplants in the Netcare St Augustine Hospital in Durban between 2001 and 2003. The six face 461 counts of fraud, forgery, uttering, assault and the unlawful acquisition, use or supply of tissue, blood or gametes. The four surgeons also face a charge of using or possessing proceeds gained from unlawful activities, after it has emerged that they were paid R2m for their role in what has been dubbed the Israeli transplant scheme. Four of the six accused appeared in the commercial crime court in Durban at the end of last month. The other two accused, transplant unit staffers Lindy Dickson and Melanie Azor were excused by the state. They face additional charges of fraud and uttering. Court documents list Drs John Robbs, Ariff Haffejee, Neil Christopher and Mahadev Naidoo as having received R371 000, R1m, R225 000 and R310 000, respectively, for performing the transplants. The accused face 109 counts of fraud in terms of section 29 of the Human Tissue Act of 1983, 109 of assault with the intent to do grievous bodily harm, 109 of unlawful acquisition, use or supply of tissue, blood or gamete and 92 counts of acquisition and the use or possession of proceeds gained from unlawful activities. According to the state prosecutor, Adv Robin Palmer, “The accused took the opportunity and, well-knowing that it did not comply with the law and the policy, put into operation the Israeli transplant scheme.” The state also contends that the accused were well aware that the suppliers and recipients were not related, as required in terms of the policy, and were aware they had been recruited to be part of the organ trade. In addition, five of the donors were younger than 21, which means they were legally incapable of giving consent. In their court documents, the state briefly highlights the role of Netcare’s national transplant coordinator, Dr Belinda Rossi, who travelled to Israel to attend meetings to gain information as to the possibility of performing kidney transplant operations in Netcare hospitals in SA. It is unclear at this stage what her role in the scheme was. She has since left Netcare and is now the transplant coordinator at the Wits Donald Gordon Medical Centre in Johannesburg. She will potentially be called as a state witness. The accused still maintain their innocence, saying they were the victims of a ‘scam’. Their attorney, Drs John Robbs and Ariff Haffejee, two of the four surgeons who, according to the latest charge sheet received a total of R2m to perform the illegal transplants Altus van Rensburg, said they were considering bringing an application to have the charges against them dropped. One of their other co-accused, Dr Jeff Kallmeyer, pleaded guilty last year and was fined R150 000. He has since turned state witness. Charges against Netcare were dropped last year after the hospital group pleaded guilty to 102 counts on the three main charges relating to 109 illegal kidney transplants conducted from 2001 to 2003 at Netcare’s St Augustine’s Hospital in Durban. The group paid a R4m fine and a confiscation order of R3.8m. ‘Perverse Incentives’ Radiologist Found Guilty Well-known Pretoria radiologist, Dr Henry Syming ton has been found guilty of paying more than R7m in ‘perverse incentives’ to colleagues to entice them to relocate their medical practices to the Netcare Pretoria East Hospital and to refer patients to the facility. He appeared before the disciplinary committee of the Health Professions Council of SA (HPCSA) last month and was found guilty on all six charges dating back from 1996 to 1999. The six counts were combined for the purpose of sentencing. He was sentenced to a period of five years suspension from practice, wholly suspended for five years on condition that he is not found guilty of either giving or receiving any form of perverse incentives or any form of incentives that may compromise the independence of medical professionals during the period of suspension. In sentencing Dr Symington, the HPCSA said that he has ‘a direct or indirect interest or shareholding in the Netcare Pretoria East Hospital’ and that he aimed to increase the income or turnover of the hospital. In addition, Dr Symington has a ‘financial interest’ in the magnetic resonance imaging scanner used at the hospital and therefore benefitted from its use. The HPCSA found him guilty of breaching the ethical norms, values and principles of his profession as well as undermining or compromising the independence of the specialists to whom he paid the incentives. Among the specialists who accepted his ‘incentives’ are four orthopaedic surgeons, Drs Chris Neser, A de Villiers, HJ van Wyk, and JA Louw, neurologist, Dr P Kritzinger and neurosurgeon, Dr PT Slabbert. Contents News Opinion 1 24 Clinical Cardiac Medicine 25 Managed Care 36 Oncology 43 Surgery 46 Winter Ailments 47 Asthma/Allergy 55 Gastroenterology 65 HIV 69 Pain Management 71 Nutrition 75 Psychiatry 77 ADHD 78 Wound Care 83 Professional Advertising 85 Periscope 87 Bonitas Finally Placed under Curatorship Bonitas Medical Fund and the Council for Medical Schemes (CMS) have agreed to a settlement which effectively brings the two-year dispute between the parties to an end, in the best interests of the scheme’s members. In terms of a court order issued by the South Gauteng Court last month, Joseph Maluleke was appointed curator for a period of 90 days during which time he will be in control of Bonitas. Acting principal officer, Gerhard van Emmenis, will revert to his former position of COO. Maluleke has served as Bonitas’ compliance officer since his appointment by the court nine months ago. His appointment as the scheme’s curator, with Van Emmenis reverting to COO, was approved by the CMS and will ensure continuity and stability. In granting the curatorship order, Justice Nigel Willis emphasised that he was not placing the scheme under curatorship due to financial or other difficulties. A curator was deemed necessary to regularise the governance of Bonitas, he said. The scheme’s 2010 audited financial results showed a sharp increase in year-on-year surpluses and its solvency ratio strengthened to 36.5%, which is significantly higher than the required 25% minimum. The Registrar of Medical Schemes, Dr Monwabisi Gantsho, who personally attended the court proceedings, reiterated that the CMS would give Bonitas and the curator all the support necessary to ensure that the interests of members are protected. The council has been trying to put the scheme under curatorship since the beginning of last year after it was found that its board was not fit to manage or control the affairs of the scheme. An earlier independent investigation also found that the trustees had been negligent and that they had broken their fiduciary duties towards the scheme and its beneficiaries. The findings related to eight allegations involving the investment of more than R80m of members’ money in, among others, the Louis Pasteur Hospital in Pretoria, Clinix and an incomplete property development in KwaZulu-Natal that allegedly put members’ money at risk. A business relationship between the scheme’s former principal officer, Bafana Nkosi and the courier pharmacy company, Pharmacy Direct was also probed. Nkosi was suspended in 2009, but resigned before he could face a disciplinary hearing. page 4 | medical chronicle | June 2011 // News Quality of Health Care in SA ‘Appalling’ The quality of health care in SA is ‘appalling’, said Prof Morgan Chetty, chairman of the Independent Practitioners Association of SA Foundation and CEO of the KwaZulu-Natal Managed Care Coalition, in a speech at the Africa Health: Quality Assessment and Improvement Conference held in Johannesburg last month. He added that hospitals and clinics have always had to bear the brunt of quality assessments, while the quality of services rendered by private practitioners are not assessed, due to a lack of legislation. He said that he has been fiercely criticised by practitioners because of his efforts to implement the assessment of private practices. They accuse him of interfering with their democratic rights. He is, however, willing to accept the criticism if it means an improved health care system in SA. Quality vs costs One of the big problems in the SA health care environment, he expounded, was the fact that quality has, to a large extent, taken a backseat to efforts to manage health care costs. Another huge problem is the existence of in equality in the health care system. It would be unfair to produce or deliver health care or to get involved in an intervention if this is not taken into account, he observed. Prof Chetty added that there are unfortunately only a few examples of sustained quality assurance evaluations in developing countries. The reason for this is that the majority of evaluations focus on measuring the mortality and morbidity rates of a hospital. This is then used to classify a facility. These studies also often only focus on intervention processes instead of quality. “It is appalling to know how little emphasis is placed on quality when doctors practice medicine in this country. We keep saying we don’t have money or people available to measure quality.” He added that improving quality is not always expensive. When investigating the possibility of implementing a quality assessment system, it is extremely important to not only evaluate the population coverage and the technological merits of a health intervention, but to also ensure that the quality of the services provided compares to prescribed standards. What is quality and why is it important? Quality must be defined in the light of the provider’s technical standards and the patient’s expectations, explained Prof Chetty. Another definition is: The proper performance according to standards of interventions that are known to be safe, are affordable to the society in question and have the ability to produce an impact on mortality, mobility, disability and malnutrition. The most comprehensive and perhaps the simplest definition of quality is that used by the advocates of total quality: ‘Doing the right thing right, right away’, he added. “We must be extremely aware that the big word for the future is consumerism. We keep forgetting the fact that the consumer is going to have a right to question the quality of service that he or she is given.” Tenets of quality According to Prof Chetty, the four tenets of quality are: Meeting the needs and expectations of the patients in the community and not necessarily meeting the needs of the health care system that is going to pay for the provision of those services; keeping detailed notes about examinations and findings; the quality of the intervention as well as a competitive team approach in solving problems and quality improvement. “Don’t be afraid to outsource some of your services or to ask colleagues for assistance. The biggest blunders often happen when we are confident about doing things which we should not be doing,” he advised. Implementating quality assurance The key activities before a quality assurance SA Gets its First Urology Skills Lab According to Janine Volschenk from J&J, enThe Pretoria Urology Hospital, Johnson & Johnson doscopic surgery is the future. Not only does it (J&J) and Karl Storz Endoskope recently joined forces limit the time the patient spends in theatre and to establish the first dedicated urology skills laborain hospital, but it also reduces the patient’s need tory in the country. for pain medication and the risk of infection. This According to Dr Marius Bongers, one of the three means that the patient’s recovery time is much surgeons based at the hospital, the skills laborafaster compared to traditional methods. tory will allow urologists from across the country to Experts from J&J and Storz will provide trainpractise and fine-tune their skills. Basic, laparoscopic ing to urologists who wish to sharpen their skills. procedures are not a problem for most urologists, but General manager of Karl Storz Endoskope, reconstructive surgeries often pose a challenge. Marion Burgess, said it was a priviledge for her “New laparoscopic techniques are developed regucompany to partner with the Pretoria Urology larly, which makes it extremely important for uroloHospital. Colin Atkinson from J&J shared her gists to have access to a dry laboratory where they can sentiments and together with Dr Bongers and practise and fine-tune their skills to ensure that they Dr Izak van Heerden officially opened the skills stay on top of their game,” said Dr Bongers. laboratory. The skills laboratory contains equipment that alAccording to Dr Bongers, urologists from both lows urologists to practise their skills in a dry labothe public and private sectors are welcome to use ratory and to teach their brains to work in the third the skills laboratory. dimension, he added. From left to right: Marion Burgess, general manager at Karl Storz, Dr Marius Bongers, Colin Atkinson from Johnson & Johnson and Dr Izak van Heerden. Drs Bongers and Van Heerden are both from the Pretoria Urology Hospital programme is implemented include sharing or communicating the reasons why you want to implement a programme with your patients as well as your staff - even the cleaner; managing the changes that the implementation will bring with it; interrogating your own practice regularly to identify shortcomings and reviewing your supervisory and related management activities. Goals of a quality assurance Each stakeholder in the health care sector has their own goals. The World Health Organization defines the goal of a primary care quality assurance programme as follows: To be the delivery of an effective, preventive and curative health care service to the full population, equitably and efficiently, while protecting individuals from catastrophic health care costs. Prof Chetty added that one of the biggest problems in SA is the fact that the health care system is too focused on curative care, instead of holistic, preventive and promotive care. Health care providers are stuck in the domain of curative care, because that is what they get paid for. Health systems must be responsive to the needs and demands of a population. Elsewhere in Africa, the focus is on essential, rather than comprehensive care. It is extremely important that essential care evolves into comprehensive care, he explained. Why should quality be assessed? “I think government needs tools to monitor and evaluate the functioning of the system on a routine basis, which will allow them to make sound decisions about the health care system, funding, organisations and policies. To do that, we need information and though we have a lot of data available in SA, we do not collect, collate or use it correctly. As a result, we cannot ‘create’ information on which to base decisions,” concluded Prof Chetty. Tips on How to Achieve and Sustain Accreditation Well-known English critic, essayist and reformer John Ruskin said quality is never an accident; it is always the result of intelligent effort. And hard work, added accreditation ‘veteran’ Laura Ziady, nurse educator at Medi-Clinic SA: Central Region. Laura Ziady, Ziady presented a nurse educator at paper at the Africa Medi-Clinic SA: Health: Quality As Central Region sessment and Improvement Conference held in Johannesburg last month entitled Achieve and Sustain Accreditation. She has been involved in the accreditation process of two hospitals in the Free State over the past 20 years. According to her, the ‘road’ to quality assurance starts with accreditation. Other elements that are essential to the success of a quality assurance programme include best care bundles or services packages; assessment tools such as clinical audits, surveys and electronic event logs; retrospective medical record audits; clinical governance aimed at the systematic raising of health care standards; and the management of poor hospital performance and compliance through quality assurance coordinators’ continuous assessments. In her presentation, she emphasised the importance of accreditation, saying that it not only creates awareness about quality of care, but it also clarifies the definitions of quality of care, provides direction for initiatives such as total quality managements and can be used as a tool for international categorisation and recognition. This is becoming extremely important as a result of globalisation, she added. Data collection For an accreditation process to be successful, all involved parties should be kept informed of the benefits, process and timeline of the accreditation programme. A baseline assessment should be done making use of internal as well as external assessors. Baseline quality data, for example medication errors, health care associated infection rates, antibiotic use and postsurgical complications should be collected and analysed. “Establish an ongoing data collection and monitoring system to identify problems and to track progress,” advised Ziady. In addition, detailed project plans should be developed that include policy and procedure revision management by committed champions and ‘mock surveys’ should be done four to six months before the accreditation survey target date. “It is also important to plan final revisions and corrections, because the better prepared you are, the better the outcome of the assessment,” she added. To sustain accreditation, hospitals should never become complacent, but should ensure that quality measures that are put in place are sustained. Ziady said it is also important to create a culture of self-supporting improvement and self-assessment which will encourage staff members to address existing problems as well as new concerns. To do that, a maintenance programme of the implemented improvements must be introduced, she recommended. She also advised that hospitals do regular minisurveys in key or high-risk areas where problems have been experienced in the past. Maintaining accreditation To maintain accreditation, regular, structured, critical and comprehensive performance self-assessments need to be undertaken. The objectives of these self-assessments are to progressively improve operation efficiency, heighten and enhance staff morale and encourage team work. “Self-assessments have to be applied consciously and active efforts should be introduced to maintain high professional care standards,” said Ziady. Other important issues in maintaining accreditation are the implementation of a system to review performance, (which is essential, because if staff are aware of their performance, it can stimulate improvement). To ensure that staff ‘own’ the process, it is extremely important to continually motivate them; continuous comparison with performance indicators can be used to track the initial achievement of goals, however, it is essential that measures be put in place to track progress and retrospective reviews of the appropriateness of hospital care (patient document audits, appropriateness of intensive care or high care accommodation) should be conducted regularly. In addition, said Ziady, audit trails have to be developed as proof that accreditation is not a onetime effort. She acknowledged that accreditation is not only moonlight and roses, but that there is a downside to it as well. “Accreditation is extremely resource-intensive and requires time, finances, human resources and expertise. It is also often viewed by staff as ‘inspection by government’ or policing. This can lead to the underreporting of negative events.” However, if accreditation is phased separately, it can have a positive impact on the cost of accreditation, she concluded. page 6 | medical chronicle | June 2011 // News Training More Specialists Not the Only Answer to Cure SA’s Ailing Health System Research undertaken by the Colleges of Medicine of SA (CMSA) shows that SA is well below the standards set by the World Health Organization (WHO) in terms of the number of health care professionals required per 1000 population to deliver quality health services. This does not bode well for government’s proposed implementation of its National Health Insurance (NHI) system, which, according to health minister, Dr Aaron Motsoaledi, requires an additional 80 000 health care professionals to succeed. According to Prof Zephne van der Spuy, of the department of obstetrics and gynaecology at the University of Cape Town (UCT), the CMSA’s research shows that there are many different issues which need to be considered. In 2008 the WHO reported that SA has Prof Zephne van der 0.77 medical profes- Spuy, sionals per 1000 popu- head: department lation in contrast to of obstetrics and 1.85 and 1.98 for Brazil gynaecology at UCT and Mexico. The CMSA research, however, suggests that SA only has 0.57 medical professionals per 1000 population and that both the public and private sectors are underserved. SA currently has approximately 0.20 medical and dental specialists per 1000 population and for a middle income country, the WHO estimates there should be at least 0.40 specialists per 1000 population. To reach WHO standards, we would have to double the number of specialists and subspecialists in practice in our country, which is an unattainable goal in the short term, and we need to develop alternative solutions, added Prof Van der Spuy. ‘Out of the box’ thinking needed Her suggestion is that innovative and alternative solutions have to be looked at, including a possible review of the training programme. “We need to recognise that in countries such as the UK, with a population of 60 million, there are 120 000 doctors, while with a population of 50 million, we have 25 000 doctors. A large number of graduates qualify every year, but they are often not being fed back into the public sector system because of a lack of funded training specialist and subspecialist posts in the country and the fact that some of them leave the country or go into private practice after completing their studies,” Prof Van der Spuy explained. Although the Health Professions Council of SA (HPCSA) has recognised that SA has the capacity to train these specialists and subspecialists and they can make an enormous difference in some areas of health care, these posts are not created. The shortage of skills is not simply among surgeons and anaesthetists; many other disciplines have been affected and the fact that SA is not reaching the Millennium Development Goals for health indicates problems with service provision in women’s health, paediatrics and public health. This is a universal problem around the country, Prof Van der Spuy added, and it has been compounded in some areas by cutbacks in service provision, which include decreases in operating time for the surgical disciplines, which impacts on training. Central to this is the availability of related disciplines such as skilled nursing staff, theatre sisters and professions such as physiotherapy. Shortage of anaesthetists Prof Gert van Zyl, dean of the faculty of health sciences at the University of the Free State (UFS), agreed and said one of the major stumbling blocks that they face is the shortage of anaesthetists, which impacts on the training of all surgical disciplines. Prof Gert van Zyl, “Without adequate dean: faculty of health theatre time, you can- sciences at UFS not train surgeons. This, in turn, leads to longer waiting lists,” he added. Although some of the problems that they have experienced have been addressed by Dr Motsoaledi, financial restraints, vacant posts, a shortage of registrar posts and bureaucratic red tape are still some of the challenges that have to be addressed. Until all these issues have been sorted out, the UFS will not increase the number of specialists that can be trained at the institution. Unfortunately the wheels of government turn slowly, Prof Van Zyl added. Improvements He did however acknowledge that some improvements have been introduced since Dr Motsoaledi took over the reins in 2009. These include for e.g. increased security at Pelonomi Hospital since the rape of a doctor last year, an increase in the number of available beds at the facility, a decrease in the number of vacant posts at the hospital and a promise of funding for training equipment. Prof Marietjie de Villiers, deputy dean: education in the faculty of health sciences at Stellenbosch University (SU), said the training of medical specialists is a complex matter that involves a number of stakeholders, including universities, provincial health departments, the Department of Higher Education and Training (DoHET) and the Department of Health (DoH). She agrees that the shortage of training posts and medical consultants to supervise the training is definitely contributing to the shortage of trained specialists. According to Prof De Villiers, another problem faced by universities is the fact that Master of Medicine (MMed) programmes are costly. It takes between four and five years to complete, while universities only receive a subsidy for one year per student. “It is therefore often not cost-effective for universities to run these programmes,” she added. Prof Van der Spuy pointed out that the HPCSA recognises that there are some 1400 unfilled training posts at specialist and many at subspecialist levels, indicating that the infrastructure is in place for filling these vacancies and embarking on training. The situation with subspecialist training is more difficult as the funding is complex and the majority of the recognised training posts are unfilled and unfunded. The solutions include being sure that the infrastructure requirements approved by the HPCSA are not undermined by cutbacks in staff, particularly trainers. The funding, which the DoHET has provided for the faculties of health sciences of SA, has made a major positive impact on both undergraduate and postgraduate training and hopefully this will continue into the future. In his budget speech this year, the Minister of Finance, Pravin Gordhan, indicated that funding was available for additional registrar posts and it is hoped that the impact will be seen in the near future, said Prof Van der Spuy. Prof De Villiers subscribes to Prof Van der Spuy’s view that the solution is not only about creating more posts. She proposed the development of an overarching framework that looks at all the constraints and opportunities regarding this matter. In an effort to find a solution to the problem, SU has implemented structures of formal and informal communication with the Western Cape DoH. Changes in ratios In order to increase the number of specialists and subspecialists in the country, the Subcommittee for Postgraduate Education and Training (Medical) of the HPCSA conducted a review of the trainer vs trainee ratio. The body consulted with all stakeholders including universities, professional associations/societies and government institutions and developed a trainer/trainee ratio policy in January 2009. The policy was implemented at a workshop held in August last year to which all the stakeholders were invited. “As it is our mission to ensure our country’s citizens have access to quality health care, the implementation of the new ratios for specialists and subspecialists will address the urgent need for specialists in the country while ensuring a high standard of training is still adhered to,” said Marella O’Reilly, acting CEO and registrar of the HPCSA. The trainer/trainee ratios have been doubled in most disciplines including for e.g. anaesthesiology, dermatology, family medicine, medical genetics, neurology, ophthalmology, paediatrics, pathology and radiation oncology. Subspecialist training ratios that have been increased include for e.g. clinical haematology, endocrinology, geriatric medicine, medical oncology, maternal and foetal medicine and child psychiatry. Although the changes in the trainee ratio have been welcomed, it does not address the underlying problem of sufficient operating theatre facilities and surgical opportunities for trainees in the surgical disciplines. The new ratios can only be implemented once the HPCSA approves an increase in the number of students that can be trained at academic institutions, said Prof van der Spuy. According to Prof De Villiers, the changes in the ratios have been useful in some instances, while in others they have been fortunate to maintain the current high-level supervision needed to produce good quality medical specialists. New Hope for Patients Waiting for Lung Transplants in SA There is nothing more inspiring and rewarding than seeing someone who was dying recover fully and go on to lead a normal, fruitful life, said pulmonologist and transplant specialist, Dr Paul Williams. He was speaking at a function held at Netcare Milpark Hospital last month to honour transplant survivors. However, having recently returned from the International Society Dr Paul Williams for Heart and Lung pulmonologist and Tr a n s p l a n t a t i o n transplant specialist Conference in the US, Dr Williams is, for the first time in many years, hopeful that long waiting lists may soon be a thing of the past due to new scientific advances that may spell a paradigm shift in the field of transplantation. “When it comes to organ transplantation, SA has the capacity to do as well as the rest of the world,” said Dr Williams. “Similarly, we also have the potential to fall terribly behind as there are new developments in the field every year and it is important to stay up to speed. The future of organ transplantation depends on the availability of suitable donor organs, of which there is a growing shortage worldwide. Our only hope, therefore, is to use and salvage as many organs as possible in order to make the most of what we have,” explained Dr Williams. At present, only 10%-15% of the organs referred for lung transplantation are useable. Hearts and kidneys, on the other hand, are a great deal more resilient than lungs and they also do not have the same high rejection rates. Because of the very short lifespan of donor lungs, lung transplant surgeons have, for many decades, followed strict guidelines to get the donor organ into the recipient as quickly as possible. Apart from that, very few of the lungs donated are of the quality required to meet the strict criteria for transplantation. Now, however, all this may be changing. Breakthrough discovery According to a recently published study in the New England Journal of Medicine, the number of donor lungs and successful transplants may be dramatically increased by treating the organs on a perfusion machine for several hours prior to transplantation. Describing it as the most exciting development in lung transplantation since its inception some 25 years ago, Dr Williams explained that the development enables the repair and use of 85% of lungs that could previously not be used because of tissue damage. Instead of keeping lungs in the traditional bucket of ice to safeguard them, a very clever method has been devised at the Toronto General Hospital in Canada whereby the lungs are hooked up to a type of ‘ventilator’ that resembles an incubator. As part of the new technique, liquid comprising oxygen, proteins and nutrients is pumped into the donor lungs after they have been removed and transported to the hospital of the recipient. “In this way, the lungs can be kept and treated for 12 hours or longer,” Dr Williams said. “At present, if the lungs are not perfect, we cannot use them. However, just imagine if we had the potential to harvest and retrieve donor lungs successfully. We could even have a team looking at the organs and repairing them. The idea is that one will take organs that were turned down due to unsuitability and make them ‘better’ through a variety of techniques.” There will be no rush to get recipients into theatre. Instead, surgeons will be able to observe the lungs for 12 hours, while flushing them with antibiotics and immunosuppressant medication that could lower the risk of rejection. He noted that while there are many reasons to explore the new breakthrough, it will, without doubt, prove expensive and time consuming to develop the programme successfully. “Thinking of the 20-25 patients that we have on the lung transplant waiting list at Netcare Milpark Hospital at any given time, there are ample reasons to get the programme up and running as soon as possible. “I believe that it is imperative that we make an effort to change the status quo and help those patients who we currently have to send away,” Dr Williams said. page 8 | medical chronicle | June 2011 // News SA Human Genome Project Will Benefit Local Society In an article that appeared in the authoritative scientific journal Nature, entitled ‘What is the human genome worth’, it is reported that the US Human Genome Project generated almost $800bn (R5513bn) in economic benefits over a period of 22 years. It is also estimated that the project generated more than 300 000 jobs over that period. In addition, DNA-based products and technologies exceeded R310bn in 2009. In a bid to strengthen SA’s capacity in this growing field, government recently threw its weight behind the establishment of the southern African Human Genome Programme (SAHGP). Heading the programme is Prof Michael Pepper and Prof Michelle Ramsay from the Universities of Pretoria and the Witwatersrand respectively. Prof Pepper cautioned that the benefits of the programme should not merely be measured in financial terms, but rather in the improvements in the health care sector. The Department of Science and Technology (DST) provided seed funding for the programme, which was launched earlier this year. Since then the stakeholders have been putting together a comprehensive report for the DST in order to secure further funding. The programme has attracted support from many sectors including several government departments, said Prof Pepper. Objectives of the SAHGP The main objectives of the SAHGP are to develop capacity for genomic research in southern Africa, to establish resources which include a database and sample repository and to translate knowledge and information into improvements in human health. In a presentation at the Africa Health: PanAfrican Ethics, Human Rights and Medical Law Conference hosted in Johannesburg last month, Prof Pepper highlighted the various important applications of genome sequencing. These include, for example, its positive impact on molecular medicine, DNA forensics, archaeo Michael Pepper, logy, anthropology, extraordinary professor evolution and human in the department of migration, energy immunology, faculty of sources as well as ag- health sciences, UP riculture and livestock breeding. In terms of molecular medicine, genome sequencing can be used to prevent diseases because of its predictive value. When combined with preventative measures or changes in lifestyle prescribed by health care practitioners on the basis of information obtained as a result of sequencing, this approach has the potential to prevent diseases with a definable genetic component. Personalised medicine Sequencing allows health care practitioners to personalise medicine, which may reduce the risk of adverse drug reactions and increases a patient’s rate of recovery. Because sequencing has the potential to play a huge role in pharmacogenomics, it can have a huge impact on the treatment of a patient through rational drug design. Knowing the sequence of an affected gene can also assist in the design and implementation of gene therapy. Social, ethical and legal issues Prof Pepper cautioned that in order for the project to succeed, national, local ethnic and gender-specific differences have to be recognised. He added that it is also extremely important that common vs rare diseases are prioritised. Despite the many benefits that genome sequencing holds, Prof Pepper said that there were still many groups that question the ethics of the project. They feel that researchers are interfering with ‘mother nature’ and thus working against evolution. They also fear the potential of genetic accidents and the dangers associated with designer orga nisms and cloning. While reproductive cloning is universally banned, designer organisms are here to stay, he said. People also fear that sequencing can lead to genetic discrimination against individuals on the basis of their genetic information or that it can lead to communities being discriminated against because of their susceptibility to diseases, their ancestry or ethnicity as well as their historical background. Prof Pepper stressed that all data will be anonymised and will remain confidential. In addition, access to information will be restricted. He added that a research project such as this cannot be undertaken without the approval of research ethics committees and the informed consent of individuals and communities. Traditional and cultural beliefs and norms as well as the literacy levels of participants in studies are taken into consideration before a study is initiated. Prof Pepper concluded by stressing that research in genome sequencing will not only benefit a country’s scientific community, but will benefit society as a whole. medical chronicle | June 2011 | page 11 News // Lymphoedema: Misunderstood and Misdiagnosed in SA The lack of understanding of the causes and treatment of lymphoedema leads to needless suffering by countless people worldwide. Nana Ntombela, has suffered from primary lymphoedema since the age of 16 and has been bedridden since 2009. Called ‘elephant woman’ by people in the community, Ntombela’s left leg weighed approximately 50kg and, at 1.45m in diameter, was almost three times larger than her right. For years, she has failed to receive proper treatment by public health facilities and was advised that amputation would be the only solution. Media attention to her plight resulted in a mercy mission involving Netcare, physiotherapist Allison Dendy, who specialises in lymphoedema, vascular surgeon Dr Dirk le Roux and journalist, Megan Small, from ETV’s 3rd Degree. After just 20 days of specialised physiotherapy, Ntombela’s calf reduced down to 64cm. An operation on 25 May removed 7kg of loose skin and two days later, her leg diameter had reduced to 50cm. Like many Zulu women, Ntombela was born without lymph nodes in one of her legs, causing the onset of lymphoedema at age 16. Other causes of lymphoedema are accidental injury to the lymph as well as surgery, and elephantiasis, a condition caused by mosquito lava in tropical and subtropical countries. Dendy is one of a handful of physiotherapists in SA qualified in Complete Decongestive Therapy (CDT) for lymphoedema. CDT uses a combination of manual lymph drainage (MLD), compression therapy, decongestive exercises, and skin and nail care to improve and manage the condition, thought to be suffered by up to three million people worldwide. Neither doctors nor physiotherapists are provided with adequate training in their undergraduate studies, she believes. Often, interventions by beauty therapists purportedly offering manual lymph drainage also cause more harm than good. According to Dendy, common mistakes in the treatment of an oedematous limb include prescribing a diuretic to reduce the swelling and prescribing a compression garment. Even more damaging is to prescribe both together. Although diuretics initially draw off the water content of the oedema, protein molecules contained in the lymph are left behind and draw more lymph into the tissue. Often, the patient is prescribed more diuretics and the cycle begins again, with the limb becoming progressively more difficult to treat. Bandaging without MLD serves merely to hold the fluid, not move it down to healthy lymph vessels that will, in turn, drain the lymph into the venous system. MLD is a gentle, manual treatment technique that requires knowledge of the lymph vascular system to be effective. Skin is also already compromised by the condition, so it is important to understand how to perform the massage without causing further damage. Cellulitis is one of the frequent complications of lymphoedema and early treatment with antibiotics is essential to ensure that infection does not become systemic. Ntombela’s case has led to a widespread acknowledgement of the urgent need for funding of a support organisation to provide treatment education and to assist the high numbers of indigent lymphoedema sufferers. Since the screening of the story in March 2011, Dendy is now treating a further 10 pro bono patients. An integrated approach to the care of lymphoedema patients involving a general practitioner, physiotherapist, exercise therapist, dietician, counselling services and, where appropriate, a vascular surgeon, can result in an excellent prognosis for the majority of lymphoedema sufferers. Nana Ntombela’s leg before she received treatment After 20 days of specialised physiotherapy and an operation to remove the loose skin the leg’s diameter was reduced from 1.45m to 50cm medical chronicle | June 2011 | page 13 News // Law in Practice Elsabé Klinck Money, the Root of all Uncertainty for Doctors With the scrapping of the Reference Price List (RPL) and in the absence of guidelines as to what one should charge, and for what one should charge, many practitioners are looking for guidance as to how they should be billing. A reference ... is only a reference The RPL and the Health Professions Council of SA’s (HPCSA) ethical tariff were merely references and not fixed fees. Each practitioner still would have to decide what he/she would charge under which circumstances. An agreement or acknowledgement that one should charge at, or at a certain percentage of, such a reference price would still amount to anticompetitive behaviour. The rationale behind competition law The idea behind healthy competition is that it should benefit consumers by leading to lower prices or better value for the same price. The part of the competition law that is very relevant to health care practices is the prohibition on collusion. Competitors should not sit around the same table and agree on what fees they should charge. Groups should therefore be careful to not nego tiate on behalf of all the competitors in a group and should also refrain from giving advice that could be construed as, in the words of the Competition Commission, ‘smoothening the uncomfortable state of competition’. In competition law, the price for goods or services must bear a reasonable relation to the economic value of those goods or services. A nonexcessive price is one that is determined by competitive conditions in the relevant market. But it is often argued that health care is not a ‘voluntary’ market with supply and demand driving prices. As patients have to go to doctors and often do not have the information to select a provider on competitive grounds or the muscle to negotiate better fees with a provider, the market is not competitive and price sensitive. The Consumer Protection Act To complicate matters further, the Consumer Protection Act (CPA) contains a number of provisions on pricing: • Prices must be ‘adequately’ displayed, e.g. consumers should know upfront what they are in for, or at least receive a sufficiently detailed quotation to allow them to make an informed decision. • Prices must not be unfair, unreasonable or unjust. In general terms, a ‘fair price’ would include a price that treats everyone as they should be treated. A ‘reasonable’ price is a price that is backed up by a good reason or rationale, e.g. changes in underlying cost structures or how complicated the service is. A ‘just’ price, would be a price that is also legally justifiable and in line with applicable legal principles. Payment in full, unless ... The interpretation of Regulation 8 by the Council for Medical Scheme’s Appeals Board also gives professionals some indication as to what level of charges would be eligible for such full payment. Circular 24 of 2009 clarified that ‘so long as the service providers’ fees were not unreasonable or unprofessional, the medical scheme involved was obliged to pay those fees in full without any co-payment or the use of deductibles’. Section 41 of the Health Professions Act of 1974 gives the Professional Boards of the HPCSA the power to investigate and rule on unprofessional conduct. But Section 53 goes even further. It gives the Professional Board the right ‘to determine the amount which, in the opinion of the professional board, should have been charged in respect of the services to which the account relates, and the board shall, as soon as possible after receipt of the application, determine the said amount and notify the practitioner and the patient in writing of the amount so determined’. Section 53 also guides practitioners on communicating with patients on fees, stating that ‘unless the circumstances render it impossible for him/her to do so’, the practitioner should inform the patient or responsible person of the fee that he/she intends to charge, but only ‘when so requested by the person’ or ‘when such fee exceeds that usually charged for such services’. This communication standard however differs from that set out by the CPA that requires price disclosure upfront. So, what is a practitioner to do? 1. Develop a billing policy for your practice that covers issues such as how to deal with differences between scheme benefits and your fees, discounts for cash payments or early settlements of accounts. 2. Let patients know upfront what the most frequently charged fees are, and when they will receive quotations for services you render. 3. Base fees on sound, rational considerations such as practice costs, patient profile, accommodating vulnerable patients, experience, etc. 4. Ensure that coding is done correctly in your practice. Provide ICD10-codes, as this enables schemes and other providers, such as pharmacists, to ensure that vital patient information is communicated. 5. Resist the temptation to ‘build some fat’ into fees, where such cannot be justified by rational considerations. Particular care should be taken where goods and/or services are bundled, such as in the case of global fees or so-called ‘package deals’. Similarly, underfunding of professional fees could force practitioners to under-service patients. 6. Keep tabs on developments at the HPCSA, Council for Medical Schemes, and Consumer Commission, as new rulings may provide further guidance as to how fees should be set. page 14 | medical chronicle | June 2011 // News Shortage of Pharmacists a Global Problem It seems as though SA is not the only country experiencing a shortage of pharmacists. The World Health Organization (WHO), the United Nations and the International Pharmaceutical Federation (FIP) joined forces early in 2000 to launch a Pharmacy Education Taskforce whose aim is to facilitate a ‘concerted and collective global action’ to train more pharmacists. Pharmacists represent the third largest health care professional group in the world. According to the WHO, the shortage of pharmacists is especially worrying in regions such as sub-Saharan Africa, where in many communities, the pharmacist is the most accessible or often the sole provider of health care advice and services. Developed countries, however, have not been spared and many have reported huge shortages. For example, it is estimated that the US has a shortage of 3000 pharmacists. In a report entitled Global Pharmacy and Migration Report, the FIP highlighted some of the reasons for the shortage of pharmacists. Some of these include: • Increases in the volume of prescriptions. • Growth in the population over the age of 65. • Greater administrative requirements for hand ling third-party payments. • The changing role of pharmacists. • The growing proportion of women in the profession who are less likely to work full time. Situation in SA Ivan Kotzé, executive director of the Pharmaceutical Society of SA (PSSA), recently said that SA’s critical shortage of trained pharmacists could have a negative impact on the expansion of the industry in future. According to Andy Gray, a senior lecturer in the department of therapeutics and medicines management at the University of KwaZulu-Natal (UKZN), SA has fewer pharmacists per 100 000 population than the median for upper-middle income countries. In 2010, 12 218 pharmacists were registered at the South African Pharmacy Council (SAPC), serving a population of approximately 50 million, meaning that SA has an average of less than 24 pharmacists per 100 000 population, more than 50% less than the required 50 per 100 000. “However, that also ignores the large number who is not practising, and the very skewed distribution. In 2010, only 2966 pharmacists were employed in the public sector, responsible for meeting the needs of 85% of the population,” said Gray. In addition, it is estimated that 40% of the pharmacists working in the private sector, is based in Gauteng. of their pharmacies. The retail group currently has 19 stores, but plans to open another four in the coming weeks. They also have problems filling their vacancies. 