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Chapter 3 A National Programme for the Improved Management of Medications Scoping the Priorities for Quality in the Health and Disability Sector Introduction This chapter discusses the process and programme to be implemented in the NZ health and disability sector to improve the management of medications provided to consumers/patients over the next two years. Definitions used Medication reconciliation in this chapter A process for reconciling the difference between a record of a patient’s medications and their actual medications. Collaborative also known as a Breakthrough Series1 An improvement method that works with multiple teams to achieve significant change over many sites over a short period of time Medication error A medication error may be defined as any error that occurs in the medication process. Medication errors often do not result in harm.2 Adverse drug event An adverse drug event (ADE) may be defined as ‘any injury due to a medication.’ This injury may be due to the wrong dose of a medication (over or under dose), the wrong medication being given, or given to the wrong person, or the medication being given by the wrong route (e.g. intrathecal instead of intravenous).3 An adverse drug event can result from an error of omission or commission. Adverse drug reaction (ADR) Any response to a drug which is noxious, unintended and occurs at doses normally used for prophylaxis, diagnosis or therapy. 4 Adverse drug reactions are a subset of ADEs Medication/medicine A product is a medicine if it has a pharmacological effect and it is used in humans primarily for a therapeutic purpose.5 Quality use of medicines The safe, effective and appropriate use of medicines.6 1 Institute for Healthcare Improvement. (1995) www.ihi.com SUM Group (2005) Safe and Quality Use of Medicines National Strategy 3 SUM Group (2005) Safe and Quality Use of Medicines National Strategy 4 World Health Organisation (2002) Safety of Medicines: A guide to detecting and reporting adverse drug reactions. http://www.who.int/medicines/library/qsm/who-edm-qsm-2002-2/esd_safety.pdf 5 SUM Group (2005) Safe and Quality Use of Medicines National Strategy 6 SUM Group (2005) Safe and Quality Use of Medicines National Strategy 2 Prepared by: Page 2 of 17 10th November 2006 Scoping the Priorities for Quality in the Health and Disability Sector Background Why is this priority important? “Medicine safety is an important area by virtue of the fact that medicines are one of the commonest therapeutic interventions used in the healthcare system. The sheer scale of medicines usage means that any major reduction or prevention of adverse drug events holds the prospect of a substantially safer health system for everyone.”7 Medication errors in hospitals are common.8 9 Approximately 1% of people admitted to hospital may experience a significant medication error and up to 5-7% of the remaining admissions will suffer less severe outcomes for a medication error.10 Many of these errors are preventable. Health systems across the western world have implemented various improvement strategies over recent years to reduce the rate of medication errors, thereby reducing the harm that is caused to patients in the care. Effective and safe medication management or quality use of medicines includes a consideration of the appropriateness of the medications prescribed, the correct dispensing and administration and the provision of accurate and appropriate information. The implementation of better systems for managing medications includes education and training, implementing improved processes for prescribing, dispensing and administering medicines and the implementation of technological solutions that assist providers to make fewer mistakes and to dispense the correct dose of the correct medicine, to the correct person, via the correct route and at the correct time. The process by which drugs are administered to patients has multiple steps. At every step in the process there is the opportunity for a mistake to occur The medication management cycle consists of:11 1. a decision on appropriate treatment 2. decision to prescribe medicine 3. record of medicine order/prescription 4. review of medicine order/prescription 5. issue of medicine 6. provision of medicine information 7. distribution and storage 8. administration of medicine 9. monitor for response 10. transfer of verified information The challenge is to make fundamental systemic change and improvement in the way that care is delivered to patients. 7 SUM Group (2005) Safe and Quality Use of Medicines National Strategy Brennan, Leape, Laird et al (1991) Incidence of adverse events and negligence in hospitalised patients. Results of the Harvard Medical Practice Study I NEJM 9 Bates, Cullen, Laird et al (1995) Incidence of adverse drug events and potential adverse drug events. Implications for prevention. JAMA 10 SUM Group (2005) Safe and Quality Use of Medicines National Strategy 11 Australian Pharmaceutical Advisory Council (2005) Guiding principles to achieve continuity in medication management. 