50 Experts agree that the number one reason for the shortage of pharmacists in the country is as a result of constraints on the number of students who can be trained at universities as well as the limited number of training institutions available in the country. SA currently only has nine training facilities as opposed to the 13 it had prior to the amalgamation of many of the country’s universities and technikons in 2004. Another reason for the shortage is the fact that huge numbers of trained pharmacists leave the country annually, said, Dr Gill Enslin, head of the department of pharmaceutical sciences at the Tshwane University of Technology (TUT). The FIP reported that in 2001, approximately 1000 pharmacy students graduated in SA and in the same year 600 emigrated. While many leave, only a handful of international pharmacists applied for positions in the country. In fact, figures indicate that since 2003, only 18 international pharmacists have registered with the SAPC. The number of pharmacists required per 100 000 population. SA has 24. The impact of the shortage on health care services Gray added that the total number of new graduates remains static at about 350-400 per year, which is hampering the development of pharmaceutical services. KwaZulu-Natal, for example, reported a vacancy rate of 76% last year, while 66% of the Department of Health’s posts were vacant. Things don’t look much better in the private sector. Kotzé cited Clicks and Pick ‘n Pay as examples of groups whose expansion plans are being severely hampered by the shortage of pharmacists. Clicks currently has 382 outlets and 266 in-store pharmacies. They plan to increase their number of pharmacies to 500 countrywide. However, they currently have 200 vacancies, despite the fact that they pay higher salaries than the state. Pick ‘n Pay too has plans to expand the number Top Proposals for Cost-efficient Care Limiting antibiotic prescribing for certain respiratory infections, avoiding imaging for low back pain and osteoporosis screening for certain patients and not ordering cardiac screening tests in low-risk patients are among the suggestions to make primary care more affordable and efficient, according to a report posted online in the Archives of Internal Medicine. The article is part of the journal’s ‘Less Is More’ series. These recommendations resulted from a project of the National Physicians Alliance (NPA) in the US aimed at improving the quality and cost-effectiveness of health care. Doctors were asked to compile the top five practices in primary care that they think could be changed to make care more affordable and high-quality. “Each activity was to be well supported by evidence, have beneficial effects on patient health by improving treatment and/or reducing risks and, where possible, reduce costs of care,” the article stated. The participating doctors represented the three primary care specialties: family medicine, internal medicine and paediatrics. They participated in teleconference calls to suggest list items, which were then weighed against evidence in the scientific literature. A mass email to all NPA members recruited 172 other doctors for a second round of field testing, which involved completing the same survey that the initial testers completed. The two groups of participants agreed with the following practices: Family medicine: Limit early imaging for low back pain, avoid the routine prescription of antibiotics for sinus infections, avoid ordering electrocardiograms (ECGs) or other cardiac screening in low-risk patients with no symptoms, reserve Pap tests for patients age 21 years or older who have not had hysterectomies for benign disease, and reserve dualenergy x-ray absorptiometry (DEXA) osteoporosis scans for women ages 65 years and older and men 70 years and older or who have risk factors. Internal medicine: Limit early imaging for low back pain, do not order full blood counts or urinalysis for screening in healthy adults with no symptoms, avoid ordering ECGs or other cardiac screening in low-risk patients with no symptoms, limit initial statin prescriptions to generic medications, and reserve DEXA osteoporosis scans for women ages 65 years and older and men 70 years and older or who have risk factors. Paediatrics: Avoid prescribing antibiotics for sore throats unless tests for streptococcus are positive, limit diagnostic imaging for minor head injuries without loss of consciousness or other risk factors, do not refer middle-ear infections (otitis media with effusion) to specialists too early, tell parents to avoid giving children over-the-counter cough and cold medicines, and ensure that inhaled corticosteroids are used properly by patients with asthma. The authors pointed out that some of the items appear on multiple lists. This commonality across specialties reinforced the importance and relevance of addressing overuse of these activities, they wrote. Source JAMA media release Reasons for the shortages of pharmacists Solutions The most obvious solution would be to increase the number of pharmacists in SA, and retaining them for the country by making the pharmacy profession more desirable for young pharmacists, said Dr Enslin. “This can be done in numerous ways including, e.g. job satisfaction, advertising of the various sectors and diverse areas in which pharmacists can be employed (not traditionally occupied by pharmacists) and the utilisation of all the skills that a generalist pharmacist has.” Gray agreed and added that the fact that the training facilities are all based in metropolitan areas also poses a problem. As a result, some training facilities, such as the one at the UKZN, are massively over-subscribed. The UKZN received more than 5000 applications this year, but could only accommodate 80 students. His solution is to increase the size of existing training institutes. The UKZN has received substantial funding to build a new academic health complex and it is anticipated that this will, once built, allow for the pharmacy intake to be increased. “That seems the best way to use the scarce academic resources. Training institutions have also argued for new graduates to be able to do community service at universities, which will help them to recruit and retain future academics and researchers. The solution also partly lies in improving the capa city and number of technicians, aiming at a 1:1 technician: professional ratio in time (it’s 1:3 at present),” said Gray. The TUT, in partnership with the University of Limpopo, annually trains 60 students. They too have decided to increase their capacity and will be establishing an independent pharmacy department at the TUT. This will add another 60 to the number of students that they train annually. Dr Enslin explained the reason for this is because they have grown into a research-focused school and need to be able to accommodate academic interns, which they can’t do under the current partnership agreement. “Due to the wording in the Pharmacy Act, we need to generate student subsidies for TUT independently, as this would be more efficient. We have the infrastructure to do so and the country needs more pharmacists,” she added. Prof Oppel Greeff, head of the department of pharmacology at the University of Pretoria (UP), agreed that the relatively small number of pharmacists that can be trained at the various institutions poses a problem, but disagreed that the number of training facilities was inadequate. He was part of the ministerial task team in the 1980s that investigated the number of institutions offering pharmacy training in the country and re commended that SA reduce the number of training institutions to nine, which was on par with international standards. According to him, legislation has had a huge impact on the profession, because small retailers are largely being replaced by groups such as Clicks, DisChem and Pick ‘n Pay. This makes it impossible for the small retailers to survive, which makes pharmacy an ‘unattractive’ career choice for many. He said a revision of the training programmes might also be something to consider. Currently, pharmacists undergo general training with no option for specialisation. This severely hampers pharmacists’ career options. In addition, he added, the role of pharmacists in the health care sector must be acknowledged and they must be paid accordingly. The future The shortage of pharmacists and strategies to address the situation was discussed at length at the PSSA, Commonwealth Pharmacists Association and the South African Pharmacy Council Conference, which was held in Durban earlier this month. page 16 | medical chronicle | June 2011 // News Reference Book to Ease GPs’ Admin Burden Members of the Alliance of South African Independent Associations (Asaipa) will soon have access to a handy ‘one-stop’ reference book that contains all the information they regularly need in running their practices. Aimed at easing GPs’ heavy administrative burden, the book was designed by Dr Mike Nicholas, chairperson of the Western Cape Independent Practitioners Association (IPA), with the support of an editorial board consisting of Dr Wessel Neuhoff of the East Rand IPA and Dr Shanaze Ghood of the Pretoria IPA. Sponsored by Arctic Health, the book covers an array of information, including ICD-10 codes, continued professional development (CPD), details of clinical programmes and courses presented at the different universities’ faculties of health sciences and contact details of the medical associations and other bodies that GPs work with on a regular basis. “Although most of this information is available on the internet and computer programmes, it is sometimes difficult to access, especially for the older generation of GPs who are not computer literate. This book compiles everything in a single The designer of the user-friendly source GP reference book, that doctors can keep Dr Mike Nicholas on their desks for easy reference,” said Dr Nicholas. It contains an up-to-date, condensed version of the ICD-10 codes that was obtained with the cooperation from the SA Medical Association (Sama) and includes both the clinical diagnosis and its description in layman’s terms. The section on CPD points includes a comprehensive article compiled with the assistance of the Health Professions Council of SA (HPCSA) on how the system works, how many points a doctor needs in the different categories to comply with the requirements, how the information should be kept and for how long. In addition, a separate page is provided for doctors to write down the details and dates of the CPD events they have attended. All the statutory requirements doctors have to comply with to practise in SA are included in the book as well as the forms GPs have to fill in for the annual renewal of their registration at the HPCSA, their Sama membership and to apply for or renew dispensing licences. Information about professional indemnity and the companies from which it can be obtained is also provided. To allow for data to be updated on a regular basis, the book is published in a file format that allows for pages to be replaced when information changes. It will also provide the sponsor the opportunity to market its products directly to GPs and to change the advertisements when new products become available. “It is a working document that will provide doctors with easy access to key information, which will not only save them time, but will also alleviate their administrative burden,” Dr Nicholas said. The book is availably free of charge to Asaipa’s 1300 members and will be delivered directly to them within the next few weeks. Research Offers Simpler TB Treatment Results from one of the largest US government clinical trials on tuberculosis (TB) preventive therapy to date, suggest that treatment for latent TB infection may soon be easier than ever before. The trial results showed that a supervised onceweekly regimen of rifapentine and isoniazid taken for three months was just as effective as the standard self-administered nine-month daily regimen of isoniazid, and was completed by more participants. Sponsored by the Centres for Disease Control and Prevention (CDC), the trial tested the effectiveness of this new preventive TB treatment regimen among persons with latent TB infection who are at high risk for progression to TB disease. The new regimen to treat latent TB reduces the doses required for treatment from 270 daily doses to 12 once-weekly doses, making it much easier for patients to take. The study The study lasted approximately 10 years and included 8053 participants over the age of two who lived in countries with low or medium TB incidence, including the US, Canada and Brazil. Because of a known drug interaction between some anti-HIV drugs and rifapentine, HIV-infected persons taking antiretrovirals were not eligible for enrolment in the study. Participants were randomised to receive one of two preventive treatment options - a regimen consisting of three months of once-weekly rifapentine 900mg and isoniazid 900mg given with supervision (that is, directly observed therapy), or the current standard regimen used to treat latent TB infection, consisting of nine months of daily isoniazid 300mg, which was not supervised (that is, self-administered by the participant). The new regimen was found to be safe and as effective as the standard regimen in preventing new TB cases with very few cases developing in either study arm. Seven cases occurred among those receiving the new treatment regimen compared to 15 among those receiving the standard treatment. Additionally, the percentage of participants completing the new, shorter regimen was substantially higher (82%) than the percentage completing the standard regimen (69%). The researchers cautioned that these results are only directly applicable to countries with low-tomedium incidence of TB. Additional studies will likely be needed before this new regimen can be recommended in countries with a high incidence of TB. medical chronicle | June 2011 | page 17 News // Advertorial Updating Doctors on the Latest Clinical Practice The academic programme kicked off with Dr Dominic Giampaolo delivering a presentation at the breakfast symposium on new research insights into multiple sclerosis. The aim was to assist the GP in optimum management of patients with this potentially debilitating condition. This was followed by a cardiometabolic session consisting of a lecture on the current trends in hypothyroidism, with an emphasis on control, by Dr Helena Oosthuizen. Diabetes management, comparing new and older, more established therapies, was discussed by Dr André Pieterse. This theme was concluded by Prof Neels Potgieter’s presentation on novel advances in hypertension treatment. Dr Anthony Rodrigues then enlightened the delegates on infertility and its management. One of the highlights was undoubtedly the discussion around the new sexually transmitted infections guidelines, by Prof David Lewis. The management of urinary tract infections and resistance issues was placed in the limelight by Dr Adrian Brink. A debate between the latter two speakers and a general Q&A added an interactive element to the symposium. Prof Neels Potgieter Dr Anthony Rodrigues Doctors were the lucky recipients of a repository of knowledge in various therapeutic areas, including the cardiometabolic field, at Merck Serono SA’s first medical symposium, which took place on 7 May at the Bytes Conference Centre in Midrand. The objective of the symposium was not only to present new and topical clinical information, but also to create a discussion forum, while assisting GPs to achieve their CPD requirements. To celebrate this momentous occasion, the maximum number of CPD points allowed per day (24 points) was made available to doctors who attended the eight-hour meeting and filled in the necessary questionnaires. Leading experts in their respective clinical areas were meticulously chosen to ensure the highest quality of disseminated information. Academic programme and speakers Drs André Pieterse and Helena Oosthuizen The future The fruitful day culminated in a much-needed ethical lecture by Prof Charles Feldman. Overall, delegates were extremely complimentary and the organisers received excellent feedback. Doctors felt that the presentations were insightful and definitely achieved the aims that were set. Klaus Boehm, managing director of Merck SA, said it perfectly in his opening address: “Merck Serono as a company strives to become a centre of excellence for sub-Saharan Africa, through strengthening partnerships, providing education and by delivering new and better treatments to fulfill the needs of the communities we serve.” The intention of Merck is that this inaugural event will set the stage for an annual Merck Serono medical symposium. “We hope that everyone enjoyed this year’s meeting and took pleasure in the offering of excellent speakers, informative presentations and interactive exhibition stands. Thanks to everyone who sacrificed an entire Saturday to attend this event,” said Dr Louis van der Hoven, head of medical and regulatory, Merck Serono South East Africa. “We will take heed of your advice and ensure that our next event will be grander and even more successful.” Dr Adrian Brink (left) and Prof David Lewis Klaus Boehm (left) and Dr Dominic Giampaolo Never Neglect Ethics Ethics is a pivotal aspect of every doctor’s life, especially with reference to the manner in which he or she practices clinical medicine. This seminar awarded five CPD points to emphasise its importance. Ethics: Lecture overview Merck Serono representatives engage with delegates Delegates socialise in the exhibition area In his presentation, Prof Charles Feldman, head of pulmonology at the University of the Witwatersrand, focused on the four basic pillars of ethics which are autonomy, beneficence, non maleficence and justice. Autonomy is one of the more modern con siderations in ethics, and recognises the independent decision-making capacity of the autonomous person. This primary pillar of ethics encompasses the procedure of informed consent, which is an essential requirement prior to many activities in clinical practice. The requirements for comprehensive informed consent are well described and include threshold, disclosure and consent elements. The recent introduction of the Children’s Act has brought with it changes to the age at which an individual (in other words a child) may consent to various medical interventions and procedures. Maleficence and beneficence include the concept of ‘do no harm’ and ‘do good’, respectively, and are the oldest ethical principles. One should always balance potential harm against doing good when determining whether any intervention is ethical in the individual patients. Justice is also a more modern ethical pillar and includes the consideration of distributive justice, which gives guidance as to how to manage and distribute medical care within the constraints of limited resources. The rapidly emerging resistance of micro-organisms to many antibiotics, predominantly as a consequence of inappropriate antibiotic use, has substantial ethical considerations. One of the leading recommendations to tackle such resistance issues has been to restrict the right of doctors to prescribe antibiotics. Such a restriction potentially brings ethical conflicts to the fore, firstly since it challenges the individual doctor’s autonomy. Additionally, the patients attending a facility with a restricted antibiotic policy may well not be aware of such restrictions, expecting their doctor to act only in their best interest, and therefore they do not have complete disclosure of their potential medical treatment. However, inappropriate antibiotic prescribing itself has ethical considerations. For example, it is well described that antibiotic use at the end of life, often in a futile situation, is an unnecessary wasteful use of antibiotics that itself contributes substantially to driving antibiotic resistance. Prof Charles Feldman medical chronicle | June 2011 | page 19 News // To Avoid Litigation, Make Sure you Know your Patient Medical malpractice suits are extremely difficult to win and that is why the majority of cases in SA are settled out of court, said Ronald Bobroff, senior director of Ronald Bobroff and Partners Inc, president of the SA Association Ronald Bobroff, of Personal Injury president of the SA Lawyers and a 30-year Association of Personal veteran in the field of Injury Lawyers medical negligence and medical law. Speaking at the Africa Health: Pan-African Ethics, Human Rights and Medical Law Conference, Bobroff said South African judges are often less inclined to find doctors guilty of negligence than, for example, their US counterparts. In addition, malpractice litigation is a relatively new field in SA, while it has almost become standard practise in the US and is fast gaining momentum in the UK and Australia. “This type of litigation is extremely important because it holds the medical fraternity accountable for the mistakes that they have made. It also offers patients recourse,” he added. Another reason why judges hesitate to find physicians guilty of negligence is because of SA’s acknow ledged lack of resources. As a result, judges may adopt a less stringent test. It must also be remembered that judges want to punish callous and negligent practitioners and not caring physicians, he said. Yet another reason why the chance of winning a suit against a physician is difficult is because local experts often do not want to testify against their colleagues. As a result, international experts have to be brought in, which increases the costs of litigation ten-fold, and can act as a deterrent to potential plaintiffs. In addition, judges also take into consideration the fact that patients often do not provide all the relevant information pertaining to their symptoms, which makes it extremely difficult for the doctor to prescribe an effective treatment regimen. In essence, negligence is hard to prove. All a practitioner has to show is that he/she has the necessary skills to perform his/her task at an appropriate level and that he/she displayed good judgement in the choices that he/she made, explained Bobroff. He added that, in his experience, very few doctors are negligent and that a small minority unfortunately often give the profession a bad name. No substitution for a doctor’s hands Having said that, he added that there are some physicians who view their patients as objects rather than people. It should be remembered that there is no substitute for the ‘hands’ of a doctor and that the personal touch can go a long way to protect him/her against litigation by facilitating a proper diagnosis. “Personal attention is often neglected and the majority of modern health care professionals have become over-reliant on objective testing, which often does not tell the full story.” His advice to health care practitioners: Get to know your patient! The importance of informed consent Bobroff had his audience in stitches when he explained that Roman Dutch law views surgery as a form of assault because the patient is ‘poisoned by anaesthesia, paralysed to avoid movement during surgery, sliced open with a sharp knife, sometimes has bones broken, sawed or drilled and after all this is stitched close’. Fortunately, this ‘assault’ is decriminalised because the patient volunteers to be ‘assaulted’. The law therefore views this as a voluntary assumption of risk. However, that does not relieve the medical professional from his/her burden of informing the patient of the reasonable risks associated with the procedure. He cited a recent case where a dentist removed the wisdom teeth of a patient, but did not warn him of the 1% chance that he might sustain nerve NHI to Put Pharma under Pressure Although pharmaceutical expenditure has been observed to grow significantly with the implementation of National Health Insurance (NHI) schemes in several countries, little has been put forward on what the potential impact of NHI would be to the pharmaceutical sector in SA. “It is certain that the implementation of the proposed NHI will increase consumption of prescription medicines in SA, especially considering that the proposed scheme is envisaged to be comprehensive and to cover the cost of these. With the implementation of NHI, it is expected that more people will seek medical care,” said Frost & Sullivan’s health care research analyst, Tinotenda Sachikonye. At the heart of the proposed scheme is the focus on primary and ambulatory care, which is cheaper than hospital care. It has been observed in several countries that primary and ambulatory care results in higher prescriptions after doctors’ visits. “With this in mind, lucrative opportunities should be expected in the pharmaceutical space with the implementation of NHI,” noted Sachikonye. But is this really true? The reality is, given SA’s current fiscal position, the sustainability of the NHI scheme will be of key importance. Demand for prescription medicines will increase, but so will the stringency of cost- containment strategies. Furthermore, cost containment on the demand side, particularly in the form of flat co-payments, would not be in the spirit of NHI in this country as this would make medicines inaccessible to the poor. Already, some cost-containment measures, such as price control in the form of the single-exit price in the private sector, are in place. “Based on experiences of other countries, we can certainly expect more cost-containment measures; some that will benefit certain pharmaceutical players while threatening the survival of others,” said Sachikonye. For example, Frost & Sullivan anticipates a system of mandatory generic prescribing and dispensing under which only generic medicines will be reimbursed under the NHI scheme. In addition, limited formularies will likely be put in place. Only drugs on the formulary will be paid for by the NHI. It is expected that ‘drug use reviews’, particularly in terms of prescribing habits will be used. Such measures may be employed to deter prescribers from over-prescribing, which would limit the demand for pharmaceuticals, in order to contain costs. It is believed that the dynamics in the pharmaceutical space will change under NHI, Sachikonye said. “Branded firms should be pondering whether it is worth their stay in SA under NHI, or at least strategise on how to remain afloat with this change in regulations. Is it worth staying just for the supply of niche medicines for which there are no generics?” Another consideration is whether local generic firms will meet the anticipated increased demand; or whether this will increase SA’s reliance on generic medicines imports. damage as a result of the procedure. After the surgery was done, the patient was left with a drooping mouth. He then proceeded to sue the dentist. The court found in favour of the patient, because the judge found that the dentist did not inform the patient of the risk and therefore did not offer him the option of a referral to a maxillofacial surgeon. The judge did, however, acknowledge that there was no evidence of negligence on the part of the dentist, but that the risk to the patient would probably have been less if the procedure was done by a surgeon. The dentist’s insurers funded an appeal and the appeal court subsequently reversed the decision of the High Court and found in favour of the dentist. In their judgement they said there was no causal link between the lack of informed consent and the harm which occurred. The patient testified that even if he had been warned of the risk of nerve damage, he would still have consented to the treatment and therefore the absence of informed consent would have made no difference. inform the patient of the reasonable risks associated with the treatment. For example, it is a well-known fact that all surgery is risky. The surgeon, however, is only obliged to warn the patient of reasonable anticipated risks and alternative treatment options,” explained Bobroff. He added that misunderstandings will often be avoided if the surgeon enters into a written contract with the patient before treatment commences. The contract should be a standard agreement that sets out the reasonably anticipated complications and risks associated with a procedure. “Courts do not expect you to do the impossible, but to do the best you can,” said Bobroff. How to avoid becoming a defendant • Good communication - if a patient perceives his/her practitioner as caring, he/she will be less inclined to sue. • Examine your patient. • Be a caring, competent practitioner. Who determines quantum? Bobroff explained that the value of a claim is calculated objectively and is based on quotations obtained from appropriate experts. For example, in a recent case where a father sued a health care facility after his son was diagnosed with cerebral palsy as a result of negligence, reports were obtained from paediatricians, who estimated the medical/care costs for the rest of the victim’s anticipated life span, the costs associated with accommodating the victim in a care facility, lifetime loss of income and general damages in respect of the loss of life quality. The choice of appropriate experts is determined by the specialist personal injury attorney. The plaintiff’s attorney is under an ethical duty to obtain the maximum appropriate damages for the client whereas the defendant’s attorney would contend for the lowest possible damages. The opposing experts will either agree on a probable lifetime scenario failing which the matter proceeds to trail with the judge making the final decisions on the damages to be awarded. According to Bobroff, nonfinancial damages e.g. compensation for the loss of amenities of life, pain and suffering and other intangibles are very modest in SA. South African law also does not make provision for punitive damages although this is the case in most other developed countries. What is informed consent? Section 6 of the National Health Act stipulates that health care practitioners must inform ‘users’ of their health status and the various treatments options available to them. Medical law, however, makes it clear that a health care professional is not obliged to warn a patient of every risk, because, in many instances, the risks associated with the treatment are too remote. “All that a practitioner is obliged to do is to Roman Dutch law views surgery as a form of assault because the patient is ‘poisoned, paralysed, sliced open with a sharp knife, has bones broken, is sawed or drilled and stitched’ Medical Chronicle welcomes D-Days medical congress announcements. Please email to [email protected]. To view a comprehensive list of congresses, please visit www.medicalchronicle.co.za June International Confederation of Midwives 19-23 June, Durban ICC. Contact Nina Freysen-Pretorius, 031-303-9852, [email protected] International Surgical Trainees Congress (SASSiT) 21-24 June, Steve Biko Pretoria Academic Hospital - Surgery Department. Contact Martie Nawn, 012-354-1721, [email protected] 2nd Ndiyeva Audiology and Auditory-Verbal Conference 23-25 June, Protea Hotel, Stellenbosch. Contact Marieta van der Sandt, 082-725-9399, [email protected] July Board of Healthcare Funders (BHF) Conference 3-5 July, Sun City. Contact Zola Mtshiya, 011-537-0200, [email protected] Child and Adolescent Psychiatry and Allied Professions - Incorporating PANDA and SAISI 17-20 July, Wits Medical School, Johannesburg. Contact Tanya Schmidt, 041-374-5654, [email protected] World Congress of the World Federation of the Deaf 18-24 July, Durban ICC. Contact Wilma Newhoudt-Druchen, 011-482-1610, [email protected] Pain, Interventions and Regional Anaesthesia (PIRA) Congress 23-24 July, Birchwood Hotel, East Rand. Contact Dr Lynette Bester, 083-656-3639, [email protected] or [email protected] SA Podiatry Association 8th Biennial Congress 29-31 July, Khaya iBhubesi, Parys. Contact Ken Richards, 083-753-2937, [email protected] page 20 | medical chronicle | June 2011 // News Pharmaceutical Giant Reconfirms Confidence in SA Global pharmaceutical and chemical company Merck recently solidified its confidence in the South African market when it celebrated its 40th year in the pharmaceutical sector and 100 years in the chemical field in the country. Merck South Africa MD, Klaus Boehm, said the celebrations were proof of the company’s renewed commitment to grow its pharmaceutical and chemical sectors in the country. According to Dr Frank StangenbergHaverkamp, chairman of the company’s Board of Partners and vice chair of the executive board and family board, SA is pivotal for Merck’s growth strategy into Africa. Dr Frank “We don’t have imStangenbergmediate plans to open Haverkamp, up more branches in the vice chairperson of rest of Africa but SA’s Merck’s board of good infrastructure directors enables us to use the country as a platform to expand our business to the rest of sub-Saharan Africa,” he stated. Last month, the company sold its pharmaceutical manufacturing operations, Merck Pharmaceutical Manufacturing (MPM), to black-owned investment company Nkunzi Investment Holdings, with the black women’s investment company, Omame, also acquiring a significant stake. The existing management team of MPM, who also acquired shares, and all other employees will be transferred to the new company, which will be called Nkunzi Pharmaceuticals. The sale of MPM forms part of Merck’s global efforts to optimise its manufacturing site network, Boehm said. A proud history Started in 1668 in Germany, the company is still controlled by descendants of the founding Merck family. A trusted name in over-the-counter and innovative prescription medicine, its main focus is the development and manufacturing of treatments for unmet medical needs. Apart from its diabetes and cardiovascular portfolios, Merck Serono is also a market leader in the field of biopharmaceuticals and oncology. It is especially active in the research and development of treatments aimed at personalising cancer treatments such as Cetuximab for patients with epidermal growth factor receptor-expressing advanced or recurrent colorectal cancer who carry the KRAS wild-type gene. Other potential cancer treatments include a therapeutic cancer vaccine for the treatment of a variety of indications. In addition, the company develops and manufactures fertility treatments and drugs for neurodegenerative diseases such as multiple sclerosis. New trends in drug development “The global perspective on drug development is that it is getting more complex with ethical questions pertaining to funding for the development of new drugs getting more topical, particularly in relation to very expensive drugs that only prolong life for a short time,” explained Stangenberg-Haverkamp. “The new development that is being brought into the market is to carefully monitor patients to determine if an expensive drug is going to be effective or not, such as testing patients with colorectal cancer for the KRAS gene. “With this type of testing, we select patients on the basis that there is a 70%-80% chance that they will positively respond to the treatment. This narrows the market and brings down the costs incurred for treating patients that are not really going to benefit from the treatment in the long term.” The drug registration challenge One of the major challenges pharmaceutical companies such as Merck is facing globally is the delay in the registration of new drugs. Currently the research and development budget is close to 1.5bn euros (R15bn) to bring a new drug to market. If registration is delayed, it gives a company less time to market and sell the drug in a country before its patent protection expires, making it more difficult to receive a return on the investment that was put into the development of the therapy, while it also prevents access to top, potentially life-saving drugs, Boehm said. “In SA, we work with the Pharmaceutical Industry Association of SA (PIASA) to find ways of supporting the Medicines Control Council to speed up registration. Solutions such as mutual recognition where drugs that have been available in other countries for several years could be beneficial,” said Boehm. Managing Cultural Differences when Dealing with Terminal and Dying Patients As SA continues to strive towards a fully integrated and multicultural society, more and more significant (previously poorly managed) health issues come to the fore. This article in the series by specialist physician, Dr Huntley Mendelsohn and clinical psychologist, Dr Melanie Krasin, aims to provide a basic framework around which these issues may be addressed. We are all shaped to some degree by the cultural background we grow up in, and so death and dying are both a personal as well as a cultural experience. Despite death and dying being universal phenomena, human beliefs, feelings and practices in this regard vary widely between different religions and cultures. Culture may impact on aspects such as: • Patients’ perception of what is suffering and what is health. • Patients’ perception of dying and death. • Patients’ perception of the roles of health care providers. • Complying or not with treatment regimes. • Forms of expression of pain (physical and emotional), grief, fear and anxiety. • Communication patterns and communication channels - who speaks to whom, how and when. • Involvement and role of the family and/or significant others. • Decision making in terms of the patients’ treatment plan. It is challenging to resist the temptation to make generalisations and assumptions that all individuals from the same culture, ethnic or religious group are exactly alike. It is also natural to want to project or impose your own cultural reality onto the patient and/or family - a tendency health care professionals need to be vigilant about. In each culture, death is surrounded by rituals and customs which help people to grieve and mourn. Rituals offer people ways to express their grief and the opportunity for community members to offer support. Despite the diversity of cultural approaches to death and dying, there are two common underlying themes that extend across cultures, namely: function and integration. Function, in the sense that things need to get done in a certain manner and integration in ensuring that the integrity of the cultural group remains intact and the death is integrated into the cultural framework. Some pointers to assist medical professionals in managing cultural diversity are: • Being aware of your own perceptions, assumptions and prejudices about other cultural practices. • Establishing rapport with the patient and/ or family and being willing to take time to converse about their needs and concerns. It may be necessary to use an interpreter in these cases. • Possessing a degree of openness toward the patients’ and/or families’ unique needs. • Working with a multidisciplinary team. • Being acutely aware of what is culturally appropriate. Quality health care should embrace culturally appropriate care where different cultural views are respected and accommodated. Some guidelines to the religious and cultural traditions encountered in SA include: African • Refer to the deceased as ‘having left us’, not as ‘died’. • Family may elect to wash the body of the patient prior to removal to the mortuary. • Xhosa/Zulu culture refers to the ‘collection of the soul’. • Patients’ clothes given to the family might be buried with the body. Jewish • Ask the family if they would like a visit from a rabbi. • Reciting of prayers. • During the last minutes of life, no one in the presence of the deceased may leave, excepting those whose emotions are uncontrollable, or the physically ill. • Watching over a person as he/she passes is a great respect. • Eyes and mouth are closed by children or family members. • The body is laid on the bed or floor with feet towards the door. • The deceased should not be touched or moved. • Body must not be washed or wrapped in plastic. • Remove all apparatus from the body. • Death certificate to be signed as soon as possible. • The deceased will be removed by a watcher. • Eight minutes to lapse before body is removed. • The body will not be taken to the mortuary. • Watchers stay with the body until burial. • To be buried within 24 hours. • Cherva Kadisha (Jewish helping hand) arranges the funeral. • Jewish helping hand removes the body from the ward and arranges the autopsy if needed. • Family do not view the body. • Orthodox Jews do not allow autopsies. Quality health care should embrace culturally appropriate care Hindu • Wears a good luck ring, medal or necklace, which shouldn’t be removed until the family agrees. • Body is placed on the floor while the family prays. • Gloves should be worn while preparing the body. • If the body is touched by a non-Hindu, the family may be upset. • The body is not washed in the hospital. • The eyes of the diseased is closed, the limbs straightened and the body is wrapped in a shroud. • Religious objects must not be removed. The authors, Drs Melanie Krasin and Huntley Mendelsohn • Autopsy disliked, but permissible. • Organ donation acceptable. Muslim • Recite the Quran or pray while the patient is dying. • Imam to visit. • Patient laid on the right side facing the Kabah or on the back with the feet towards the Kabah. • Cover the face and the body with a sheet. • Do not strip the body naked. • Death certificate must be produced as soon as possible. • Body collected soon after death, will not be taken to the mortuary. • Body should lie with the head pointing towards Mecca. • Should be washed by another Muslim of the same sex. • The body is not to be left alone between death and burial. • Ideally not to be touched by non-Muslim. • Autopsy, cremation and organ donation is unacceptable. Buddhist • Considered dead when loses body temperature and consciousness. • Considered a lack of respect if the body is disturbed during this process. • Body should not be disturbed for eight hours. • Remove all apparatus attached to the body. medical chronicle | June 2011 | page 21 News // Professional Indemnity: What Are the Options? All health practitioners in private practice will soon be required by law to have professional indemnity cover. In this series of articles supplied by the Medical Protection Society, the many issues around professional indemnity are discussed to ensure that practitioners are well informed about this type of cover when it becomes mandatory. Not all professional indemnity is the same. There are differences between the two main types of cover; short-term insurance and membership of the Medical Protection Society (MPS). Understanding the differences will help doctors to make an informed decision. Insurance is a contract. If the terms are met, the policy will pay out. This is a familiar concept. The contract terms will specify what is and is not covered. That’s straightforward if you are insuring a car, but clinical negligence is Simon Kayll, MPS Finance Director more complex. How do you define what clinical activity is allowed and what is not allowed? Also, who reads the small print? Additionally, medicine is forever changing and it’s difficult to continually update contracts for these changes. MPS indemnity is not subject to the terms of a contract, as in an insurance policy. An individual pays a subscription, not a premium, to become a member of MPS. A member is entitled to apply for assistance with professional matters related to his or her work. Assistance is granted at MPS’s discretion. It may seem strange that an indemnity should be discretionary and not enforceable under a contract. But there is much in favour of discretionary indemnity and it is no coincidence that discretion has stood the test of time for about 60 years in SA. The majority of doctors in SA rely on discretionary indemnity, as is the case in the UK, Hong Kong, Singapore, Canada and Ireland, among other places. Discretion gives flexibility to decide how best to respond to a situation - not all requests for assistance are the same. Not having to define the terms of indemnity in a policy means that MPS assistance keeps pace with the changing nature of medicine. By contrast, insurance allows little flexibility to respond to the requirements of a specific request. However, discretion is not a lottery as there are safeguards under common law determining how discretion can be exercised. Insurance and MPS indemnity respond in different ways to a negligence claim. Insurance contracts tend to be claims made and MPS indemnity are claims incurred. An insurance policy will only respond if the insured had a valid policy at the time of the adverse incident giving rise to the claim and when the claim is made. It can be many years between the date of an incident and the making of a related claim. There is a risk that the insured fails to maintain insurance cover over this period, so that when the resulting claim is made, it is rejected. A MPS member can seek an indemnity, provided they had valid membership at the time the claim was incurred, the time of the adverse incident, irrespective of when the claims is made or whether the doctor is still a member. Claims incurred means that there is no risk of a failure to maintain cover. Run-off is associated with the difference between claims made and claims incurred, and applies solely to insurance. Insurance needs to be in force when an adverse incident happens and when the resulting claim is made. Thus, doctors need to keep a policy ongoing for many years. In clinical practice this is rarely a problem, however when they stop work due to illness, retirement, sabbatical or any other reason, they may forget or not realise they have to renew an annual policy to maintain cover. The solution is to buy ‘run-off cover’. This is an agreement between the insured and the insurer that the insured will make a single payment to effectively buy future insurance. The sum will depend on the insurer’s assessment of the risk. Run-off cover is usually built into the pricing for death, disability and retirement of the insured. For all other incidents where doctors stop practice, they may need run-off cover. This is not applicable to MPS membership, as an indemnity is provided for the claim no matter when it is reported, provided the member was a member at the time of the adverse incident. MPS indemnity has no limit and no excess. MPS will meet all claim-related costs. By contrast, insurance policies tend to have indemnity limits and excesses. It’s not only the absolute value of the limit that is important, but whether it is index linked, which is rarely the case. MPS is a mutual, owned by its members and run in their interest. It’s also not-for-profit, as surplus funds are retained for the benefit of members. By contrast, most insurance companies are owned by shareholders and run for profit in the interest of the shareholders. Most insurance companies only provide an indemnity for clinical negligence claims. Membership of MPS assists with matters other than clinical negligence, resulting from the professional life of doctors, such as disciplinary matters and regulatory hearings. This article is not anti-insurance, but points out the pitfalls of insurance compared to MPS indemnity. page 22 | medical chronicle | June 2011 // News Regulation of Medical Devices Will Benefit SA Patients The impending regulation of medical devices in SA and the recently implemented marketing code for health products should be welcomed as major steps towards ensuring that health technology and diagnostics brought into the country meet required safety and quality standards. According to Waclaw Lukowicz, CEO of Siemens Healthcare in the Middle East and Africa, the move towards a tighter regulatory environment for medical devices in SA will not only benefit patients, but also companies that have complied with the highest standards in their research and development of innovative health care technologies and diagnostics. Lukowicz was in the country for the African Health Exhibition, the biggest exhibition of health care products and services ever to be held in SA, of which Siemens was one of the main sponsors. Waclaw Lukowicz, CEO of Siemens Healthcare in the Middle East and Africa, and Helen Brown, CEO of Siemens Healthcare in SA, at the African Health Exhibition Commenting on the proposed registration of devices in SA by the soon-to-be established new regulatory body, the SA Health Products Regulatory Authority, the CEO of Siemens Healthcare in SA, Helen Brown said it will effectively stop companies from using SA as a dumping ground for products that don’t meet the required safety and quality standards. However, she stressed that there isn’t much clarity yet on the way the registration of medical devices will be conducted and whether it will also apply to products that are already being used in the country. “It is important that there should be extensive discussions between large companies and the regulatory authority before regulations are implemented,” Lukowicz noted. Compliance programme Siemens subscribes to a strict benchmark compliance programme that prevents the company from any involvement in bribery, corruption and perverse incentives. Before products are brought to market, extensive research and evaluations are done and peerreviewed by leaders in the health technology field. The company also offers extensive support and training services with all its products to ensure that they are correctly applied, used and maintained. Stressing the company’s commitment to help solve SA’s many health care problems through the provision of integrated health care innovations, and services and investment in education and training programmes, Lukowicz emphasised the importance of SA as a leader in the field of health care in Africa. Alleviating the skills shortage According to Brown, one of the biggest challenges the country is facing, is the shortage of skills, particularly in health sciences and technology. To address this, the company is proactively involved in training and education initiatives that are aimed at marketing these fields as career choices to students, and providing bursaries and internships to previously disadvantaged students. The largest provider of clinical diagnostics in the world following Siemens’ acquisition of Dade Behring and Bayer Healthcare Diagnostics a few years ago, the integration of these products and services provides a myriad of benefits to both patients and health care providers. Because it fully coordinates imaging technology and laboratory diagnostics, it enables faster, accurate diagnosis, the detection of diseases at an earlier stage and more efficient treatment and monitoring of patients, which contribute to better management of diseases, outcomes and quality of care, while also reducing the costs associated with late diagnosis and treatment. “Our main objectives in developing new diagnostics are tests that provide faster results, are more userfriendly and which can be conducted closer to patients, particularly those in rural areas,” said Brown. Bringing health care to the patient Particularly relevant to SA and the rest of Africa was Siemens’ development of the Versant kPCR Molecular System, which does viral load testing in a very short time, allowing for more efficient monitoring of HIV/AIDS patients and which can be done in a mobile laboratory. Similar assays have been developed for the detection of other sexually transmitted diseases. Siemens’ point-of-care diagnostics produce results in minutes, simplifying the work of health care practitioners and allowing them to make accurate treatment decisions. The company is also actively involved in the development of telemedicine solutions through its IT division that will enable access to specialised health care to poorly resourced, remote areas. But, said Brown, before it can be widely implemented in SA and the rest of Africa, it is imperative that the infrastructure required to support and utilise telemedicine is in place because of the large amounts of data that need to be transferred over networks. “We believe strongly in our technology and have great IT solutions for the advancement of telemedicine in Africa, but to properly implement it, we need to ensure that we have a telecommunication infrastructure in place that is able to handle the data efficiently and reliably,” Brown said. medical chronicle | June 2011 | page 23 Events // Siemens Healthcare Participates in First Africa Health Exhibition Siemens was proud to participate in the inaugural Africa Health Exhibition as one of five founding sponsors. The exhibition was held at Nasrec, Johannesburg from 9-11 May, and brought together practitioners from around the African continent. Andrew Forder, country division head, HIM Southern Africa, was enthusiastic about the opportunities presented for the health industry by the exhibition. “Africa Health presented an opportunity to network with key government and other stakeholders in the health care industry from the African continent,” he said. Knowledge sharing Forder added that this is important because there is a growing need for collaboration between specialists. “With fewer professionals entering the industry, we need to encourage knowledge sharing, because we can all learn from each other. For instance, certain diseases are more prevalent in certain countries, so there are valuable lessons to be imparted from practitioners in different countries on the African continent.” The exhibition further provided a showcase for suppliers to display their offerings to the industry. Siemens, for instance, took advantage of the platform to present the latest technologies impacting on the acquisition and distribution of digital radiological images. Leaders in Healthcare Conference The company was also a platinum sponsor of the Leaders in Healthcare Conference. Tom Miller, CEO of Customer Solutions for Siemens globally, was the keynote speaker. Siemens was also a gold sponsor of the MEDLAB and Imaging and Radiology Conferences. Juanita Ward, marketing manager of Siemens Southern Africa Healthcare Diagnostics, reported that their booth garnered attention from health care officials within the South African government as well as delegates tasked with overseeing spend on health care from funders operating in Africa. “Our HIV disease management tools attracted special interest, especially those focusing on decentralised and point-of-care testing,” said Ward. Siemens also enjoyed a presence through Julian Pillay, sales and marketing manager for Automation and Healthcare Consulting Services, who informed delegates about laboratory workflow efficiencies. His presentation was attended by numerous laboratory managers. Scope for growth “This was the first event of its kind in Africa, and it has enormous scope for growth,” Forder commented. “We look forward to greater attendance as the Africa Health Exhibition becomes a recognised scheduled meeting on the African continent.” * Content supplied by Siemens Healthcare Official opening ceremony at Africa Health From left to right: Allyson Towle, managing director, IIR SA; Phila Mazamisa, hospital support directorate, Gauteng Department of Health; Abdul Rahman, chief operations officer, Gauteng Department of Health; Simon Page, managing director: Life Sciences Exhibitions, IIRME; Waclaw Lukowicz, head of Siemens Healthcare, Middle East and Africa; Tom Miller, CEO Customer Solutions, Siemens Healthcare; Helen Brown, head of Siemens Healthcare in SA; Dr Norman Mabasa, chairman, South African Medical Association and John Wallace, Group: Marketing, IIRME. Left to right: Waclaw Lukowicz, head of Siemens Healthcare, Middle East and Africa; Tom Miller, CEO, Customer Solutions, Siemens Healthcare and Helen Brown, head of Siemens Healthcare in SA Juanita Ward, marketing manager at Siemens Healthcare Diagnostics interacting with Dr Norman Mabasa and the rest of the officiating team Interested delegates at the Siemens stand Siemens imaging, therapy and clinical products stand at Africa Health page 24 | medical chronicle | June 2011 // Opinion Practice Matters Doctor’s Voice ... Prof Morgan Chetty Dr AM Levin Issues around Low-option Medical Schemes Managing the Cost of Private Health Care Doctors are experiencing many problems with low-option schemes, and patients belonging to these schemes appear to be oblivious to the restrictions these health plans place on the spectrum and quality of health services they can access. This, however, appears to be a worldwide phenomenon. In recent meetings with GPs, a number of concerns and questions around low-option schemes have repeatedly emerged. They all have the same pattern. Several aspects of the current competitive managed care marketplace do not appear to be conducive to achieving the goals of primary care. The restrictions on doctors and patient choices have raised concerns about the potential detrimental effect of managed care on the patient-physician relationship. Managed care is conceptualised as a set of organisational restraints and financial incentives that are intended to focus and limit the doctor’s use of health care resources. Patients who purchase the lower-end options believe that the reduction in the premium will still afford them the traditional spectrum of services. Many of us are of the opinion that patients intentionally choose low options; when, they in, fact are in a higher salary bracket or have multiple comorbidities necessitating a higher volume and intensity of care. In fact, across the board, patients on low-option plans believe that their entitlements are the same as those of any traditional managed care patient. They often abuse the system and the demand for care outweighs the need for care. Patients believe in their entitlement of unrestricted and demand-driven care. However, the financial and organisational restrictions of a managed care plan does lead to huge problems for doctors. It also appears as if doctors are used as a buffer between the scheme and the patient when controversial issues with the plans arise. These factors raise questions about the impact of these plans on doctors’ time and their ability to continue to deliver effective primary care. Physician ‘hassle’ is assessed in terms of increased administrative activities and management tasks generated by the plan. Grumback and colleagues found that 57% of doctors surveyed reported that they felt pressure from the managed care organisation to limit referrals, 75% felt pressure to see more patients per day and 17% and 24%, respectively, felt that limiting referrals and seeing more patients per day compromised patient care. Administrative hassles are also attributed to added administrative burden such as the need to make phone calls, write letters and the length and repetition of required forms, pre-authorisations and motivation for additional use of essential drugs and services not covered by the plan. There appears to be a serious need for some meaningful legislative oversight that demands minimum quality assurance, and a reduction of risk to the doctors with low-option schemes. There must also be a continuous monitoring of the quality of care delivered and to evaluate the restrictive clauses contained within a plan option. There should also be a salary band level for entry into lower plans and the impact of patients with multiple comorbidities buying down into low plans when the volume and intensity of care they need will be compromised. There is a need for us to eradicate the hassle factors and ‘diminished’ quality as it will impair the health outcomes of most of the vulnerable members, the elderly, the critically ill and the poor. However, in SA, the medical forums interfacing with medical schemes are regularly working on eradicating the above administrative issues and providing quality in health care delivery. Our concern is those schemes that work independently of any formal GP input. The South African Medical Association (Sama) has publicly proclaimed that the nonhealth care services of the medical schemes are responsible for the escalation of medical service costs in the private health sector. Of particular concern was the question of managed health care. The purpose of managed health care is to educate both patient and medical service provider regarding the availability of medical scheme funding for a given consultation or procedure. Surgical treatment, and certain investigative evaluations, especially x-rays such as magnetic resonance imaging, computed tomography and positron emission tomography scans are the important costly events affecting the patient’s medical scheme’s ability to contain expenditure within the ambit of the patient’s medical scheme financial benefits. Managed health care administrators, especially through personal engagement with both patient and doctor, endeavour to provide the correct information to establish the affordability of those requested undertakings so as not to embarrass the patient, and to ensure that the medical service provider receives the designated payment for services rendered. In this way, all three parties, namely patient, medical professional and medical schemes are satisfied regarding the monetary aspects of the services rendered, and thus savings will accrue. Two pertinent factors result in escalating costs of private health care. The first has already been alluded to, and that is the lack of knowledge pertaining to the availability of medical scheme funds as prescribed to by the patient. Any misinformation will jeopardise the patient’s treatment expectations, as well as the medical practitioner’s fee, which does not conform to the availability of these funds. Managed health care avoids these monetary catastrophes. The second factor is the almost unlimited charges levied by medical practitioners for consultations, investigations and procedures for ill health, which falls under the umbrella of Prescribed Minimum Benefits (PMBs). The patient should be advised, hopefully through managed health care, that the PMB tariff should also be negotiated to fall within the guidelines of the patient’s medical scheme benefits. The solution to the private medicine financing debacle is the implementation of the free market principles of freedom of choice and especially freedom of negotiation for services rendered. This applies to both doctor and hospital fees. Though this commercial ideology has been vehemently opposed, it is interesting to note that the new Consumer Protection Act advocates that there must be negotiation of prices for products and services with clients, which would also include private medical attention. Likewise, Prof Morgan Chetty, in a recent issue of the Medical Chronicle, encouraged ‘enforced consumer-driven health care plans’, which would restore free market forces in the health care industry. These suggestions are free market principles. It is evident that private medicine can only survive in a free market. This is evidenced by the Competition Commission’s rejection of a fixed tariff structure. Negotiation of fees for services is fundamental for successful private medical practice. The SA Proposal for Health Sector Reform lll Kathy Tyacke Principle Advisor: KPMG Health Sector Two key characteristics of the current health sector in SA have largely driven government’s decision to introduce a National Health Insurance (NHI) system. Firstly, inequitable access to quality health services between those with health insurance and those without. This continues to pose a challenge to government. Those with private health insurance (15%) use internationally comparable private hospital services, while those without (85%) use the ailing and overstretched public health system. Secondly, medical costs in the private sector have escalated to levels widely considered to be unacceptable with medical inflation becoming increasingly higher than the Consumer Price Index (CPIX). Between 2000 and 2008, overall medical inflation increased 3.65% per year more than the CPIX (Schussler, 2008) and was 8% higher than CPIX by 2010 (Jacobs, 2010). Experience from countries such as Canada, which has a well-established national health insurance system in place, demonstrates that the creation of a single payer (one national) scheme can substantially decrease medical costs. This is because the central body has optimal control of prices that may be charged by health service providers (hospital and clinics), who need to manage costs accordingly. The decision to introduce the NHI is, therefore, an attempt to curtail the private sector cost escalation and at the same time improve access for the majority of the population to quality services. How has the proposed NHI been designed to achieve this? The NHI proposals According to the ANC’s 2010 NHI document, the defining features of the plan include: • Compulsory membership of all citizens universal coverage. • Cross-subsidisation of the unemployed by employed taxpayers. • A publicly funded, tax-based system, administered through both public and private health facilities. • A single-payer system with one central health authority administering contracts with service providers. • Accreditation of both private and public health facilities to enable participation in the NHI, using a single set of standards. • The option to continue with private medical scheme over and above mandatory NHI contributions. • Provision of free service at the point of care to all South Africans and other legal residents who need it - from primary health care to highly specialised services. Response to the proposal Criticism of the proposed system has revolved primarily around the question of affordability. SA has high levels of unemployment (around 24% in the last quarter of 2010) and a large informal sector. The costs involved in upgrading the public health system are extensive and the small pool of taxpayers, about seven million individuals in 2010, (14% of the population), are set to carry much of the burden. Concern has also been expressed about governance and accountability mechanisms. The shift in the role of the national authority from provider of services to purchaser involves a significant role and skill shift - with little information as to how this gap may be filled. Furthermore, centralised buying is regarded to be conducive to corruption, given the number of large contracts awarded from a single office. Finally, should government apply the principle fundamental to the functioning of the Canadian system - that no private health provider outside of the NHI may charge for a service that is already offered by the NHI, both private hospitals and medical schemes could face substantial shrinkage. Private medical schemes would be limited to covering ‘top ups’, specialised services such as ophthalmology and plastic surgery, not covered by the NHI. Private hospitals would, in turn, be faced with the decision of either contracting into the NHI, at prices controlled by the central authority, or offering ‘top up’ services only. Either way, the sector is likely to face significant efficiency challenges. Perhaps central to government’s success in taking the plan forward will be opening up the detailed plans and costing to public scrutiny. There is a wide range of health sector stake holders whose input and buy-in could substantially bolster taxpayer confidence in the changes to come. The president’s recent promise of the release of a policy on NHI early in 2011 offers a long overdue opportunity to rally support. The views and opinions expressed in this article are those of the author and do not necessarily represent the views and opinions of KPMG. cardiac medicine Call Lynn on 084-400-1235 or email: [email protected] The Link Between Posttraumatic Stress Disorder and Cardiovascular Risk Consulting Editor ... Posttraumatic stress disorder shown to negatively impact on cardiovascular health, such as coronary artery disease and diabetes. Correlations with Cardiovascular Risk Factors Since the 1960s, psychiatrists from Krakow studied and reported on a group of former concentration camp prisoners and described a specific syndrome they called ‘postconcentration camp’ syndrome in which this disorder persisted for years after the stressor disappeared. This has evolved into the posttraumatic stress disorder in its current diagnostic criteria as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV). Studies of the adrenergic system in patients with posttraumatic stress disorder have shown elevated plasma noradrenalin levels and increased 24-hour urinary excretion of noradrenaline metabolites as compared to people without posttraumatic stress disorder. Some authors have previously noted higher overall cardiovascular risk in patients with posttraumatic stress disorder (PTSD).1 71.3% higher prevalence of CAD in PTSD group deported to Siberia Walczewska Study2 The aim of this study was to investigate the current cardiovascular health in old age of patients who were deported to Siberia in their childhood. Study population A total of 195 help-seeking people left for Siberia during their childhood. These individuals were born between 1928 and 1941 and they were deported to a specific region in Siberia, where they stayed for at least five years. They underwent medical and psychiatric evaluations between January 2004 and December 2005. This group of people fulfilled the criteria for the diagnosis of posttraumatic stress disorder. After exclusion criteria were applied, 80 people were enrolled in this study. There was a matched control group without a traumatic history and without PTSD. In this way, 70 matched control people were selected from the general practice of the University Hospital of Krakow. Measurements The diagnosis of PTSD was based on DSM-IV criteria. Clinical examination and blood tests were performed, evaluating all cardiovascular risk factors as well as cardiovascular diseases. Each individual had a pulse wave velocity measurement. Result The group with PTSD due to their deportation to Siberia in childhood had: • A higher prevalence of coronary artery disease (CAD) (71.3% vs 44.3%) p<0.001. • Diabetes (26.3% vs 11.4%) p<0.05; hearing impairment (23.8% vs 2.9%) p<0.001 vs the control group. The PTSD group also had a significantly higher prevalence of blood pressure, fasting blood glucose, lower levels of HDL-cholesterol and higher levels of triglycerides. These PTSD patients also had significantly higher aortic pulse wave velocity which increased with the severity of the PTSD. Conclusions 1. The patients with PTSD due to childhood deportation had elevated cardiovascular risk as compared to a group of people who did not have PTSD. 2. Possible mechanisms explaining the higher cardiovascular risk are neurobiological changes such as increased adrenergic activation as confirmed by elevated plasma and urinary noradrenergic levels in people with PTSD. This can lead to dyslipidaemia and hyper glycaemia, which may explain the higher prevalence of cardiovascular disease. 3. In this study, there is an association between increasing pulse wave velocity (reflecting higher arterial stiffness) and increasing severity of PTSD. 4. This study yielded similar data and results as some previous studies which also demonstrated increased prevalence of cardiovascular disease such as hypertension. References 1. Kang HK, Bullamn TA, Taylor JW. Risk of selected cardiovascular diseases and post-traumatic stress disorder among former World War II prisoners of war. Ann Epidemiol 2006;16:381-386. 2. Walczewska J, Rutkowski K, et al. Stiffness of large arteries and cardiovascular risk in patients with post-traumatic stress disorder. Europ Heart J 2011;32:730-736. Prof James Ker // Comment Sudden cardiac death, mainly due to ‘malignant’ arrhythmias is a reality. The diagnosis can be difficult, sometimes requiring a specialist in the field (electrophysiologist). Some diagnostic techniques are mentioned so that one can see how much is available. Some therapeutic strategies are mentioned. The standard 12-lead electrocardiogram (ECG) still remains an important diagnostic tool. Narrow complex tachycardias are mostly supraventricular and broad complex tachycardias (≥3 small blocks on ECG) are mostly ventricular in origin. Importantly, the structural or functional abnormality of the heart needs to be diagnosed as part of the treatment of arrhythmias. Catheter ablation has solved many arrhythmias and implantable cardiac defibrillators have reduced mortality significantly. Depression and stress have been shown to be important risk factors in the INTERHEART case-control study of myocardial infarction. The population attributable risk of depression/stress was considerable. An interesting article appeared on the cardiovascular risk associated with posttraumatic stress in a well-described group of people deported to Siberia in their childhood. They were evaluated for cardiovascular disease many decades later and compared to people from the same city who were not deported. This association could be driven by adrenergic activation as demonstrated by elevated serum and urine noradrenaline levels. This group of people also had abnormal increased pulse wave velocity due to more stiff aortas. This information is another addition to the growing evidence of the importance of depression/stress in cardiovascular disease. It remains an important question - when should one discontinue aspirin use before cardiac surgery - especially coronary artery bypass grafting. Early or late discontinuation made no difference in outcome, but late discontinuation of aspirin was associated with increased blood transfusion requirements. In the management of hypertension, we know that reducing blood pressure is all important. The problem is adherence to antihypertensives. As a class, adherence is worst with diuretics and beta-blockers and best with ACE-inhibitors and ARBs. What we still don’t know is how to improve overall adherence to antihypertensive drug therapy. What we now need is a clinical trial of antihypertensive therapy to evaluate the possible effect on microvascular damage of the brain. Can we start to add microvascular damage to the brain as a worthwhile goal to prevent with the treatment of hypertension? page 26 | medical chronicle | June 2011 Cardiac Aspirin Discontinuation before Coronary Artery Surgery - Late or Early? Current guidelines differ in their recommendations with some advising to stop aspirin three to five days before surgery and others recommending seven to 10 days. Antiplatelet therapy, especially the inclusion of aspirin therapy, is one of the important therapies in the primary and secondary prevention of stable and unstable coronary artery disease. It is important after percutaneous coronary interventions (PCI). Stent thrombosis during PCI is associated with many risk factors but the most important risk factor is premature cessation of dual antiplatelet therapy, but also premature cessation of aspirin therapy.1 It has also been shown that ±5% of patients who have a PCI will have to undergo cardiac or nonc ardiac surgery within the first year after stenting.2 A previous meta-analysis has shown that up to 50% of patients on low-dose aspirin who underwent surgery, will have peri-operative bleeding complications, but it did not translate into an increased morbidity or mortality.3 Acute withdrawal of chronic aspirin therapy results in a prothrombotic state, potentially placing the peri-operative patient at excess risk. The clinical question Should aspirin be stopped before coronary artery bypass grafting (CABG) and if so, when? The clinical problem Aspirin is associated with bleeding in both cardiac and noncardiac surgery, although the absolute detrimental effects seem to be modest.4 Late discontinuation of aspirin resulted in no difference in postoperative outcome Study by Jacob et al 5 At the Cleveland Clinic over a period of six years, 4143 patients who underwent coronary artery bypass graft surgery (CABG) were all taking pre-operative aspirin. Of these patients, 2298 discontinued aspirin six or more days before surgery (early discontinuation) and 1845 patients still took aspirin within five days of surgery (late use). Propensity score analysis and matching, based on 31 variables, was used to compare the outcomes between these two groups: early discontinuation vs late discontinuation. The results showed that there were no significant differences in outcome of mortality, myocardial infarction and stroke (1.7% vs 1.8%, p=0.80). Late use of aspirin was associated with more intra-operative transfusions (23%) vs early discontinuation (20%) p=0.03 and postoperative transfusions, but a similar number of reoperations for bleeding (3.4% vs 2.4%, p = 0.10). Conclusion 1. Among patients undergoing CABG, late discontinuation of aspirin resulted in no difference in postoperative outcome. However, there were increased transfusion requirements. 2. A bigger question remains - whether or not aspirin should be stopped at all. This is evaluated in the current ongoing Aspirin and Tranexamic Acid for Coronary Artery Surgery trial. 3. Currently, clinicians should weigh the risks and benefits of late use of aspirin based on the specific patient’s risk profile before CABG. References 1. Möllman H, Net HM, Hamm CW. Antiplatelet therapy during surgery. Heart 2010;96:986-991. 2. Vicenzi MN, Meislitzer T, et al. Coronary artery stenting and non-cardiac surgery - a prospective outcome study. Br J Anaesth 2006;96:686-693. 3. Burger W, Chemnitius JM, et al. Low dose aspirin for secondary cardiovascular prevention - cardiovascular risks after it’s perioperative withdrawal versus bleeding risks with its continuation - review and meta-analysis. J Intern Med 2005;257:399-414. 4. Myles PS. Stopping aspirin before coronary artery surgery: between the devil and the deep blue sea. Circulation 2011;123:571-573. 5. Jacobs M, Smedira N, et al. Effect of timing of chronic preoperative aspirin discontinuation on morbidity and mortality in coronary artery bypass surgery. Circulation 2011;123:577-583. page 28 | medical chronicle | June 2011 Cardiac Sudden Cardiac Death Due to Arrhythmias In the previous issue of Medical Chronicle, Prof James Ker discussed specific diagnostic methods used to investigate arrhythmias. This article explores other diagnostic methods as well as the various therapeutic modalities. Diagnosis lll Exercise testing Exercise can bring out some arrhythmias: Commonly ventricular ectopic beats may develop during exercise, but both tachyarrhythmias and bradyarrhythmias can be precipitated by stress (exercise) electrocardiogram (ECG) testing. lll Long-term ECG recording • Ambulatory ECG recording (Holter): Typically this ECG tape recorder records three ECG channels for 24 hours with the patient continuing his/her daily tasks. One of the strengths of this technique is the ability to correlate the symptoms of the patient with the ECG abnormality as captured on the recording. The recordings can also be used to monitor anti-arrhythmic drug efficacy. • Event recorder: These devices may be kept for 30 days and are patient activated. • Implantable loop recorder: This device is inserted under the skin and can produce either patientactivated recordings or event-activated recordings. These recordings are used where neither the Holter nor the event recorded were useful. lll Heart rate variability Heart rate variability recordings evaluate the influence of the vagal and sympathetic tone on the action of the sinus node. There are frequency domain analyses as well as time domain analysis available. lll Quartile coefficient of dispersion Heterogeneity of refractoriness as well as heterogeneity in conduction velocity can be measured. One measure is to determine the difference between the longest and shortest Quartile coefficient (QT) intervals on a resting ECG - the larger the difference, the more QT dispersion that has been correlated with risk of arrhythmic death. lll Signal average ECG Signal averaging can detect cardiac signals of a few microvolts in amplitude. Mapping techniques can record myocardial activation from damaged areas that occur after the end of the standard surface ECG QRS complex. These delayed signals have such low amplitude that they cannot be seen on a standard ECG. lll T-wave alternans Beat-beat alternation in amplitude and/or the morphology of the ST-segment or (T-waves) have been found in conditions that favour the risk of ventricular tachyarrhythmias. lll Tilt-table testing This test is useful to determine if there is a vasodepressor and/or cardio inhibitory response that is causing syncope. It is thus sensitive to establish a neurally mediated syncope. lll Invasive electrophysiological studies This involves introducing multiple catheter electrodes into the circulation and positioning them at various intracardiac sites to record and/or stimulate cardiac electrical activity. The use of this technique for diagnosis of and therapy of various arrhythmias is a speciality in its own right. Pharmacological therapy lll General principles Most anti-arrhythmia drugs have blocking actions on sodium, potassium or calcium channels and beta adrenoreceptors. The actions of these drugs are very complex and this makes their classification difficult. However, the Vaughan Williams classification (despite limitations) is a commonly used one: • Class IA: Prolong action potential duration quinidine, procainamide, disoprymide. • Class IB: Shorten action potential duration mexiletine, phenytoin, lidocaine. • Class II: Block beta adrenergic receptors - beta-blockers. • Class III: Block potassium channels - sotalol, amiodarone. • Class IV: Block slow calcium channels - e.g. verapamil, diltiazem. lll Therapy for supraventricular tachycardias After failure of vagal manoeuvres or intravenous adenosine, the specific therapy depends on a lowest diagnosis. Long-term treatment of most supraventricular arrhythmias will be a choice between catheter ablation or permanent drug therapy. Long-term anti-arrhythmic drug therapy is also discouraged in patients with infrequent sympto matic episodes and women considering pregnancy. Catheter ablation is recommended as the treatment of choice for many supraventricular arrhythmias. Flecainide and propafenone may be used for prophylaxis of some of these arrhythmias. Amidiarone is an option where other drugs have failed, but its toxicity remains a problem. lll Therapy for ventricular tachycardias Ventricular Tachycardias (VT) can be recognised by the broad QRS-complexes (> 3 small blocks) and can be monomorphic or polymorphic. Emergent cardioversion is necessary for sustained VT causing symptomatic hypotension, pulmonary oedema and myocardial ischaemia. An important point is that patients with ventricular ectopic beats and nonsustained VT should not be given anti- arrhythmic drugs merely to suppress it, because it will not reduce mortality. Rather find the cause and treat that. Class I anti-arrhythmic drugs (e.g. quinidine, flecainide, propafeone) actually increased mortality in patients with ventricular arrhythmias and prior myocardial infarction. lll Implantable cardioverter defibrillators Implantable cardioverter defibrillators (ICD) effectively terminate VT and ventricular fibrillation and reduce mortality. Specialist opinion is mandatory on the indications for implantation. References available on request. medical chronicle | June 2011 | page 31 Cardiac Better Compliance to Antihypertensive Medication Reduces Cardiovascular Risk Many randomised clinical trials have demonstrated reductions in the risk of fatal and nonfatal cardiovascular events with a hypertension treatment intervention. The problem is that effective reductions and control are rare in the hypertensive population and there are many people with uncontrolled blood pressure. Although there may be several factors that contribute to the poor control of blood pressure in the management of hypertension, many people would agree that compliance with medication is a problem - patients either take their medication irregularly or permanently discontinue their medication after a while.1 There are some data showing that poor com pliance with antihypertensive therapy is related to poor blood pressure control and not reaching the goal.2 The impact of compliance with antihypertensive drugs and the effect on cardiovascular event outcome is not well known. A study was conducted to assess the relationship between long-term compliance to antihypertensive drug treatment and the risk of cardiovascular events.3 Antihypertensive Drug Class and Adherence A study was conducted and the aim of this metaanalysis was to evaluate and determine the impact of antihypertensive drug class on adherence to blood pressure medications. Articles were sought that measured adherence using medication refill data and included data that compared adherence between two distinct antihypertensive drug classes and had sufficient data to calculate a measure of relative risk of adherence and its variance. Results Seventeen articles met the inclusion criteria of which five were rated excellent and 12 were rated good. The included articles in the meta-analysis assessed adherence to antihypertensive medications in 935 920 patients. The mean overall persistence with antihypertensives ranged from 35%-84%. The pooled mean adherence by drug class: • 28% adherence for beta-blockers. • 65% adherence for angiotensin receptor blockers (ARBs). There was lower adherence to diuretics as compared to all other drug classes. There was better adherence with ARBs compared to: • Angiotensin-converting enzyme (ACE) inhibitors: Hazard Ratio 1.33 [95% CI 1.13 to 1.57]. • Calcium channel blockers: Hazard Ratio 1.57 [95% CI 1,38 to 1.79]. • Diuretics: Hazard Ratio 1.95 [95% CI 1.73 to 2.20]. • Beta-blockers: Hazard Ratio 2.09 [95% CI 1.14 to 3.85]. After the publication bias was accounted for, there were no longer significant differences between ACE inhibitors and ARBs or between diuretics and beta-blockers. Conclusion In clinical settings, there are important differences in adherence to antihypertensive classes. The lowest adherence is to diuretics and beta-blockers. The highest adherence is to ARBs and ACE-inhibitors. However, in all the studies, adherence was suboptimal, regardless of drug class. Poor adherence to antihypertensives remains an important cause of poor blood pressure control. Poor adherence has been associated with complications, such as increased cardiovascular events and health care costs. References available on request. Method Data were retrieved from the National Health Service in a specific region in Italy (nine million people constituting ±16% of the population). All patients who received at least one antihypertensive drug at any time during 2000/2001 were followedup until June 2007 (±six years follow-up). All cardio vascular events were recorded. Results There were 242 594 patients treated for hyper tension in 2001/2011. Of these, 12 016 experienced an outcome. Those who continued treatment vs those who discontinued therapy had a 37% risk reduction of cardiovascular outcome (95% CI: 34-40%). Conclusion In a real-world setting, compliance to antihyper tensive medications is effective in the primary prevention of cardiovascular outcome. The longer patients adhered to their treatment regimen, the greater the reduction in risk, both for coronary heart disease and stroke. There is evidence that even a single episode of drug discontinuation has a negative effect on outcome. References 1. Bourgault C, Sénécal M, et al. Persistence and discontinuation patterns of antihypertensive therapy among newly treated patients: a population-based study. J Hum Hypertens 2005;19:607-613. 2. Krousel-Wood M, Thomas S, et al. Medication adherence: a key factor in achieving blood pressure control and good clinical outcomes in hypertensive patients. Curr Opin Cardiol 2004;19:357-362. 3. Corrao G, Rarodi A, et al. Better compliance to antihypertensive medications reduces cardiovascular risk. J Hypertens 2011;29:610-618. page 32 | medical chronicle | June 2011 Cardiac Ivabradine Improves Quality of Life and Survival in Heart Failure Patients Results of a new analysis from the largest-ever morbidity-mortality study of treatments for chronic heart failure show that the heart rate-lowering agent ivabradine (Coralan®) significantly improves health related quality of life.1 The new data from Systolic Heart Failure Treatment with the If Inhibitor Ivabradine Trial (SHIFT), presented for the first time at the Heart Failure Congress 2011, are particularly important as quality of life is greatly impaired in patients with congestive heart failure. “Improving survival and alleviating patient suffering are the major goals in the management of heart failure patients,” said SHIFT co-chairman, Prof Karl Swedberg from the University of Gothenburg. “However, currently prescribed heart failure treatments that prolong life such as beta-blockers only improve quality of life for heart failure patients modestly, if at all, while therapies such as diuretics that significantly improve quality of life have no demonstrable effect on survival. We need new therapies such as ivabradine that improve quality of life and survival.” The SHIFT quality of life study involved 1944 patients with chronic heart failure from 24 countries who were randomised to receive either ivabradine or placebo on top of standard heart failure therapy. Health-related quality of life was assessed for two years using the Kansas City Cardiomyopathy Questionnaire (KCCQ), a validated, disease-specific measure of functional status and quality of life.2 The KCCQ is a self-administered questionnaire that quantifies various aspects of day-to-day life such as physical limitations, symptoms, selfefficacy, social interference in chronic heart failure patients. Figure 1: Clinical summary score An improvement was observed in the ivabradine group. In a specific analysis that excluded patients who died, the increase in clinical summary score (CSS) reporting on clinical symptoms and overall summary score (OSS) including clinical and social aspects, was up to twice more in the ivabradine group (Figures 1 and 2). Figure 2: Overall summary score These new results complement the main findings of the SHIFT study, which showed that ivabradine reduced the risk of hospitalisation due to worsening heart failure by over a quarter (26%, p<0.0001) and the likelihood of death from heart failure by the same amount (26%, p=0.014). Despite the fact that patients were already well treated, these benefits were seen in just three months of treatment with ivabradine. Chronic heart failure affects 15 million patients in Europe (2% to 3% of the overall population). It impairs the heart’s ability to pump effectively and maintain sufficient circulation to meet the body’s needs. Heart failure has an enormous impact on the prognosis and lifestyle of patients and is a major health care and economic burden. Heart failure impacts all aspects of patients’ daily lives, but particularly their mobility and usual activities such as housework and socialising. Sadly, half of all heart failure patients die within four years. When compared with other major chronic illnesses, patients with chronic heart failure showed the same pattern of reduced quality of life as patients on chronic haemodialysis, depression and hepatitis.3 Along with therapeutic advances that increase the longevity of heart failure patients, it is essential that these patients are able to perform routine day-to-day activities and have a better quality of life. “These new results on quality of life further reinforce the main SHIFT results suggesting a need to consider heart rate-lowering with ivabradine in heart failure patients in sinus rhythm and heart rate above 70bpm,” concluded Prof Komajda. References 1. Ekman I. Ivabradine is associated with improved health related quality of life. Results from SHIFT, presented orally at a late breaking trial session of the Heart Failure Congress 2011. 2. Green CP, Porter CB, Bresnahan DR, Spertus JA. Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health status measure for heart failure. J. Am. Coll. Cardiol. 2000;35;1245-1255. 3. Juenger J, et al. Health related quality of life in patients with congestive heart failure: comparison with other chronic diseases and relation to functional variables. Heart. 2002;87:235-241. medical chronicle | June 2011 | page 35 Cardiac Vascular Risk Factors Important in the Search for Dementia Interventions In the search for interventions to delay or prevent dementia, vascular risk factors may be important. Previous studies have shown an association between midlife hypertension, especially if left untreated, and the likelihood of developing dementia.1 Hypertensive individuals are at increased risk of dementia, depression, physical disability and falls.2 22% of hypertensive individuals will develop mobility, cognition or mood impairments Previously, it was shown that impaired mobility, impaired executive cognitive function and change in mood, constitute a triad of impairments which reflects microvascular damage to the frontal subcortical region of the brain.3 Hypertension, on the other hand, is associated with cerebral microvascular disease, which manifests as white matter hyperintensities (WMH) on brain imaging.4 Hypothesis in the Hajjar et al 5 study The authors proposed that hypertension can lead to poor cognitive function, depression and gait disturbances (impaired mobility) by causing a specific microvascular effect, manifesting as WMH. They used data from the Cardiovascular Health Study, a population-based longitudinal study of adults aged 65 years or older. The study followed 4700 participants for >10 years. Measurements Cardiovascular risk factors were measured and two seated blood pressure readings were taken at each visit. Mobility was assessed by gait speed, cognitive function measured by Digit Symbol Substitution Test, and mood was assessed using a depression scale. A total of 3600 people also underwent brain magnetic resonance imaging. Hypertensive individuals are at risk of dementia, depression, physical disability Results At baseline, 498 subjects (11%) had concurrent impairments and 3086 (66%) were intact on all three measures - mobility, cognitive function and mood. In the next seven years, 651 (21%) became impaired in all three domains. Hypertensive individuals were more likely to be impaired at baseline and to become impaired during the follow-up. A greater degree of WMH was associated with impairments in the three domains and mediated the association with hypertension. Impairments in the three domains also increased subsequent disability with hypertension. Hypertension mortality was also increased in those impaired compared to unimpaired hypertensive individuals. Conclusion 1. Hypertension increases the risk of impairments in mobility, cognition and mood. 2. The association between hypertension and these impairments is mediated in part by microvascular injury as seen with white matter hyperintensities. 3. The impairments in hypertensive individuals are associated with increased disability and mortality. 4. Close to one quarter (22%) of hypertensive individuals will eventually develop these impairments in the three domains, which may constitute a hypertension-specific pattern of impairment. 5. Future clinical hypertension trials need to assess the effects of antihypertensive treatments on these impairments. References 1. Stewart R, Xue Q-L, et al. Change in blood pressure and incident dementia: A 32-year prospective study. Hypertension 2009;54:233-230. 2. Terry PD, Abramson JL, Neaton JD. Blood pressure and risk of death from external causes among men screened for the multiple risk factor intervention trial. Am J Epidemiol 2007;165:294-301. 3. Pugh KG, Lipsitz LA. The micriovascular frontalsubcortical syndrome of aging. Neurobiol Aging 2002;23:421-431. 4. Dufouil C, de Kersaint-Gilly A, et al. Longitudinal study of blood pressure and white matter hyperintensities: the EVA MRI cohort. Neurology 2001;56:921-926. 5. Hajjar I, Quach L, et al. Hypertension, white matter hyperintensities and concurrent impairments in mobility, cognition and mood: The Cardiovascular Health Study. Circulation 2011;123:858-865. page 36 | medical chronicle | June 2011 BHF CareCross Group Turns a Healthy 13 The CareCross Group has turned 13 years old this year. It is indeed a far cry from the humble beginnings in 1998 when founder Dr Reinder Nauta contacted the first GPs to become part of what would turn into the largest capitated provider network in southern Africa. With the now familiar logo on more than 1000 GP practices, CareCross has stuck to its vision of offering ’quality health care you can afford‘. Millions of patient visits have been made possible through the partnership approach between participating GPs and CareCross. The group has reinvented itself and has diversified into several health care sectors. On the provision side, it owns Occupational Care South Africa. It also owns the provider network The CareCross board, From left to right Dr Nhlanhla Mabaso, Mark Mawman, Keely Stevenson, Ian Black (chair) Dr Eveline Schurink, Yaseen Bhayat and Dr Reinder Nauta ONECARE, focusing very successfully on designated service provider contracts. More than 1500 specialists and 3000 GPs are the core of this network. On the pharmaceuticals side, the company has acquired Akacia Healthcare (formerly Thebe Pharmaceutics) that is headed up by Yaseen Bhayat. According to Bayat, the company has brought several new products to the South African market in recent months, including, Lozaan, the first 100mg angiotension receptor antagonist plus diuretic. Group chairperson Ian Black (who teamed up with Dr Nauta two years after he started CareCross) said, “Affordability is a need that stretches across all facets of health care and with the synergies between our providers and our products, we aim to be champions of that cause.” With the corporate head office in Newlands, Cape Town, and the headquarters of Acacia Healthcare in the newly-acquired Roche plant in Isando, Johannesburg, the group has a national presence. With a turnover just shy of a R1bn per annum, it can look back at a very successful period in difficult times during the last 13 years. A substantial shareholding by BEE partners UFF (funded by Future Growth), and Soweto GP group First Care, makes CareCross a truly South African company that is fully committed to transformation. Approximately 8% of the company was bought in 2010 by a Swiss investment group, which heralds the beginning of international interest in CareCross. With National Health Insurance (NHI)a certainty in the near future, the CareCross Group has positioned itself to be a certain partner when the need for provider contracting and capitation arises. Dr Nauta, who has worked in the UK National Health System (NHS) as well as in the Red Cross Children’s Hospital before he started CareCross, is cautiously optimistic about the future of health care in SA. “What we cannot afford is to alienate our GPs, and force them into a system that has no perceived or real value for them,” he stated. “We have learned that only through mutual respect and a partnership approach, will doctors come to the table to ensure affordable health care solutions.” Nauta and his team have spearheaded capitation in SA, and have most of the leading medical schemes as their clients today. Modern and custom-designed IT infrastructure, dedicated staff and the ethos of sustainability have turned CareCross into one of SA’s biggest success stories in managed care. A typical CareCross practice medical chronicle | June 2011 | page 37 Board of Healthcare Funders (BHF) Conference Sun City, North West 3 – 5 July BHF The BHF Conference: The Turning Point The Board of Healthcare Funders’ (BHF) annual South African conference will take place from 3-5 July at Sun City. The Minister of Health, Dr Aaron Motsoaledi, has been invited to officially open the conference with a keynote address on providing insights into the health care policy direction for SA. The conference theme, The Turning Point reflects the potential opportunities and threats to the private health care industry prompted by current and future changes to the industry. The conference programme has been structured to explore those issues which address the continued viability and sustainability of the entire health care system, its ability to offer efficient and affordable health care to consumers, and to position the industry in such a way as to ensure a constructive and robust relationship between funders and providers. Pricing negotiating forum One of the key topics of the conference will be the proposed pricing negotiating forum - arriving at fair and reasonable prices for all. It is envisioned that this forum will help to address the history of imbalanced and problematic price determination in the private health care sector and address the various recent developments which have exacerbated the disarray. Industry experts will address the many aspects related to arriving at prices, such as: reconciling the moral and economic goals which co-exist within one industry and will share insights into the pricing models in other countries. National Health Insurance With the National Health Insurance (NHI) White Paper in the offing, another key focus of the event will be a session entitled The Industry Proposal to NHI. This session will see members of the BHF NHI Task Team, made up of industry experts such as actuaries and clinicians, outlining details of the industry proposal, which addresses many aspects relating to the implementation of the NHI. Among these are issues relating to the benefit package, mergers and consolidation, reserves, administration systems, data collection and analysis as well as fraud prevention. BHF believes that the private health care funding sector is an extensive repository of expertise and sophisticated infrastructure - all attributes which will be required under the new system. Consumer Protection Act The introduction of the Consumer Protection Act (CPA) has a potentially enormous impact on the health care industry, both as consumer and supplier. The CPA aims, among other things, to establish a legal framework for the achievement and maintenance of a consumer market that is fair, accessible, efficient, sustainable and responsible for the benefit of consumers generally, to promote fair business practices and to protect consumers from unconscionable, unjust or unreasonable business practices. To fully examine the impact on the health care industry, an invitation has been extended to a consumer law expert as well as the national Consumer Commissioner, Mamodupi Mohlala. Oncology care The funding of oncology care presents one of the largest cost drivers in the private funding sector. To examine ‘where, when and how’ the monies are spent, as well as the consumer angle of this vexed issue, industry and consumer experts have been invited to share their insights with delegates. Other highlights Other programme highlights include: international benchmarking and pharmaco economic evaluation of drugs. the role of corporate SA in health care funding, a preventative care package for medical scheme members, the tools and steps required in developing a formulary, are we in danger of creating a medical scheme oligopoly?, balancing the ethics of funding or not funding, with the financial aspect and equity in the financing of health care, which will be addressed by renowned international expert, Dr Ramon Castano-Yepes, from Colombia. Dr Victor Ramathesele, well known for his charismatic facilitation style and expertise in health care funding issues, will ensure that the sessions are interactive and constructive. Register for conference The BHF conference attracts upwards of 900 delegates from the health care industry, including local, regional and international health care executives, health care professionals, policy makers and regulators. Should you wish to register, please log on to the BHF website, www.bhfglobal.com To take advantage of having your brand associated with this prestigious event please email [email protected] page 38 | medical chronicle | June 2011 BHF Dynamic Coding and Tariff Structures Vital for Private Health Sector The unfortunate intervention by the Competition Com mission (CC) into the activities of the private sector in 2004, which resulted in the SA Medical Association (Sama), the Hospital Association of SA and the Board of Dr Chris Archer, Healthcare Funders SAPPF CEO (BHF) being fined for what was deemed to be collusive activities, created an anarchic situation from which the introduction of the then Reference Price List (RPL) was supposed to rescue the industry. However, the RPL never achieved what it should have. In July last year it was declared illegal and invalid by Acting Judge Pieter Ebersohn, which has left the industry in a state of limbo. An unfortunate and unanticipated consequence of the interference by the CC has been that the maintenance of the coding structure has been dislocated, and although new codes have been introduced by Sama and other provider organisations, there has been no mechanism by which these code revisions, additions and deletions, could be communicated to and accepted by the funding industry, for inclusion in their tariff of benefit schedules. Suffer the poor patients Patients have been the unwitting and unwilling victims in this unfortunate scenario, because doctors performing one of these new procedures has not been made aware of the fact that the procedure has not been accepted by the funders, with the result that patients end up paying the full cost. The RPL process was supposed to provide a new and transparent mechanism for the introduction of Application Form The SAPPF has been established in response to the extraordinary times we are living through and the enormous competing challenges facing the medical profession. Please join and assist in establishing a better deal for specialists in the long term. 2011 Annual Subscription Fee R1500 incl vat Name:..................................................... ID:........................................................... Address:................................................. Practice No. and Discipline:.................... ............................................................... HPCSA Reg. No.:................................... Tel:.......................................................... Fax:......................................................... Email Address:....................................... Please return above completed form and a copy of your bank deposit slip by fax to: 011‑782‑0270. Bank details: South African Private Practitioners Forum, ABSA Bank - account number 4072908323 new codes with the value of the procedure being based on input costs. The RPL therefore represented a radical departure from what had preceded it. This earlier process had been characterised by the unilateral application by the profession, of a relative value unit to a new code and descriptor, following which, discussions took place between the profession and the funding industry on the application of an acceptable annually adjustable Rand Conversion Factor (RCF) to arrive at a fee. Appropriate fee disparity Over time, what the medical profession considered an appropriate fee for its services, began to differ markedly from what the funding industry considered appropriate as a benefit. This increasing disparity increased tension between the parties, eventually culminating in Sama threatening to interdict BHF for copyright infringement with respect to the Sama Doctors’ Billing Manual. The BHF appealed to the Department of Health to intervene, following which, the CC fined the warring parties and the RPL was introduced, to be run initially by the Council for Medical Schemes (CMS). Towards the end of last year, following the demise of the RPL, the new Director-General of Health, Malebona Matsoso, announced that the Minister of Health, Dr Aaron Motsoaledi, had requested that the CMS again lead the search for a replacement for the RPL. Subsequently, the CMS produced a discussion document that all parties in the private sector were asked to comment on. This document, dated 28 October 2010, was entitled Discussion Document: Determination of Prices in the Private Sector and called for comment before 15 December 2010. The discussion document indicated that it was aimed at the determination of service provider prices as well as levels of medical scheme reimbursement (rather than at the development of a RPL or other guideline). The proposal that the determination of a fee above which a practitioner may not charge, constitutes a dramatic inroad into the rights that service providers, medical schemes and patients currently have to contract freely. Furthermore, it amounted to an infringement of the constitutional rights to property and freedom of trade, occupation and profession. Price regulation not the solution The South African Private Practitioners Forum (SAPPF), in its response, submitted that such a system of price regulation for health professionals was also likely to discourage entry into and participation in the health care sector which would, in turn, negatively affect the provision of private health care in SA. Price regulation was, the SAPPF believed, unjustified, particularly given that there was no good reason for the introduction of such a dramatic regime in respect of health professionals, for there were other effective legal and market mechanisms (including competition and the downward pressure exerted by medical schemes), which regulate the manner in which health professionals are compensated, and there was no evidence of market failure in the market for the provision of services by health professionals. Despite these misgivings, the SAPPF and other respondents agreed to participate in the attempt to find an acceptable alternative to the RPL. Benefits of a guideline tariff The SAPPF, in principle, supported the determination and publication of a RPL that would serve as a guideline to reimbursement by medical schemes, provided that: • Such a guideline is properly determined and covers the cost of providing the health care service and allowed the service provider to make an appropriate return, and; • That the coding, which underpins the guideline, is medically appropriate and takes into account new technology and recent developments in health care practice. The SAPPF is keen to support the negotiation process to establish a new benchmark for professional fees because there is an absolute need for the industry to move forward to a new paradigm with respect to the reimbursement for professional service. The now defunct RPL process should have achieved this with the emphasis on the reference price reflecting the cost of providing the service rather than on the much more problematic concept of what a medical scheme could afford. Wherever the fee for service system operates, a coding and tariff system is employed to ensure the orderly application of fees and the reimbursement of benefits To date, the funding industry has not been prepared to come to terms with the notion that provider input costs are another reality that is critical to the success of a sustainable industry capable of attracting new professionals to it and retaining them. An industry based on the principle that a supplier should adjust its fee according to what a third-party payer believed it could afford to reimburse is on ‘shaky’ foundations. Open debate required The SAPPF therefore would welcome a situation in which such an open debate between all parties could be held - not with a view to setting noncompetitive prices, but rather to create an environment in which a more realistic pricing policy that is fair to all parties could be established. Such a guideline would promote certainty in relation to levels of reimbursement and would provide an all-important coding structure to facilitate efficient medical scheme reimbursement to service providers and patients. The SAPPF is, in principle, not opposed to the establishment of such a guideline through an independent regulatory authority or voluntary negotiations (subject to obtaining a suitable exemption from the CC prior to engaging in such negotiations). However, the SAPPF cautions that this is a complex matter and that the manner in which either of these mechanisms is structured will require careful consideration and will, in our view, take some time. Throughout the world, wherever the fee for service system operates, a coding and tariff system is employed to ensure the orderly application of fees and the