8 Prepared by: Page 3 of 17 10th November 2006 Scoping the Priorities for Quality in the Health and Disability Sector Progress in the New Zealand Health and Disability Sector, Introduction A coordinated approach to medication management in New Zealand health and disability services has been “on the radar” for several years. The following information is provided from the Safe and Quality Use of Medicines National Strategy that was published in September 2005. Policy directives or strategies to date The District Health Boards New Zealand (DHBNZ) Chief Executives Group established the Safe Use of Medicines (SUM) Group in April 2003 as a collaborative venture between the District Health Board’s. This group organised the Medication Safety and Quality Use of Medicines in New Zealand Workshop in May 2004 both to inform people about the projects the group were working on and to determine the way forward for the group. The delegates at the workshop provided a clear mandate to the group to include quality use of medicines in its focus. The group as a result became the DHBNZ Safe and Quality Use of Medicines Group (SQM). This safe and quality use of medicines strategy covers activities in both primary and secondary care. It has been designed to provide both a national framework and the national co-ordination of activities to improve medicine related outcomes and to encourage consistency and effectiveness of, and participation in safe and quality use of medicines activities whilst reducing duplication of effort. Key features of the Safe and Quality Use of Medicines strategy are: 1. Identification of national Safe and Quality Use of Medicines activities to be co-ordinated by the DHBNZ SQM 2. Prioritisation of these national Safe and Quality Use of Medicines activities identified in the strategy document to be co-ordinated by DHBNZ SQM 3. Promotion of a safety culture within the health sector and wider community 4. Encouragement and support for more widespread involvement of all DHB’s in safety and quality use of medicines initiatives 5. Identification of quality use of medicines initiatives at a local level so that these can be evaluated and shared nationally 6. Maximisation of outcomes, minimisation of risks and improvement in safety associated with medication use A co-ordinated approach to the safe and quality use of medicines in New Zealand is expected to take a number of years to become established. Prepared by: Page 4 of 17 10th November 2006 Scoping the Priorities for Quality in the Health and Disability Sector Policy directives or strategies to date (continued) In their 2005 publication Safe and Quality Use of Medicines National Strategy, the SUM Group identified 8 objectives. 1. To promote a culture of safety within the health sector and wider community that supports leadership and coordination of quality and safe use of medicine’s initiatives within all parts of the health sector 2. To encourage and support more widespread involvement of all DHBs’ in “Safe and Quality Use of Medicines” initiatives through the establishment and support of active networks, dissemination of information and ideas, and shared learning and review 3. To maximise outcomes, minimise risks and improve safety associated with medication use by establishing, reviewing and improving practice standards for all aspects of prescribing, dispensing and administration 4. To identify high risk medicines and high risk situations, including those disease states targeted for special input in primary care eg cardiovascular disease, diabetes and asthma. To identify options and advocate for and implement solutions to minimise these risks 5. To improve the effectiveness and consistency of infrastructure such as systems, processes, technology, information systems used by DHBs’ in association with medication use 6. To improve health outcomes for patients who are treated in primary care and DHB hospitals acknowledging that the interface between these areas requires particular emphasis 7. To promote a culture of enquiry that fosters audit, monitoring and evaluation, and research into the areas of “Safe and Quality Use of Medicine” 8. To involve and engage consumers about the safe and appropriate use of medicines and to increase consumer awareness in relation to the level of medication errors in New Zealand The Collaborative improvement programme combined with the implementation of bar coding, as identified in this chapter will provide the implementation plan for a number of these objectives. Prepared by: Page 5 of 17 10th November 2006 Scoping the Priorities for Quality in the Health and Disability Sector Policy directives or strategies to date (continued) A variety of activities and initiatives are currently offered within DHBs particularly within hospitals. Some hospitals undertake a significant amount of drug utilisation review (DUR) work or guideline development and implementation, while others have little resource to do so. Some hospitals have their own formulary and process for maintaining that formulary. The level of clinical pharmacy ward services provided and the degree to which pharmacy services are involved in discharge procedures is also variable. Drug information centres are in place in some areas and in some cases provide smaller regional support services and assistance to the community sector. Data collection systems, internal processes (such as established medical committees etc) and staffing levels may be factors in the apparent differences between hospitals in this regard. Thus existing quality and safe use of medicine activities may include, but are not limited to: º º º º º º º º º º º º º º Drug utilisation review Development of guidelines, formularies and pharmaceutical policies Medication event (“incident”) reporting/management Adverse drug reaction reporting/management Medication