reimbursement of benefits. This process of necessity requires that there is agreement on what investigations and procedures are appropriate to ensure that the current best practice of medical care is possible. Agreements need to be reached through discussions and negotiations not only on descriptors and codes, but also on the relative value of procedures, without which the code is rendered useless as a regulatory tool for an industry in which there are many thousands of different procedures. This subtlety seems to have been missed by the CC for in the commission’s reply to the Sama request for an advisory regarding the Doctors’ Billing Manual, it stated that that in its view, the linking of a relative value to a descriptor code would be tantamount to direct or indirect price fixing. The need for code ‘values’ It is essential to understand why there is a need for a weighting or relative value to be applied to each code. The orderly arrangement of procedures in terms of their increasing complexity in terms of time taken to perform the procedure, their degree of difficulty and their relative risk, all require a relative value to be applied. Comparing the ranking of medical procedures in terms of their relative value with the motor industry may serve to illustrate the point. In gynaecology, there are different types of hysterectomies with differing weightings that reflect their differing complexities; such as a total abdominal hysterectomy, a subtotal hysterectomy, a radical hysterectomy, a vaginal hysterectomy, and so on. In the motor trade, a manufacturer produces a range of motor vehicles in different classes, e.g. an A-class or a B-class or a C-class, whereas another manufacturer may produce a similar range of vehicles but these may be called a one- or a three- or a five-series. These categories are weightings, which enable a comparison that is not directly price related. But unlike medical procedures, any visit to a showroom floor or a test drive will immediately enable one to discern the differences between these different classes and therefore enable a price/value comparison to be made. Such comparisons are not possible in the health industry, which makes a comparison that is not related to price much more difficult in the absence of a relative value unit. As in the motor trade, where an A class may attract a slightly different rand value between different dealers, the price for a vaginal hysterectomy in which the relative value unit is fixed, may nevertheless (and almost always does) attract a different price between competing gynaecologists. Taking the comparison one step further, the application of a relative value to a code would allow for comparisons between different disciplines, comparing hysterectomies with prostatectomies for example, in the same way that motor vehicle customers could compare a three-series from one manufacturer with a C-class from another. This type of interdisciplinary comparison would not be possible without the application of relative value units. That said, the envisaged process requires that the Minister of Health and the Minister of Economic Development approach the CC with the view to the designation of the private health industry for an exemption from competition law to enable such negotiations to begin. However, there is, to date, no indication that such an approach has been made by the ministers concerned and, in consequence, the industry remains stuck in limbo. This is an unacceptable and unconscionable state of affairs and has placed patients in a completely unacceptable position, in which there are no guidelines to assist them with respect to what constitutes an appropriate fee for a procedure, or an appropriate level of reimbursement from the funding industry. The view of the CC with reference to their understanding of the need for relative value units is clearly also of concern. What is called for is clear vision and understanding together with strong and decisive leadership, to enable the establishment of the proposed independent regulatory authority. We have waited long enough. medical chronicle | June 2011 | page 39 BHF Subacute Care in the Managed Care Environment Dr Hendrik Hanekom, CEO, Intercare Group and Dr Belinda Richards, Clinical Risk Management, Discovery Health The challenge for health care reform is not unique to SA. All over the world, fundamental assumptions are being reassessed in the quest for greater efficiency. To ensure future relevance, the subacute industry must be prepared to take quantum leaps. It must have the courage to look beyond the status quo, and not be afraid of the unknown. Definitions of subacute care have been prepared by several organisations. The definition developed by the International Subacute Healthcare Association (ISHA), appears to contain the key components reflected in most other definitions. The ISHA defines subacute care as follows: It is a comprehensive and cost-effective inpatient programme for patients who have had an acute event as a result of an illness, injury, or exacerbation of a disease process, have a determined course of treatment and do not require intensive diagnostic and/or invasive procedures. The severity of the patient’s condition requires physician direction, intensive nursing care and significant utilisation of ancillaries, as well as an outcomes-focused interdisciplinary approach utilising a professional team to deliver complex clinical interventions (medical and/or rehabilitation). Subacute care is offered as an alternative to con tinued hospitalisation or acute care. However, it encompasses a multidisciplinary service model and should be: • Comprehensive: Subacute care programmes should offer the full range of necessary medical, rehabilitation and professional services required to provide efficient and effective multidisciplinary care for the specific medical conditions treated within a programme. • Cost effective: Subacute programmes should provide added value to patients and funders of health care by rendering a service with optimal results, using cost-effective services and programmes. • Outcomes orientation: Subacute programmes should be designed to ensure that the patient’s reentry into the social and working environment is without compromise in terms of clinical treatment and physical functionality. It should achieve quantifiable and measurable outcomes such as, but not necessarily limited to, functional restoration, clinical stabilisation and avoidance of medical complications or exacerbation of a disease process. • Qualified professionals: Subacute treatment, because of its duration, complexity and intensity, must be provided under the direction of a medical practitioner. An interdisciplinary team providing a coordinated programme of care may include a medical practitioner, nurses, speech therapists, physiotherapists, occupational therapists, social workers, psychologists, pharmacists, dietitians, case managers and other professionals. • Programme descriptions: Programmes should be organised around patient populations with similar treatment or service needs. This will result in cohesion among patients, collective achievement of goals and efficient allocation of resources. Subacute programmes may include medical rehabilitation, respiratory, cardiac, oncology and wound care programmes. Levels of intensity for specific disciplines will vary from programme to programme but will generally range from four to eight nursing hours per patient per day. • Continuation of care: Subacute care is essential to the development of a complete continuum of care in a controlled environment. Subacute programmes are necessary components of any health care system. Subacute care categories In practice, the term subacute care is often used as an umbrella term to describe a huge variation of clinical and care services. This may range from rehabilitation to frail care, from specialist to nursing care and from short-term to long-term care. One subacute facility clearly cannot provide services across the entire spectrum of subacute care. This often results in organisations/roleplayers compiling unique definitions to describe their own services. The responsibility of a managed care company is to allocate appropriate funding. This responsibility is not limited to those members requiring health care services, but to all members who contribute towards a medical scheme. It is therefore important for funders to categorise services in a way which clarifies the ‘product’ for which funding is provided. The following categorisation addresses the spectrum of subacute services according to patient’s clinical/care needs: • Severe disability with specialised needs: Patients with severe functional impairment require specialised multidisciplinary care. Likewise, specialised facilities and equipment is required to manage such patients. The conditions requiring such care typically include spinal cord injuries and ventilated patients. In SA, these facilities are sometimes referred to as acute rehabilitation facilities. • Severe disability with significant reversibility and/or with significant comorbidities: Patients require not only rehabilitation, but also secondary disease prevention, which includes education and addressing an adjusted lifestyle as well as discharge planning. For this, multidisciplinary care by gene ralists in a less specialised environment is needed. In SA, these services are typically offered in facilities registered as subacute rehabilitation facilities. • Severe disability with ‘irreversibility’: Care that includes planning for long-term convalescent, frail or terminal care for those with profound levels of impairment that may never recover. These patients mainly need nursing care. In SA, these services are typically offered in facilities registered as general subacute facilities. Keys to success for subacute providers The keys to success in a managed care environment are as follows: • The subacute facility must reflect the characteristics that the referring specialists, patients and families seek: The quality care of the acute hospital environment, an interdisciplinary, holistic approach to care and the warmth and comfort of a facility in which patients may stay for long periods ranging from two weeks to three months or longer. • The subacute programme should have clearly defined protocols or programme outlines for those programmes in which the institution specialises. The admission criteria, continuing stay criteria and discharge criteria should be clearly outlined for each programme. In subacute facilities registered as rehabilitation facilities: Clinical direction should be provided by a doctor who is qualified to do so based on training and/or experience in the programme being offered. Dedicated clinical teams should be developed and nurtured. This should consist of an interdisciplinary team comprising nursing and medical staff as well as social services, rehabilitation therapists, dietitians and psychologists who should provide care to patients in the subacute facility. Patient outcomes should be measured by means of industry-compliant record-keeping and data collection focusing on functional status and discharge placement. • Service delivery to referral sources should include timely admissions and a user-friendly administrative process. Procedures may involve pre-admission assessments of hospitalised patients, which should be performed within two hours of the receipt of the referral by the subacute provider. • Financial reports must be adequate to provide detailed information about the cost of care and the operating margins by individual patient type and funder source. The subacute provider must thoroughly understand the financial interrelationships among costs, payment rates and methodologies. Managed care reimbursement mechanisms Traditionally in SA, payment to subacute facilities was based on the Reference Price List (RPL) for subacute facilities with a ‘49’ practice number. Although the RPL is not valid anymore, reimbursements are still mainly based on this guide to billing with annual tariff increases being added. Unlike acute health care facilities, subacute facilities in SA are not organised in large network groups. For this reason, tariff negotiations between funders and subacute facilities are not sophisticated and structured processes. Providers of care in subacute facilities also typically bill for services provided in their own professional capacity. Internationally, many different models of funding exist. This can range from per diem fees to global full risk-sharing agreements, which include the professional’s services. Per diem and global fee arrangements in SA (including professional services) exist mainly within the specialised/acute rehabilitation environment. Some ‘per case’ negotiations sometimes happen around discounted bed rates for individual patients. Ideally, however, managed care organisations would strive to differentiate payment according to patient need and according to appropriate services provided to such patients. Due to the lack of standardisation and definitions of levels of care in the subacute environment, such strategies and negotiations are complex. During the past few years, some funders have shown some interest and attempts to create appropriate structures, based on members’ needs, whereby differentiated payments could be negotiated. Such interest from the managed care environment will, no doubt, stimulate the subacute industry. However, such movement towards alternative, more sophisticated payment arrangements will imply a change in risks for both the provider and the funder. Cost-effectiveness and outcomes-based patient management will thus become increasingly important. The providers of subacute services will need to carefully assess their business models and ensure that managed care contracts include protective mechanisms to ensure a sustainable subacute industry. Conclusion The subacute industry has rapidly evolved into a recognised niche within health care. Its continued growth will depend on clear demonstration of the cost-saving potential of moving patients out of highcost acute care hospitals and into lower-cost subacute care units. Savings of ‘replacing a higher acute ward fee with a lower, subacute ward fee’ is not the only benefit required by managed care organisations. The real benefit for funders lies in what is being achieved during the subacute stay. The interventions and care patients receive during their subacute stay should be aimed at maximising long-term health, which in turn reduces long-term costs to the funder. As health care providers move from competitors to collaborators with funders and managed care administrators, the potential of developing win-win programmes for patients/members, providers and funders are within reach. Some experts predict that national integrated health care delivery systems will control the majority of the market in the next 20 years. It is likely that each integrated delivery system will include a variety of subacute providers and that the role of each provider will depend on the types and roles of other providers acute, subacute, home health, and out-patient - within the integrated health care delivery system. Reference: Griffin KM. Handbook of sub-acute health care. Aspen Publishers Inc, 1995. page 40 | medical chronicle | June 2011 BHF Managed Care: A Benefit to Patients or Just Another Profit Source? Dr Andrew Good Lifechoice MD and Pierre Robertson Lifechoice Informatics Director Our beautiful country is filled with possibilities. We have a very bright future. But we do have challenges. Crime is arguably our greatest challenge but South Africans have innovated to manage their crime risk. These innovations include high walls, electric fences, security systems, private policing companies and armed response. But are these measures addressing the underlying problem? Are they contributing to a drop in our crime rate? Will these measures solve our crime problem? To address this crime challenge we need continued national debate. Companies with vested Graph 1: Key parameters per life per annum in 2008 prices Source: Prepared by Good and Childs using Council for Medical Schemes (CMS) data. All graphs have been corrected for inflation using Consumer Price Index interests in building high walls, supplying electric fences and selling private policing services cannot be relied on to lead this debate. International experience suggests that engaging communities, education, improving socioeconomic conditions and grassroot initiatives (broken window policies) are more likely to help us deal with this challenge than higher walls and increased policing. In SA’s private health sector, our greatest challenge is the increasing cost that makes belonging to a medical scheme ‘unaffordable’. In research presented by Lifechoice and Lighthouse actuarial consulting at the 2010 Board of Healthcare Funders (BHF) conference, we showed how the cost of belonging to a medical scheme has increased by 400% in real terms in the last 30 years. See the blue contribution line in Graph 1. We need to keep medical schemes affordable. We have innovated to manage this challenge by developing managed care solutions. Scheme investment in managed care began in earnest in 1996 and increased dramatically in the next few years. See the blue contribution line in Graph 2. Are these investments paying off? Many trustees are unconvinced. Certainly the financial performance of the industry suggests these measures are failing. Benefit expenditure continues to outstrip inflation despite all these managed care interventions being in place. See the red benefit line in Graph 1. Clinically managed care has also battled to demonstrate improved health. Testimony to this is that only nine schemes out of an industry of over 100 participated in the 2009 Health Quality Assessment clinical quality survey. There are virtually no published, peer-reviewed scientific articles showing that this R2bn industry is improving how diseases are being managed. So should this lack of performance surprise us? Using SA’s response to the high crime rate as an analogy, our current suite of managed care interventions are effectively ‘high walls’, ‘electric fences’ and ‘private policing’. The current hospital risk, medicine risk and oncology risk programmes do not address the underlying causes of increasing costs. We are in serious need of national debate about how to decrease the rising cost of private health care. However, companies with vested interests in supplying the ‘high walls’ and ‘private policing’ cannot be relied on to lead this debate. They should be part of the debate, their input is valuable, but we must not forget that their vested interests do not lie in developing a health system that functions well and has no need for managed care. The leading authority on health matters, the World Health Organization (WHO), in its annual report of 2008, entitled “Primary Health Care: Now More Than Ever” discussed three main trends that undermine health outcomes: 1. A disporportionate focus on specialist, tertiary care, often referred to as ‘hospital-centrism’. 2. Fragmentation as a result of mutiplication of programmes and direct access to specialists. 3. Pervasive commercialisation of health care in an unregulated health system. ... to page 42 medical chronicle | June 2011 | page 41 BHF Making the Case for Managed Care It is 16 years since managed care was introduced locally. The trend started in the US in the 1970s in response to the uncontrolled rise in health care costs, and by 1995 it was clear that something had to be done in SA to transform the private health care sector and contain costs. The introduction of a managed care system in SA was not without its problems. In fact, in the 1999 South African Health Review, managed care was described as ‘a contact sport’ and ‘not for sissies’. SA has come a long way since then, and, with the maturing of the industry, new solutions have been found. However, it is not out of the woods yet, and with the introduction of a National Health Insurance (NHI) system, there are new challenges to be faced. “Trustees and other medical scheme stakeholders see their scheme costs escalating rapidly year after year and conclude that managed care is not working. They do not realise that there are powerful forces underlying these cost increases, and without managed care, the situation would be a lot worse,” said Metropolitan Health’s senior actuary, Taurayi Chinowona. Dr Ngubekhaya Gobinca, managing director of Metropolitan Health Risk Management, pre viously Qualsa, agrees. “Managed care is achieving the objective of reducing costs without compromising the quality of care,” he commented. “But it is restrained by industry dynamics. We operate in an environment where the benefits are seen as a basic social need. The legislation then defines the benefit in a generous manner, while the price for procuring it is not regulated in an industry where demand outstrips supply.” Measuring the benefits One of the problems facing managed care is that its benefits are difficult to measure and this results in scepticism from observers and stakeholders. There is also a lack of availability of a comprehensive set of client risk information due to fragmentation of risk initiatives and inadequate links with providers. “The employer groups and employees are the ultimate funder of most health care costs, including managed care, but they have minimal influence in the way it is run,” Dr Gobinca said. “This allows the most vocal interest groups to disrupt the effectiveness of the cost-reduction measures. The fragmentation of health care initiatives means that there is bound to be duplication of health care expenditure.” There are often unreasonable expectations by stakeholders on what managed care should or can do due to the complicated nature of the industry. “It is important to remember that the benefits of some aspects of managed care are not immediately obvious. The benefits of disease risk management, for example, are not immediate, but may be realisable many years in the future. That makes measurement of the effectiveness of these programmes even harder than for something like medicine risk management,” Chinowona said. The wellness programme debate The 2010 Old Mutual Actuaries and Consultants (OMAC) health care survey delivered some scathing commentary on the effectiveness of some aspects of managed care. A key finding in the survey is the perception that disease management and wellness programmes fail to add significant value - in spite of a dramatic increase in uptake by employers. The survey found that the implementation of disease management programmes in the workplace increased significantly from 26% of employers surveyed in 2005 to around 90% of employers surveyed in 2010. The use of wellness programmes increased from 12% in the employer survey in 2005 to 63% of employers using open schemes and 18% of employers using closed schemes in 2010. In spite of this, the medical schemes surveyed did not attribute much value to the effectiveness of these programmes. According to the survey’s authors, this is due to inappropriate communication methods being used to educate members about their disease and generate interest in using wellness programmes. They also conclude that providers should be more involved in the process. Chinowona takes cognisance of the OMAC survey, but points out that it is difficult to measure the effectiveness of these programmes. “Another benefit of wellness programmes for open schemes that is often overlooked is that they help them to attract and retain younger members. Their effectiveness, in this regard, is even harder to quantify,” he said. Dr Gobinca said that there are multiple examples of successful and unsuccessful implementations, mostly due to the fact that medical schemesare often a ‘grudge purchase’, where clients may lack capacity to monitor and evaluate the programme’s impact. In addition, they tend to appoint the cheapest provider, which could result in limited experience and fragmented initiatives with no global view of the overall programme and data. Measuring the savings Metropolitan Health’s executive manager: clinical best practice, Prof Manie de Klerk, explained that the exact measurement of managed care savings is not a simple exercise, but one that hinges around the expenditure and the impact from time of development. “It is difficult to ringfence savings that are solely achieved through the application of good medicine practice protocols,” he said. “The only way to come to a conclusion is to use ... to page 42 page 42 | medical chronicle | June 2011 BHF Managed Care: A Benefit to Patients or Just Another Profit Source? ... from page 40 The WHO recommends a primary health care approach to ensuring financial performance of a health system and improved outcomes. We need to listen to what the WHO is saying and embrace this thinking in our private health system. This will require engaging scheme members and their doctors, member education, disease prevention, a coordination of care model, limiting direct access to specialists and hospitals and constructive cooperation by all the market players. So as we head into the planning cycle for 2012, one needs to be asking: Is the managed care strategy based on ‘high walls’ and ‘private policing’? Is your managed care supplier trying to sell you yet another security system or is it time to start working with the provider community to build a health system that doesn’t rely on these outdated managed care interventions? We are not suggesting that you do away with your ‘high wall’ just yet but we need to start investing in relationships and initiatives with providers that will eliminate the need for the ‘high walls’ and ‘private policing’. This calls for ground-level interventions to ‘fix broken windows’. With medical scheme expenditure on managed care now running at R2bn compared to the R5.67bn schemes spend on GP reimbursement (CMS Annual report 2009); this change in approach is arguably long overdue. It’s time to take a serious look on the return you are getting from your managed care and your long-term managed care strategy. The future of the industry lies in working with providers to keep South Africans healthy. Graph 2: Nonhealth care costs in rand per life per annum (plpa) in 2008 prices Source: Prepared by Good and Childs using CMS data There are those who will disagree that provider engagement and involvement is the answer to addressing our health challenge. Indeed, there are those who still believe that the solution to our crime problem is simply sending out the Caspirs, rounding up any suspicious-looking characters and liberally using sjamboks. The approach of some managed care interventions suggests that this thinking is alive and well. Our beautiful country is filled with possibilities. We have a very bright future. The bright future will depend on people working together to realise our dreams. References available on request. Making the Case for Managed Care ... from page 41 a multidimensional approach that recognises a number of outcomes measures, such as clinical and access outcomes, as well as customer satisfaction. Ultimately, the processes to ensure that we maintain and improve outcomes will work best if the road is travelled in partnership with the scheme.” The results of research Metropolitan Health carried out with its clients to measure the efficacy of managed care and the results have been encouraging. “We know that schemes where managed care systems failed for some time experienced very high increases in costs, especially in hospitals and medicines,” Prof De Klerk said. “Disease management programmes that were structured according to internationally accepted standards (as defined by the Disease Management Association of America) showed returns on investment.” The research also showed considerable reductions in costs quite early in the disease management cycle in chronic disease and HIV/AIDS risk management for very large schemes. Managed care in an NHI system With an NHI system on the cards, managed care is becoming all the more important. “The need for effective management of providers, especially in terms of quality of service and pricing, will require strong managed care expertise,” Dr Gobinca said. “The standardisation of the clinical and financial language to be used will require managed care expertise. There will still be a need to rationalise utilisation of benefits using modified case management techniques. The strategic analysis of the risk of the population under management and the response will also require top-class managed care expertise.” It is clear that managed care in isolation will not have an impact in controlling health care costs. For it to be truly effective, it needs clients who coordinate their health care initiatives well and consolidate all or most related information. The NHI system will not reinvent managed care, but all indications are that it will use combinations of selected existing managed care initiatives, in particular those that are in line with the fund’s strategic focus, Prof De Klerk said. medical chronicle | June 2011 | page 43 Oncology The Effect of Low-dose Aspirin on Risk and Survival of Colorectal Cancer Worldwide, colorectal cancer (CRC) is responsible for almost half a million deaths, ranking it as the second most common cause of cancer mortality. The implementation of screening programmes in most health care systems is limited by cost, so the identification of drugs that may help to prevent colorectal cancer may be particularly useful, especially for individuals at high risk, such as those with a genetic predisposition or those who have previously had CRC. Observational studies have indicated that aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs) may protect against CRC. Furthermore, randomised clinical trials have also demonstrated that low-dose aspirin (81-325mg/day) reduces the risk of colorectal adenomas in both average and high-risk populations. However, the most and least effective doses of aspirin and duration of treatment required are currently unknown, as are the ideal starting age for chemoprevention and the latency of effect. Studies suggest that it may need to be administered for at least five years and the latency of effect may be up to 10 years. In order to investigate these issues, Farhat Din from the University of Edinburgh and colleagues undertook a large population-based case-control study, including 2254 cases and 2907 controls from a population in Scotland matched for age, gender and area of residence. The subjects completed lifestyle and cancer questionnaires reporting their status one year prior to diagnosis (cases) or recruitment (controls), which included information concerning duration and amount of aspirin intake, NSAIDs and other analgesics. Compared to nonusers, there was an approximately 30% lower incidence of CRC in those with any use of NSAID, which remained significant after adjusting for confounding factors, including age, energy, alcohol and fibre intake, physical activity, smoking, gender, body mass index and deprivation index. Aspirin was protective at low doses (75mg/day; odds ratio (OR) 0.79; 95% CI 0.66-0.95) and the protective effect increased with dose, but not proportionately (>525mg aspirin/week; OR 0.66; 95%CI 0.41-1.05). The risk of colorectal cancer decreased with increasing duration of use of low-dose aspirin, which was modest after one year and becoming statistically significant after five years of use (see Table 1). Table 1: Adjusted risk of CRC associated with duration of use of aspirin 75mg Duration of use (years) Cases (n) Controls (n) Odds ratio (95%CI) >0 & ≤1 53 78 0.87 (0.59-1.28) >1 & ≤3 72 96 0.84 (0.59-1.18) >3 & ≤5 51 91 0.75 (0.52-1.08) >5 & ≤10 71 125 0.63 (0.45-0.87) >10 62 101 0.82 (0.58-1.16) P for trend = 0.004 The inverse relationship between CRC risk and aspirin use (dependent on dose and duration) was observed in both male and female subjects, but a cumulative dose effect was statistically significant only in men, perhaps as a reflection of more men being on 75mg aspirin for cardiovascular protection. Interestingly, the inverse association between nonaspirin NSAID use and CRC was statistically significant only for females. No association was demonstrated between allcause mortality or CRC-specific mortality and NSAID use. There were also no differences between cases and controls in the incidence of deaths that may have been due to NSAID-related complications, including bleeding and cerebrovascular accidents. This study is the first to show that low doses of aspirin, as used for cardiovascular protection, (75mg daily) have a protective effect against CRC that is evident as early as one year after use, increasing up to 10 years’ use and becoming statistically significant after five years of use. The results are applicable to a general population and not only to those at high risk for CRC. While there was a trend towards a dosedependent association, risk reduction was not proportional to dose. Although the study found no association between NSAID use and mortality from CRC, it may be that the sample size was too small, or the duration of treatment was too short to show such an effect. Aspirin does fulfil some specific criteria that make it attractive for use as a chemoprotective agent. It is effective, convenient, inexpensive and easy to take. Furthermore, many patients are already taking daily low-dose aspirin for cardiovascular protection. However, daily aspirin may also be associated with an increased risk of gastrointestinal bleeds and patients who are candidates for daily aspirin need to be assessed for bleeding risk. It is noteworthy that this study did not detect any difference between cases and controls in the incidence of fatal bleeding. Reference Din FVN, Theodoratou E, Farrington SM, et al. Effect of aspirin and NSAIDS on risk and survival from colorectal cancer. GUT 2010;59:1670-1679. * Content supplied by Reckitt Benckiser medical chronicle | June 2011 | page 45 Oncology Forum Dr Adam Nosworthy Mesothelioma: Systemic Treatment for Irresectable Disease Mesothelioma is a rare malignancy worldwide, but with a significant geographic distribution in SA. It arises most commonly from the mesothelial surfaces of the pleural cavity and occasionally from the peritoneal surface. It has an extremely poor prognosis with the median survival being four to 13 months for untreated patients and six to 18 months for treated patients, regardless of the therapeutic approach. Pleural mesothelioma The development of systemic treatment for pleural mesothelioma has been difficult because of limited numbers of patients, challenges in determ ining whether an individual patient is benefiting from treatment, and the poor prognosis associated with advanced disease. In all the large surgical trials done to date, histology has a significant impact on prognosis, with sarcomatoid and biphasic subtypes having worse outcomes. The small number of mesothelioma patients enrolled on clinical trials and the heterogeneity of study populations has limited the identification of molecular biomarkers for prognosis, but new molecular technologies, such as gene expression profiling, may eventually classify patients into distinct prognostic subgroups. Response assessment There are several ways of assessing clinical benefit - response rate, disease control rate, progression-free survival and overall survival. Both of the objective response rate and progressionfree survival have been used as surrogates for efficacy in phase III mesothelioma studies due to the poor outcomes when attempting to measure overall survival. In malignant pleural mesothelioma studies, there are two radiographic measurement systems that are employed using thoracic computed axial tomography (CT) scans - Response Evaluation Criteria in Solid Tumors (RECIST) and modified RECIST. Modified RECIST measures the pleural rind or tumour thickness in a perpendicular manner to the chest wall in two positions at three separate levels on a chest CT scan. Other imaging modalities are under investigation for use in mesothelioma tumour measurements. Positron emission tomography combined with CT scanning (PET/CT) can detect a decrease in metabolic activity in the tumour and may be a better predictor of time to progression rather than objective response as determined by computed tomography alone. The PET/CT endpoint has, however, not been validated in phase III trials. Benefit of chemotherapy Three randomised clinical trials have established that cisplatin-based doublet chemotherapy significantly prolongs survival compared to single agent chemotherapy or best supportive care (BSC). The only randomised trial that directly compared chemotherapy to ASC failed to demonstrate a significant improvement in survival with either single-agent vinorelbine or an older regimen of mitomycin, vinblastine, and low-dose cisplatin. The study was terminated prematurely because of poor accrual after 409 patients were enrolled, and the two active chemotherapy arms were combined for a survival analysis. Survival in those receiving chemotherapy plus BSC was marginally prolonged, but the difference was not statistically significant (8.5 vs 7.6 months with BSC alone). Two trials comparing contemporary doublets combined with an antifolate (cisplatin plus pemetrexed and cisplatin plus raltitrexed) both demonstrated significant increases in survival compared to cisplatin alone. The median survival with cisplatin alone in both of those trials was nine months, which is very similar to that observed with BSC alone in the other randomised trial. Although single-agent chemotherapy has not been shown to prolong survival in previously untreated patients, these agents may have a role as second-line therapy in some patients. Agents that have shown substantial activity in phase II include the following: • Cisplatin - In a meta-analysis of virtually all phase II trials published until 2001, cisplatin was the most active single agent. Carboplatin may also have activity although the data are much less extensive. • Pemetrexed had significant activity as a single agent in phase II studies and an expanded access programme. • Gemcitabine has shown activity in phase II studies and may be particularly useful in combination with cisplatin. • Anthracyclines - Multiple studies have shown significant response rates with doxorubicin. • Vinca alkaloids - Phase II studies have shown objective responses with the vinca alkaloids, vinorelbine and vinflunine. Pemetrexed and cisplatin, with prophylactic folic acid and vitamin B12, is standard treatment Combination chemotherapy The superiority of chemotherapy with a cisplatin doublet compared to single-agent chemot herapy has been demonstrated for pemetrexed plus cisplatin and for raltitrexed plus cisplatin. There are no randomised trials that directly compared these two regimens. Pemetrexed with cisplatin is an active regimen in mesothelioma, and the combination prolongs survival compared to cisplatin alone in patients with advanced mesothelioma. In the single-blinded Evaluation of Mesothelioma in a phase III trial of Pemetrexed with Cisplatin (EMPHACIS), 456 patients were randomly assigned to cisplatin plus either pemetrexed or a placebo, both given once every three weeks. The median survival was significantly longer for the combination (12.1 vs 9.3 months), as was the time to progression (5.7 vs 3.9 months) and the objective response rate (41% vs 17%). In addition to the survival benefit, combination therapy was associated with improvements in symptoms and quality of life. All parameters favoured the combination therapy group, including global quality of life, pain, dyspnoea, fatigue, anorexia and cough. Differences in survival were most striking in patients who received supplementation with folic acid and vitamin B12 during therapy. Treatmentrelated toxicity was significantly less, and the mean number of administered cycles of therapy (both single-agent cisplatin as well as the combination) was significantly greater in supplemented compared to nonsupplemented patients. Based on these results, the combination of pemetrexed and cisplatin, with prophylactic folic acid and vitamin B12, has become the standard of care for patients with malignant pleural mesothelioma whose disease is either irresectable or who are not otherwise candidates for potentially curative surgery. The role of maintenance pemetrexed after four to six cycles of the platinum-based doublet is still under investigation. In an effort to decrease toxicity, carboplatin has been substituted for cisplatin in conjunction with pemetrexed. In the larger of two nonrandomised phase II studies, 102 patients were treated every 21 days with carboplatin (AUC 5) plus pemetrexed, folic acid and vitamin B12 supplementation. Objective responses were observed in 19%, with a median time to progression of 6.5 months and a median survival of 12.7 months. The addition of raltitrexed to cisplatin prolongs survival compared to cisplatin alone in patients with previously untreated advanced mesothelioma. This was illustrated in a phase III trial in which 250 patients were randomly assigned to raltitrexed plus cisplatin or the same dose of cisplatin alone. Raltitrexed is not commercially available in SA. A number of other combinations have been evaluated in phase II studies. Randomised trials will be required to establish the role of these regimens: • Gemcitabine plus a platinum - Gemcitabine has been combined with cisplatin, carboplatin, and oxaliplatin. Response rates for these combinations have ranged from 15% to 48%, with acceptable levels of toxicity. • Cisplatin has also been combined with a number of older chemotherapy agents in phase II studies. These include anthracyclines, the combination of fluorouracil, mitomycin, plus etoposide, and the combination of methot rexate plus vinblastine. The results from these studies do not suggest any advantage compared to combinations of cisplatin plus either pemetrexed or gemcitabine and, in fact, may be somewhat inferior. Although data are limited, second-line chemotherapy may be useful in patients with malignant pleural mesothelioma. The most extensive data in the second-line setting are for pemetrexed, either alone or in combination with cisplatin. Other drugs that have been used include gemcitabine, vinorelbine and anthracyclines. Immunotherapy and gene therapy Immunotherapy with systemically administered interleukin (IL)-2 has limited efficacy and substantial adverse effects. In a study of 29 patients with advanced mesothelioma who received recombinant IL-2 as a single agent, there were only two partial responses (objective response rate, 8%). Nevertheless, further studies of systemic IL-2, as well as artificial upregulation of endogenous IL-2 by gene transfer are underway, based on data from murine models of mesothelioma. One of the most attractive targets for therapy is mesothelin, a tumour differentiation antigen that is overexpressed by most epithelial mesotheliomas, but not by normal cells. Three mesothelin-t argeted agents are in various stages of clinical development. These include SS1P (antimesothelin dsFv-PE38), a recombinant immunotoxin composed of an antimesothelin Fv fragment linked to a truncated Pseudomonas exotoxin, MORAb-009, a chimeric antimesothelin monoclonal antibody, and CRS-207, a live-attenuated Listeria monocytogenes vector encoding human mesothelin. The rationale for mesothelin as a tumour vaccine is that mesothelin elicits a strong T-cell response in patients. Phase I trials have been completed with SS1P and MORab-009, and some evidence of minor antitumour activity has been observed with SS1P. Preclinical models suggest significant synergy between these agents and systemic chemotherapy, and trials of combined therapy are underway. Peritoneal mesothelioma Peritoneal and pleural mesotheliomas share somewhat similar biologic and clinical characteristics - both are associated with a history of asbestos exposure, and both are characterised by extensive local growth. Morbidity and mortality are almost entirely due to disease progression within the peritoneal cavity. Aggressive regional therapy using a combination of cytoreductive surgery (CRS) and intraperitoneal chemotherapy has been increasingly applied to patients with peritoneal surface malignancies, including malignant peritoneal mesothelioma (MPM). Some expert centres report median survival durations that approach five years using this approach in appropriately selected patients. For patients with advanced (irresectable or recurrent) disease who are not candidates for aggressive regional therapy, palliative systemic chemotherapy is identical to that noted above for pleural-based disease. First-line treatment with pemetrexed plus cisplatin has been associated with dramatic responses in some patients and is generally well tolerated. page 46 | medical chronicle | June 2011 Surgery Optimal Medical Therapy not Administered to Patients Before and After PCI Data from a cardiovascular registry indicate that less than half of patients with stable coronary heart disease undergoing percutaneous coronary intervention (PCI), balloon angioplasty or stent placement are receiving optimal medical therapy (OMT). According to a study in the 11 May issue of JAMA, approximately one-third are also not receiving OMT at discharge following PCI. Although PCI may improve outcomes for patients with acute coronary syndrome, OMT results in similar rates of cardiovascular events when compared with PCI in patients with stable coronary artery disease (CAD). Findings of a meta-analysis of 11 trials concluded that there was no benefit of PCI in preventing heart attack or death in patients with stable CAD. In addition, the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) study, which provided OMT to all patients, demonstrated no incremental advantage of PCI on outcomes other than angina-related quality of life in stable CAD, suggesting that a trial of OMT is warranted before PCI. “It is unknown to what degree OMT is applied before PCI in routine practice or whether its use increased after the COURAGE trial,” according to background information in the article. Dr William Borden from Cornell University in the US and colleagues conducted a study to examine the use of OMT before and after PCI and to evaluate whether the use of OMT changed after the publication of the COURAGE trial (March 2007). The study included data from the National Cardiovascular Data Registry of patients with stable CAD undergoing PCI between September 2005 and June 2009. Analysis compared use of OMT, both before PCI and at the time of discharge, and before and after the publication of the COURAGE trial. Optimal medical therapy was defined as either being prescribed or having a documented contraindication to all medicines (antiplatelet agent, betablocker, and statin). 44.2% Patients receiving OMT before PCI A total of 467 211 patients receiving PCI procedures were included in the analysis, with 173 416 patients (37.1%) and 293 795 patients (62.9%) in the before and after COURAGE periods, respectively. The researchers found that 206 569 patients (44.2%) received OMT before PCI and 303 864 patients (65%) received OMT at the time of discharge. Before the COURAGE trial, the rate of OMT at the time of PCI was 43.5%. Although the increase in the proportion of patients receiving OMT before PCI after the COURAGE trial was statistically significantly higher, it was of little clinical significance (131 188 patients [44.7%]). One-third of patients are not receiving OMT at discharge following PCI The rates of OMT before PCI in each study period month showed a small increase during the 46 months of observation, with an OMT rate before PCI of 43.4% in September 2005 and an OMT rate after PCI of 45% in June 2009, the authors wrote. The overall rate of OMT after PCI, a time at which the diagnosis of significant obstructive CAD had been confirmed, was 63.5% before the COURAGE trial and 66% after the COURAGE trial. “Our study demonstrated that less than half of patients undergoing PCI are taking OMT before their procedure, despite the guideline-based re commendations to maximise OMT and the clinical logic of doing so before PCI so that the need for additional symptom relief from revascularisation can be appreciated.” Even after publication of the COURAGE trial, little change in this practice pattern was observed. Although clinicians did increase the use of OMT before discharge, with antiplatelet agents being almost universally applied, almost a third of patients were not treated with OMT, a pattern that also did not change after the COURAGE trial was published. Collectively, these findings suggest a significant opportunity for improvement and a limited effect of an expensive, highly publicised clinical trial on routine clinical practice, the authors concluded. Source JAMA. 2011;305(18)1882-1889. medical chronicle | June 2011 | page 47 Winter Ailments Symptomatic Treatment of Colds and Flu Should be Considered First-line Therapy With the increasing concern about the emerging antibiotic resistance, involving all classes of antibiotic drugs, it is clear that symptomatic treatment should be considered as standard therapy when dealing with colds and flu-like illnesses of an uncomplicated nature. The primary problems facing doctors are the ability to distinguish between a bacterial and a viral infection, as well as ascertaining when the illness is serious and complicated enough to warrant an antibiotic. “One of the main factors that drives antibiotic resistance is that antibiotics are prescribed when they are not indicated,” said Prof Charles Feldman, professor of pulmonology and chief physician, Charlotte Maxeke Johannesburg Academic Hospital. “Other issues exacerbating the situation are problematic antibiotic prescriptions, i.e. the way antibiotics are prescribed, the incorrect anti biotics are prescribed for the wrong indications, incorrect doses are prescribed, such as too low doses over prolonged periods of time, etc. And of course, patients don’t always comply with antibiotic use,” he continued. The common cold has local involvement, while the flu has a systemic effect Colds and flu are completely different Laypeople and patients erroneously refer to both colds and influenza as the flu, when, in fact, they are completely different entities. It is therefore important for the doctor to explain the difference to the patient as this impacts on the management of the illness. In general, the common cold is caused primarily by viruses such as the rhinovirus and it is characterised by symptoms that slowly creep up on the patient causing some irritation, without being debilitating. These include a runny nose, sneezing, watery eyes, nasal congestion, nasal itching, slight cough, seldom a fever, no body aches. Viruses do not respond to antibiotics, therefore the cold almost never requires this therapeutic option. Agents targeting symptoms will be useful in this situation. There are a few instances where the cold does complicate, leading to a more serious secondary infection with a bacterial aetiology. One such complication of a cold is pneumonia, which necessitates the use of an antibiotic but this is an uncommon occurrence. Influenza, on the other hand, is a much more serious and severe illness caused by influenza viruses. Whereas the common cold has local involvement, the flu has a systemic effect, involving the entire body. “If you’ve ever had it, you will definitely know, as you literally cannot get out of bed due to the severity of the condition,” stated Prof Feldman. It may consist of similar symptoms to the common cold, in addition to having a sudden onset, high fever, which is not a significant feature of the common cold; muscular aches, sore joints, asthenia, fatigue and malaise, a terrible sore throat, headache and an inability to function normally. “The cluster of symptoms primarily characterising flu is known as the flu FACTS: fever, aches and pains, coughs, sore throat and sudden onset. So, you may wake up feeling fine but by lunch time you can have what appears to be the flu,” said Prof Feldman. “Symptomatic treatment is again useful in making the patient more comfortable.” A potential consequence of influenza is that it often complicates into pneumonia. Antibiotics are not generally indicated for influenza, unless the secondary complication has a bacterial origin, the patient is in a high-risk group susceptible to complications or the patient is sick enough to be hospitalised, as he/she may be prone to pneumonia. “I always ask GPs to interrogate their decision to prescribe antibiotics when faced with a patient exhibiting flu-like symptoms. Doctors need to stop for a second and ask themselves whether they really believe the patient needs an antibiotic. If there is uncertainty but they would prefer to prescribe an antibiotic or if the patient really needs one, then go for it. But if the doctor is unsure that the patient needs one, then discuss the reasons with the patient and do not prescribe initially. The decision can be re-evaluated if the patient deteriorates,” confirmed Prof Feldman. About complications The first sign that a cold is becoming complicated is that it does not seem to settle. The patient may begin to experience a fever and the secretions transition from being clear and watery to thick and purulent. The patient feels more unwell. Common causes of complications and secondary infections include allergies, sinusitis, middle ear infections, etc. With regard to flu, serious complications such as pneumonia, meningo-encephalitis, meningitis or serious cardiac involvement may ensue. “The latter complication is the primary reason we advise patients not to exercise or exert themselves ... to page 48 page 48 | medical chronicle | June 2011 Winter Ailments Symptomatic Treatment of Colds and Flu Should be Considered First-line Therapy ... from page 47 when they have colds and flu, as this may induce a heart attack,” stated Prof Feldman. Which symptoms indicate the presence of complications? This is seldom a straight-forward, clear-cut observation. With regard to pneumonia, which is one of the more common complications, the patient generally has a fever and coughs up secretions, which appear to be infected. The secretions are no longer clear and watery, but may consist of purulent yellow to greenish sputum, which would appear more viscous and opaque. The patient will warrant hospitalisation. The more purulent the sputum, the darker and greener it becomes - particularly in the presence of other associated features indicating a bacterial infection. Secondary bacterial infections do not have clear mucus and sputum. The influenza virus may cause pneumonia on its own; however, influenza may also be complicated by pneumococcal pneumonia and in that situation the viral infection is complicated by a bacterial infection. GPs may confirm the presence of pneumonia by taking a good clinical history and referring to a chest x-ray. Sputum samples can also confirm the presence of pneumonia. Many GPs belong to the national surveillance network - Viral Watch at the National Institute of Communicable Diseases - and they often take swabs to inform about the types of organisms circulating throughout the year, which can impact on communities. “However, nasal swabs are not routine practice and the diagnosis is primarily a clinical diagnosis,” stated Prof Feldman. With bacterial infections, sputum sampling may be useful and more extensive specialised testing can be performed, e.g. blood cultures. Who is at high risk of complications and secondary infection? This group includes children, the elderly, pregnant women, immunocompromised patients and those with underlying conditions such as cardiorespiratory diseases. In the latter instance, anti biotics are administered earlier in combination with the antiviral medication. “A group that is often not thought of is the HIV-positive population. We know that these patients can acquire a terrible flu and are at greater risk of getting complicated flu,” said Prof Feldman. Treatment With the common cold and uncomplicated flu, symptomatic treatment is first-line treatment. This includes agents such as cough mixtures, lozenges, throat sprays, gargles and general cold and flu medications that have antipyretic and analgesic properties. Caution should be heeded when treating children with certain agents. “It must be reiterated that antibiotics do not work in these uncomplicated cases of viral origin,” said Prof Feldman. For pneumonia, however, a patient will receive an antibiotic which covers the most likely causative organisms. lll Guidelines “There are no guidelines on how to treat the common cold, but solid SA guidelines are in place for managing influenza,” said Prof Feldman. High-risk cases should receive special care and antivirals should be considered in these instances. If the condition deteriorates and becomes more serious, leading toward underlying complications, an antibiotic may be indicated with or without an antiviral. The two classes of antivirals available consist of neuraminidase inhibitors, such as oseltamivir or zanamivir, and the adamantines, of which only amantadine is available in SA. 25% of patients receive antibiotics unnecessarily The guidelines cover all aspects in the overall management of influenza, including the high-risk groups, various strains such as H1N1, and different complications such as the upper respiratory tract infections (URTIs), middle ear, sinuses, pneumonias, etc. The guidelines and recommendations are based on what is occurring in the country, resistance patterns and the international guidelines. “Doctors are urged to access this information from the Federation of Infectious Diseases Societies of Southern Africa and Thoracic Society’s websites (www.fidssa.co.za; www.pulmonology.co.za), which elaborate on the guidelines for upper and lower respiratory tract infections, paediatric and adult pneumonias and antibiotic recommendations for acute exacerbations of chronic obstructive pulmonary disease (COPD), which include bronchitis,” said Prof Feldman. Nonpharmacological elements such as bed rest, adequate fluid intake and traditional home remedies also have an important role, according to Prof Feldman. Focus on education Education is vital in clarifying the distinction between viral and bacterial infections. Doctors need to be enlightened in this area. One suggestion is to raise the bar on antibiotic prescription. “A survey was conducted in the UK to ascertain GPs’ antibiotic prescribing habits. GPs were asked to review the last 100 patients they prescribed anti biotics to for URTIs, and to establish whether the patient definitely needed one, probably needed one, definitely did not need or probably did not need an antibiotic. In a quarter of the cases, the GP admitted that the patients definitely did not or probably did not need an antibiotic,” noted Prof Feldman. It is therefore imperative for doctors to ask themselves whether an antibiotic is really needed in a particular situation. Patient education is also important, as they are often demanding. Many countries in the UK and northern Europe have implemented awareness campaigns around antibiotic use, and this has ... to page 49 medical chronicle | June 2011 | page 49 Winter Ailments Symptomatic Treatment of Colds and Flu Should be Considered First-line Therapy ... from page 48 made a marked difference to the GPs. It is definitely a two-way discussion between the patient and doctor. The doctor can also revise the decision after a few days if circumstances change, according to Prof Feldman. Patient education should include advice on maintaining a healthy lifestyle to boost immunity. People should avoid people who are ill as a primary measure in staying well. Therefore, it is important for people to get vaccinated or stay at home when ill to prevent people from infecting their colleagues. People should be taught proper hygiene - wear masks, frequent hand washing, sneezing into tissues, disposing of tissues after blowing one’s nose, etc. Final message to doctors • Not all respiratory tract infections need anti biotics, as many have a viral aetiology. • Education and increased awareness is imperative in identifying the signs that suggest viral or bacterial infection. • Rather than automatically prescribing an antibiotic, consider whether it is really necessary in this instance and individualise every case. • Make a proper diagnosis. • Ascertain if the complication is pneumonia, an acute exacerbation or COPD, sinusitis, etc. • Follow the guidelines for optimum management. Symptomatic treatment is firstline therapy in uncomplicated cases Why Colds and Flu are More Common in Winter? Many patients are fascinated by the fact that colds and flu appear more prevalent in winter. The question is why? The common cold viruses circulates throughout the year, however, people become infected to a greater extent in winter. Influenza is primarily a winter disease and the associated viruses differ from those related to colds. Pneumococcal infection commonly follows a viral infection that may be initiated by influenza or a common cold, as the latter two conditions are risk factors that predispose individuals to pneumococcal pneumonia, therefore this ailment also increases in winter. The influenza virus is much more active during the winter season, as it thrives in colder temperatures, therefore the amount of circulating virus is far higher in winter as opposed to summer. This does not mean that the virus is not present the rest of the year. More interesting questions What happens to the virus? Where does it go? Research now indicates that South America is the destination where all the viruses travel to and subsequently mix. This is a far cry from what was commonly believed previously. The virus is extremely active in the winter months in the northern hemisphere, becoming active in the southern hemisphere six months later. The word ‘active’ implies that the virus itself becomes much more vigorous and more likely to infect, with a much higher circulation in terms of number of organisms. Another reason is that people spend a longer period of time indoors around a heater or television, in closer contact to each other. All it takes is one individual with the sniffles to pass the viruses onto the next person. This may culminate as a viral infection which may complicate with pneumococcal infection or it may colonise in the individual without being majorly symptomatic, waiting to be passed onto the next individual. All people are colonised with pneumococcus at some stage in their lives, although it is more common in childhood. Additional risk factors, such as the common cold, make a person more susceptible to pneumonia. Influenza, however, can be contracted from others who are infected via aerosol transmission. Should Health Professionals be Obliged to Have their Flu Shots? The trend in influenza vaccination is that the rationale and campaigns were always focused on the public domain, especially high-risk population groups. With dangerous strains circulating such as the H1N1, as well as a large number of patients at high risk of contracting influenza at hospitals, should health professionals be vaccinated as a mandatory proceeding? This issue as is a very controversial subject. From the point of view of infectious diseases (of which, influenza is one), vaccination is clearly an ethical consideration. The first fundamental principles of ethics, above all, is to do no harm. This implies that doctors should first protect themselves from contracting influenza because they run the risk of passing it on to their patients while working. This is especially a sensitive issue when working with high-risk patients such as paediatrics, the elderly and immuno compromised patients. In some US states, there has been an attempt to legislate compulsory vaccination for health care workers, which has been challenged in court. Concern has been that compulsory vaccination goes against an individual’s autonomy and therefore has been difficult to enforce. The solution Because of the incredible controversy fuelled by those who are against vaccination, it is more advantageous to better educate, add encouragement and make vaccination easier to implement rather than legislating the concept and forcing health professionals to abide by it. There are circumstances where one’s autonomy may be overturned, e.g. small pox was eradicated because it was compulsory for people to have the vaccine, due to the immense overall societal bene fit. Small pox was a highly infectious, serious illness with a high mortality. In this instance, the greater societal benefit potentially outweighed individual autonomy. medical chronicle | June 2011 | page 51 Winter Ailments Cell Culture-derived Flu Vaccine is as Effective as Current Flu Vaccines A flu vaccine derived from cell culture is as effective as currently available flu vaccines, but would be less susceptible to manufacturing problems. It would also be possible to incorporate that year’s predicted seasonal strains into the vaccine much later than is currently possible, reducing the chances of error. These findings appeared in an article published online in February 2011 by The Lancet written by Dr P Noel Barrett from Baxter BioScience based in Austria and colleagues. Vaccines derived from cell culture are produced in state-of-the-art manufacturing facilities using well-characterised cell lines, which are available in unlimited amounts and allow reliable and flexible vaccine supply. Currently, most influenza vaccines are produced using embryonated hens’ eggs. This is a cumbersome process and manufacturing difficulties have led to vaccine shortages in the past. The use of cell culture overcomes these problems by utilising standardised, closed manufacturing systems, which allow for more reliable production and supply of influenza vaccines. In this study, the authors analysed a vaccine derived from Vero cell culture. Vero cells are well characterised and have been used for over 25 years for the production of human vaccines such as polio and rabies and more recently, also the rotavirus vaccine, of which hundreds of millions of doses have been safely used. A randomised controlled phase three trial was carried out in 36 centres in the US, in which healthy adults (aged 18-49 years) were assigned in a 1:1 ratio to one injection of either placebo or Vero cell culture-derived influenza vaccine during the 2008/09 season. A flu vaccine derived from cell culture is as effective as currently available flu vaccines A total of 7250 participants were randomly assigned to vaccine (n=3626) and placebo (n=3624). Overall protective efficacy for antigenically matched influenza infection was 78.5%. The authors claim that this compared well with current egg-derived vaccines, with one recent review reporting average protective efficacy of 73% when the vaccine strains matched circulating strains. The new vaccine was well tolerated with no treatment-related serious adverse events. Adverse events were mainly mild and transient. The anti body response (level of antibodies required for protection) produced by the new vaccine was similar to existing vaccines. The authors said: “This study is the first published report of the clinical efficacy of a Vero cell culture-derived influenza vaccine. Comparison with previously published meta-analyses shows that the Vero cell-derived seasonal influenza vaccine is at least as immunogenic and efficacious as traditional egg-derived vaccines. Our data also provide the first evidence that prove that the protection established for egg-derived influenza vaccines are also appropriate for cell culture-derived vaccines. “The data presented here show that a novel, inactivated Vero cell-derived influenza vaccine, which is safe, immunogenic, and efficacious, will be a valuable addition to the currently licensed vaccines for the prevention of seasonal influenza,” they added. In a linked comment, Dr Paul Glezen from the Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, Texas, US, said: “The key to influenza control is the dependable availability of sufficient quantities of vaccine early in the season, preferably in August in the northern hemisphere. This schedule will allow more time for vaccine delivery. Safe vaccines which contain antigens that closely resemble the epidemic viruses will assure the likelihood of protection and increase the demand for vaccine.” The abstract may be accessed on www.thelancet.com/journals/lancet/article/ PIIS0140-6736(10)62228-3/abstract Source www.eurekalert.org page 52 | medical chronicle | June 2011 Winter Ailments Influenza Immunisations are Invaluable - SA Needs to Increase the Uptake Prof Barry Schoub, NICD To put it rather bluntly, SA has a rather dismal record when it comes to influenza immunisation. Although SA is classified as an upper middle income country by the World Bank, immunisation coverage falls quite well below many countries in the world with lower per capita gross national income (GNI). In 2000, SA peaked its vaccine usage at 2.3 million doses shortly after the aftermath of the severe A/Sydney influenza outbreak in the northern hemisphere at the turn of the millennium. Since then, usage has steadily declined with less than one million doses used in 2009. This translates to 19 doses per thousand population compared to over 350 per thousand population in Korea. Several studies have been carried out to investigate reasons for this poor uptake, abroad and in SA, and also in both private and public sectors. Among the most common reasons given is that the vaccine doesn’t work (‘last year I got the shot, but still got flu’), or because of the side effects of the vaccine (‘last year the vaccine made me ill’, or even ‘last year the vaccine gave me the flu’), or, simply, that flu is a trivial disease and not worth the trouble of going to get immunised. To answer all of these immunisation barriers would require a detailed, lengthy review article with many supporting literature references. Suffice to say that the efficacy of the vaccine has been established in a large number of studies in many parts of the world, among children and the elderly, and among both healthy and ill subjects. A recent publication from the Centers for Disease Control (CDC) in the US (Morbidity and Mortality Weekly Report (MMWR), 6 August 2010; Vol 59/No RR-8) stated that the ‘effectiveness of influenza vaccine among healthy adults against influenza-related hospitalisation measured in the most recent studies was 90%’. However, the effectiveness will vary according to a number of factors. Firstly, age is an important modifier of effectiveness. The vaccine is less effective in young children and this is why children under nine years old who have never been immunised require two doses, as they are unlikely to have been primed by previous infection. Also, at the other extreme of age, in the elderly, the efficacy is also reduced because of immunosenescence. Secondly, immunocompetence is important clearly, patients whose immune system is depressed by infections such as HIV or medications such as for cancer or posttransplant patients will also respond less effectively. Thirdly, strain similarity plays a role - it is important to match the strains incorporated into the vaccine with those circulating in the community. Children under nine years old who have never been immunised require two doses For this reason, a surveillance network under the World Health Organization of some 125 sentinel laboratories throughout the world, including SA, regularly characterise influenza virus isolates to detect any antigenic changes and, if necessary, to submit these for further characterisation and possible incorporation into the forthcoming vaccine. Influenza vaccine is administered every year because strains keep evolving and also because the duration of immunity is less than a year. We tend to use the terms ‘efficacy’ and ‘effectiveness’ rather loosely. Efficacy refers to the serological response; e.g. specific antibody production, whereas effectiveness means the protection against a predetermined clinical outcome, be it a case definition of influenza or outpatient visits, hospitalisations, etc. How well the vaccine performs will therefore also depend on what is being measured. But even when measuring all-cause reduction of illness in the winter season, influenza vaccine has been shown to be protective at levels exceeding 40%. However, what needs to be emphasised is that influenza vaccine protects specifically against infection with the influenza virus. It does not protect against the myriad of other infectious agents responsible for upper respiratory tract infections. The value of the vaccine is because it targets specifically influenza that is the major cause of serious complications and even death. With respect to side effects, yes, the influenza vaccine commonly causes injection-site tenderness, which may last a day or two perhaps with some surrounding inflammation and mild lymphadenopathy. Rarely, a mild pyrexial illness may follow a few days after immunisation. Because the vaccine is composed only of the proteins of the virus, it ... to page 54 page 54 | medical chronicle | June 2011 Winter Ailments Influenza Immunisations are Invaluable - SA Needs to Increase the Uptake ... from page 52 cannot cause influenza. Unfortunately, it is often the elderly and the debilitated who complain about side effects from the influenza vaccine, but these are precisely the risk groups who especially need vaccine protection. Complacency certainly does play a role in poor vaccine uptake. It is true that with fit, healthy adults, influenza is, in the vast majority of cases, a relatively trivial disease with complications occurring only very rarely. However, influenza is not always a trivial disease. In the US alone, influenza has been attributed to be responsible for 17 000 to 51 000 deaths and close to 250 000 hospitalisations annually. In the developing world, the mortality is considerably higher. A study in SA carried out last year at the National Institute for Communicable Diseases (NICD) showed that influenza-attributable deaths were 3.5 times greater than in the US (Cohen C et al. Clin Infect Dis 2010;51;1362-1369). Who then should and who should not get influenza vaccines? A comprehensive guideline to influenza vaccines is published annually in the February edition of the SA Medical Journal. Essentially, one can divide up the indications into three main groups. The first group comprises those individuals where it is medically mandated, simply because the vaccine is very effective in reducing the incidence of severe complications. This list includes patients with underlying pulmonary and cardiac conditions, metabolic and renal diseases and immunosuppressed people including those with HIV. More recently, two new risk groups were added following on the H1N1 pandemic of 2009/2010. These are pregnancy at all stages (previously firsttrimester was regarded as a contraindication, but after a number of observations and studies have provided reassurance that the vaccine has no ill effects on the foetus, this has been changed now to include all stages of pregnancy). Also morbid obesity, with a body mass index of greater than 40 is now recognised as a significant risk factor. South African recommendations include 65 years and over as the age for routine immunisation. Regarding paediatric immunisation, South African recommendations differ somewhat from those of the US. Universally, it is clear that all children who have the same risk factors with respect to chronic pulmonary, cardiac and other conditions listed above should be immunised annually. Also, children up to the age of 18 years who are on aspirin therapy for various conditions are also candidates for influenza immunisation because of the risk of Reye’s syndrome. However, SA has not adopted the US policy of routinely immunising all children between six months (the vaccine is not indicated for infants less than six months) and four years. In fact, most recently, the CDC have gone even further and now recommend immunising all individuals over the age of six months (MMWR, 6 August 2010; Vol 59 RR-8). The motivation for immunising healthy children is two-fold - firstly, the rates of complicated influenza and hospitalisation for influenza-related illnesses are significantly higher in children than adults and secondly, children serve as the major reservoir of the virus in the community. Immunisation of children has been shown in a number of population studies to have a significant, indirect effect conferring herd immunity in the community. Influenza vaccine doesn’t protect against all agents responsible for URTIs The second group of vaccine recipients consists of individuals who come into close contact with the high-risk people mentioned above. This includes health care workers, people living in the same household and carers of at-risk individuals. The third group of vaccine recipients is people who are not medically at risk, but are annually immunised because influenza immunisation has been shown to play a significant role in reducing work absenteeism. It is also a useful option for anyone who would simply like to protect themselves from an illness that can be debilitating and which may result in quite a number of days off work. There are very few contraindications to the influenza vaccine. The very rare individuals who have experienced an anaphylactic allergic response to egg protein (as there may be minute traces remaining in the vaccine) or to any of the preservatives in the vaccine should, of course, not receive the vaccine. It is also recommended that individuals with an acute pyrexial illness, (but not an apyrexial common cold), should preferably wait until recovery. In conclusion, influenza is a vaccine-preventable disease. Influenza vaccine is a relatively cheap, very safe, and at least moderate to highly effective vaccine. Its usage needs to greatly increase in SA, which would make a significant impact on the burden of winter-related illness. medical chronicle | June 2011 | page 55 Asthma / Allergies Optimum Asthma Management - It’s Primarily about Adherence and Delivery Adequate education of doctors and patients has been cited as the primary factor responsible for patients achieving target levels of asthma control. Patients have the erroneous belief that they will always be plagued by symptoms, but they should be made aware that asthma symptoms are not part and parcel of the condition and that attaining a symptom-free state is very achievable. Doctors should increase patients’ understanding of asthma control and treatment. According to Dr Michael Levin, head of allergy in the department of paediatrics and child health at the Red Cross Children’s Hospital in Cape Town, the goals of treatment are as follows: • Patients should be free of symptoms. • Patients should have a minimal need of reliever therapy as symptoms are minimal. • Asthma attacks can be avoided. • Patients no longer require hospitalisation. • Patients are able to sleep without disruption. • Patients have a normal or near-normal lung function. • Patients have no side effects from medication. • Normal activity can be maintained - work, school, sport or exercise. “It is important for patients to understand that the above goals translate into asthma control, which will enable them to work toward it,” stated Dr Levin. Doctors should also assess asthma control by obtaining proper insight into the patient’s history and behaviour through asking relevant questions, which elicit informative responses. Increase patients’ understanding of asthma control and treatment Question your patients • How many times a week do you experience asthma symptoms? • How many times a week do you experience asthma symptoms at night? • Are you able to perform normal daily activities? • How many times a week do asthma symptoms restrict your normal activities? • How much reliever medication did you use in the last week? • Have you missed school or work because of asthma in the last month? Practitioners need to know how to translate these questions and goals of treatment into a formal assessment to gauge the level of asthma control. This can be accomplished by referring to the Global Initiative for Asthma (GINA) guidelines (www.ginasthma.com). These guidelines also contain criteria that divide asthma control into controlled, partly controlled or uncontrolled. In controlled asthma, daytime symptoms occur less than twice a week and subsequently require less than two doses of reliever therapy (short- acting beta 2 agonists) a week, without any limitation of activities. No night-time symptoms and sleep distur bances are present and the patient has normal or near-normal lung function. An assessment of control is that if the patient is using his/her reliever medication more than twice a week, adequate control has not been established. Partly controlled asthma is present when any one of those criteria are violated in a week - the patient may have daytime symptoms more than twice a week (implying that rescue therapy is required more than twice), activity may be limited, nocturnal awakening may occur or lung functions (either peak flow rate or FEV1) of less than 80% may be present. Lung function criteria only apply to patients older than five years old. Completely uncontrolled asthma is cha racterised by three or more features of partly-controlled asthma in any week. The action for partly-controlled and uncontrolled asthma is the same. “Simply pay attention to why the patient’s asthma is uncontrolled. A critical error doctors make is that they presume the medication is incorrect and prescribe a different increased level of medication,” warned Dr Levin. The ideal response is to examine the case more closely and investigate the logistics around adherence and technique for drug delivery before modifying the treatment regimen. At least 95% of patients with problematic asthma control can rectify the situation by looking at these factors. In terms of adherence, ascertain whether the patient is actually taking the medication. “When you ask patients whether they are taking their medication, they might say they do so twice a day, everyday. When you ask them how many times a week they forget to take it, they sometimes admit to being human and a degree of nonadherence, so it opens the door for them ... to page 56 page 56 | medical chronicle | June 2011 Asthma / Allergies Optimum Asthma Management - It’s Primarily about Adherence and Delivery ... from page 55 to disclose that they are fallible and they reveal a more accurate picture of the real situation,” advised Dr Levin. More specific questions should then be asked, such as whether the dose was skipped in the morning or night. “Then try to get them to reveal how many times they really take their medication each week. They may eventually come clean and admit they only take it twice a week. You have finally identified the root cause of the problem, even though they told you a few minutes ago that they use it everyday, because they know what they are meant to do, but don’t always follow through,” said Dr Levin. The other component is to assess technique through direct observation. The best way is to ask the asthma patients to bring their pump and spacers to every appointment and to demonstrate how they use the device. If an error is identified, the patient should be re-educated on the process, which may be time consuming. A well-trained asthma nurse and educator may prove invaluable in the remediation context. Assessing the technique is simple and specific techniques are used for the various types of inhalers - metered-dose inhaler, metered-dose inhaler with spacer, dry-powder inhaler. Furthermore, different techniques and devices are required depending on the age of the patient, and these aspects change as the patient gets older, e.g. patients younger than five years old usually need a mask and then move onto a mouth piece when a little older. Who is responsible for managing a patient’s asthma? The type of practitioner managing a patient’s asthma depends on the severity of the asthma. The doctor who sees the patient first should assign him or her to one of four levels according to the assessment of severity. Asthma severity is used as a guide to decide which initial therapy to start the patient on (level one, two or three). Asthma is divided into intermittent and persistent asthma, with the latter type subdivided into mild, moderate and severe persistent asthma. The categorisation of asthma severity depends on the factors mentioned when assessing asthma control. • Intermittent: Daytime symptoms occur less than twice a week, night-time symptoms occur less than once a month and peak flow rate is more than 80%. • Persistent, mild: Daytime symptoms occur two to four times a week, night symptoms occur two to four times a month, and peak flow rates are greater than 80%. (The frequency of night-time symptoms holds greater value in indicating severity). • Persistent, moderate - there are more than four incidences of daytime symptoms per week, more than four occasions of night-time symptoms per month, and peak flow rate of 60%-80%. • Persistent severe: Daytime symptoms are almost continuous, night-time symptoms are very frequent and peak flow rate is less than 60%. All grades of asthma, including intermittent asthma require reliever therapy and control over the environment. Intermittent asthma does not require any regular maintenance (controller) therapy. All patients with persistent asthma require regular anti-inflammatory controller therapy. Intermittent or mild, persistent asthmatic may be comfortably managed by a GP. A patient with severe, persistent asthma and those on level three therapy may need referral. Other indications for referral are when the diagnosis is in doubt, there are multiple severe concomitant allergic diseases, asthma that is difficult to control or where patients experience life threatening asthma, have frequent attacks, require regular oral steroids or immunotherapy is being considered. 70% Of patients fall into the mild persistent asthma category These patients as well as young children under the age of two years should be seen by a pulmonologist, allergist, paediatrician, specialist paediatrician or a physician with a special interest in asthma. In general, about 70% of patients fall into the mild persistent, 25% into the moderate persistent and only 5% into the severe persistent categories. Therefore, approximately 95% of patients can be managed by primary care practitioners who have been appropriately educated and trained. “Severity is never re-assessed after the initial assessment. Only control is assessed. You assess whether the patient is controlled or not to decide whether you should go to the next level of therapy after you establish adherence and technique of delivery. If the patient has been fine for three to six months, you can reduce the therapy by one step,” stated Dr Levin. Final message The biggest challenge is to understand the meaning of control. Doctors and patients should be taught that assessing control is important and that obtaining control is not about drugs - it is about adherence and drug delivery. Educating patients on how to use the devices effectively also implies the doctor should be au fair with the techniques. Dr Levin recently published an article in the journal, Current Allergy and Clinical Immunology that looked at errors in optimal drug delivery. A national asthma certificate course is available to guide doctors and nurses on how to manage asthma and educate their patients adequately. The website, www.asthma.co.za serves as a great source of information for doctors, and patients can also be referred to this resource. medical chronicle | June 2011 | page 57 Asthma / Allergies Children, Males and Blacks are Population Groups at an Increased Risk of Acquiring Food Allergies A new study estimates that 2.5% of the US population or about 7.6 million people have food allergies. Food allergy rates were found to be higher for children, blacks and males, according to the researchers. The odds of male black children having food allergies were 4.4 times higher than others in the general population. The research, which was funded by the National Institutes of Health (NIH) and appeared in the October 2010 edition of the Journal of Allergy and Clinical Immunology, is the first to use a nationally representative sample, as well as specific immuno globulin E (IgE) or antibody levels to quantify allergic sensitisation to common foods, including peanuts, milk, eggs and shrimp. The hallmark of food allergy is the production of IgE antibodies to a specific food protein. Once IgE antibody is made, further exposure to the food triggers an allergic response. IgE levels are often high in people with allergies. 4.2% Food allergy rates for children aged one to five years “This study is very comprehensive in its scope. It is the first study to use specific blood serum levels and to look at food allergies across the whole life spectrum, from young children aged one to five years, to adults 60 years and older,” said Dr Darryl Zeldin, acting clinical director at the NIH’s National Institute of Environmental Health Sciences (NIEHS) and senior author on the paper. “This research has helped us identify some high risk populations for food allergies,” he said. In addition to the identification of race, ethnicity, gender and age as risk factors for food allergies, the researchers also found an association between food allergy and severe asthma. Food allergy rates were highest (4.2%) for children one to five years. The lowest rates (1.3%) were found in adults over the age of 60. The prevalence of peanut allergies in children aged one to five was 1.8% and in children aged six to 19, it was 2.7%. In adults, the rate was 0.3%. The odds of patients with asthma and food allergies experiencing a severe asthma attack were 6.9 times higher than those without clinically defined food allergies. “This study provides further credence that food allergies may be contributing to severe asthma episodes, and suggests that people with a food allergy and asthma should closely monitor both conditions and be aware that they might be related,” said Dr Andrew Liu from the National Jewish Health and the University of Colorado School of Medicine and lead author on the paper. The data used for the study come from the National Health and Nutrition Examination Survey (NHANES) 2005-2006. NHANES is a large nationally representative survey conducted by the National Center for Health Statistics, a part of the Centers for Disease Control and Prevention. Drs Zeldin and Liu noted more research is needed to understand why certain groups are at The lowest food allergy rate (1.3%) was found in adults over the age of 60 increased risk for food allergy. The authors commented in the paper that food allergies may be under-recognised in blacks, males and children because previous studies relied on self-reporting and not food-specific serum IgE levels. “Having an accurate estimate of the prevalence of food allergies is helpful to public health policy makers, schools and day care facilities and other care providers as they plan and allocate resources to recognise and treat food allergies,” said Dr Linda Birnbaum, NIEHS director. Source www.eurekalert.org page 58 | medical chronicle | June 2011 Asthma / Allergies Sticker to Encourage Patients to ‘Stick’ with Asthma Compliance Programmes A new asthma awareness campaign to educate patients on correct inhaler technique as well as boost patient compliance with their daily asthma management has been launched. The campaign is centred on the Turbuhaler®, which features an innovative design that allows for accurate dosage of asthma medications Symbicord® and Pulmicort® without any propellant gas or other additives. “The campaign has two distinct aims: to improve patient compliance by dispelling any patient uncertainty around using the inhaler through the introduction of an innovative way for patients to personalise their Turbuhalers and to help alleviate the stigma around asthma,” said Dr Jasvanti Bhana, senior manager: medical, regulatory and quality assurance for AstraZeneca. When the Turbuhaler was introduced in 1987, it was welcomed as a revolutionary inhaler design. It was the first powder inhaler synchronised to operate with the patient’s breathing, thus replacing the need for propellant gas. “As with any novel design, patients may be uncertain on how to use the Turbuhaler correctly. Unfortunately, this uncertainty can lead to poor administration of medication, a lack of trust in the medicine’s efficacy and poor compliance,” said Dr Bhana. Dr Bhana explained that to combat this, AstraZeneca Pharmaceuticals will be distributing step-by-step instruction stickers to doctors’ rooms and pharmacies. These stickers are to be applied to the exterior surface of the Turbuhaler and provide a quick and easy explanation of how to use the device correctly. These stickers provide a quick and easy explanation of how to use the device correctly To meet the second objective of the campaign, AstraZeneca will be introducing ‘Style My Turbuhaler’ at doctor’s rooms. Style My Turbuhaler is a collection of removable, themed stickers that allow patients to personalise their Turbuhaler. “The concept draws on the trend of customisation by offering 25 bold designs in a variety of themes including sports, nature and the arts,” added Dr Bhana. The stickers are easy to apply and remove, allowing patients to swop as they please. “The rationale behind Style My Turbuhaler is that customisation allows patients to identify with their inhalers and therefore encourages proactive ownership of the disease,” said Dr Bhana. “Apart from this, one of the aims of the campaign is to encourage destigmatisation of the disease. “We know so much more about treating asthma effectively these days. The right medicines and following the correct regimen should have a positive impact on both patients’ asthma and quality of life. Using an inhaler correctly and as often as prescribed is a key part of any such regimen,” concluded Dr Bhana. About AstraZeneca AstraZeneca is a leading global pharmaceutical company, which employs over 65 000 people in more than 100 countries across the Americas, Europe, Asia, Africa and Australasia. Its 2008 sales totalled over $32bn (R227bn), with R&D budgets of over $5bn (R35bn). For further information, contact Christo Olivier, product manager: respiratory, AstraZeneca on 011‑797‑6000 or at [email protected] * Content supplied by AstraZeneca Pharmaceuticals page 60 | medical chronicle | June 2011 Asthma / Allergies Broadening Patient Access: Asthma Care AstraZeneca Pharmaceuticals’ innovations in the field of asthma treatment include the design of a dry powder inhaler operated solely by a patient’s breathing called the Turbuhaler®, and the development of adjustable maintenance dosing. This is a treatment concept known as Symbicord® (budesonide/formoterol) maintenance and reliever therapy, which allows patients to quickly gain and maintain control of a variable disease with the same inhaler. “Respiratory remains one of AstraZeneca’s key therapeutic areas and the company is committed to providing a wide arsenal of asthma treatments for medical practitioners and also enabling more patients to access key AstraZeneca asthma medicines,” said Dr Jasvanti Bhana, senior manager: medical, regulatory and quality assurance for AstraZeneca. Treatments offered include: • Bricanyl® (terbutaline) is a short-acting beta2-agonist, which is indicated for the treatment of bronchial asthma, chronic bronchitis, emphysema and other lung diseases where bronchospasm is a complicating factor.1 • Pulmicort® (budesonide) Turbuhaler is an inhaled corticosteroid for the prophylaxis of the symptoms of asthma.2 • Symbicord Turbuhaler, indicated in the treatment of asthma in adolescents and adults where use of combination (inhaled corticosteroid and long acting beta-2-agonist) is appropriate.3 “Pricing is an important factor in enabling greater patient access to our medicines and is especially relevant to daily, chronic medication. We have therefore taken the strategic decision to reduce the pricing on Pulmicort Turbuhaler, a move that should enhance our competitiveness and make the medication much more affordable to patients,” added Dr Bhana. Pulmicort Turbuhaler is the company’s inhaled corticosteroids treatment for patients with moderate to severe asthma.2 While a well-established treatment (budesonide was first developed in the 1970s), the product is still widely prescribed for asthma worldwide. According to the Global Initiative for Asthma’s guidelines, inhaled corticosteroids, of which Pulmicort Turbuhaler is an example, are the most effective anti-inflammatory agents available in the treatment of asthma.4 It is fast-acting and helps achieve asthma control, which is maintained over time.5 As alluded to previously, it is impossible to refer to AstraZeneca’s contribution to asthma management without referring to the Turbuhaler, the first powder inhaler on the market operated by a patient’s breathing, removing the need for chemical propellants such as CFCs. Not only is the Turbuhaler device easy to use even by children,6 it is also an efficient method for the delivery of the medicine. When budesonide is inhaled from the Turbuhaler, approximately twice as much of the metered dose (34%) is deposited in the lungs compared with a pressurised metered dose inhaler (pMDI; 15%).6 Lower pricing enables greater patient access to daily, chronic medication The innovative design was first created by Swedish designer Kjell Wetterlin in 1987 at the then Astra Draco after his daughter complained about the taste of additives from her asthma medication. Since then it has won numerous design awards including the 2010 Good Design Award from the Japan Industrial Design Promotion Organization. “This award recognises AstraZeneca’s contribution to patient care - it is simple, user-friendly and suited to all age groups (children from the age of six to adults). It is a wonderful acknowledgment of the company’s contribution to both asthma management and reaffirms its ongoing commitment to the improvement of patients’ lives,” said Dr Bhana. While still a chronic condition, with the right medicines and the correct asthma preventative regime, asthma should no longer be scary. “We know so much more about treating asthma effectively these days. The right medicines and complying with a regime should have a positive impact on both patients’ asthma and quality of life. We hope that the reduction in the price of one of our key asthma treatments will allow more patients to benefit from this drug,” concluded Dr Bhana. References: 1. Bricanyl Turbuhaler South African Registered Package Insert. 2. Pulmicort Turbuhaler South African Registered Package Insert. 3. Symbicord Turbuhaler South African Registered Package Insert. 4. Global Initiative for Asthma (GINA) guidelines. Updated 2008. 5. Kemp J, Wanderer AA, Ramsdell J, et al. Rapid onset of control with budesonide Turbuhaler in patients with mild-to-moderate asthma. Annals of allergy, asthma and immunology. 1999;82:463-471. 6. Shapiro G, Bronsky EA, LaForce, CF, et al. Dose-related efficacy of budesonide administered via a dry powder inhaler in the treatment of children with moderate to severe persistent asthma. The Journal of Pediatrics; 1998;132:976-982. * Content supplied by AstraZeneca Pharmaceuticals medical chronicle | June 2011 | page 61 Men’s Health Understanding Testosterone Deficiency Syndrome Dr Poobalan Pillay Sports Physician, Ballito, KwaZulu-Natal Testosterone deficiency syndrome (TDS) and men’s health were the hot topics for discussion by urologist Dr Riaan Venter, endocrinologist, Dr Sindeep Bhana and sexologists, Drs Prithy Ramlachan, Lorraine Becker and Etienne Kok, at the Men’s Health Forum, hosted by Bayer Healthcare at the Selborne Country Club in KwaZulu-Natal last month. TDS is defined as the clinical and biochemical syndrome associated with advancing age and characterised by symptoms and a deficiency in serum testosterone levels. This condition may result in a decreased quality of life and can negatively affect multiple organ systems. Table 1: TDS-related somatic changes in men Androgen target organ Change Clinical signs Bones Osteopaenia/ osteoporosis Pain in bones Musculature Atrophy Neurasthenic weakness exhaustion Erythropoeisis Anaemia Chronic fatigue Libido Loss of libido Decreased sexual activity Potency Erectile dysfunction Impaired potency Adipose tissue Visceral deposition of adipose tissue Weight increase, obesity Fractures Lipomastia Metabolic effects Table 2: Typical symptoms in older men Osteoporosis Backache, fractures, decrease in height Body composition Increase in adipose tissue, lipomastia, gynaecomastia Muscle strength Muscle atrophy, diminishing strength, neurasthenic weakness Skin Dryness, lack of sebum production Sexual function Loss of libido, erectile dysfunction Anaemia Chronic fatigue, neurasthenic weakness Vegetative and subjective symptoms Hyperhidrosis, hot flushes, lethargy, lack of enthusiasm, apathy, lack of self-confidence, anxiety, depression, lack of perspective, sleep disorders Signs and symptoms of TDS include loss of libido, increased visceral fat, decreased lean body mass, depression, lethargy/fatigue, sleep disturbances, irritability, regression of secondary sexual characteristics and erectile dysfunction. Signs and symptoms In addition to the multiple aetiological causes of TDS, presentation may vary from patient to patient, therefore making an accurate diagnosis a challenge. There are six clinical changes that should alert doctors to the possibility of TDS: decreased sexual desire, decreased morning erections and quality of erections, decreased cognitive function, decreased lean body mass, body hair and skin changes, decreased bone mineral density and increased visceral fat. Restoring plasma testosterone levels to a normal range alleviates the symptoms of TDS and improves various aspects of wellbeing. Investigations Who are the potential candidates for treatment and how can clinicians best evaluate the situation and the success of treatment? It is vital for doctors to work-up the patient fully. This includes a detailed history and full physical examination. There are two questionnaires currently available for evaluating men with low testosterone levels. One of these is the Ageing Males’ Symptoms Questionnaire, which the patient has to complete. The health care professional then tallies the score in order to classify the patient as normal, little, moderate or severely symptomatic. In addition to the routine blood tests, testosterone profile, luteinising hormone, follicle-stimulating hormone and prolactin tests should be performed. In the past, a total testosterone level above 8.0nmol/ℓ was considered normal. However, the third Consultation of Sexual Medicine refers to levels of more than 12nmol/ℓ that does not usually require replacement and to 12-27nmol/ℓ as normal. Management Androgen replacement therapy can safely alleviate the detrimental effects associated with decreasing androgen levels in ageing men. It serves to treat patients with consistently low testosterone levels and symptoms associated with andropause. Treatment in these patients may positively impact on body composition, bone mineral density, angina, exercise-induced ischaemia and other androgen- regulated physiological functions. Several androgen replacement therapies are available for the treatment of andropause. In SA, these include oral preparations and intramuscular injections. Efficacy of treatment is typically measured by increases in serum testosterone levels. Vigilant monitoring of potential complications, such as increased haematocrit and gynaecomastia, should take place. As with any therapy, safety is of paramount concern. The major issue surrounding androgen replacement therapy is its potential role in prostate carcinogenesis. As far as the relationship between serum hormone levels and prostate cancer is concerned, there is no evidence that androgen supplementation increases the risk of cancer. However, androgen replacement therapy does promote the growth of already existing carcinomas, thus necessitating that patients undergo digital rectal examinations and prostate-specific antigen testing prior to treatment and thereafter annually. One of the latest treatment options is testosterone undecanoate 1000mg which involves a 12-weekly deep intramuscular injection administered for two minutes. The first and second doses should be administered six weeks apart. Individualisation of therapy is necessary to meet the patient’s needs. medical chronicle | June 2011 | page 63 Dermatology International Aesthetic Surgical Trends Dr Anton Potgieter, Consultant Plastic Surgeon For the first time in many years, the annual International Society Of Aesthetic Plastic Surgery (ISAPS) SA congress was held at a new venue in warm Cape Town weather at The Lord Charles Hotel in Somerset West. Delegates from around the country made the trip to listen to lectures from international invited speakers as well as local experts in their respective fields. The fat revolution Twenty years ago, fat was considered to be a fairly uninteresting tissue, primarily made up of swollen adipocytes, quietly doing very little other than storing up excess calories and tending to look unsightly. Well, the world has changed and plain, old, wobbly fat appears to be loaded with stem cells, which under the right circumstances, seems to be capable of the most remarkable feats of wound healing and regeneration. Dr Steve Ray from Oxford University provided fascinating insights into cell banking of adiposederived mesenchymal stem cells, and their potential uses in anti-ageing and regenerative medicine. Dr Domenico de Fazio from the University of Modena in Italy demonstrated the practical and re levant results of fat transplantation and liposculpture in his practice. Lipofilling of ‘deflated’ areas results in a remarkable, ‘youthful’ change Every other invited speaker echoed similar themes about the usefulness of fat. Dr Dirk Richter from Germany gave a very interesting presentation on periorbital rejuvenation combining classical skin excision with fat redistribution, while Dr Michael Sheflan from Israel impressed with his results of lipoaspirate and transfer. Dr Patrick Tonnard from Ghent University in Belgium provided some of the most compelling outcomes by showing the impressive results that can be achieved by combining his minimal access cranial suspension facelift procedure with microfat grafting. The ultimate message was: Lipofilling of ‘deflated’ areas, especially the subtle regions of the ageing face, will result in a remarkable, ‘youthful’ change. Bariatric surgery Weight reduction surgery, by means of gastric or intestinal procedures, has been increasing worldwide over the past few years. Many experts predict a ‘flood’ of massive weight loss patients lining up at the doors of aesthetic surgeons. Dr Dirk Richter gave several very useful lectures outlining his approach to managing patients who had successfully lost tremendous amounts of weight and required lower and upper body lifting procedures, abdominoplasty (tummy tuck) and thigh lifting. Polyurethane implants Most plastic surgeons who have used polyurethane-coated breast implants, talk about them like long-lost lovers. However, plastic surgeons over the years, have been schooled to be cynical and wary of these implants. Dr Tonnard gave one of the most thoughtprovoking presentations of the congress by initially critically evaluating the complication rates of the current ‘state-of-the-art’ breast prostheses and reminding delegates of the criticisms, theory and virtues of polyurethane-coated implants. He concluded by showing very low complication rates and excellent results over 15 years. Breast surgery Dr Sheflan started his presentation by recounting anecdotes about the idiosyncrasies of practicing in Tel Aviv, before reminding everyone to be cognisant of how female breasts will age over the years and then provided ways to prevent and deal with the problems that may arise. Ethics Elsabe Klinck, a legal consultant, gave a very useful lecture covering issues such as informed consent, medical tourism, health law and the new, controversial Consumer Protection Act. Jeremy Gardiner from Investec in Cape Town spoke about the state of the local and world economy as well as reminding delegates of the events of the past year, which contributed to the current world economic situation. His extremely polished presentation included stirring footage from the world cup, which had a few members in the audience wiping their eyes. In addition … Local speakers provided experience on some of the emerging technologies and the trade exhibitors didn’t disappoint by launching other new and potentially very useful devices. Dr David Presbury updated the audience about the various uses of lasers, while Dr Vernon Ching discussed his experience with the Slim-Lipo system and Dr Ewa Siolo described the use of assisted high definition liposelection sculpture (VASER) in her practice. Dr Michael Colonna ran a workshop on the Canfield VECTRA X3 Imaging System, which performs amazing pre- and postoperative analyses of patients’ results. Clinical workshops were also held at the Somerset West Aesthetic Clinic, where Dr Ching performed a live Slim-Lipo demonstration, followed by Dr Vivien Jandera who demonstrated advanced techniques of Restylane injections. page 64 | medical chronicle | June 2011 Vaccines Improved Addition Offers Broadest Coverage of Any Pneumococcal Conjugate Vaccine Prevenar 13® (13-valent pneumococcal conjugate vaccine, Pfizer Laboratories) was developed as a successor to Prevenar® and includes the 13 most prevalent serotypes in young children worldwide. Prevenar 13 is based on the scientific foundation of Prevenar and uses the same CRM197 carrier protein and conjugation technology that has been utilised in various paediatric vaccines. Invasive pneumococcal disease remains a leading cause of morbidity and mortality in children below the age of five years and accounts for approximately 11% of all deaths in this age group throughout the world. Pneumococcal infect ions remain the leading cause of death from a vaccine-preventable illness in children younger than five years of age. Prevenar 13 contains the seven serotypes already included in Prevenar, plus six additional pneumococcal serotypes 1, 3, 5, 6A, 7F and 19A, which will increase the percentage of vaccinepreventable cases of invasive pneumococcal disease by to up to 90% or more in most regions of the world. The paediatric serotypes, 6A and 19A, now included in this vaccine, are known to be major causes of serious pneumococcal disease in a number of countries, including SA and have a tendency to develop resistance to commonly used antibiotics. Increased serotype coverage of Prevenar 13 is expected to have a substantial public health and economic impact by preventing substantially more pneumococcal disease and childhood mortality than currently licensed pneumococcal conjugate vaccines. References 1. De Gouveia L, Von Gottberg A. Streptococcus pneumoniae. Comm Dis Surveillance Bull 2010;8(2):38-41. 