disposal/management of discontinued medicines Drug information services Compliance aids Quality assurance in relation to prescribing practice Community/hospital transition management Repeat prescribing in primary care Consumer/practitioner education methods (e.g. peer review, feedback, self-audit etc) and material (e.g. bulletins, Consumer Medicine Information etc). Quality assurance in relation to dispensing, distribution and administration of medicines in hospitals and in the community. Clinical pharmacy services/medication review services. Critical appraisal of medical literature. As one can see there are many activities that one could do, part of the challenge is to use the very limited resources in an effective manner. Prepared by: Page 6 of 17 10th November 2006 Scoping the Priorities for Quality in the Health and Disability Sector Policy directives or strategies to date (continued) A recent survey of DHBs which was undertaken to identify activity that relates to the six priorities for quality has revealed that a number of DHBs are working on various aspects of incident management and the reduction of medication errors and harm. Strategies that were identified through the survey include: º Waikato DHB: A trial of the PYXIS system, review of the medication chart, improved documentation of patient allergies and adverse drug reactions, development and monitoring of medication storgage standards document control of standing orders and development of prescribing guidelines. º Wairarapa DHB: The introduction of bedside dispensing and the trialling of a new format medication chart. º Counties Manakau DHB: Include strategies for improving the management of high risk medications, anti-coagulant and antibiotic improvements, Drug Utilisation Evaluation (DUE) of ciprofloxacin, surgical prophylaxis, a "Nil by mouth not Nil by Medicines" for surgical patients, allergy reporting and adherence to policy, electronic discharge summary in AT&R, ‘One Chart' draft development medication review and reconciliation. º Northland DHB: Storage /identification of medications that are multi strengths storage of medications for self administration and development of a medication focus group º Otago DHB: implemented electronic prescribing and the rollout of electronic administration continues º Bay of Plenty DHB: has implemented a programme to improve morphine management. º Auckland DHB: has had a medication safety plan in place since August 2004. The key strategies involve working on communication and leadership for safety, the safety culture, medication incident notification and management, high risk medication management, medicines reconciliation supporting technology and community involvement in medication safety. Further, Auckland DB is engaged in a community medications reconciliation programme. An attempt will be made to include this programme in the proposed collaborative process. º Waitemata DHB: has implemented the PYXIS system across the whole DHB. This DHB also has a data base that records every medication error that is reported by pharmacists and provides feedback to clinicians on these issues. º Taranaki DHB: has also implemented the PYXIS ystem across the whole DHB. Prepared by: Page 7 of 17 10th November 2006 Scoping the Priorities for Quality in the Health and Disability Sector Bar coding of medicines A further significant strategy that has commenced in the NZ Health and disability sector is the development of a case for the implementation of bar codes for unit doses of medications. It has been shown in health systems in other countries that the introduction of bar code systems has significantly reduced the number of medication errors and consequently prevented large numbers of patient deaths and injury. In industries outside of health, bar code technology has been widely adopted because of its ease of use and high degree of reliability. In the context of pharmacy dispensing, if all medications in the pharmacy had a bar code scanned to ensure that the correct medication in its correct dose and formulation is being dispensed, dispensing errors may be substantially reduced. On the basis of these theoretical benefits for patient safety, the US Food and Drug Administration mandated bar codes for all medication use in hospitals in the US by April 2006. It is suggested that bar coding should be introduced in the in the NZ health and disability sector because of the benefits that bar coding has to patients, specifically Bar coding can reduce the length of stay of patients in hospital, and significantly reduce mortality and morbidity. This can also result in savings to DHBs, through efficiencies gained in the supply-chain.12 A process of consultation and business case development for the implementation of bar codes has already commenced and will continue on its current course. The further improvement strategies identified in this report will work had in glove with the implementation of bar coding to ensure the effectiveness of the system when it is implemented. 12 Ministry of Health (2006) Health Report: Bar Coding Medicines: A patient safety and DHB cost effectiveness proposal. Prepared by: Page 8 of 17 10th November 2006 Scoping the Priorities for Quality in the Health and Disability Sector Work place change to accompany bar coding As identified in the previous section of this report, technological solutions to patient safety problems are very important. Human factors research has shown in recent years that better systems design and the implementation of good technology can provide engineered barriers and forcing functions in systems that reduce a persons capacity to make mistakes. If developed correctly, the bar coding system has the capacity to do this. However, it must be recognised that just the implementation of a technological solution will not necessarily result in improvement. If the purpose of the system is not recognised and the culture of the organisation is not conducive to the use of the system, humans will find ways to over ride the benefits. It has for example been noted in the VA health system in the US that well intentioned nurses were able to establish “work-arounds” so that they didn’t disturb patients whilst they were sleeping. It is essential to develop the safety culture in an organisation, and the work practices that are going to be supported by the new technology before the technology is implemented. The IHI Collaborative improvement process proposed in this report will do just that. It will be implemented whilst the bar coding system development is taking place and in fact will, in part, inform the functional specification of the bar code system. Common medication chart A national medication chart project is well underway in New Zealand and is being sponsored by the Safe and Quality Use of Medicines Group. The project started as a Waitemata DHB initiative to review and update their medication chart. The project evolved into the design of one medication chart after the initial redesign was presented ast the national hospital Pharmacists Conference in 2003. Several overseas and NZ medication charts were collected and reviewed and the best features were incorporated into a design that was sent out for consultation twice in 2004 The chart is now ready for implementation across the country. This implementation will form part of the Collaborative proposed in this report. Prepared by: Page 9 of 17 10th November 2006 Scoping the Priorities for Quality in the Health and Disability Sector Review of international action International strategies A search of the literature and the internet has revealed that many, many countries have over recent years placed an emphasis on the improved management of medications. A variety of processes and methods has been used to achieve change and improvement. It appears that a common approach has been to undertake a Breakthrough Series or Collaborative as developed by the Institute for Healthcare Improvement (IHI) in the United States. A number of collaboratives have been conducted in the United States, some by the IHI and others by health care provider organisations. The objectives or goals for these various collaboratives have varied and included improving º oral medication administration in the home setting º medicines reconciliation between the community and the inpatient setting and within the inpatient setting at points of transfer of care º reducing harm (generally) º improving the management of high risk drugs º drug labelling º patient self administration of medicines º correct patient identification for drug administration º the legibility of medication charts Other strategies adopted internationally have included the implementation of bar coding systems model of a combination of teamwork and information sharing, the participating VA facilities reported an improvement in medication management the use of interactive voice response systems (IVR) the implementation of automated dispensing systems that help ensure that medications are secure, organized, tracked and ready for use. Such systems help health care professionals to reduce or eliminate labourintensive tasks by automating the management of medications. (PYXIS is one brand of such machines.) pharmacist participation on post-admission ward rounds. One national medication chart has been introduced in many countries for the purposes of standardisation of prescribing, and administering drugs. The NHS in the UK standardised their charts in 1960, introducing two format designs. More recently Australia and Wales have introduced national medication charts. Studies in Queensland suggest the implementation of their standard medication chart has reduced the relative risk of errors by 25%.13 It is therefore recommended that one chart be introduced in NZ. If this is not possible for some reason, the recommendation would be to introduce one chart across a whole region or district. 13 National Inpatient Medication Chart www.health.wa.gov.au/nimc/faqs/index.cfm Prepared by: Page 10 of 17 10th November 2006 Scoping the Priorities for Quality in the Health and Disability Sector The Australian National Medication Safety Breakthrough Collaborative Probably one of the most ambitious improvement strategies that was undertaken by the Australian Council for Safety and Quality in Health Care was the National Medication Safety Breakthrough Collaborative (NMSBC). It began in September 2003 and the final conference presentation session was held in May 2005. . The Collaborative aimed to achieve a national improvement in medication safety by º reducing harm associated with medication use by 50% among clients of participating healthcare teams º developing a national network and system to sustain and transfer improvements in medication safety to other health services following the completion of the collaborative. One hundred teams from all States and Territories of Australia participated and these teams were divided into two waves. Wave 1 teams focussed on medication processes and high risk medications in the acute care setting . Wave 2 teams worked to improve the community issues for medication practices. The teams took a multidisciplinary approach to the project and team membership was drawn from nursing, medicine, quality and pharmacy, included an executive sponsor, a community representative and a consumer.14 As the lessons and improvements from this Collaborative have been published, they are able to form the basis upon which a similar Collaborative (but of course far better!) can be conducted in the NZ health and disability sector. 