2. Duggan ST. Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed) [Prevenar 13®]. Drugs 2010;70(15):1973-86. 3. PneumoADIP. Pneumococcal Global Serotype Project. Available at: www.preventpneumo.org/ pdf /GSP%20Summary%20for%20S AGE%20 Nov6-8%202007_Oct%2019-07.pdf 4. Reinert RR, Paradiso P, Fritzell B. Advances in pneumococcal vaccines: the 13-valent pneumococcal conjugate vaccine received market authorization in Europe. Expert Rev Vaccines 2010;9(3):229-36. * Content supplied by Pfizer Laboratories Pneumococcal Vaccination Helps Prevent Pneumonia Preventing pneumococcal infection through vaccination curbs the incidence of pneumonia-related cases, because most pneumonia is not caused directly by the influenza virus, but occurs as a secondary bacterial infection, according to National Research Foundation A-rated scientist, Shabir Madhi, professor of vaccinology at the University of the Witwatersrand. However, there are instances where influenza, in itself, can cause pneumonia. High-risk populations groups are especially at risk of acquiring pneumonia. The HIV epidemic claims the lives of many South Africans, particularly children, as a result of pneumococcal pneumonia and influenza. Streptococcus pneumoniae or pneumococcus is responsible for pneumococcal pneumonia. Examining and understanding the sombre ‘shadow’ cast by this bacterium, Prof Madhi has undertaken groundbreaking research internationally for years. Streptococcus pneumoniae was first described over 100 years ago and there are now effective antibiotics available for the treatment of pneumococcal infections in humans, however antibiotic resistance is an issue and prevention strategies are becoming increasingly important. According to Prof Madhi, the massive increase in HIV infection has led to a surge in the number of patients succumbing to pneumococcal disease. Many children and some adults, especially those infected with HIV, harbour pneumococci in their nose and throat and acquire these from other carriers. The organisms may invade the body and cause active disease which manifests differently in the various parts of the body. Pneumonia is a common consequence, but serious blood infections and even meningitis are possibilities. “Although vaccines are widely available to most children in developed countries, the challenge remains in making these vaccines available and affordable to children where childhood mortality from pneumococcal disease is greatest,” stated Prof Madhi, who has focused much of his research on pneumococcal vaccines and the many issues surrounding their use, especially in developing countries. “The battle against pneumococci is slowly being won, but it remains to be seen whether this bacterium will adapt to the antibiotics currently being used and continue to be ‘the captain of death of men’ in developing countries. Until then, prevention of pneumococcal disease needs to be coupled with optimising the management and treatment of individuals who become ill because of this dreaded bacterium,” concluded Prof Madhi. medical chronicle | June 2011 | page 65 Prof Reid Ally Dr Keith Pettengell Dr John Wright Gastroenterology Forum Heartburn, Normal Endoscopy - What Next? Gastro-oesophageal reflux disease (GORD) is becoming an increasingly common clinical problem. The current prevalence is estimated to be between 10% and 20% in western countries and 5% in Asia. Consultation rates have been estimated at only 20%40% of sufferers, as the majority self-medicate. Heartburn and acid regurgitation are significantly related to acid reflux episodes identified on 24-hour oesophageal pH studies. Heartburn has a sensitivity and specificity of around 70% for GORD. Other symptoms such as the globus syndrome, hoarseness and cough, chest pain, nausea and pain on swallowing may all be due to GORD, but the relationship is not specific. When further investigation of heartburn becomes necessary, endoscopy is the first step, but unfortunately there is little or no correlation between heartburn, its frequency and severity, and endoscopic findings. Erosive oesophagitis and even Barrett’s oesophagus may exist in the absence of heartburn and daily severe heartburn may be present in patients with a normal endoscopy. In a series of 149 consecutive patients with heartburn, 71 had a normal endoscopy. This group was then investigated with 24-hour oesophageal pH monitoring. Approximately 52 had abnormally high oesophageal acid exposure and can be classified as nonerosive reflux disease (NERD) while 19 had normal acid exposure. Of these 19 patients, seven had heartburn correlated with episodes of physiological reflux. This group can be described as having a hypersensitive oesophagus. The 12 other patients had heartburn unrelated to any episodes of acid reflux and for this group, the term ‘functional heartburn’ is appropriate. Functional heartburn In patients with NERD, symptoms are similar to those patients with erosive oesophagitis. Such patients demonstrate an enhanced sensitivity to acid within the oesophagus but also to mechanical stimulation (balloon distension), and for this reason, tend to have a suboptimal response to proton pump inhibitor (PPI) therapy. In patients with functional heartburn where symptoms are unrelated to episodes of oesophageal acid exposure, the putative mechanisms include bile reflux, alkaline reflux, volume distension, hyper-vigilance, abnormal central sensory processing and psychological-related factors. Patients with functional heartburn have little or no response to PPI therapy. Diagnosis The diagnosis of NERD is not altogether straightforward, as it implies no recent treatment that might heal erosive disease, prior to the endoscopy. However, the condition cannot be diagnosed without endoscopy, as the range of symptoms is similar to those of erosive reflux disease (ERD). The quality of life in patients with NERD is similarly impaired to that of GORD patients and is equivalent to that found in patients with ischaemic heart disease. In general, NERD occurs less frequently in the elderly. Progression to ERD seems to be infrequent occurring in only around 10% or less of patients. NERD sufferers are more likely to have functional dyspeptic symptoms accompanying their heartburn, such as bloating, burping and easy satiety than their ERD counterparts. However, NERD itself is not without pathology. Recent investigations using the new generation of high definition endoscopes and confocal endomicroscopy have shown evidence of micro-erosions and vascular abnormalities (capillary dilatation and increased capillary looping) at the junction where the pale oesophageal squamous mucosa meets the glandular. In general, the response rate of NERD to PPI therapy in controlled clinical trials is lower than that of ERD and it may take 10-12 weeks for complete relief of heartburn on standard PPI therapy in NERD patients. Doubling the dose has not been shown to improve response. Many NERD patients may require long-term maintenance therapy. Management So when confronted with a patient with heartburn and a normal endoscopy, what should one do? Firstly, think again of a cardiac cause for the patient’s symptoms and if necessary, actively exclude this. Then it is time for a trial of PPI therapy in either standard or double dose, and this may need to be continued for 10-12 weeks. Where a good response is achieved as it will be in NERD patients and some with a hypersensitive oesophagus, this group can be treated as any other GORD patient. Where the response is inadequate, compliance and dose scheduling should be checked, remembering that most PPIs should be taken on an empty stomach. If all is in order, the patient should be referred for 24-hour oesophageal pH monitoring. This will sort out those patients with acid-related disease from nonacid-related disease. However, such referrals will be unusual. processing of visceral stimuli would seem appropriate and is well worth a three-to-four-month trial. Treatment Most patients with endoscopy-negative heartburn will have NERD and will respond to treatment in the same way as ERD patients. A small proportion of patients will not improve on prolonged PPI therapy and have either a hypersensitive oesophagus or functional heartburn. PPI failures should be referred to 24-hour oeso phageal pH monitoring to establish the diagnosis and guide therapy. The utmost care should be taken to avoid referring patients with functional heartburn or a hypersensitive oesophagus for antireflux surgery. References available on request. For the majority of patients with heartburn and a normal endoscopy, PPI treatment (eventually) will prove effective. For patients with functional heartburn, treatment remains empirical. Alginates and sucralfate have their proponents. Baclofen has recently been shown to reduce transient lower oesophageal sphincter relaxations and to be beneficial in patients with bile reflux. Although convincing evidence is lacking, the use of tricyclic antidepressants in a low dose to reduce visceral hypersensitivity and modify the central Conclusion page 66 | medical chronicle | June 2011 Gastroenterology Symptoms of Paediatric Oesophagitis Abstract: Children and adolescents with symptomatic gastro-oesophageal reflux disease (GORD) and erosive oesophagitis (EO) of grade ≥2 or nonerosive oesophagitis (NEO) were assessed to determine the relationship between presenting symptoms, oesophagitis severity and patient age. Overall, regurgitation/vomiting, abdominal pain and cough were the most frequent symptoms. The prevalence and severity of anorexia/feed refusal was significantly greater in EO vs NEO children. This symptom was also significantly more prevalent in younger children (aged one to five) (both NEO and EO groups) compared to older children. Cough was significantly less severe in NEO adolescents than in younger children. Cough, anorexia/feed refusal and regurgitation/vomiting were more severe and heartburn was less severe in EO children aged one to five years compared with older patients. In conclusion, GORD in children manifests differently than in adults and symptoms vary with patient age. Symptoms were not predictive of presence or lack of mucosal damage. Discussion Heartburn is often referred to as the hallmark symptom of GORD among adults. In contrast, regurgitation/vomiting, abdominal pain and cough were the most common presenting symptoms seen in the paediatric patients with GORD in this study; >60% of children and adolescents reported these symptoms. Interestingly, with one exception, no significant differences were observed in the prevalence and/ or severity of the symptoms between children with NEO and EO. The prevalence and severity of anorexia/feed refusal, albeit a less frequently reported symptom, was significantly greater among those with EO compared with those without erosive disease. This seems understandable. EO is more likely to be associated with odynophagia and/or dysphagia, although to date this has not been studied in children. Several interesting trends emerge when symptoms associated with NEO and EO are stra tified by patient age. Anorexia/feed refusal was more common among younger children (one to five years) than older patients. In patients with EO, the severity of anorexia/feed refusal, regurgitation/vomiting and cough as well as the prevalence of anorexia/feed refusal were found to be significantly greater in the younger children compared with their older counterparts. On the other hand, heartburn was less severe in the younger patients with EO compared with older children with EO. This is not surprising; younger children may find it difficult to recognise or articulate the symptom of heartburn. The other manifestations of reflux in younger children are physical signs rather than symptoms and therefore do not require descriptive cognitive ability by the child. Symptoms of GORD are considerably different in children from those in adults Making the diagnosis of GORD in childhood is important for several reasons. Firstly, data suggest that some early childhood GORD persists into adolescence and that GORD in children and adolescents often persists into adulthood. Although these studies are flawed in some respects, including their retrospective designs, their conclusions are probably true for patients with GORD that is severe and chronic or recurrent. Secondly, it is reasonable to speculate that early detection and treatment of GORD in children and adolescents may result in fewer complications such as growth failure or poor weight gain, severe EO and peptic stricture. This has been shown for peptic stricture in adults, but not for the other complications in childhood. Furthermore, early treatment intervention may also result in improved quality of life and ultimately reduce the overall health care burden. However, there is no evidence to indicate that the development of serious, rare complications of GORD, such as Barrett’s oesophagus and oesophageal adenocarcinoma, can be prevented by intervention with medical or surgical antireflux therapy. In conclusion, data show that the presenting symptoms of GORD are considerably different in children from those in adults, in whom heartburn is the most common. In addition, symptoms of GORD differ between age groups in children. Regurgitation/vomiting, abdominal pain and cough were the most frequently reported symptoms in children and adolescents in the study. However, the presence and severity of these frequently encountered symptoms were not predictive for EO vs NEO in our study. Cough and anorexia/feed refusal appeared with greater frequency and severity in younger children. Although a less frequently reported symptom, anorexia/feed refusal was more prevalent in EO than NEO patients. Evaluation for GORD should be initiated when the above symptoms are present, particularly the atypical symptoms that occur in younger children. Excerpted from: Gupta SK, Hassal E, Chiu Y-L, et al. Presenting symptoms of nonerosive and erosive esophagitis in pediatric patients. Dig Dis Sci 2006;51:858-863. medical chronicle | June 2011 | page 67 Gastroenterology Older Colon Cancer Patients Have Less Side Effects with Chemo after Surgery Even though older patients with colon cancer are less likely to receive chemotherapy following surgery because of concerns of adverse events, new research indicates that when they do receive this treatment, it is less toxic and of shorter duration than therapy younger patients receive. In addition, older patients experience fewer adverse events, according to a study published in the March 2010 issue of the Journal of the American Medical Association (JAMA) dedicated to cancer. Dr Robert Fletcher from Harvard Medical School in the US presented the findings of the study at a JAMA media briefing. Randomised trials Randomised trials have shown reductions in cancer death and recurrence in patients with stage III colon cancer treated with adjuvant (supplemental after surgery) chemotherapy, with clinical trials also showing that surgery and adjuvant chemotherapy increases survival over surgery alone in selected patients with this stage of colon cancer. Average number of unique adverse events was higher for adjuvant chemotherapy users vs nonusers But, in practice, older patients with stage III colon cancer are much less likely to receive this treatment. “Doctors cite the lack of randomised controlled trials evaluating the effectiveness of adjuvant chemotherapy for patients older than 80 years as well as comorbid (co-existing illnesses) conditions and drug toxicities as the most common reasons for not treating older patients with adjuvant chemotherapy,” the authors wrote. Analysis Dr Fletcher and colleagues analysed the use of adjuvant chemotherapy and adverse events by age, through medical records and surveys, in a multiregional group of 675 patients diagnosed with stage III colon cancer from 2003 through 2005, who underwent surgical resection (removal of part of the colon). The patients, who were followed up for as long as 15 months after their diagnosis, were from five regions (Alabama, Iowa, Los Angeles County, northern California and North Carolina), five integrated health care delivery systems, and 15 Veterans Affairs hospitals. Results The researchers found that overall, 513 of 675 patients with stage III colon cancer (75%) received any adjuvant chemotherapy. Of the 202 patients 75 years and older, 101 (50%) received supplemental chemotherapy compared with 87% of younger patients. Patients aged 65 years and older were more likely than younger patients to discontinue chemotherapy at all follow-up times. For example, by 150 days, 40% of patients at least 65 years old had discontinued chemotherapy, compared to 25% of younger patients. Among patients receiving adjuvant chemotherapy, adjusted rates of late clinical adverse events were lower for patients 75 years and older vs for younger patients. Regarding adverse events, 24% of patients had at least one adverse event (defined as 31 days after resection and 15 months after diagnosis). These events occurred in more than twice as many patients receiving vs not receiving adjuvant chemotherapy. The average number of unique adverse events was also higher for adjuvant chemotherapy users vs nonusers. “Strategies to help clinicians who are uncertain about the safety of adjuvant chemotherapy for older patients with comorbidity could increase the likelihood that evidence-based chemotherapy benefits are realised in population-based settings. Using decision support tools built on published trials and population-based analyses such as these can help clinicians predict effectiveness of chemotherapy, even for patients with comorbid conditions and advanced age,” the authors wrote. “Systematic monitoring of symptoms and signs among chemotherapy users, combined with interventions to evaluate and treat these clues, could help clinicians support patients in meeting evidence-based treatment dosage and duration goals. “Clinicians who identify symptoms and signs early and take steps to avoid serious adverse outcomes may enable their patients to complete recommended treatment courses while also improving quality of life.” Source JAMA 2010;303(11):1037-1045. medical chronicle | June 2011 | page 69 HIV Forum Dr Fatima Laher Understanding HIV, HAART and Preterm Birth A preterm birth is defined as birth before the 37th week (258 days to be exact) of gestation. Especially in the context of low birth weight, preterm birth is associated with adverse infant outcomes, such as early neonatal mortality and a long list of morbidities. The incidence of preterm birth is variable by region. A World Health Organization (WHO) Bulletin in January 2010 reported the highest incidence (17.5%) in southern Africa and the lowest (3.8%) in eastern and central Asia. Multiple risk factors for preterm labour have been identified, including low socioeconomic status, maternal age <18 or >40 years old, smoking, stress, low zinc levels, maternal underweight and infections, to name a few. The latter two may be seen more often in untreated HIV cases. In SA, is untreated HIV a risk factor for preterm delivery, as compared to HIVnegative women? To answer this question, Prof Eckhart Buchmann from the Department of Obstetrics at the University of the Witwatersrand, shared his re-analysis of a study published in the journal Obstetrics and Gynecology in 2004 with his colleague Dr Karlyn Frank. The study included women who had given birth in 2002 at midwife-run clinics or at Chris Hani Baragwanath Hospital in Soweto. At this time, highly active antiretroviral therapy (HAART) was not available in SA. Results showed that in HIV-negative women, the rate of preterm birth was 19.6% and in untreated HIV-positive women, it was 25.4% (p=0.0015). This phenomenon of a higher rate of preterm birth in HAART-naïve HIV-positive women remained significant, even when women with pre-eclampsia, the most common reason for iatrogenic preterm birth, were excluded: 17.6% vs 24.7% preterm in HIV negative vs untreated positive women respectively (p<0.0001). In 2011, untreated HIV during pregnancy is not an option. The benefits of antiretroviral therapy for mother and child are indisputable. The appropriate use of HAART can reduce vertical transmission to <1%. Current national guidelines firmly recommend HAART for those who qualify, e.g. a CD4 <350 cells/mm3, or those who have WHO Stage 4 disease, or tuberculosis (TB), and a short course of azidothymidine (AZT) is advocated in pregnancy for women who do not qualify for HAART. Some studies report protease inhibitor HAART regimens in pregnancy as a risk factor for low birth weight, but not preterm delivery. My own work with colleagues at the Perinatal HIV Research Unit confirms no difference in preterm rates when comparing final trimester use of protease inhibitor vs efavirenz vs nevirapine in patients also taking two nucleoside reverse transcriptase inhibitors. While no intervention has been proven to ob literate preterm incidence, here are some reasonable suggestions for expectant HIV-infected mothers worried about preterm delivery. Firstly, treat HIV in pregnancy: Give the baby the best chance of survival. Remember to provide HAART to pregnant women who qualify (contrary to the incorrect practice of some health care workers who merely prescribe short-course AZT to all pregnant women). Secondly, cotrimoxazole prophylaxis (two singlestrength tablets a day) should be given to pregnant women with CD4 counts <200 cells/mm3, regardless of the trimester or breastfeeding status. This (despite rumours) is not controversial. It is a WHOendorsed recommendation. Even though the mode of action of cotrimoxazole is inhibition of folate synthesis, there is no evidence of an increased risk of adverse events in pregnancy. The maternal-foetal benefits overwhelmingly outweigh any theoretical foetal risks. A landmark Zambian study found significantly improved outcomes in pregnant HIV-positive HAART-naïve women with CD4<200 cells/mm3 who used cotrimoxazole - less chorioamnionitis (0% vs 6%), less prematurity (18% vs 31%), and fewer neonatal deaths (0% vs 9%) in those who had taken cotrimoxazole through pregnancy compared to those who had not. Thirdly, treat all infections such as asympto matic bacteriuria, TB, opportunistic infections, etc, timeously. Finally, the importance of adequate nutrition cannot be overemphasised. While the value of nutritional intervention has not been demonstrated in a clinical trial, multiple observational studies link low maternal weight with preterm birth, including one study published in the Journal of Obstetrics and Gynaecology Research, 2009, which reported weight gain <0.25 kg/week and body mass index <20 kg/m 2 as independent risk factors for preterm delivery. Nutritional supplements, such as Ensure, may be a valuable adjunct. For more information, contact Dr Fatima Laher, University of the Witwatersrand Donald Gordon Medical Centre, on 011-482-8297/8, or visit www. hivdoctors.weebly.com page 70 | medical chronicle | June 2011 Pain Management The Evidence for Tramadol/Paracetamol as Add-on Treatment in Pain Three randomised, double-blind, placebo-controlled studies and a subgroup analysis of one study assessed the efficacy of tramadol/paracetamol 37.5mg/325mg fixed-dose combination as add-on therapy in patients with moderate to severe rheumatoid arthritis pain, osteoarthritis pain or pain associated with an osteoarthritis flare. Patients had osteoarthritis pain with osteophytes (confirmed by radiograph within two years of study), osteoarthritis flare pain for two to five days or pain associated with symptomatic rheumatoid arthritis for ≥2 days before study entry. Eligible patients had pain scores of ≥40 or ≥50mm on visual analogue scale (VAS) and at least moderate pain on a four-point scale, symptomatic osteoarthritis of the hip or knee for ≥1 year or rheumatoid arthritis (diagnosed according to American College of Rheumatology criteria) for ≥6 months. Patients also had to be receiving stabledose nonsteroidal anti-inflammatory drugs (NSAIDs), cyclo-oxygenase (COX)-2 inhibitors and/or disease-modifying antirheumatic drugs (DMARDs) for two weeks or ≥30 days prior to study entry. Tramadol/paracetamol add-on therapy for up to three months was effective in providing pain relief and improving health-related quality-of-life (HR-QOL) in patients experiencing moderate to severe osteoarthritis flare pain, osteoarthritis pain or rheumatoid arthritis pain. In patients with osteoarthritis flare pain, mean daily pain relief and pain intensity scores through days one to five improved significantly with the addition of four to eight tablets/day of tramadol/ paracetamol to ongoing treatment with NSAIDs or COX-2 inhibitors (primary endpoint, with improvements being sustained until study end (day 10)). A dose-dependent effect on pain relief was observed, with two tablets (but not one tablet) providing significant (p=0.037 vs placebo) pain relief, as assessed by the sum of pain relief and pain intensity difference scores during the first four hours after the initial dose. In addition, add-on treatment was assessed as ‘very good’ or ‘good’ by more patients and doctors than ongoing treatment. Tramadol/ paracetamol add-on therapy for up to three months was effective in relieving pain HR-QOL parameters also improved with tramadol/paracetamol add-on therapy relative to existing therapy in this study, as indicated by significantly (p<0.05) lower overall Western Ontario and McMaster Universities osteoarthritis index (WOMAC) questionnaire scores (table VIII) and scores for the individual WOMAC items of pain and physical function in tramadol/paracetamol recipients. There was no significant betweengroup difference for the category of joint stiffness. Furthermore, a subgroup analysis of this study showed that the addition of tramadol/paracetamol to existing treatment was also beneficial in elderly patients (aged ≥65 years) with osteoarthritis flare pain. Significant (p<0.05) improvements in efficacy outcomes and overall WOMAC scores, as well scores for the WOMAC items of pain and physical function (but not joint stiffness), were observed with tramadol/paracetamol relative to placebo add-on therapy in these patients. Patients with rheumatoid arthritis or osteo arthritis pain also experienced significant pain relief with the addition of tramadol/paracetamol to ongoing treatment with NSAIDs, COX-2 inhibitors and/or DMARDs. Add-on treatment with up to eight tablets per day of tramadol/paracetamol for seven days in patients with rheumatoid arthritis and for three months in patients with osteoarthritis resulted in significant improvements in mean daily pain intensity or VAS scores, as well as pain relief scores, relative to existing therapy. In addition, add-on treatment was assessed as ‘very good’ or ‘good’ by more patients and doctors than ongoing treatment in both studies. In both studies, HR-QOL parameters (as assessed by WOMAC and SF-36 scores or the Health Assessment Questionnaire score) did not differ significantly between patients receiving tramadol/paracetamol add-on therapy and those continuing on existing therapy, with the exception of significant (p<0.05) improvements with add-on therapy in the WOMAC category of physical function and the SF-36 category of rolephysical in patients with osteoarthritis. Excerpted from: Dhillon S. Tramadol/Paracetamol fixed-dose combination: A review of its use in the management of moderate to severe pain. Clin Drug Invest 2010;30(10):711-38. * Content supplied by Janssen medical chronicle | June 2011 | page 71 Pain Forum Dr Luc Evenepoel The Impact of Genetics on Painkillers The therapeutic effect of most drugs varies from patient to patient. For example, some patients find that pethidine makes them nauseous, but not morphine (or vice versa), or that the one works better than the other - yet both drugs act on the same receptors. There are several reasons for this inter-individual variability: age, comorbidities, interactions with other drugs, ethnicity, etc. However, 20%-40% of the perceived differences seem to be genetic. In future, it will be possible to determine the genetic code of all patients, and treat them with the drugs that are the most appropriate for them individually. This is in the distant future, but we can already learn valuable lessons from the early results of this new branch of pharmacology, called pharmacogenetics. Genetics can explain interindividual variability of drug effects via, among others, differences in drug absorption and their binding to receptors. The most important seems to be the influence on drug metabolism. The ‘cytochrome P450’ group of enzymes responsible for drug metabolism is rather heterogeneous and allows people to be categorised as ‘poor metabolisers’ (PM), ‘intermediate metabolisers’ (IM), ‘extensive metabolisers’ (EM) and ‘ultra metabolisers’ (UM). Genetics can explain interindividual variability of drug effects What are the practical applications? Some drugs are prodrugs: they need to be etabolised into their active form (e.g. codeine, m tramadol). They will be effective in UM and EM, but not in IM and PM. UM and EM experience good pain relief with codeine, but might also suffer morphine-like side effects such as respiratory depression. On the other hand, codeine does not give any pain relief to PM, but might still show adverse effects such as sedation. Approximately 46% of children studied have inadequate analgesia after codeine, but do become sedated (as many mothers know, codeine-containing preparations are sometimes used solely to keep children quiet). Drugs that need not be metabolised to be active (pethidine, morphine, fentanyl etc.), will be more effective in PM and IM, and less so in EM and UM because of their faster breakdown. Females seem to metabolise pethidine, fentanyl and midazolam 40% faster than males. PM have a decreased pain threshold and tolerance: They feel more pain, but are more responsive to opioids such as morphine, pethidine, etc. The reason is probably that they synthesise less endogenous opioids. Genetic differences are not only responsible for opioids’ inter-individual variability in analgesic effect, but also for their side effects: • A certain opioid might cause less nausea and sedation than another for the same analgesic effect, allowing for a higher tolerance. However, the respiratory depressant effect may be the same. Traditionally, it was thought that opioid-induced sedation precedes respiratory depression, and acts as a warning signal, but this is not always the case. • Red-haired, fair-skinned females (but not males) seem to have a genetically increased sensitivity for certain opioids, and a naturally inhibitory mechanism against pain. All of the factors mentioned are also applicable to other analgesics, like nonsteroidal anti-inflammatory drugs (NSAIDs) and paracetamol, but clinical studies are still lacking. Anecdotally though, many patients who tried different NSAIDs report that the one works better for them than another. Very little research has been done about the variability in efficacy of local anaesthetics, yet, again anecdotally, we know that they seem to be less effective in some patients than in others. Routine access to every patient’s genetic code will not happen for at least another decade or so, but we can use the early findings of pharmacogenetics to adjust our prescription habits in the following ways: • One drug does not fit all, and one dose definitely does not fit all. Peri-operatively, intravenously titrate opioids to effect, either manually (in the recovery room), or via patient-controlled analgesia pump in the ward. • Ask your patients which opioids they received previously, and what their effect and side effects were. Did morphine help? Or did it make them so nauseous that it needed to be changed to pethidine? Did tramadol help at all, or did it have more side effects than analgesic effect? • Ask which oral painkillers that they use at home are effective for them. You might find that diclofenac helps, but not ibuprofen, or that mefenamic acid works well for their menstrual pain, but not for anything else. Do codeine-containing preparations give them more relief than noncodeine ones? Or do they only suffer the side effects (e.g. constipation) without any extra analgesic effect? • If there is no history available, try one analgesic and change to another one of the same group if needed. • Ideally, stay away from combination preparations, and prescribe paracetamol and the NSAID separately. Explain to the patients that the drugs work on different receptors in the body, and that they themselves must try out what works best for them: the one, the other or the combination? medical chronicle | June 2011 | page 73 Pain Management Responsible Self-management of Pain, Fever: Taking Patients Back to Basics In the management of pain and fever, it is important to remind patients from time to time of the side effects and dangers of using over-the-counter (OTC) medicines in combination with other drugs, or if they have underlying conditions. In the interests of holistic patient care, there is also room for taking patients back to basics and advising them of the place for nonmedicinal treatment, at least in certain stages of pain and fever. Fevers over 38°C are generally signs that the patient could benefit from some kind of medication to reduce the fever. However, patients often rush to selfmedicate at the first sign of fever, without considering the important role that fever plays in fighting infection. Fever serves as one of the body’s natural defences against bacteria and viruses that cannot live at a higher temperature. For that reason, low fevers should normally go untreated, unless they are accompanied by further symptoms such as pain or swelling. 41.6°C The temperature from which fevers are considered high-grade and dangerous While values may vary according to different clinicians and the condition and age of the patient, generally, low-grade fevers range from about 37.7°C-38.3°C while high-grade fevers range from about 39.4°C-40°C and higher. Dangerous highgrade fevers range from over 41.6°C or higher (also termed hyperpyrexia). Pain can be classified as acute (short duration, identifiable pathology, a predictable prognosis and usually due to injuries) chronic nonmalignant (goes on for longer, associated with progressive, debilitating diseases such as arthritis) and chronic malignant (advanced, progressive diseases such as cancer). Headaches are the most common cause of pain and can be considered a separate class of pain, and can generally be described under three categories: muscle contraction, migraine or vascular, and sinus headaches. In all cases, OTC medications are a first line of relief. However, people with chronic pain should be warned against overuse, which can lead to side effects. Stronger prescription medications are usually necessary for chronic malignant pain. Paracetamol is the analgesic of choice for mild to moderate pain and is also used to reduce fever. It is suitable for both adults and children and is safe for people who do not have stomach ulcers and who cannot take aspirin. Aspirin, the common name for acetylsalicylic acid, is a nonsteroidal anti-inflammatory drug and one of the most common OTC analgesic drugs in use today, having been used since the 1890s. Both of these medicines work by inhibiting prostaglandin in the brain. When injured, the body produces prostaglandins, which are complex fatty acids that act as hormones within body tissues. Prostaglandins act by stimulating the dilation of blood vessels and muscle contraction, which are the beginning of pain. Paracetamol products are suitable for most people including the elderly and young children. It does not interact negatively with other treatments and can generally be taken by people who are sensitive to aspirin. Paracetamol is also well tolerated by people with peptic ulcers and generally, by asthma sufferers. Because of its broad-spectrum usage, there is a danger that it can be overused, leading, in extreme cases, to liver damage. While highly effective, aspirin should not be used by pregnant and breastfeeding women, people who suffer from asthma or other breathing-related disorders, who have a history of bleeding, gout or ulcers, as well as chronic alcohol usage. Just about every household contains aspirin; however, children under age 17 are never given aspirin because of the concern about Reyes syndrome, a potentially deadly disease affecting the brain and the liver. In particular, adults and children should not take aspirin before or during a viral illness. The probability of contracting Reyes syndrome is small, but there is no need to take the risk when other pain relievers are available. In addition to reminding consumers about the possible side effects and dangers of combining medicines when self-medicating their pain and fever, it is also useful to inform patients about alternative methods of treating their symptoms. For early treatment of fever, simple instructions such as the importance of maintaining body fluid by drinking as much water as possible, rest, avoiding sudden changes in atmospheric temperatures and taking tepid baths constitute sound advice. The management of pain, especially chronic pain, offers many alternatives that do not include medication, including acupuncture, guided imagery, chiropractic treatment, yoga, hypnosis, biofeedback, aromatherapy, relaxation, herbal remedies, massage and many others. page 74 | medical chronicle | June 2011 Pain Management Countering Abuse of Over-the-counter Drugs André Esterhuizen Pharmacist With the increase in self-medication by patients, awareness raising is vital to prevent abuse or misuse of certain drugs. Although the most serious consequences of abuse of medicines occur with prescription drugs as these are usually more potent and have a higher potential for abuse, the most common form of widespread abuse occurs with overthe-counter (OTC) drugs, as these are generally much more accessible. Pharmacists and pharmacists’ assistants therefore have an important role to play in enforcing the correct and safe use of OTC drugs. Abuse and misuse of medicines occur when they are used for a purpose and/or in a quantity which falls outside of its licensed indication. Almost any medicine that can be purchased without a prescription can be abused. Even unscheduled preparations of paracetamol and aspirin that can be purchased from a supermarket are sometimes used in excessive quantities and for a purpose outside of its licensing. The most commonly abused OTC drugs are those that have stimulant, sedative or euphoric effects. Laxatives can also be abused for weight loss purposes. Stimulants are found in almost all cold and flu preparations, as they have a decongestant effect in the sinuses. The stimulant effect results from an agonistic effect on the sympathetic nervous system which results in increased alertness, mental performance and energy. Examples include ephedrine, pseudoephedrine and phenylpropanolamine. Sedatives include opioid pain killers, of which codeine is the only available OTC agent. Antihistamines and cough suppressants are also abused for their sedative, stress-relieving and euphoric effects. In excessive quantities, some formulas may even induce psychosis. These drugs generally include the painkiller and cough suppressant, codeine, the antihistamines, diphenhydramine, doxylamine, cyclizine and promethazine, as well as cough suppressants, dextromethorphan, noscapine and pholcodine. A number of measures are in place to curb the abuse of drugs. It is the responsibility of the pharmacist and pharmacists’ assistants to enforce these. A true addict will obviously find ways of purchasing the drugs by visiting different pharmacies and fabricating a problem, but it is any pharmacist’s responsibility to ensure, as far as possible, that this does not occur under his or her authority. The various measures that are in place and are required by law include the following: 1. Supervision Any scheduled substance has to be purchased under the supervision of a pharmacist. This is to ensure that a sale can be refused should misuse of any substance be suspected or that correct advice can be given regarding the correct use of a substance. 2. Accessibility This ties in closely with the supervision requirement. Scheduled substances should be kept out of reach of the general public behind a counter to eliminate self-selection of drugs and force the sale to go via a pharmacist. 3. Pack sizes or quantities Unscheduled substances which can be bought from a supermarket or via self-selection are available in small packs only. Examples of this is paracetamol, which is unscheduled in small pack sizes, but classified as schedule 1 in bigger packs, to prompt intervention by a pharmacist, should larger quantities be required. Following widespread abuse and the manufacturing of illicit drugs from ephedrine and pseudoephedrine, all pure ephedrine-containing products have been reclassified as schedule 6. It is still available in cold and flu remedies, provided it is combined with another substance and that it not sold in a quantity exceeding 720mg. Most pack sizes for products containing these agents have been changed accordingly and it is illegal to sell more than that quantity to any given customer. 4. Licensed indications All products that can be bought without prescriptions are for symptomatic relief only and the box or package insert will state that the treatment period should not exceed a certain number of days without consulting a doctor for a proper diagnosis. It is important to enforce this, as some substances such as codeine and certain antihistamine combinations are still available in large packs and are heavily abused for purposes other than tension headaches or cough suppression, for which they are indicated. 5. Record keeping The details of the person buying any scheduled substance must be recorded. This includes the name and quantity of the drug purchased, the date, as well as the name and address of the purchaser. This obviously provides details of how regularly a certain drug is purchased. In SA, larger pharmacy chains have computer systems that are linked within the company. Ideally, there should be a system that links all pharmacies across the country, which will help to identify addicts who purchase the various drugs at different pharmacies. Pharmacists can also choose not to sell certain products over-the-counter if abuse is suspected in certain instances. Measures such as not stocking a product or keeping stock out of sight and only selling them on prescription are sometimes employed. *Article written on behalf of Adcock Ingram Healthcare medical chronicle | June 2011 | page 75 Nutrition Forum Nutritional Insights: Enteral Feeding Acute pancreatitis creates a catabolic stress state promoting a systemic inflammatory response and nutritional deterioration. Adequate supply of nutrients plays an important role in recovery. Total parenteral nutrition (TPN) has been standard practice for providing exogenous nutrients to patients with severe acute pancreatitis. However, recent data suggest that enteral nutrition (EN) is not only feasible, but safer and more effective. Therefore, the authors sought to update their systematic review to re-evaluate the level of evidence. 2.5 days Hospital stay was reduced in EN vs TPN groups Objectives To compare the effect of TPN vs EN on mortality, morbidity and length of hospital stay in patients with acute pancreatitis. Search strategy Trials were identified by computerised searches of the Cochrane Controlled Trials Register, the Medical Literature Analysis and Retrieval System Online and the Excerpta Medica Database. Additional studies were identified by searching Scisearch, bibliographies of review articles and identified trials. The search was undertaken in August 2000 and updated in September 2002, October 2003, November 2004 and November 2008. No language restrictions were applied. Selection criteria Randomised clinical trials comparing TPN to EN in patients with acute pancreatitis. Data collection and analysis Two reviewers independently abstracted data and assessed trial quality. A standardised form was used to extract relevant data. In patients with acute pancreatitis, enteral nutrition significantly reduced mortality Main results Eight trials with a total of 348 participants were included. Comparing EN to TPN for acute pancreatitis, the relative risk (RR) for death was 0.50 (95% CI 0.28 to 0.91), for multiple organ failure (MOF) was 0.55 (95% CI 0.37 to 0.81), for systemic infection was 0.39 (95% CI 0.23 to 0.65), for operative interventions was 0.44 (95% CI 0.29 to 0.67), for local septic complications was 0.74 (95% CI 0.40 to 1.35), and for other local complications was 0.70 (95% CI 0.43 to 1.13). Mean length of hospital stay was reduced by 2.37 days in EN vs TPN groups (95% CI -7.18 to 2.44). Furthermore, a subgroup analysis for EN vs TPN in patients with severe acute pancreatitis showed a RR for death of 0.18 (95% CI 0.06 to 0.58) and a RR for MOF of 0.46 (95% CI 0.16 to 1.29). Conclusion In patients with acute pancreatitis, enteral nutrition significantly reduced mortality, multiple organ failure, systemic infections and the need for operative interventions compared to those who received TPN. In addition, there was a trend towards a reduction in length of hospital stay. These data suggest that EN should be considered the standard of care for patients with acute pancreatitis requiring nutritional support. Cochrane Database Syst Rev Jan 2010;20(1):CD002837. Enteral Nutrition and Cardiovascular Failure Cardiovascular failure and low flow states may arise in very different conditions from both cardiac and noncardiac causes. Systemic haemodynamic failure inevitably alters splanchnic blood flow, but in an unpredictable way. Prolonged low splanchnic blood flow causes intestinal ischaemia, increased mucosal permeability, endotoxaemia and distant organ failure. Mortality associated with intestinal ischaemia is high. Why would EN be desirable in these complex patients when TPN could easily cover energy and substrate requirements? Metabolic, immune and practical reasons justify the use of EN. In addition, continuous enteral feeding minimises systemic and myocardial oxygen consumption in patients with congestive heart failure. Further, early feeding in critically ill mechanically ventilated patients has been shown to reduce mortality, particularly in the sickest patients. In a series of cardiac surgery patients with compromised haemodynamics, absorption has been maintained, and 1000-1200kcal/d could be delivered by enteral feeding. Therefore, early EN in stabilised patients should be attempted, and can be carried out safely under close clinical monitoring, looking for signs of incipient intestinal ischaemia. Energy delivery and balance should be monitored and combined feeding considered when enteral feeds cannot be advanced to target within four to six days. Journal of Parenteral and Enteral Nutr 2009;33(6):702-709. Excerpted from: Clinical nutrition highlights: Science supporting better nutrition. 2010;6(1):16-17. medical chronicle | June 2011 | page 77 Psychiatry Forum Dr Ian Westmore Managing Depression in Pregnancy Postnatal depression, often termed ‘baby blues’, is a well-documented condition. However, not as much is known about depression in pregnancy - a common occurrence. Although pregnancy is generally considered to be a time of emotional wellbeing for most women, depression is a common occurrence and needs to be adequately managed to ensure the sustained mental and physical health of both the mother and unborn baby. Unfortunately, the diagnosis is frequently not made, and when identified, confusion exists as to what constitutes appropriate treatment for unipolar depression in pregnancy. Meta-analyses have indicated that the range of antenatal depression is between 6.5%-12.9%, and a systematic review in 2004 estimated the prevalence of depression as 7.4%, 12.8% and 12.0% for the three consecutive trimesters of pregnancy, respectively.1,4 Of note is that the prevalence rates are even higher than those reported for gestational diabetes (4%-8%) or preeclampsia (3%).2 Women already suffering from depression at the time of conception are at risk for relapse, especially if they discontinue their medication during pregnancy. It is also known that depression during pregnancy is considered to be an independent risk factor for subsequent adverse obstetric, foetal and neonatal outcomes. Patients suffering from untreated depression during pregnancy are inclined to do less well with self-care, have impaired bonding with their babies, abuse substances and self-medicate with potentially hazardous effects.1 Yet, statistics show that many depressed pregnant women go untreated.3 Diagnosis The criteria for unipolar depression during pregnancy do not differ from that outside of pregnancy. However, some of the symptoms of depression such as fatigue and energy loss, and changes in sleeping and eating patterns, are known to occur during pregnancy and could be considered to be normal phenomena. Patients who are at risk for developing depression during pregnancy are those who have a previous history of depression or premenstrual dysphoric disorder, live alone, have limited social support, are younger, experience marital problems and are ambivalent about their pregnancy.1 As is always the case, consideration should be given to the possibility of the depression forming part of a bipolar mood disorder, and patients should be screened for previous manic or hypomanic episodes. Treatment of bipolar disorder in pregnancy is complex, and should be undertaken by a psychiatrist. Treatment Nonpharmacological: These interventions are particularly useful in women with mild depression during pregnancy. Psychotherapy can, and should, be considered for treatment of depression during pregnancy, either as a single modality, or in combination with medication. Cognitive-behavioural therapy (CBT) and interpersonal therapy are frequently used in depressed patients. However, there are no studies to demonstrate the efficacy of CBT in pregnancy.1 There are some case reports that suggest that the use of bright light therapy is useful in treating depressed pregnant women, even in those who suffer from a nonseasonal type of depression. Physical exercise has been shown to be effective in reducing depression and anxiety in pregnant women who exercised during the first and second trimester of pregnancy. Further research is needed to demonstrate clearly whether omega-3 fatty acids are useful in treating depression during pregnancy.1 Pharmacological: It has been estimated that 3% of pregnant women take antidepressants.2 Psychotropic medications remains the first-line treatment for women suffering from severe depression during pregnancy. However, there are no studies to quantify the efficacy of antidepressants in pregnancy. Physicians are naturally concerned about the use of psychotropic medications during pregnancy. Warnings are in place, considering identified risks of teratogenicity, perinatal syndromes and abnormal postnatal development. The risks for development of these problems is, however, generally small. Pregnant women are cautious about taking medication during pregnancy, and as is always the case, the risk-benefit ratio needs to be considered. Antidepressants that have been used in pregnancy include the tricyclic antidepressants (TCAs); the selective-serotonin re-uptake inhibitors (SSRIs) and selective serotonin-noradrenalin re-uptake inhibitors (SNRIs), and atypical antidepressants. The TCAs are generally not considered to be safe for use, considering their risk of harm in the event of overdose. The SSRIs are considered to be a safe option for use during pregnancy. However, studies have shown that maternal use of paroxetine during pregnancy did result in an increased risk of cardiovascular birth defects. A review has found that, compared to infants who were exposed to other antidepressants during the first trimester, those who had been exposed to paroxetine had a 1.5-two fold increased risk of congenital cardiac malformations. However, a recent review from unpublished prospective cases found that infants who had been exposed to paroxetine during pregnancy did not have a higher rate of congenital cardiac malformations compared to the general population incidence of approximately 1%.1 Another concern with the use of SSRIs during pregnancy has been the possible development of persistent pulmonary hypertension of the newborn. This could be associated with exposure of the foetus during the last trimester. It has, however, been questioned whether this serves as an independent risk ... to page 78 page 78 | medical chronicle | June 2011 Psychiatry So it Exists - What Does it Look Like? Defining adult ADHD More and more evidence has accumulated that attention deficit hyperactivity disorder (ADHD) in adults is highly genetically inherited. Many children with the condition grow up to become adolescents and adults with persistent features of dysfunction. Despite the robust research findings, adult ADHD has been a controversial and unpopular diagnosis. Dr Dora Wynchank, Psychiatrist in Private Practice in Johannesburg So, what does adult ADHD look like? As it has been recognised for decades in children, ADHD presents with a combination of three symptom clusters: inattention, impulsivity and hyperactivity. By the time patients reach adulthood, these symptom clusters have mutated. The presentation of the disorder is quite different in adults. Barkley has identified four possible areas of problematic functioning: the ability to sustain attention, inhibit behaviour, resist distraction and regulate one’s level of activity. If we were to examine each of the symptom clusters in more detail: poor attention occurs often and is a hallmark feature. On performing repetitive or boring tasks, focus is noticeably lacking. Many adults with ADHD can concentrate well in areas that fascinate them. Only in very severe cases, would the inattention be globally present. Concentrating on protracted tasks is often disrupted by distraction. Patients with ADHD are chaotic, disorganised and seem to react to novelty more quickly than others. They experience difficulty in multitasking and are poorly motivated. They struggle to persist with one mental activity; they might move from one uncompleted activity to another, without finishing what they set out to do. They find it challenging to shift attention from task to task. They are plagued with procrastination and may only complete boring tasks under time pressure. They struggle to sort out personal administration. Some highly skilled individuals are unable to work independently. They cannot complete assignments without direct supervision. They may battle to stay alert, or even awake in boring situations (incidentally, many adults with ADHD have sleep disturbances too.) Difficulty in inhibiting one’s impulses and behaviour is another key symptom cluster in adult ADHD. These patients interrupt frequently in conversation. They may finish the sentence of the person they are talking to. They battle to delay gratification. In the workplace, they may find it difficult to work for a Managing Depression in Pregnancy ... from page 77 factor, as many other maternal and infant factors could play a role.1 Poor neonatal adaptation may occur in up to 30% of infants with exposure to SSRIs. This is characterised by jitteriness, poor muscle tone, weak cry, respiratory distress, hypoglycaemia, low Apgar scores and seizures. These symptoms generally start within hours after delivery, but in most cases require only supportive care and clear up within one to two weeks. Finally, other foetal malformations such as risk for omphalocele, craniosynostosis and anencephaly have been associated with SSRI exposure, but the absolute risk has been found to be very small. Combination of treatments Although it probably follows that, as is the case with nonpregnant women, a combination of pharmaco- and psychotherapy may be purported to be superior to either treatment modalities alone, the efficacy of concurrent therapy has not been studied in pregnant women. Which antidepressant should I choose for pregnant women? • When deciding on the use of an antidepressant long-term reward as opposed to immediate gratification. They may be highly impatient. This may manifest in irresponsible behaviours, such as driving fast and recklessly, promiscuous sex, drug taking or gambling. ‘Hyperactive’ adults are rarely seen, but regulation of activity level is often dysfunctional. Patients describe themselves as restless, fidgety or ‘on the go’. They are always busy and driven. They may be observed tapping, shifting position, shaking and wriggling while performing boring tasks. They may be workaholics, full of nervous energy, unable to relax and easily bored. Their desire for constant activity may lead to family tension. They may self-select highly active, stimulating jobs and avoid sedentary situations, with little physical activity. Not only do patients present with these types of symptoms, but their thinking style or executive function may also be affected. Barkley (1997) has described two further areas of difficulty: these involve working memory and the ‘mind’s voice’. Working memory is the capacity we have to hold information in mind. We then allow this information to guide our actions. Difficulties with working memory result in patients being labelled as ‘forgetful’ or disorganised thinkers. They may lose track of the goal of the activities. They are unable to anticipate what may well happen and therefore they prepare poorly for future events. This also translates into chaotic time management and planning. Patients may over schedule themselves, underestimating how long planned activities will take. They are therefore often rushing, late or reneging on promises to deliver. In fact, one of the areas of greatest difficulty that I observe in my adult patients is a faulty sense of time and poor planning abilities. They cannot estimate accurately how long a planned activity will take. They procrastinate and then rush. They are often late. We use the mind’s voice for private conversations we have with ourselves when contemplating events and directing our own behaviour. A delayed development of internal rule-following interferes with the ADHD adult’s ability to self-regulate. Patients struggle to follow through on rules and instructions. They find it difficult to persevere with their own plans. They may even break rules, as the ineffective mind’s voice stops them from acting with legal or moral principles in mind. A final area of difficulty in these patients is their emotional regulation. Managing moods and feelings can be very disturbed in these adults. They may appear emotionally immature, reactive or quick-tempered. They seem to lack willpower or self-discipline. In order for patients to regulate their feelings, they need to take time to reflect. They must distinguish emotion from fact. Without this ability, they cannot judge the significance of what is happening in relationships. What is happening to brain function in adult ADHD? Dopamine is the neurotransmitter that has been implicated in ADHD. Dopamine action is believed to be deficient in the link between the frontal lobes and the limbic system - the emotional regulator of the brain. The limbic system controls our basic emotions of fear, anger and pleasure and formulates long-term memories. One theory of the causation of ADHD is that there is weak frontal cortex inhibition (rational thought) over the limbic area (emotional centre). The prefrontal cortex controls an important brain function known as ‘executive function’. Deficiencies in executive function seem to mirror ADHD symptoms. Housed in the frontal and prefrontal cortices, executive functions combine different brain activities in order to plan a response. Memory functions (where we came from) are integrated with the ability to future plan (where we want to go to, how to assess the consequences of our actions). Appropriate, controlled behaviour is then carried out. In this way, executive functions enable us to prioritise the best action while keeping track of time. Adult ADHD patients experience difficulty with thinking through their responses. Their foresight is very poor. They are unable to inhibit present distractions and battle to keep the future in mind. Consequences seem to catch them unawares. They are also often unable to inhibit motor responses, organise information, plan and complex problem-solve. In study situations, they may struggle to learn (boring) verbal material and to recall in this population, factors such as previous response to an antidepressant, severity of illness and patient preference need to be considered. • If a patient is currently taking an antidepressant to which she has previously responded, and relapses during pregnancy, a dose increase should be considered. Studies have shown that a dose increase might be necessary in the second half of pregnancy, from week 27 onwards. • When an antidepressant is reintroduced, it should be done so at therapeutic doses. Subtherapeutic doses increase the risk of relapse, and also increase the risk of exposing the foetus to undertreated maternal illness. • If a pregnant woman needs to take an antidepressant and has never been exposed to one before, consideration should be given to prescribing an antidepressant that genetically linked family members have responded to. When no such information is available, the current drug of choice is sertraline - an SSRI that shows low placental transfer, and has a good safety record in pregnancy and in breastfeeding women.1 C: Adverse effects in animals and no human data available. D: Human foetal risk seen (may be used in lifethreatening situations). X: Proved foetal risk in humans (no indication for use, even in life-threatening situations). FDA Rating of Drug Safety in Pregnancy A: No foetal risks in controlled human studies. B: No foetal risk in animal studies, but no controlled human studies or foetal risk in animals, but no risk in well-controlled human studies. Table 1: Rating of drug safety in pregnancy Drug FDA category SSRIs Fluoxetine Sertraline Paroxetine Fluvoxamine Citalopram Escitalopram C C D C C C NDRIs Bupropion B SNRIs Venlafaxine Duloxetine C C NASSAs Mirtazapine C TCAs Amitriptyline Clomipramine Desipramine Imipramine Nortriptyline C C C D D Other Trazodone C Source: Medscape.com it at a later stage. Problems may arise for them in sustaining attention, planning, organising, prioritising, impulsive thinking and decision making. These difficulties are, of course, independent of the patient’s IQ. Another aspect of executive function that is deficient is the ability to ‘self talk’. Adults use this process when working through different choices using words and thoughts. It is an internalised, silent, automatic process. If one is unable to have an internal discussion about the pros and cons of a reaction, and simply responds impulsively, the consequences may be serious. In summary, ADHD symptoms form a constellation of poor self-regulation and self-motivation, especially for the impulsive/hyperactive types. Adult ADHD is so much more than poor concentration. Patients may be affected in work, relationships, heeding the law, self-esteem … and the list continues. References 1. Barkley RA. Behavioral inhibition, sustained attention, and executive functions: Constructing a unifying theory of ADHD. Psychological Bulletin 1997;121:65-94. 2. Biederman J, Faraone S, Spencer T, et al. Patterns of psychiatric comorbidity, cognition, and psychosocial functioning in adults with attention deficit hyperactivity disorder. American Journal of Psychiatry, 1993;150:1792-1798. 3. Faraone SV, Biederman J, Mick E. The age-dependent decline of attention deficit hyperactivity disorder: a meta-analysis of follow-up studies. Psychol Med 2006;36:159-165. 4. Gualtieri CT, Johnson LG. Efficient Allocation of attentional resources in patients with ADHD: Maturational changes from age 10 to 29. Journal of Attention Disorders 2006;9:534-542. 5. Marczinski CA. Subclinical ADHD, stress, and coping in romantic relationships of university students. J Atten Disord 2005;8:182 -187. 6. Overbey GA, Snell WE, Kallis KE. Subclinical ADHD, stress, and coping in romantic relationships of university students. J Atten Disord 2011;15:67-78. 7. Woods SP, Lovejoy DW, Ball JD. Neuropsychological characteristics of adults with ADHD: A comprehensive review of initial studies. The Clinical Neuropsychologist, 2002;16:12-34. Adapted from Kaplan and Sadock’s Synopsis of Psychiatry 10th edition p867. Refer to Table 1. Conclusion Treating unipolar depression during pregnancy remains a challenge for most physicians. The above serves as a guideline, but there are many factors to consider in treating these patients, particularly the ‘risk-benefit ratio’. Successful treatment minimises the risk of relapse in a vulnerable patient population. A complete assessment includes screening for mood disorders in pregnancy and treatment options should be discussed with the patient as soon as possible. If possible, patients who are at risk should be informed about the risks and benefits of treatment, and relapse, prior to their falling pregnant. References 1. Raudzus J, Misri S. Managing unipolar depression in pregnancy. Curr Opion Psychiatry 2009;22(1):13-18. 2. Buck ML. Drugs in Pregnancy and Lactation: Literature and Resource update. Pediatr Pharm 2010;16(1). 3. Flynn HA, Blow FC, Marcus SM. Rates and predictors of depression treatment among pregnant women in hospital affiliated obstetrics practices. Gen Hosp Psychiatry 2006;28:289. 4. Hackley B. Antidepressant Medication use in pregnancy. J Midwifery Womens Health 2010;55(2):90-100. medical chronicle | June 2011 | page 81 Sexual Health Forum Rory du Plessis Sexual Health Myths: Ejaculate Volume On reviewing a number of online forums regarding sexual health, I am struck by how many of the postings reflect concerns that bear no relation to pathology, illness or aspects of mental health. Rather, a large portion is based on sexual myths propagated by the media. For the purposes of this article, one sexual myth will be explored, namely a concern regarding ejaculate volume. 2%-5% The amount of sperm in semen The majority of postings are described as follows: “Is there anything I can do to increase my sperm volume?” and “Are there any foods/ drinks that help build up sperm?” Although only two quotes are provided, they reflect one of the overarching themes shared by the majority of such postings: a conflation and confusion with the terms sperm, ejaculate and semen. Rather, there are distinct differences between sperm, semen and ejaculation. Biologically, sperm makes up only between 2%-5% of a given sample of semen. Semen is released through the penis during ejaculation. One result of this conflation is that semen and ejaculation are imbued with the importance allotted to sperm - its role in reproduction and markers related to fertility. A further aspect that is shared in the postings is related to the fact that no actual volume of ejaculate is recorded. As such, the issue of ejaculate volume may not necessarily be about auditing the amount of ejaculate. Rather, I argue that it is primarily related to the aesthetics of ejaculation as is evident in pornography. This argument runs parallel to Lisa Moore’s (2007) belief that our understanding of sperm is based on sociocultural representations of human semen. Therefore, to account for the sociocultural context of sperm in the 21st century, one needs to recognise the role of pornography. This account is not solely based on academic analysis and interpretation, but is explicitly acknowledged and peddled in the marketing of supplements that claim to increase ejaculate volume. The role of pornography has been outlined in numerous publications as a key influence in contributing to ideas in society about sex from what constitutes sex or sex acts to what is considered sexy. In particular, pornography specialises in representing a variety of techniques to animate ejaculation and semen (Moore 2007). In other words, ejaculate becomes scripted and framed just like the actors in the film, to achieve certain narrative aims. This is so much so that much of the scenes in a pornographic films can be argued to be about the achievement and impressive display of ejaculation - the force of ejaculate, the amount and its aim (Moore 2007). In this line of reasoning, we may consider that pornography has cast ejaculation as a quintessential role in the genre itself. This idea is supported by a number of pornographic genres that focus solely on semen as the central theme of the narrative and the action (Moore 2007). Pornography frames ejaculation as a focus point - and in doing so, the more spectacular the ejaculation, the larger the volume, the more eruptive and explosive the force, the better. The framing of ejaculate in the above terms is also noticeable in mainstream films - these films have adopted many of the stylistic conventions related to displaying ejaculation in pornography. Dr Etienne Kok is in agreement with the main argument of this article that the importance allocated to ejaculation volume ‘is very much based on myth and false expectations’. To counter these myths, it is important to consider the scientific facts of ejaculation. Most notably, ejaculation volume is established as being between 2-5ml. The variations in ejaculation volume are based on a number of factors - time of abstinence as well as amount of and duration of stimulation. Furthermore, Dr Kok cautions that rather than being a quality to be esteemed; a large ejaculate volume poses a significant fertility problem. If the ejaculate is constantly more than 6ml in an individual, it is known as hyperspermia and can lead to a fertility problem. The high volume of ejaculate that mainly consists of secretions from the seminal vesicles and prostate gland can dilute the sperm and result in an insufficient concentration of sperm that are unable to find their way to the fallopian tubes for fertilisation to take place. Ejaculate constantly more than 6ml (hyperspermia) can lead to fertility problems The central motivating factor of this article has been that it is imperative to analyse the social structures that shape and influence sexuality. This goal was approached through recognising the influence that pornography has in defining and representing male ejaculation - the very influence of which leads to heightened levels of anxiety for men regarding the volume of ejaculation. References available on request. Herpes and Relationships: How to Tell Prof Elna McIntosh, Getting the facts Sexologist The more emotionally charged an issue, the more important it is to find out the facts. Most people know little or nothing about herpes. Frequently, what knowledge patients have is colouredby myth and misconception. Some of the basic facts that could be provided to them include: • Herpes simplex virus (HSV) most often shows up as small blisters or sores on either the face or mouth (cold sores or fever blisters) or the genitals. • HSV can be passed on when one person has the virus present on the skin or mucosa and another person makes direct skin-to-skin contact with the live virus. • The virus is likely to be present on the skin from the first sign of prodrome (tingling or itching where the outbreak usually occurs), until the sores have completely healed and new skin is present. • There are likely to be certain periods of time (possibly only a few days out of the year) when the active virus might be on the skin, even though there are no obvious signs or symptoms. • Always using latex condoms may possibly reduce the risk of transmitting the virus during these times. • Herpes is very frequently transmitted by infected persons who don’t know they are infected. Since they have not been diagnosed, they are unaware that they may be contagious from time to time. • Once diagnosed, a person generally is able to take the simple precautions necessary to protect partners - avoiding contact during prodrome or an outbreak, and practising safer sex when no symptoms are present. Additional educational materials will offer more information. It is important for both partners to find out as much as possible about the condition. It would be helpful to provide the patient with educational materials on genital herpes, which Many people do not feel comfortable talking about sexuality and sexual health issues. The health professional can assist patients diagnosed with genital herpes in coming to terms with their condition by offering some practical advice to help them feel more confident in sharing this vital information with potential sexual partners. This article will explore various aspects in this regard. Facial herpes (including cold sores on the lips) and genital herpes are medically the same condition at different sites. The significant difference arises from the stigma that tends to accompany an infection that is sexually transmitted. While some people may experience an unsupportive response, in fact, most have found their partners both supportive and understanding. Fear of rejection runs deep, and it leads some to question why they should risk talking about herpes. Instead, they abstain during outbreaks, practice safe sex at other times, and hope for the best. This strategy has more disadvantages than advantages. It’s much harder to tell someone who has just found out they’re infected, or for them to find out elsewhere. For most people, the anxiety of not telling is worse than the telling itself. If a person enters into the relationship with full knowledge of their partner’s infection, the likelihood of them becoming infected is reduced. When an outbreak occurs. Failure to confide may lead to a person being talked into sex, even during a possible outbreak. On the other hand, if two people are able to discuss the situation openly and honestly, they can negotiate around it. Imaginative lovers find ways to weather temporary setbacks. Self-esteem, adaptation and acceptance People can, and do, tell potential partners successfully. While there is no fail-safe method, a number of approaches can make it much easier. Firstly, it’s important to remember that herpes doesn’t change all the good things about a person. To some extent, likelihood of infection is like the toss of a dice. It can happen to anyone. It has nothing to do with intelligence, social habits or bank account. Genital herpes is extremely common, with studies suggesting that in some countries, up to one in five people are infected with this virus, whether they know it or not. Despite the fact that it is so common, negative stereotypical beliefs related to herpes abound and have become subconscious beliefs for the herpes sufferer. It is important for the patient to learn to recognise these and to consciously replace them with positive statements and to continually reinforce these. This aids acceptance by a person that he/she has herpes, which will, in turn, make it easier to let others into their life. will give them further information and provide them with something they can give to their partner to read. Preparing to tell partners Tips for telling partners include: • Timing: Before sexual contact is initiated, ideally, when a degree of comfort and trust in each other’s company has been achieved and when the couple can enjoy undivided, uninterrupted attention. • Opportunities: Advise the patient to look for logical opportunities to bring up the subject. ‘Safe sex’ and AIDS are common topics today. • Place: Somewhere neutral, safe and comfortable, or while taking a walk. Ideally, where partners feel free to share emotions. • Be positive and confident: Expecting rejection increases the chances of an unhappy outcome. Telling one’s partner is the right thing to do for both parties. • Delivery affects the message: They should speak calmly and clearly, and look the person in the eye. • Avoid melodrama: This is not a confession or a lecture, but simply the sharing of information between two people. • Practise: They might consider practising by telling a friend first. Realistic and unrealistic expectations People may need a little time to think it through or to gather more information. The majority of people will react well and negative reactions are often the result of misinformation. Whether or not the relationship works out, the person has been enlightened with education and experience. Some of the myths about herpes that cause so much harm have been corrected, while the barrier of silence that makes it so difficult to speak about herpes has been removed. The patient will have confronted a difficult issue in his/her life with courage and consideration. medical chronicle | June 2011 | page 83 Wound Care Quicker Healing of Venous Stasis Wounds Imagine a battlefield medic or emergency medical technician providing first aid with a special wad of cottony glass fibres that simultaneously slows bleeding, fights bacteria, stimulates the body’s natural healing mechanisms, resists scarring and - because it is quickly absorbed by surrounding tissue may never have to be removed in follow-up care. Alternatively, imagine diabetics with hard-to-heal wounds finding a source of relief from the battle against infections and limb amputation. These scenarios are the hope of the developers of a revolutionary borate glass nanofibre material, which appears have sped up and helped the final healing of long-term wounds in eight out of 12 venous stasis wound sufferers in a recent clinical trial held at a medical centre in the US. Details about the trials and the glass fibre material were published in the May issue of the American Ceramic Society’s Bulletin magazine. The story reports on the discovery of the fibres and on an empirical study that began in late 2010, supervised by the internal review board of the Phelps County Regional Medical Center (PCRMC). The trial groups originally had 13 volunteers, but one dropped out during the early stages. The cottony glass fibres slow bleeding, fight bacteria and resist scarring According to Peggy Taylor, the registered nurse who administered the treatments, all of the volunteers who took part in the trial are enthusiastic about the use of the glass fibre product, which she said ‘looks like candy floss’. “All of the participants had diabetes and several of them had wounds that had been unhealed for more than a year,” said Taylor, a specialist in wound care. “One patient had the same wound for three years. After using the glass fibre product for a few months, we were able to repair the skin in eight of the patients. Remarkably, the other four have made a lot of progress and all of their wounds should be healed soon, too.” The patients in the test group suffered from problems associated with venous stasis, a condition where blood circulation in extremities is poor. As the blood pools, typically in the lower legs, fluids accumulate causing unusually high pressure on skin tissues. Sores and wounds can then develop when the fluid ‘weeps’ from skin cracks, cuts or abrasions. Because of an enzyme in the weeping fluid, the skin surrounding small venous stasis injuries can quickly erode and turn into large and deep wounds. Even small bruises can eventually develop into bone-deep openings. The goal of the trial was to provide an initial evaluation of the effects of the novel fibrous glass material. ‘Bioglass’ materials aren’t particularly new to the medical field, but thus far all bioglass has been formed from silica-based glass compositions, and these primarily have been used in hard-tissue regeneration, such as bone repair. Glass scientist Steve Jung, who helped develop the new material, said he and co-developer, Prof Delbert Day, had wondered whether a different type of bioactive glass material could be used for soft-tissue regeneration. “Our in vitro studies showed that bioactive glasses containing boron should react to body fluids much faster than silicate glasses,” said Jung. “We also knew that another in vitro study of lithium borate glasses had showed it to have beneficial effects against bacteria, such as E coli, salmonella and staphylococcus microbes.” Lastly, Jung and Prof Day recalled that they were interested in a composition that was rich in calcium. “Previously, investigators have reported that calcium is important for wound healing. It appears to assist the migration of epidermal cells and help the body regulate the healing process of open wounds,” said Jung. Besides composition, Jung and Prof Day thought the structure of the material may be important to consider too and suspected that providing a healing ‘scaffold’ might be beneficial to skin reconstruction. “We wanted to have a material that could mimic the microstructure of fibrin that normally forms the basis of a blood clot. We reasoned that if the structure could imitate fibrin, it might trap blood platelets and allow the formation of a wound cover that could support the healing process.” Jung and Prof Day finally settled on a particular borate glass composition that could be formed into cottony glass fibres, 300 nanometres to five micrometres in diameter. After animal tests showed no adverse effects, the company approached PCRMC about starting the small-scale human test. The trial was approved in July 2010 and Taylor saw her first patient one month later. Once the study was underway, the company provided Taylor with individual, foil-sealed packets containing pads made of the glass fibres. She said the material was easy to apply and seemed to disappear over time, a phenomenon that has been observed with other bioglasses. Taylor acknowledges that the wounds would have probably required expensive vacuum-assisted healing systems as an alternative. Besides low cost and ease of use, Taylor said the glass fibres seem to offer another stunning benefit: low scarring. The next step is expanded human trials and Jung and Prof Day are optimistic about a new era in wound treatment. Source www.healthandbeautyreview.co.za page 84 | medical chronicle | June 2011 Women’s Health Exploring Bone Health Solutions - DXA Hologic developed the first DXA bone densitometer, which remains the gold standard for spine and hip bone screening around the world. Its densitometry systems are used by more leading medical schools, universities, osteoporosis opinion leaders and pharmaceutical trials than any other bone densitometer. Advantages of Hologic Discovery Speed and image quality: The OnePass single sweep scanning captures the hip and spine with 10-second scanning time. No other system comes close to the combined speed and imaging resolution of Discovery, with better than 1.8Lp/min. Automatic hip positioning: The AccuView finds the bone edge for perfect positioning and automatically centres the hip the same way on followup exams for improved precision. It helps eliminate common positioning errors, saving time and eliminating unnecessary rescanning. Superior visualisation: The device’s imaging technology provides superb image quality by eliminating the beam overlap errors and image distortion found in rectilinear systems. A computer-aided fracture assessment is also incorporated to quantify and display the degree of vertebral compression and helps to confirm the existence and severity of deformities. Consistency from exam to exam: The device performs continuous, automatic calibration, ensuring precise measurements results from exam to exam. Preferred scan protocols can be created and automated to speed analysis and improve workflow. Integrated structural analysis of the hip: The technology enables a new dimension in bone health assessment with Hip Structural Analysis (HSA), which uses DXA measurements to calculate the structural geometry of the hip. HSA provides a better predictor of biomechanical strength than using bone mineral density (BMD) alone. This exclusive feature helps determine whether bones are reduced in strength to the point that they require treatment and, if the patient is being treated, if the bones are getting stronger. Superior vertebral fracture assessment: Hologic pioneered the next generation of vertebral fracture assessment (VFA) technology, high-definition instant vertebral assessment (IVA-HD), which dramatically improves the detection of vertebral fractures. IVA-HD doubles the resolution of previously available techniques with a safe low-dose, single energy image. Discovery is the first system to integrate the definitive factors for osteoporotic fracture risk: BMD and VFA. Heart disease detection through calcification visualisation: Using the enhanced visualisation provided by IVA-HD, Discovery can help medical practitioners appreciate calcifications in the abdominal aorta. Clinical studies have shown that abdominal aortic calcification (AAC) is a significant indicator of heart disease. Patients who have osteoporosis are often at risk for cardiovascular problems - the number one cause of morbidity and mortality in older women and men. Whole body composition: Obesity is a growing health concern worldwide. According to the World Health Organization, there are an estimated 400 million obese adults worldwide. In the last 20 years, morbid obesity (BMI>40) has gone from one in 200 adults to one in 50 adults in the US alone. One in five schoolage children (9.2 million) are either overweight or obese. The Body Composition Analysis accurately measures fat mass, lean mass and total mass for the entire skeleton and for up to seven user-defined subregions. This information provides one with a comprehensive analysis of fat distribution. It also allows one to monitor results for your pediatric patients to a variety of criteria (e.g. height vs weight, weight vs age, Centers for Disease Control and Prevention growth curves). Paediatric bone health assessment: Discovery uses advanced analysis algorithms to detect and measure the low-density bone mass that is characteristic of paediatric patients. Evaluate therapies with supine lateral BMD: Discovery offers more clinical options for vertebral assessment than any other bone densitometer available today. Supine lateral spine BMD provides a more sensitive means of detecting bone loss or gain than AP spine BMD measurement alone, especially in older patients. With the push of a button, the Discovery C-arm automatically moves into position for highly precise supine lateral scanning. The rotating C-arm eliminates patient repositioning, which means more precise lateral and anteroposterior views. With Discovery’s advanced fan-beam DXA, you get a clear measurement and visualisation of trabecular-rich vertebral bodies, which are usually the first bone tissues to show degeneration as well as positive response to therapy. 3D hip measurement for more accurate fracture assessment Hologic is pioneering 3D hip measurements, a breakthrough dimension in fracture risk assessment. Analysing bone structure requires creating a 3D volumetric density model. Combining low-dose tomographic technology with the rapid image sequencing made possible by a rotating C-arm, Discovery can capture multiple views of the femur at different angles and mathematically construct a 3D rendering. Three-dimensional hip measurement will provide a powerful new tool for measuring the true strength of the femur and more accurately determining the risk of future fractures. (US Food and Drug Administration clearance is pending). Osteoporosis Screening - Just do it! As people age, they accumulate a number of illnesses, which increases their risk of morbidity. Osteoporosis is such a disease. Unfortunately, it is a silent disease and patients seek medical attention when it is too late. Most patients present with osteoporotic fractures, indicative of a more established form of disease, which is more difficult to treat. It is much more beneficial to the patient to treat the illness as early as possible. Therefore, screening is imperative for early detection. According to Dr Brent Tipping, geriatrician at the Wits Donald Gordon Medical Centre in Johannesburg, osteoporosis in men is grossly underdiagnosed. “Women’s magazines are fantastic at raising awareness of osteoporosis in women, but the same does not apply for the media targeting men.” It is not uncommon for men around 85 years old to suffer from osteoporosis and men who sustain fractures or break bones have a worse prognosis and a higher mortality. High-risk patients High-risk patients need to be identified and screened to manage the onset of the disease or detect early signs of osteopenia. Identifying and treating patients at risk of fracture, but who have not yet sustained a fracture, will substantially reduce the longterm burden of osteoporosis. Reducing the risk of first fracture from 2% to 8% can reduce the five-year fracture incidence from approximately 10% to 34%. Risk factors • Age (women 45 years and older; men from 65 years onward). • Menopausal status. • Specific illnesses that can accelerate bone loss, e.g. thyrotoxicosis, parathyroid abnormalities. • Family history of thinner bones. • • • • • • Certain medications such as cortisone. Testosterone deficiency. Rheumatoid arthritis. Smoking. Excessive alcohol consumption. Nutritional status (severe eating disorders, malnutrition). • Falling. About bone densitometry Traditionally, the dual energy x-ray absorptiometry (DXA) bone densitometer ascertains the bone mineral density. “These days, we also incorporate risk factors to assess fracture risk and the DXA scan helps to confirm who should start prophylactic strategies or treatment,” affirmed Dr Tipping. Computerised tomography, ultrasound and bone biopsies are used more in the research arena and are not available in clinical practice in SA. The frequency of screening depends on the results of the scan and older women are advised to be screened every three years. “The procedure is quick, easy and painless with a very low dose of radiation,” said Dr Tipping. “It is vital that trained radiographers carry out the procedure.” Hospital x-ray departments generally carry out these scans. Final thoughts on screening “Unfortunately, in my practice, I see very advanced cases. GPs promote primary health care and should aim to prevent illnesses. In modern times, the doctor’s role is to keep patients well. Osteoporosis is a preventable, manageable disease and early screening helps ensure early detection, which clearly benefits patients,” Dr Tipping concluded. medical chronicle | June 2011 | page 85 Professional Advertising Professional Medical Accounts Management Collection, processing, submission and follow up of medical accounts. Detailed reports and payment directly into your own bank account. We deal with medical scheme and patients on your behalf. Experience in all disciplines. In business since 1997. For the perfect solution, contact Hester 083‑680‑8353 [email protected] Financial safe haven in the USA Craig Field, CA(SA) living in Charlotte, North Carolina, offers: • • • • • • • • • • • Establish US$ bank accounts US debit/credit cards Establish US credit record Postal and/or physical address Company formation Tax returns & tax planning Safe harbour for offshore investment funds Business and/or residence visas Assistance with buying property/business SA exchange control advice Offshore trust and estate planning Botulinum Toxin(BoNT-A) and Dermal Filler Training Dates Training provided in a real working clinic Each course approved for 8 clinical CPD points • Basic Dermal Fillers- Wed 29 June 2011 • Advanced Botulinum Course - Wed 27 July 2011 • Advanced Dermal Filler- Wed 31 Aug 2011 Visit www.medisculptclinic.co.za or contact 011-958-2261 / [email protected] for more information. Work through a knowledgeable, trustworthy and accessible ex SA www.craigfieldtrust.com Offices to Rent A Grade Medical Suite, 80m2 office to rent at Crompton Medical Centre adjacent and direct access to Life Crompton Hospital. Contact: Mandi-Lee Head Tel: 031 701 1069 Fax: 031 701 1036 www.venturepartners.co.za For Medical Chronicle Professional Advertising Contact Dick White 011-787-4969 [email protected] page 86 | medical chronicle | June 2011 // Periscope Updates and New Products Document Solutions for the Medical Industry Providing Quality Surgical Products without Compromise Bytes Document Solutions’ Xerox division has appointed Med-e-Mass as a value-added reseller to serve the country’s medical industry. Med-e-Mass already services over 9000 customers in the medical practitioner, hospital, specialist, group, administrative bureaux as well as the dental and auxiliary health services markets. “Med-e-Mass, part of the Altron group, is an independent software vendor, which means it owns its IP, and its footprint extends throughout SA and into sub-Saharan countries,” said Peter Vieira, national channel manager of Xerox system sales at Bytes Document Solutions. “Xerox is a world-renowned and quality brand associated with printing, copying and document management,” said Jayesh Reddy, general manager at Med-e-Mass. “We want to pass on to our clients the certainty that they are dealing with a solution of substance.” Med-e-Mass offers product support through a national call centre, backed by four regional offices and 48 dealers that deliver further telephonic or on-site support. The national call centre, which is the client’s first port of call, is staffed by skilled customer service agents with years of industry and product knowledge. They not only handle technical queries, but through a tailored call logging system, they can map clients’ needs and support trends. Med-e-Mass leases its product for a monthly fee and offers regular updates, support and maintenance to ensure that clients always comply with the latest regulations in the rapidly evolving health care industry. This is the perfect platform to offer printing solutions as a value-added service to Med-e-Mass’s existing client base. Med-e-Mass has already kick-started the partnership by selling Xerox printers, multifunction devices and consumables for Xerox devices and Xerox replacement consumables for HP devices to its customers through a mail campaign. “The Xerox hardware is fully integrated with Med-e-Mass’s suite of products and doctors, pharmacies and hospitals will enjoy benefits through the partnership in terms of price, delivery and a three-year warranty,” said Vieira. Xerox also has an international agreement with Aycan for its x-ray printing solution that was recently cemented locally through a partnership between Bytes Document Solutions’ Xerox division and Shinda Medical, the local Aycan agent. This has seen radiologists around the country realise millions in savings. lll For more information, contact Jayesh Reddy on 012‑347‑2323, at [email protected], or go to www.medemass.com Pharmaceutical Company Launches New Dermatology Division In line with its vision of being a leading, world-class, focused health care company, Adcock Ingram has established a new dermatology business unit which offers a range of prescription dermatological products. “Adcock Ingram Dermatology is committed to improving the quality of patients’ lives and providing dermatologists with additional solutions for their patients’ needs,” said recently appointed head of Adcock Ingram Respiratory and Dermatology, Gary Vine. Vine said the establishment of Adcock Ingram Dermatology will ensure therapeutic alignment across the company’s product range. The products will be marketed by an established national dermatology sales force and the new structure will ensure a high level of focus within each therapeutic area. The therapeutic areas that the dermatology division will focus on include eczema, acne, psoriasis and skin infections. “Through strategic collaboration with our valued partners including LEO Pharma, Novartis, MSD and Roche, we are now able to offer health care professionals and our patients a wide range of prescription dermatological brands,” said Vine. Some of the key brands within these areas include Elidel, Elocon, Roaccutane, Dovobet, Famvir, Fucidin, Fucidin H and Quadriderm. “We are extremely proud to introduce our full range of dermatological products to the market for the effective treatment of skin conditions,” said Vine. lll For further information, contact dermatology brand managers, Nicolette Kotze, on 011-635-0627 or Shakti Pillay, on 011-635-0642. Adcock Ingram Limited. Reg. No. 1949/034385/06 Private Bag X69, Bryanston, 2021 South Africa Telephone + 27 11 635 0000 www.adcock.com Legacy Medical, distributing for CHEX Healthcare, Manufacturers of Frankenman International, features products with high-quality design and high-quality manufacturing. Products have the necessary quality accreditation - full CE and ISO 13485, 9001 accreditation and US Food and Drug Administration clearance since June 2009. All product design is tested as strenuously as possible. Tests are performed in-house and by qualified outside contractors. Continuous feedback is incorporated in the manufacturing and design development process. The end product received for patient use is thus quality without compromise. The process does not end there: • The company receives feedback from surgeons who are using the products. • Surgeons’ reports are read. • Surgeons are invited to brainstorm with the company. The company chooses to put the patient ahead of the manufacturing process. lll For more information, call Legacy Medical on 012‑997‑2155, fax 012-997-2070, email [email protected] or go to www.legacymedical.co.za New Lease on Life for Schizophrenic Patients Olanzapine (Olexar) has been launched as Cipla’s first atypical antipsychotic agent in its extensive range of psychiatric medicines. Olanzapine is indicated for the treatment of psychotic disorders including psychotic manifestations of schizophrenia and acute mania in patients with bipolar disorder. It is also indicated for the prevention of recurrence of a manic or depressive episode in a patient with bipolar disorder.¹ From the results of the Clinical Antipsychotic Trials for Intervention Effectiveness (CATIE) trial and Cochrane Collaboration Comparison Study, it was concluded that olanzapine is the most effective antipsychotic compared to several other available agents since:²,³ • Patients who took it demonstrated a greater reduction in psychopathology. • It allowed for a longer duration of successful treatment (patients continued with treatment for a longer period of time). • Its use was associated with a lower rate of hospitalisation. The medication is available at an extremely affordable price and offers a 45% to 60% cost saving, compared to the originator. It is priced as follows (SEP excluding VAT):4 * Olexar 2.5mg R250 * Olexar 5mg R390 * Olexar 10mg R500 lll For further information, contact Wouter Lombard, product manager CNS, Cipla Medpro on 021-917-5620 or email wouter@ ciplamedpro.co.za References 1. Olexar PI. 2.Lieberman JA, et al. September 2005. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N Engl J Med 2005;353:120923. Congress Highlights • Pre-Congress Workshops: Ultrasound, NAEP Asthma Symposium & Minimally Invasive Cardiac Output • Interactive Academic Programme: • Adult & Paediatric Critical Care, Pulmonolgy and Nursing Sessions • World-class international and local invited faculty • CPD & Ethics points • Sensational Social Programme Telephone +27 (0)11 447-3876 Fax +27 (0)11 442-8094 www.criticalcare.org.za 3.Komossa K, et al. 2010. Olanzapine versus other atypical antipsychotics for schizophrenia (Review). The Cochrane Collaboration. Published in the Cochrane Library, Issue 12. 4.SEP (excl. VAT) as per PCD 4 May 2011. medical chronicle | June 2011 | page 87 Updates and New Products Periscope // Taking the Itch Vitamin D Key Treating Acute Mania out of the Scratch to Fighting Flu in Bipolar Patients The launch of two revolutionary new skin care products, Cetaphil Restoderm Skin Restoring Body Wash and Cetaphil Restoderm Skin Restoring Body Moisturiser, is good news for atopic dermatitis sufferers, as they will do much to reduce redness, dryness and irritation - common symptoms of this skin condition. Both contain patented ceramide and flaggrin technology, which helps replenish the skin’s natural lipids and restore moisture to help rebuild the damaged skin barrier. Clinically proven to be nonirritating, these products are highly tolerable and fragrance free, with studies showing that they can be used in children as young as three months with atopic skin. These products, when included in the daily cleansing and moisturising regimen, will do much to provide increased tolerability. lll Product information and references available on request. Galderma Laboratories South Africa (Pty) Ltd Co Reg No: 1996/000311/07. Vitamin D may be the key to preventing winter colds and flu. A recent study published in Nature Immunology found that without vitamin D, T cells cannot activate and launch an immune response.1 Recognition of an antigen, the first step in the process of T cell mobilisation, signals the transcription of vitamin D receptors. Only once the new vitamin D receptors bind vitamin D, is a signal sent to the T cell’s DNA to encode phospholipase C gamma1, which, in turn, catapults the T cell into action. If insufficient vitamin D is present then the whole process comes to a standstill and the T cell never launches its immune response. There is far less sun in the winter months and, consequently, vitamin D levels are low. Insufficient vitamin D means less T cell activation and a poor immune response in the face of a threat. With this new understanding, it’s easy to see why winter is synonymous with colds and flu, while lending additional support to previous findings which found that supplementation with 1200IU of vitamin D3 (the most active form of vitamin D) lowered the incidence of seasonal flu by 42%.2 lll For more information, contact SOLAL Technologies on 011‑783‑3939 or email [email protected] References 1.Von Essen MR, Kongsbak M, Schjerling P, et al. Vitamin D controls T cell antigen receptor signaling and activation of human T cells. Nature Immunology, 2010;11:344-349 2.Urashima M, Segawa T, Okazaki M, et al. Randomized trial of vitamin PO Box 71150, Bryanston, 2021. Tel: (011) 706-2339. www.galderma.com D supplementation to prevent seasonal influenza A in schoolchildren. Am J CET 1006-5. Clin Nutr, 2010;91:1255-60. Supporting Epilepsy SA to Combat Stigma At the recent 2011 Neurological Association of SA congress, Cipla Medpro once again showed its commitment to creating awareness about the social challenges of patients living with epilepsy. Epilepsy SA has a programme consisting of five virtual walls of ‘True Potential’ in support of, and representing, its major service programmes. This project aims to decrease discrimination towards people with epilepsy and raise funds to ensure sustainable service delivery. At the congress, Cipla Medpro made a large contribution to one of the walls - the Wall of Empowerment - on behalf of the delegates, thus raising additional funds. Apart from manufacturing medicine to treat epilepsy (Epitec), the company also understands the importance of providing continued patient education and supports awareness campaigns surrounding the management of the condition, hence its involvement in Epilepsy SA. lll For more information, contact Wouter Lombard, Cipla Medpro, on 021-917-5620. Collaborating to Save Children’s Sight in Africa To establish 10 paediatric eye-care clinics in 10 years in sub-Saharan Africa - that was the commitment from multinational sight-saving organisation, ORBIS, a nonprofit organisation dedicated to saving sight worldwide. The announcement was made at a conference held in Cape Town last month aimed at developing strategies to prevent childhood blindness in Africa. Eye-care nongovernmental organisations, ophthalmologists, health department officials and academics from 15 countries attended the conference. With a direct link between the incidence of blindness and poverty, sub-Saharan Africa carries the Prof Colin Cook, heaviest burden with 23% of the head of world’s blind population (India has ophthalmology, 19% and China 13%). University of Cape “In terms of global blindness Town alleviation, southern Africa is a priority region,” said Lene Øverland, programme director for ORBIS Europe, Middle East and Africa. At the meeting, she challenged stakeholders to add on to the organisation’s pledge of $1m (R6.7m) to establish one paediatric eye care clinic each year, over the next 10 years. “There are fewer paediatric ophthalmologists and paediatric eye centres in Africa than anywhere else in the world. Correcting the tragedy of preventable blindness in the region is an urgent public health priority,” Øverland said. According to Prof Colin Cook, head of ophthalmology at the University of Cape Town, Groote Schuur Hospital and Red Cross War Memorial Children’s Hospital, 50% of childhood blindness is avoidable. The World Health Organization recommends one paediatric ophthalmic centre per 10 million people. SubSaharan Africa is grossly under-catered for in this field with just 11 centres across the 47 countries. SA only has one dedicated children’s facility at the Red Cross Hospital and many countries in the region do not even have a paediatric ophthalmologist. Olanzapine (Redilanz) is an atypical antipsychotic indicated for the management of the manifestations of psychotic disorders and for the treatment of acute mania in bipolar disorder. Olanzapine will be available as 2.5mg, 5mg and 10mg. It should be administered on a once-a-day schedule without regard to meals, beginning with an initial dose of 5-10mg/day, with a target of 10mg/day being reached within several days. Further dose adjustments, if indicated, should occur at intervals not less than one week. Dr Reddy’s Laboratories (Pty) Ltd. Reg no. 2002/014163/07. South Wing, The Place, 1 Sandton Drive, Sandton 2196, South Africa. Tel: +27-11-783-0104. Fax: +27-11-388-1262. www.drreddys.co.za S5 Redilanz 2,5/5/10. Each tablet contains olanzapine 2,5 mg/5 mg/10 mg. Reg. No’s. 42/2.6.5/0813;0814;0815. Toothpaste’s Solution to Tooth Sensitivity Colgate-Palmolive SA introduces Colgate Sensitive ProRelief toothpaste, a major advance in the treatment of tooth sensitivity. With its patented, Pro-Argin formula, the product offers relief to the 29% of South Africans who have claimed to have suffered from sensitivity. It is the first and only toothpaste to incorporate Colgate’s ProArgin technology and is clinically proven to deliver instant and lasting sensitivity relief. While most of the sensitive toothpastes currently marketed primarily numb sensitivity pain, this product effectively plugs the channels that lead to sensitive tooth nerves, thereby blocking the transmission of heat, cold, air and pressure that stimulate pain receptors within teeth. “The product can be directly applied to a sensitive tooth, using your finger tip to gently massage for one minute, to deliver instant relief from sensitivity,” said Dr William DeVizio, VP, Global Technology, Colgate-Palmolive. Tooth sensitivity is an oral condition that affects up to 57% of consumers worldwide. The touch of a dental instrument can make routine dental visits unbearable. This discomfort may lead sensitivity sufferers to avoid regular checks ups - neglect that can result in a progression of oral care problems. lll For more information, go to www.instantrelief.co.za page 88 | medical chronicle | March 2011 Product & Service Listing // Directory Refer to Company Listing for contact details Ambulances and Accessories •3M •Afrivent •Afrox Medical Gases •B Braun •Dräger Medical SA •Gabler Medical •Live Wire Learning •Myriad Medical •Miracle Medical •SSEM Mthembu Medical Ambulance Equipment •3M •Afrivent •Afrox Medical Gases •B Braun •Gabler Medical •Myriad Medical •Miracle Medical •Respiratory Care Africa •Sere-med •SSEM Mthembu Medical •Viking Medical •Welch Allyn Anaesthetic Equipment •Afrivent •Afrox Medical Gases •CareFusion •Clinical & Medical Services •Covidien •Dinaledi Medical •Dräger Medical SA •Edwards Lifesciences •Gabler Medical •Marland Medical •Med Loyd •Myriad Medical •Respiratory Care Africa •R. Moloney & Company •Scientific Group •Surgimed Hospital Supplies •Viking Medical Anaesthetic Masks, Breathing Bags, etc. •Afrivent •Afrox Medical Gases •Clinical & Medical Services •Dräger Medical SA •Intersurgical RSA •Laurike Marketing •Marland Medical •Myriad Medical •SSEM Mthembu Medical •Surgimed Hospital Supplies •Viking Medical Anaesthetic Trolleys •Kendon Medical •Surgimed Hospital Supplies Aneurysm Clips •Viking Medical Architectural Systems •Dräger Medical SA Archiving and Documentation Equipment Bandages •3M •Hartmann - Vitamed •Health In Form •Johnson & Johnson Medical •Kendon Medical •Laurike Marketing •Med Loyd •Miracle Medical •Sere-med •Surgical & Ophthalmic Supplies •Surgimed Hospital Supplies Bath Tubs and Showers •Franke Kitchen Systems Bed Pan Flushing Equipment •Franke Kitchen Systems •SAFMED •Scientific Group Bed Pans •Health In Form •Kendon Medical •Miracle Medical •Surgimed Hospital Supplies Bedding •Miracle Medical •Restonic Bedside Tables and Cupboards •BioClin Solutions •Cook Chill •Medical Excellence •Miracle Medical •Respiratory Care Africa •Scientific Group •Surgimed Hospital Supplies Biopsy Forceps •Johnson & Johnson Medical •Medequip •Surgimed Hospital Supplies Biopsy Needles - Bone Marrow •Adcock Ingram Critical Care •Philisa Biomedical •Surgimed Hospital Supplies Biopsy Needles - Soft Tissue •Adcock Ingram Critical Care •Philisa Biomedical •Vertec Scientific Blood Bank Equipment •Clinical Sciences Diagnostics •Hemocue South Africa •Scientific Group •Viking Medical Blood Bank Refrigerators •Surgimed Hospital Supplies Blood Gas Analysis •Hartmann - Vitamed •Ilex •Myriad Medical Blood Grouping Equipment •Ilex •Tidy Files Arthroscopy •Flurovizion Assistive Listening Devices •Hearing Innovations •Live Wire Learning Audiology Diagnostic Equipment •3M •Amtronix •HASS Industrial •Hearing Innovations •Medical Excellence •Surgimed Hospital Supplies •Viking Medical •Welch Allyn Automated External Defibrillators •Kendon Medical •Live Wire Learning •Medical Excellence •Miracle Medical •Sere-med •SSEM Mthembu Medical •Welch Allyn Autopsy Tables •Dinaledi Medical •Franke Kitchen Systems Baby Warmers •BioClin Solutions •Dinaledi Medical •Gabler Medical •Medical Excellence •Miracle Medical •Surgimed Hospital Supplies Balance Assessment Equipment •Amtronix Bandage Trolleys •Cook Chill •Health In Form •Surgimed Hospital Supplies Blood Grouping Kits •Ilex Blood Pressure Monitoring Equipment •Alcomed Medical Supplies •BioClin Solutions •Clinical & Medical Services •Dinaledi Medical •Edwards Lifesciences •Hartmann - Vitamed •Kendon Medical •Manta Medical •Medical Excellence •Miracle Medical •Sere-med •SSEM Mthembu Medical •Surgimed Hospital Supplies •Welch Allyn Blood Transfusion Equipment •B Braun •CareFusion •Clinical Sciences Diagnostics •Viking Medical Blood-warming Equipment •Augustine Medical SA •BioClin Solutions •Clinical & Medical Services •Covidien •Dinaledi Medical •Gabler Medical •Medical Excellence •Surgimed Hospital Supplies Body Contouring •Intamarket •Radiant Healthcare •Technolase Bone Density Tests •Mammography Centre Bone Mineral Analysers and Densitometers •Vertec Scientific Brachytherapy •CR Bard Breast Implants •Conquest Surgical Supplies •Genop Healthcare Breast Self-Examination Gel •Vertec Scientific Building Administration and Supplies Management •Radiant Healthcare Building Technical Management •Radiant Healthcare Cannulae, Rigid and Flexible •Afrox Medical Gases •Conquest Surgical Supplies •Covidien •Edwards Lifesciences •Flurovizion •Manta Medical •Med Loyd •Ophthalmic Precision Instruments •Radiant Healthcare •Respiratory Care Africa •Surgical & Ophthalmic Supplies •Viking Medical Cardiology - Balloon Catheters •B Braun •Johnson & Johnson Medical •Manta Medical •Viking Medical Cardiology Catheter Sheath Introducers •B Braun •Johnson & Johnson Medical •Manta Medical •Viking Medical Cardiology Diagnostic Catheters •B Braun •Johnson & Johnson Medical •Manta Medical •Viking Medical Cardiology - Guidewires •B Braun •Johnson & Johnson Medical Cardiology High Pressure Syringe •Covidien Cardiology - Stents •B Braun •Johnson & Johnson Medical •Viking Medical Catering Equipment and Contractors •Cook Chill •Franke Kitchen Systems Catheters •Alcomed Medical Supplies •B Braun Medical •Covidien •CR Bard •Edwards Lifesciences •Manta Medical •Medequip •Med Loyd •Miracle Medical •Nu Angle Medical •Philisa Biomedical •Surgimed Hospital Supplies •Viking Medical Certification and Testing of Medical Devices •Myriad Medical Chest Drains •Covidien •Dinaledi Medical •Johnson & Johnson Medical •Viking Medical Children’s Cots and Basinettes •Health In Form •Surgimed Hospital Supplies Cleaning of Buildings •Manta Medical Cleaning of Health care Facilities •Evolution Medical •Mediguard Healthcare Services Clinical Education and Support •3M •Afrivent •B Braun Medical •CareFusion •Live Wire Learning •Manta Medical •Myriad Medical •Viking Medical Clinical Management •BHG (SA) •CareFusion •SleepNet/BreatheNet Clinical Pathology •Abbot Laboratories •Hemocue South Africa Colorectal Solutions •B Braun Medical •Covidien •Johnson & Johnson Medical Complete Equipping of Hospitals •Afrox Medical Gases •CareFusion •Clinical & Medical Services •Live Wire Learning •Miracle Medical •Radiant Healthcare Computer Hardware •Delta 9 Hospital Software Solutions •Pro Med Computer Services Computerised Tomography (CT) Equipment •Philips Healthcare •Pro Med Computer Services •Vertec Scientific Conference Venues •CSIR Conference Centre •Eskom Conference Centre Conforming Gel Pads for Ultrasound •Alcomed Medical Supplies •Vertec Scientific •Viking Medical Convention Centres •Cape Town International Convention Centre •Durban International Convention Centre •Sandton Convention Centre Cosmetics •G A Active •Lesmed Procucts •Radiant Healthcare Critical Care •Ilex •Viking Medical Cryotherapy and Cryosurgery Equipment •Nitran Surgical Systems •Radiant Healthcare •R. Moloney & Company •Sere-med •Surgimed Hospital Supplies Darkroom Equipment •Imagex •Lomaen Medical Defibrillators •Alcomed Medical Supplies •Dinaledi Medical •Medical Excellence •Miracle Medical •Philips Healthcare •Sere-med •SSEM Mthembu Medical Dialysis Consumables •Adcock Ingram Critical Care •B Braun Medical •Covidien •SSEM Mthembu Medical •Viking Medical Dialysis Equipment •Adcock Ingram Critical Care •B Braun •CR Bard •SSEM Mthembu Medical Dialysis Fluids •Adcock Ingram Critical Care •B Braun Medical Diathermy Equipment •B Braun Medical •Clinical & Medical Services •Covidien •Laurike Marketing •Medequip •Medical Excellence •Miracle Medical •Nitran Surgical Systems •Onemed •R. Moloney & Company •Scientific Group •Sere-med Digital Radiography/Computed Radiography Equipment •AGFA Healthcare •Carestream Health •Imagex •Lomaen Medical •Philips Healthcare •Pro Med Computer Services •Scientific Group •Vertec Scientific Disabled Access •Evolution Medical •JessenDakile Disinfectant Cleaner for Ultrasound Probes •Alcomed Medical Supplies •Evolution Medical •Vertec Scientific Disinfectants •Alcomed Medical Supplies •Evolution Medical •Health In Form •Johnson & Johnson Medical •Kendon Medical •Miracle Medical •SAFMED •Scientific Group •Sere-med •Vertec Scientific Disinfecting Washers •Evolution Medical •Franke Kitchen Systems •Johnson & Johnson Medical •Miele •SAFMED •Scientific Group Disinfection Preparations •Laurike Marketing Disposable Articles for Hospitals •3M •AGFA Healthcare •B Braun •Coloplast •Dinaledi Medical •Dräger Medical SA •Kendon Medical •Laurike Marketing •Myriad Medical •Miracle Medical •Ophthalmic Precision Instruments •Respiratory Care Africa •Viking Medical Doctors’ Bags, Emergency Cases •Miracle Medical •Sere-med Drug Tests •Clinical Sciences Diagnostics •Health In Form •Kendon Medical •Miracle Medical •Philisa Biomedical ECG Equipment •BioClin Solutions •Clinical & Medical Services •Covidien •Dinaledi Medical •Imagex •Kendon Medical •Medical Excellence •Miracle Medical •Philips Healthcare •Respiratory Care Africa •Surgimed Hospital Supplies •Welch Allyn Educational Appliances •Live Wire Learning •Miracle Medical EEG Equipment •Kendon Medical •Respiratory Care Africa •R. Moloney & Company •SSEM Mthembu Medical EEG Monitoring Equipment •Philips Healthcare •Respiratory Care Africa •SSEM Mthembu Medical Electronic Healthcare Records •BHG (SA) •CareFusion •Delta 9 Hospital Software Solutions •Pro Med Computer Services Electronic Patient Record Software •BHG (SA) •CareFusion •Delta 9 Hospital Software Solutions •Pro Med Computer Services Electrophysiology •CR Bard Electrosurgical Instruments •B Braun •Covidien •CR Bard •Flurovizion •Johnson & Johnson Medical •Laurike Marketing •Nitran Surgical Systems •Ophthalmic Precision Instruments •Scientific Group •Surgimed Hospital Supplies Electrotherapy Equipment •Alcomed Medical Supplies •CR Bard •Nitran Surgical Systems •Radiant Healthcare •Scientific Group •Viking Medical Emergency and Transport Ventilators •Afrox Medical Gases •Clinical & Medical Services •Dräger Medical SA •Myriad Medical •Miracle Medical •Respiratory Care Africa •Scientific Group •SSEM Mthembu Medical •Viking Medical Emergency Room Equipment •3M •B Braun •Myriad Medical •Miracle Medical •Respiratory Care Africa •SSEM Mthembu Medical •Surgimed Hospital Supplies •Viking Medical •Welch Allyn Endoscopy Equipment - Flexible •B Braun •Covidien •Imagex •Medequip •R. Moloney & Company Endoscopy Equipment - Rigid •B Braun •Covidien •Flurovizion •Imagex •Medequip •Nitran Surgical Systems •Onemed •R. Moloney & Company •Smith & Nephew •Welch Allyn Endotracheal Tubes •Covidien •Dinaledi Medical •Laurike Marketing •Med Loyd •Miracle Medical •SSEM Mthembu Medical •Viking Medical ENT Diagnostic Equipment •Amtronix •BioClin Solutions •Clinical & Medical Services •Dinaledi Medical •Flurovizion •Kendon Medical •Medical Excellence •Miracle Medical •R. Moloney & Company •Sere-med •Surgimed Hospital Supplies •Viking Medical •Welch Allyn Equipment Accessories •B Braun •Franke Kitchen Systems •Kendon Medical •Myriad Medical Equipment for Day Wards •Afrox Medical Gases •BioClin Solutions •B Braun •Clinical & Medical Services •Cook Chill •Dinaledi Medical •Medical Excellence •Respiratory Care Africa •SSEM Mthembu Medical •Welch Allyn Equipment for Neonatal Units •3M •Afrivent •BioClin Solutions •B Braun •CareFusion •Clinical & Medical Services •Dräger Medical SA •Gabler Medical •Medical Excellence •Myriad Medical •Philips Healthcare •Respiratory Care Africa •Scientific Group •SSEM Mthembu Medical •Viking Medical Ergometers •Welch Allyn medical chronicle | March 2011 | page 89 Product & Service Listing Directory // Refer to Company Listing for contact details Exam, Treatment, ICU and Recovery Rooms equipment •Afrivent •Afrox Medical Gases •BioClin Solutions •B Braun •Clinical & Medical Services •Dräger Medical SA •Gabler Medical •Health In Form •Medical Excellence •Miracle Medical •Philips Healthcare •Respiratory Care Africa •SSEM Mthembu Medical •Viking Medical Examination and Medical Lamps •BioClin Solutions •Clinical & Medical Services •Dinaledi Medical •Dräger Medical SA •Kendon Medical •Medical Excellence •Miracle Medical •R. Moloney & Company •Scientific Group •Sere-med •SSEM Mthembu Medical •Welch Allyn Exhibition Organisers •Fair Consultants Feeding Tubes •Covidien •Med Loyd •Miracle Medical •Respiratory Care Africa •Viking Medical Fibre-optic Equipment •Kendon Medical •Miracle Medical •R. Moloney & Company •Welch Allyn First-aid Equipment •B Braun •Kendon Medical •Miracle Medical •Sere-med Floor Coverings, Wall Cladding and Ceilings •Polyflor Fluid Management Pumps •B Braun •Flurovizion Foetal Monitoring Equipment •Bioclin Solutions •Clinical & Medical Services •Medical Excellence •Miracle Medical •Nitran Surgical Systems •Philips Healthcare •Respiratory Care Africa •SSEM Mthembu Medical •Surgimed Hospital Supplies Fontanelle Scanning Pads for Ultrasound •Vertec Scientific Food Supplements •Meri Brands Forced Air Warming •Augustine Medical SA •Clinical & Medical Services •Covidien Gas and Compressed Air Systems •Air Liquide Gas Therapy Equipment (oxygen, ozone, etc) •Afrox Medical Gases •Air Liquide •Gabler Medical Gaseous Exchange Monitoring Equipment and Breathalysers •Air Liquide •Myriad Medical Gases for Cold Sterilisation •Air Liquide Genetic Counselling •Gknowmix Genetic Care Centre Genetic Testing •Gknowmix Genetic Care Centre Gloves Examination and Protective •Alcomed Medical Supplies •Auckland Orthopaedics •B Braun •Covidien •Hartmann - Vitamed •Kendon Medical •Laurike Marketing •Manta Medical •Med Loyd •Miracle Medical •Sere-med Gloves - Surgeon •Alcomed Medical Supplies •B Braun •Covidien •Hartmann - Vitamed •Kendon Medical •Laurike Marketing •Manta Medical •Med Loyd •Sere-med Gynaecology Diagnostic Equipment •Afrox Medical Gases •Alcomed Medical Supplies •BioClin Solutions •Dinaledi Medical •Kendon Medical •Medical Excellence •Miracle Medical •Nitran Surgical Systems •Onemed •Philips Healthcare •R. Moloney & Company •SSEM Mthembu Medical •Viking Medical •Welch Allyn Hammers, Percussion and Reflex •Alcomed Medical Supplies •Miracle Medical Hearing Aids •Hearing Innovations Hearing Instruments •Oticon SA Heart Valves (Aortic and Mitral) •Edwards Lifesciences •Viking Medical Heart-Lung Machines •Scientific Group •Viking Medical Heating Technology •Edwards Lifesciences •SSEM Mthembu Medical Haemodynamic Monitoring •Edwards Lifesciences •SSEM Mthembu Medical •Viking Medical Hip Endoprotheses, Knee & Shoulder Prostheses •Auckland Orthopaedics •B Braun •Laurike Marketing HIV Diagnosis & Management •Dr Keyser & Marshall HIV Testing •Dr Keyser & Marshall Hospital Beds •BioClin Solutions •Cook Chill •Health In Form •JessenDakile •Medical Excellence •Scientific Group Hot-air Sterilisers •Miracle Medical Image Documentation Systems •Nobel Biocare SA •Pro Med Computer Services Implantable Catheters and Long-term Access •CR Bard •Manta Medical Implants and Protheses •Auckland Orthopaedics •B Braun •Conquest Surgical Supplies •CR Bard •Dinaledi Medical •Genop Healthcare •Johnson & Johnson Medical •Nobel Biocare SA •Surgical & Ophthalmic Supplies •Synthes Incontinence and Stoma Aids •Coloplast •CR Bard •Holister SA •Manta Medical •Nu Angle Medical Incontinence Products •B Braun •Hartmann - Vitamed •Johnson & Johnson Medical •Nu Angle Medical Infant Incubators •BioClin Solutions •Clinical & Medical Services •Dräger Medical SA •Medical Excellence •Respiratory Care Africa •Scientific Group Infusion Pumps •Adcock Ingram Critical Care •B Braun •CareFusion •Clinical & Medical Services •Fresenius Kabi •Gabler Medical •Myriad Medical •Scientific Group Infusions Sets •Adcock Ingram Critical Care •B Braun •CareFusion •Fresenius Kabi •Gabler Medical •Kendon Medical •Myriad Medical •Scientific Group •Sere-med Inhaler and Aerosol Equipment •Myriad Medical Insect Repellent •Acorn •BioClin Solutions Instrument and Syringe Sterilisers •BioClin Solutions •Sere-med Insulin Syringes and Injectors •B Braun •Health In Form •Kendon Medical •Manta Medical •Med Loyd •Sere-med Intraoperative Drains •Dinaledi Medical •Johnson & Johnson Medical Invasive Pressure Monitoring Products •Manta Medical •SSEM Mthembu Medical Laparoscopic Equipment •B Braun •Covidien •Gabler Medical •Johnson & Johnson Medical •Medequip •Nitran Surgical Systems •Onemed Laryngoscopes •BioClin Solutions •Clinical & Medical Services •Dinaledi Medical •Kendon Medical •Live Wire Learning •Medequip •Medical Excellence •Miracle Medical •R. Moloney & Company •Sere-med •Welch Allyn Laser Equipment - Aesthetic •Intamarket •Radiant Healthcare •Scientific Group •Technolase Laser Imaging Equipment •Carestream Health •Scientific Group Laser Surgery Equipment •Radiant Healthcare •Spectra-Medic Laser Therapy Equipment •Alcomed Medical Supplies •Genop Holdings •Radiant Healthcare Laundry Equipment & Facilities •Evolution Medical Lifting Platforms •JessenDakile Lighting Equipment •Dinaledi Medical •Medical Excellence •SSEM Mthembu Medical •Welch Allyn Linen •Health In Form Liposuction •Radiant Healthcare •Sound Aesthetics Liposuction - Radio Frequency •Radiant Healthcare •Technolase Lithotripsy Equipment •Spectra-Medic Lubricants - Sterile •Johnson & Johnson Medical Male Sling - Advance •Marcus Medical Mammo Pads •Vertec Scientific Mammography •AGFA Healthcare •Carestream Health •Mammography Centre •Philips Healthcare •Vertec Scientific Mattresses •BioClin Solutions •Health In Form •Medical Excellence •Respiratory Care Africa •Restonic Medication Safety Software •CareFusion Microdermabrasion •Radiant Healthcare •Technolase Microscopes •Carl Zeiss •Clinical Sciences Diagnostics •Medequip •Nitran Surgical Systems Minimally Invasive Surgery •Medequip •Radiant Healthcare Mobile X-Ray Equipment •AGFA Healthcare •Imagex •Lomaen Medical •Philips Healthcare •Vertec Scientific Molecular Diagnostics •Ilex •Molecular Diagnostic Services Monitoring Equipment Pulse, Respiration & ECG •Afrivent •BioClin Solutions •Clinical & Medical Services •Dräger Medical SA •Medical Excellence •Myriad Medical •Miracle Medical •Philips Healthcare •Respiratory Care Africa •Scientific Group •SSEM Mthembu Medical •Welch Allyn MRI Equipment •Afrivent •Dräger Medical SA •Philips Healthcare Nebulizers •Sere-med Needle-free Disposable Devices •Alcomed Medical Supplies •B Braun •CareFusion •Gabler Medical •Manta Medical •Radiant Healthcare •Viking Medical Neonatal Care Equipment •B Braun •Clinical & Medical Services •Dräger Medical SA •Gabler Medical •Medical Excellence •Myriad Medical •Scientific Group •SSEM Mthembu Medical •Viking Medical Nephrostomy Sets, Stone Baskets •Philisa Biomedical Neurology Diagnostic Equipment •Philips Healthcare •SSEM Mthembu Medical Neurosurgery Equipment •Medequip •Nitran Surgical Systems •Viking Medical Nuclear Medicine •Covidien Nuclear Medicine Equipment •Philips Healthcare Occupational Therapy Equipment •Alcomed Medical Supplies •Live Wire Learning Ocular Diagnostic Equipment •Genop Healthcare •Ophthalmic Precision Instruments Office Furniture •CN Business Furniture OMF Implants •Marcus Medical Operating Room Textiles •Manta Medical Operating Tables •Clinical & Medical Services •Dräger Medical SA •Miracle Medical •Respiratory Care Africa •SAFMED Ophthalmic Implants, Artificial Eyes, Lenses •Carl Zeiss •Genop Healthcare •Surgical & Ophthalmic Supplies •Viking Medical Ophthalmic Instrumentation and Fluids •Carl Zeiss •Flurovizion •Marcus Medical •Ophthalmic Precision Instruments •Viking Medical Ophthalmic Monitoring Equipment •Amtronix •Ophthalmic Precision Instruments Ophthalmic Units •Carl Zeiss •Genop Healthcare •Gerry van Winsen Optics •Surgical & Ophthalmic Supplies Ophthalmoscopes •Dinaledi Medical •Genop Healthcare •Gerry van Winsen Optics •Medical Excellence •Sere-med •Welch Allyn Optometry Instruments •Gerry van Winsen Optics OR Lights •Clinical & Medical Services •Dräger Medical SA •Medical Excellence •Miracle Medical •SAFMED •Scientific Group •SSEM Mthembu Medical OR Technology and Equipment •Dräger Medical SA •Myriad Medical •Respiratory Care Africa •SSEM Mthembu Medical Orthopaedic Prostheses - Hip •Auckland Orthopaedics •Laurike Marketing Orthopaedic Prostheses - Knee •Auckland Orthopaedics •Flurovizion •Laurike Marketing Orthopaedic Prostheses - Shoulder •Flurovizion •Laurike Marketing Orthopaedic Prostheses Small joint •Flurovizion •Laurike Marketing Orthopaedic Powertools •Flurovizion Orthopaedic Per systems •Flurovizion Orthopaedic Trauma Products •Auckland Orthopaedics •Flurovizion •Laurike Marketing •Marcus Medical •Philips Healthcare •Smith & Nephew •Surgimed Hospital Supplies Oximeters •Alcomed Medical Supplies •BioClin Solutions •Clinical & Medical Services •Covidien •Dinaledi Medical •Health In Form •Laurike Marketing •Medical Excellence •Miracle Medical •Respiratory Care Africa •Scientific Group •Sere-med •SleepNet/BreatheNet Oxygen Generating Systems •Air Liquide •Intaka Tech •Medical Excellence •Miracle Medical Oxygen Therapy Equipment •Afrivent •Afrox Medical Gases •Clinical & Medical Services •Gabler Medical •Intersurgical RSA •Radiant Healthcare •Respiratory Care Africa •Sere-med •SSEM Mthembu Medical •Viking Medical PA Catheters •Edwards Lifesciences •SSEM Mthembu Medical Patient Care Trolleys •BioClin Solutions •Medical Excellence Patient Lifting Equipment •Kendon Medical •Scientific Group Patient Monitors •BioClin Solutions •Clinical & Medical Services •Dinaledi Medical •Dräger Medical SA •Kendon Medical •Medical Excellence •Miracle Medical •Nitran Surgical Systems •Philips Healthcare •Respiratory Care Africa •Scientific Group •SSEM Mthembu Medical •Surgimed Hospital Supplies •Viking Medical •Welch Allyn Patient Transfer Equipment •Respiratory Care Africa •Scientific Group PCA Devices •CareFusion •Gabler Medical •Viking Medical Penile Prostheses •Marcus Medical •R. Moloney & Company Pharyngeal Tubes, Laryngeal Masks •Dinaledi Medical •Med Loyd •Myriad Medical •Scientific Group •SSEM Mthembu Medical Physiotherapy Equipment •Alcomed Medical Supplies •Nitran Surgical Systems Plaster of Paris Bandages •Kendon Medical •Sere-med Pregnancy Tests •Clinical Sciences Diagnostics •Kendon Medical •Philisa Biomedical •Sere-med Premature Baby Products & Services •Little Miracle Products & Services •Viking Medical Prolapse Surgery Products •Johnson & Johnson Medical •Marcus Medical •Onemed Prostate Thermotherapy Equipment •CR Bard Prostheses - Eyes •Custom Eyes Prostheses - Hip •Auckland Orthopaedics •Laurike Marketing •Smith & Nephew Prostheses - Knee •Auckland Orthopaedics •B Braun •Laurike Marketing •Smith & Nephew Prostheses - Shoulder •Laurike Marketing •Smith & Nephew Protective Clothing •AGFA Healthcare •Alcomed Medical Supplies •Miracle Medical •Vertec Scientific page 90 | medical chronicle | March 2011 Product & Service Listing // Directory Pulmonary Function Equipment and Spirometers •Covidien •Medical Excellence •Respiratory Care Africa •R. Moloney & Company •SSEM Mthembu Medical •Welch Allyn Radiotherapy Equipment •CR Bard •Nitran Surgical Systems •Vertec Scientific Rebreathing Bags •Clinical & Medical Services •Covidien •Intersurgical RSA •Laurike Marketing •Myriad Medical •Miracle Medical •Scientific Group •SSEM Mthembu Medical •Surgimed Hospital Supplies Reconstruction Instruments and Implants •Synthes Refer to Company Listing for contact details Services - Financial Services •PPS Insurance Services - Lawyers •Webber Wentzel Services - Managed Healthcare •Agility Global Health Solutions Services Medical Administrators •Health-Worx •Status Medical Administrators Services - Medical Aid Care •Eternity Private Health •Fedhealth Services - Medical Scheme •GEMS •Genesis Medical Scheme •Resolution Health Medical Scheme Services - Medical Scheme Managed Care Services •Agility Global Health Solutions Services - Ocularist Rehabilitation Devices and Equipment •Alcomed Medical Supplies Rescue Helicopters and Aircraft •B Braun •CareFusion •Myriad Medical •Miracle Medical Respiration Masks •Afrox Medical Gases •Covidien •Dräger Medical SA •Intersurgical RSA •Laurike Marketing •Myriad Medical •Respiratory Care Africa •SleepNet/BreatheNet •SSEM Mthembu Medical •Surgimed Hospital Supplies Respiratory Monitoring Equipment •Afrox Medical Gases •Amtronix •Myriad Medical •Nitran Surgical Systems •Respiratory Care Africa •SSEM Mthembu Medical •Surgimed Hospital Supplies Rib and Sternal Fixation •Synthes •Custom Eyes Services - Pathology Services •Ampath •Lancet •Toga Services Practice Revenue Management •Quantum Revenue Management Services - Recruitment •Thymic Connections Services - Smoking Cessation •Dr Gavin Zipp & Associates Services - Staff Outsourcing •Quintiles Commerical Solutions Services - Travel Agency •Edenvale Travel •Rosebank Travel Service •Thompson’s Leisure Travel •XL Travel Sleep Disorders Diagnostic Equipment •Respiratory Care Africa •SleepNet/BreatheNet •SSEM Mthembu Medical Slit Lamps •Gerry van Winsen Optics RIS/PACS Systems •AGFA Healthcare •Carestream Health •Imagex •Lomaen Medical •Philips Healthcare •Pro Med Computer Services Scales •BioClin Solutions •Live Wire Learning •Medical Excellence •Miracle Medical •R. Moloney & Company •Scientific Group •Sere-med Scalpel and Surgical Blades •B Braun •Medequip •Sere-med Self-Retaining Retractors •Marcus Medical •Medequip Self-Monitoring Equipment •Dräger Medical SA •Health In Form •Sere-med •Vertec Scientific Sentinel Node Detection Equipment •Johnson & Johnson Medical Services - BLS Training Centre •Sere-med Services Information Technology •Switch Services Insurance Underwriters •Alexander Forbes Compensation Technologies Services - Financial Advisors •First Health Finance •Imperial Bank Software •AGFA Healthcare •Amtronix •Delta 9 Hospital Software Solutions •Pro Med Computer Services Specialised Skin Care •Environ Skin Care •Radiant Healthcare Sphygmomanometers •Alcomed Medical Supplies •BioClin Solutions •Dinaledi Medical •Medical Excellence •Miracle Medical •R. Moloney & Company •Scientific Group •Sere-med •Welch Allyn Spinal Anaesthesia Products •B Braun •Manta Medical Spinal Implants •Astech •Laurike Marketing Splints •Kendon Medical •Miracle Medical •Sere-med Stapling Devices Open and Laproscopic •Covidien •Gabler Medical •Johnson & Johnson Medical Stents •B Braun •CR Bard •Johnson & Johnson Medical •Philisa Biomedical •Viking Medical Sterilisation Containers •Marcus Medical Sterilisation Indicators - Biological Swimming Goggles and Dive Masks •Danker Lenses •3M •SAFMED Sterilisation Indicators - Chemical •3M •SAFMED Sterilisation Packaging Syringe Drivers •B Braun •CareFusion •Clinical & Medical Services •Gabler Medical •Myriad Medical •Miracle Medical •SAFMED Sterilisers - Low Temperature •3M •SAFMED Sterilisers - Steam (Autoclaves) •3M •BioClin Solutions •Kendon Medical Steriliser Ultra violet •Sere-med Stereotactic Biopsy Equipment •CR Bard •Johnson & Johnson Medical •Vertec Scientific Stethoscopes •3M •Alcomed Medical Supplies •BioClin Solutions •Dinaledi Medical •Kendon Medical •Medequip •Medical Excellence •Miracle Medical •R. Moloney & Company •Sere-med •Welch Allyn Suction Equipment •Alcomed Medical Supplies •BioClin Solutions •Clinical & Medical Services •Dräger Medical SA •Gabler Medical •Kendon Medical •Medequip •Medical Excellence •Myriad Medical •Miracle Medical •Nitran Surgical Systems •Radiant Healthcare •Scientific Group •Sere-med Surgical Dilatators •Onemed Surgical Drapes •3M •AGFA Healthcare •Hartmann - Vitamed •SAFMED •SSEM Mthembu Medical Surgical Haemostat •B Braun •Dinaledi Medical Surgical Instruments and Devices •BioClin Solutions •B Braun •Conquest Surgical Supplies •CR Bard •Dinaledi Medical •Environ Skin Care •Flurovizion •Intamarket •Johnson & Johnson Medical •Marcus Medical •Marketspace Medical •Medequip •Medical Excellence •Nitran Surgical Systems •Onemed •Ophthalmic Precision Instruments •SAFMED •Scientific Group •Sere-med •Surgical & Ophthalmic Supplies •Surgimed Hospital Supplies •Synthes Surgical Operating Loupes and Lights •Danker Lenses Sutures •Alcomed Medical Supplies •B Braun •Covidien •Dinaledi Medical •Flurovizion •Gabler Medical •Johnson & Johnson Medical •Kendon Medical •Laurike Marketing •Sere-med •Surgical & Ophthalmic Supplies Syringes •Alcomed Medical Supplies •B Braun •CareFusion •Conquest Surgical Supplies •Kendon Medical •Laurike Marketing •Manta Medical •Med Loyd •Miracle Medical •Sere-med Technical Service, Training and Support •AGFA Healthcare •B Braun •CareFusion •Flurovizion •Medical Excellence •Myriad Medical •Pro Med Computer Services •Radiant Healthcare Telemedicine Equipment •AGFA Healthcare •Carestream Health •Welch Allyn Telemetry Systems •Dräger Medical SA Testicular Implants •Conquest Surgical Supplies •Marcus Medical •Nu Angle Medical Thermal Ablation Equipment Women’s Health •Johnson & Johnson Medical •Radiant Healthcare Thermometers •Alcomed Medical Supplies •Hartmann - Vitamed •Kendon Medical •Medical Excellence •Miracle Medical •Sere-med •Welch Allyn Thermotherapy Equipment •Covidien Topical Skin Adhesives •Dinaledi Medical •Johnson & Johnson Medical Torniquet Machines •Surgimed Hospital Supplies Tracheostomy Tubes •Covidien Training Equipment •Live Wire Learning •Miracle Medical •R. Moloney & Company •Scientific Group Transcutaneous Nerve Stimulators •Alcomed Medical Supplies •Nitran Surgical Systems Trial Lenses •Gerry van Winsen Optics Tubes for Anaesthesia •Clinical & Medical Services •Covidien •Intersurgical RSA •Myriad Medical •Respiratory Care Africa •Scientific Group •SSEM Mthembu Medical Tympanometers •Hearing Innovations •Medical Excellence •Welch Allyn Ultrasonic Cleaning Equipment •Alcomed Medical Supplies •BioClin Solutions •Gerry van Winsen Optics •Medical Excellence •SAFMED Ultrasonic Nebulizers •Alcomed Medical Supplies •Myriad Medical •Miracle Medical •Nitran Surgical Systems Ultrasonic Surgical Instruments and Devices •Johnson & Johnson Medical •Nitran Surgical Systems Ultrasonic Therapy Equipment •Nitran Surgical Systems •Ophthalmic Precision Instruments Ultrasound Equipment - Diagnostic Vision Aids •Danker Lenses Vision Therapy •Danker Lenses •Vertec Scientific Walking and Mobility aids •Vertec Scientific Ward Equipment •Imagex •Kendon Medical •Lomaen Medical •Medical Excellence •Miracle Medical •Ophthalmic Precision Instruments •Philips Healthcare •Respiratory Care Africa •Scientific Group •Sound Aesthetics •SSEM Mthembu Medical •Vertec Scientific •B Braun •Cook Chill •Dräger Medical SA •Franke Kitchen Systems •Health In Form •Medical Excellence •Miracle Medical •Respiratory Care Africa •Scientific Group •SSEM Mthembu Medical •Welch Allyn Ultrasound Gel - High Viscosity •Covidien •Alcomed Medical Supplies •Kendon Medical •SSEM Mthembu Medical •Vertec Scientific •Solid Waste Technologies •Wasteman Healthcare Ultrasound - HIFU •Intamarket Ultraviolet and Infrared Radiation Equipment •Alcomed Medical Supplies Ultraviolet Germicidal Irradiation •R. Moloney & Company Urine Bags •Adcock Ingram Critical Care •B Braun •Covidien •CR Bard •Holister SA •Kendon Medical •Laurike Marketing •Med Loyd •Nu Angle Medical •Sere-med Urology Bulking Agents •Manta Medical Urology Diagnostic Equipment •CR Bard •Philips Healthcare •R. Moloney & Company •SSEM Mthembu Medical Urology Products •AGFA Healthcare •B Braun •Covidien •Medequip •Med Loyd •Nu Angle Medical •Philisa Biomedical •SSEM Mthembu Medical Vaginal Specula •BioClin Solutions •Dinaledi Medical •Kendon Medical •Medequip •Med Loyd •Onemed •Sere-med •SSEM Mthembu Medical •Welch Allyn Vein Strippers •Marcus Medical •Scientific Group Ventilation and Respiration Equipment •Afrivent •Clinical & Medical Services •Covidien •Dinaledi Medical •Dräger Medical SA •Med Loyd •Myriad Medical •Respiratory Care Africa •Scientific Group •Sere-med •SleepNet/BreatheNet •SSEM Mthembu Medical Video Endoscopes and CCD Cameras •Medequip •Nitran Surgical Systems •Smith & Nephew Virtual Colonoscopy - Viatronix •Vertec Scientific Warming Blankets Waste Processing/Treatment Wheelchairs •Alcomed Medical Supplies •Miracle Medical Working Clothes and Protective Clothing •Health In Form •Manta Medical •Vertec Scientific Wound Care •3M •AGFA Healthcare •Coloplast •Covidien •Dinaledi Medical •Johnson & Johnson Medical •KCI Medical SA •Laurike Marketing •Manta Medical •Sere-med •Smith & Nephew Wound Drainage Equipment •Coloplast •Dinaledi Medical •Filterworks •Gabler Medical •Johnson & Johnson Medical •KCI Medical SA •Manta Medical Wound Management - Advanced •3M •Coloplast •Covidien •Dinaledi Medical •KCI Medical SA •Manta Medical •Sere-med •Smith & Nephew X-ray Chemicals •Afrox Medical Gases •AGFA Healthcare •Carestream Health •Dinaledi Medical •Radshield X-ray Contrast Media •AGFA Healthcare •Radshield X-ray Equipment •AGFA Healthcare •Carestream Health •Imagex •Lomaen Medical •Philips Healthcare •Scientific Group X-ray Film Processors •AGFA Healthcare •Carestream Health •Imagex •Lomaen Medical •Radshield X-ray Films and Screens •AGFA Healthcare •Carestream Health •Imagex X-ray Protection Items •AGFA Healthcare •Imagex •Lomaen Medical X-ray Quality Assurance Software, Phantoms •AGFA Healthcare •Radshield medical chronicle | March 2011 | page 91 Company Listing Directory // ADCOCK INGRAM CRITICAL CARE www.adcock.com Bard Medical South Africa (Pty) Ltd www.crbard.com Carestream Health www.carestream.com Dräger Medical South Africa (Pty) Ltd www.draeger.com/ZA/en/ Adcock Ingram Critical Care is a company which has committed itself over the last 60 years to the development of the health care community. Products include intravenous solutions, minibags, SVPs, pour bottles, IV antibiotics, infusion pumps and administration sets, dialysis equipment, theatre disposables and blood collection systems. CR Bard Inc is a leading multinational developer, manufacturer, and marketer of innovative, life-enhancing medical technologies in the product fields of vascular, urology, oncology and surgical specialities. BARD’s core values of quality, integrity, service, and innovation represent our reality and our aspirations and prepare us for the challenges ahead, guiding our everyday activities and aligning us to our mission. CARESTREAM HEALTH is a leading provider of medical and dental imaging systems including information technology solutions, molecular imaging systems and x-ray products for non-destructive testing. Carestream Health’s medical digital imaging portfolio includes RIS, PACS, CR, DR, Laser Printers, as well as Mammography & Oncology Solutions. Dräger Medical South Africa (Pty) Ltd is a solution provider for all Care Areas like ER, ICU, Operating Theatres, NICU and Maternity. We supply Patient Monitoring & IT Solutions, Anaesthesia Work Stations, Ventilators, Incubators and Architectural Systems. Dräger Medical South Africa has offices in Johannesburg, Durban, Cape Town and Bloemfontein. Our local supplier in the Eastern Cape is AD Medical. PO Box 6888 Johannesburg 2000 PO Box 1977 Kelvin 2054 PO Box 1901 Cramerview 2060 PO Box 4676 Rivonia 2128 Tel: (011) 494-8000 Fax: (011) 494-8757 Email: [email protected] Tel: 086-102-2273 Fax: (011) 444-6047 Email: [email protected] Tel: (011) 794-8322 Fax: (011) 794-6979 Email: [email protected] Tel: (011) 557-2300 Fax: (011) 557-2301 Email: [email protected] EDWARDS LIFESCIENCES (Pty) Ltd www.edwards.com Genop Holdings (Pty) Ltd www.genopholdings.co.za Johnson & Johnson Medical KCI Medical South Africa (PTY) LTD www.kci-medical.co.za Global leader in the science of heart valves and haemodynamic monitoring, with more than five decades of experience in developing life-saving innovations. Edwards treats advanced cardiovascular disease with its market-leading heart valve therapies, critical care and vascular technologies. Global brands include Carpentier-Edwards, Cosgrove-Edwards, Edwards SAPIEN, FloTrac, Fogarty, PERIMOUNT Magna and Swan-Ganz. “Innovative products displaying world leading technologies, coupled with good value pricing, passionate staff and professional service. The Genop 4P’s. It’s what has kept our brand at the forefront of our industry for over 80 years. And will continue to do so for many years to come.” L Abrahamson - CEO Together we can fly the flag for eye care in South Africa. Johnson & Johnson is the world’s largest medical devices company, with leading businesses in minimally invasive surgery, suture and mechanical wound closure products, interventional and diagnostic cardiology, diagnostic equipment and instruments, orthopaedic joint reconstruction and spinal products and disposable contact lenses. Since 1930, the Company has been serving the health care needs of all South Africans. Kinetic Concepts, Inc. is a leading global medical technology company devoted to the discovery, development, manufacture and marketing of innovative, high-technology therapies and products for the wound care, tissue regeneration and therapeutic support system markets. 20 Regency Drive Route 21 Corprate Park Irene, Centurion 0062 Genop House 53 Commercial Street Cape Town PO Box 273 Halfway House 1685 Building 24 Thornhill Office Park 94 Bekker Road Midrand, 1685 Tel: (012) 345-2482 Fax: (012) 345-5848 Email: [email protected] Tel: (021) 464-5400 Tel: (011) 538-4200 Email: [email protected]. Tel: (011) 265-1000 Live Wire Learning (Pty) Ltd www.livewirelearning.com R. MOLONEY & COMPANY radiant healthcare www.radianthealth.co.za Live Wire Learning (Pty) Ltd distributes basic and advanced medical training simulators and anatomical models for universities, nursing colleges and emergency services. We market advanced obstetric manikins, geriatric training dolls, auscultation and X-ray models (among many others), as well as CPR manikins, skeletons, anatomical charts and DVDs, ideal for patient or advanced education. Since 1990 as the exclusive distributor for Heine Diagnostic Instruments in South Africa, we offer this German equipment with a five-year warranty and after sales support worthy of the name. New 3SLED headlamp and surgical loupe for all disciplines of surgery. UltraViolet germicidal irradiation systems. Protect your rooms and your staff area against TB pathogens. Call for a demonstration. Radiant Healthcare - suppliers of medical and aesthetic equipment •Servicing the fields of dermatology, plastic surgery, aesthetic medical practitioners and medi-spas with lasers, IPL, microdermabrasion, cellulite reduction etc. •New hospital and clinic turnkey consultation PO Box 969 Rivonia 2128 46 Drysdale Road, Sundowner Ext. 2 Randburg, South Africa Tel: (011) 807-7716 Fax: (011) 807-7856 Email: [email protected] PO Box 84375 Greenside 2034 Tel: (011) 327-1201, (021) 939-3070, (031) 266-9871 Fax: (011) 442-5863 Email: [email protected] The Scientific Group www.scientificgroup.com Sere-med www.seremed.com Smith & Nephew (Pty) Ltd www.smith-nephew.com/za The Scientific Group is a distributor of niche products for the electro medical, laboratory and surgical fields. Our reputation is based on supplying and supporting quality products into South Africa and Sub Saharan countries. A BEE empowered healthcare company with core values and a reputation to deliver innovative technology for an improved patient outcome. Sere-med is an established and trusted supplier to the medical industry. Situated in Sandton, Sere-med provides the professional health care market namely GP’s, specialists, pharmacies, clinics, mine hospitals and the public sector with over 600 products. Our range includes medical consumables, surgical dressings, medical equipment, instruments, first aid and emergency care products. Sere-med provides products that are innovative, affordable and at the forefront of medical technology. Smith & Nephew is a specialist supplier of Orthopaedic Trauma, Arthroplasty, Endoscopy and Advanced Wound Management products that help healthcare professionals treat patients more effectively. The company has been committed to helping people regain their lives for over 150 years globally, and 75 years in Africa. 1 New Road Midrand 1686 Unit 1, Eastborough Business Park Cnr Olympia & Spartan Crescent Eastgate Ext. 11, Sandton 30 The Boulevard Westend Office Park Westville 3629 Tel: (011) 635-0000 Fax: 086-553-0954 Email: [email protected] Tel: (011) 262-2220 Fax: (011) 262-2226 Email: [email protected] Tel: (031) 242-8111 Solid Waste Technologies SA (Pty) Ltd www.swtsa.co.za SSEM MTHEMBU MEDICAL (PTY) LTD www.ssemmthembu.co.za Vertec Scientific SA www.vertecsa.co.za Solid Waste Technologies SA (SWTSA) is one of the leading players in the health care risk waste treatment sectors in South Africa. SWTSA owns a 25 ton a day electro thermal deactivation processing plant in Cape Town with a month capacity of 1200 tons, as well as a plant in City Deep, Johannesburg, with a monthly capacity of 2540 tons. SSEM Mthembu Medical (Pty) Ltd is a distributor of electro-medical devices and medical consumables throughout Southern Africa. We provide an extensive range of medical equipment for the ICU, high care, emergency and operating room as well as to the specialist physician and home care market. Vertec Scientific SA has built up an enviable reputation for delivering and supporting quality products over a wide range of modalities, including analogue and digital mammography, bone densitometry, mini c-arms, digital radiography, dedicated head CT and radiotherapy immobilisation products. We build and nurture long-term relationships with our customers and offer outstanding after sales service, including technical and clinical applications. 6 Hunt Road Killarney Gardens Cape Town, 7441 PO Box 5007 Tygervalley 7536 PO Box 2530 Johannesburg 2000 8 Charmaine Avenue President Ridge Randburg 2194 Tel: (021) 556-9167 Email: [email protected] Fax: (021) 556-9168 Tel: (011) 430-7000 Fax: (011) 444-8171 Email: [email protected] Tel: (011) 789-7177 Fax: (011) 789-7391 Email: [email protected] Genop Centre New Doornfontein Johannesburg Fax: (011) 265-1114 PO Box 590 Sundowner 2161 Tel: (011) 794-8253 Fax: (011) 794-8251 Email: [email protected] Tel: (011) 315-0445 Fax: (011) 315-1757 Email: [email protected] SOUTH AFRICAN MEDICAL DEVICE INDUSTRY ASSOCIATION www.samed.org.za Expanding on the association’s maxim - ‘Advancing Innovation Responsibly’ - SAMED’s mission is to achieve ‘the responsible and ethical advancement of the interests of the medical devices industry within the South African health care environment, while promoting better patient outcomes’. PO Box 651761 Benmore 2010 Tel: (011) 467-0855 Email: [email protected] Fax: (011) 467-1697 Fax: (031) 242-8251 Call Lynn on 084-400-1235 Classifieds Place a free ad in Medical Chronicle’s classifieds! Doctors only. Commercial classifieds accepted - but not free. Call Tarien on 011-787-4969 or fax her on 011-787-1819 or Email us: [email protected] Taking the Gap Dr Ron Kemper Doctors and Discovery - Real Partners at Last? The medical profession has, in the last few years, been sorely stressed by the need for ICD-10 codes to define every contact that they make with patients. When the codes were introduced, doctors were expected to buy the books and the software containing the instructions as well as the codes. Then they were expected to upgrade their software to make provision for inclusion of those codes on their invoices and statements. They were left with no option but to upgrade their hardware to cope with the more sophisticated software packages and had to undergo training to do it properly. Staff also had to be sent on training courses to administer all of it. Some doctors even had to take on extra staff. The amount of time and money spent by doctors in the interests of applying the coding system across the country was astronomical. All of this, despite the fact that the codes are of no use to doctors whatsoever, and add no value to the doctorpatient relationship. Not only that, but, as so many doctors’ columns and letters have attested, ICD-10 coding takes up a significant part of every day, what with looking up obscure codes, trying to find codes to replace those that have been withdrawn (without warning), sorting out the interminable queries from Discovery’s petty administrators and redoing accounts to meet with Discovery’s very inflexible requirements. And, in my experience, it has only been Discovery that has wasted my time and spoiled my day with ICD-10 code hassles. Now, with the National Health Insurance system looming, it is rumoured that Discovery is set to sell their database of accumulated ICD-10 coded statistics to the South African government, for purposes of planning primary health care provision. And you can bet that it is going to be a really good shakedown. My question is: Does Discovery have the right to sell our blood data? And, if it does, how will it share the proceeds with the medical profession who have both financed and provided the entire database? Discovery has merely collated and stored the data, and their time and financial investment has been minuscule by comparison with that of the medical profession. If we were to consider selling our database, I would say that a fair split of the payout would be 80% to the doctors, and 20% to Discovery. For argument sake, let us attach a purchase price of R50 million for the transaction. That leaves R40 million to be shared among the doctors. If we assume that there are 10 000 doctors who have contributed to the Discovery database, we (let’s call us database shareholders) could each be in for a R4000 dividend in recognition of our costs, efforts and frustrations. That’s only fair. Since Discovery is always so keen to call us their partners in health, I would imagine they would appreciate the opportunity to recognise us in this small way. I mean, are there any other contributors or shareholders who have bled more to produce all that data? lll PRACTICES FOR SALE GP practice for sale in Port Elizabeth. Rooms shared with GPs, dentists and a psychologist. Full or half day. Contact [email protected] Well-equipped solo practice in spacious rooms available in small mining town in the Northwest province. Current practitioner wishes to retire. No goodwill required. Modern equipment including electrocardiograph and lung function machine for sale. Call Saul on 084-2080-935. Well-established practice in fast-growing Mpumalanga Highveld town needs an assistant with a view to partnership. Wide spectrum GP practice work done. Contact [email protected] or phone 082-416-4939. lll POSITION AVAILABLE Looking for an assistant/partner for a busy fiveman practice in the Northern Cape. Services required from 1 July 2011. Please contact 083-259-6929. C H RONIC L E © Copyright Medical Chronicle 2011 Site-based medical services manager EDITORIAL required in Paulshof, Johannesburg. MBChB EDITOR-IN-CHIEF Marietjie van den Berg email: [email protected] qualification and being registered with the HPCSA required, as well as five years’ management experience. Key responsibilities include SBMS operations, medical services, health and safety, HR, Spacious consulting and examination rooms are available on a sessional or full-time basis in a GP’s consulting room in a busy medical centre adjacent to Bedford Gardens Hospital. Receptionist, security, furniture, off-street parking, water and lights included. This would be an excellent opportunity for medical specialists, psychologist, dietician, biokineticist, speech and hearing therapist, podiatrist, occupational therapist or another allied medical professional to establish a practice in a thriving medical centre. Please phone 011-616-1577 for more information. MEDICAL finance and logistics, and sales & marketing. Please contact Michael Emery on 011-803-7707 for enquiries. Please forward your CV to [email protected] using ‘SBMS Manager’ as a reference. DEPUTY EDITOR Nazli Jugbaran email: [email protected] Senior journalist René Bosman email: [email protected] PRODUCTION EDITOR Claire Smith email: [email protected] CONTRIBUTORS Prof Morgan Chetty, Rory du Plessis, Andre Esterhuizen, Dr Luc Evenepoel, Dr Andrew Good, Dr Hendrik Hanekom, Dr Ron Kemper, Prof James Ker, Elsabé Klinck, Dr Melanie Krasin, Dr Fatima Laher, Dr AM Levin, Prof Elna Mcintosh, Dr Huntley Mendelsohn, Dr Adam Nosworthy, Dr Keith Pettengell, Dr Poobalan Pillay, Dr Anton Potgieter, Prof Barry Schoub, Mike Scott, Dr Belinda Richards, Dr Ian Westmore FEATURE WRITERS René Bosman, Nazli Jugbaran, Maggie Monsieur, Marietjie van den Berg lll POSITION REQUIRED PHOTOGRAPHS I am looking for a temporary or permanent Unless previously agreed in writing, Medical Chronicle owns all rights to all contributions, whether image or text. position at a practice in Port Alfred. I have extensive health care experience in reception, office support and administration. Call Samantha on 073-1238-913 or email [email protected] lll B UILDING FOR SALE/ RENT Building to rent or for sale. Call Saul on 084-2080-935. SOURCES: Shutterstock, supplied images, editorial staff. ADVERTISING ADVERTISING EXECUTIVES Dick White Peter van Dyk Tel: 082-896-1813 Tel: 082-555-9611 [email protected] [email protected] Cindy Riederer Tel: 082-492-0229 [email protected] Merinda de Kocks Tel: 084-611-5632 [email protected] Bonney Cinnamond Tel: 082-338-2258 [email protected] Chantal Adlard Tel: 082-717-9051 [email protected] Media 24 Magazines Business & Custom PUBLISHER Werner Lindeque email: [email protected] June Treasure Hunt PRODUCTION Tarien Lampen email: [email protected] LAYOUT & DESIGN Allison McCallum email: [email protected] REGISTRATION/circulation Jenny de Beer Tel: 011-787-4969 email: [email protected] Pg Pg Pg Total the six page numbers ____________ Be a winner with our Treasure Hunt Competition! Each block contains an extract from an advert in this publication. What you want are the page numbers on which they can be found. Once you have all six page numbers, total them. Send us your answer, by fax, email or post. The first correct entry drawn wins. The winner will be announced in the August 2011 issue. Pg Pg Pg Our lucky winner will receive a 2010 MIMS Desk Reference (MDR) and an exclusive Wilbury laptop bag. 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Wannenburgh, Fred J (4) Media 24 Magazines Business & Custom Per Issue R46.65 VAT Incl. While precautions have been taken to ensure the accuracy of its contents and information given to readers, neither the editor, publisher, or its agents can accept responsibility for damages or injury which may arise therefrom. All rights reserved. © Medical Chronicle. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means, photocopying, electronic, mechanical or otherwise without the prior written permission of the copyright owners.