14 Australian Council for Safety and Quality In Health Care (2005) Medication Safety The Breakthrough Collaborative Project Chronicle Prepared by: Page 11 of 17 10th November 2006 Scoping the Priorities for Quality in the Health and Disability Sector World Patient Safety Alliance To address the issue of patient safety, an “Action on Patient Safety” (High 5s) initiative—supported by the Commonwealth Fund and sponsored by the World Health Organization’s (WHO) World Alliance for Patient Safety—is proposed. This initiative seeks to leverage the implementation of five standardised patient safety solutions that would have broad impacts in preventing avoidable catastrophic adverse events (death or serious injury) in hospitals. The initiative will build on the established partnership and collaboration built by the Commonwealth Fund with Australia, Canada, New Zealand, the United Kingdom and the United States and the more recent expansion of its international program to include Germany and the Netherlands. The objective of the initiative is to achieve significant, sustained and measurable reduction in the occurrence of 5 patient safety problems over 5 years in at least 7 countries and build an international, collaborative learning network that fosters the sharing of knowledge and experience in implementing innovative, standardized, safety operating protocols The following 5 solution areas have been selected as the focus of the High 5s initiative. These are derived from the international priorities for solutions development which form the basis for the work of the Collaborating Centre: 1. Prevention of patient care hand-over errors 2. Prevention of wrong site / wrong procedure / wrong person surgical errors 3. Prevention of continuity of medication errors 4. Prevention of high concentration drug errors 5. Promotion of effective hand hygiene practices Prepared by: Page 12 of 17 10th November 2006 Scoping the Priorities for Quality in the Health and Disability Sector The recommended programme scope Introduction This section of the report provides the details of the intended approach to improving medication management in the health and disability sector. The proposed programme will bring together the several bodies of work that are being undertaken now and will provide an implementation plan for many other proposed but as yet not implemented initiatives. This proposal combines : the medicines bar coding project the implementation of a common medication chart that the QSM Group with DHB NZ are sponsoring the work that is proposed with the World Patient Safety Alliance and the current efforts of the DHBs around improving medication management. Programme objectives The primary objectives of a national medication management programme are: 1. Reduced harm caused to patients 2. Improved medication safety and effectiveness (reduced medication errors improved benefit) 3. Implementation of a technical solution that will assist clinicians to provide medications to patients/consumers more safely. The secondary objectives are to improve medication safety by : implementing a common medication chart in each of the health and disability regions introducing effective medication reconciliation to all health and disability services effectively managing high risk drugs introducing better work practices to prepare the workplace for the effective implementation of the medications bar coding system developing all the components of the bar coding system. Prepared by: Page 13 of 17 10th November 2006 Scoping the Priorities for Quality in the Health and Disability Sector There are two main components of this programme that need to be developed and implemented in parallel over approximately eighteen months to two years. By the end of this period the two components will come together to form an integrated medication management system for New Zealand. COMPONENT 1 COMPONENT 2 A Breakthrough Series Collaborative for: Common medication chart Medicines reconciliation High risk drugs management Work practice change Development of bar coding system Implementation of the bar coding system 18 – 24 months Scope summary An integrated consistent approach to medication management across all health and disability services Ongoing Ongoing national: Monitoring, support, education and training for providers Policy development for improving medication management System maintenance Continued on next page Prepared by: Page 14 of 17 10th November 2006 Scoping the Priorities for Quality in the Health and Disability Sector Implementation Plan Collaborative Method The method to be used to achieve nation improvement in medication management will be a modified Breakthrough Collaborative Process. The Breakthrough process was designed by the Institute of HealthCare Improvement in the US and has been use across the work to bring about sustainable improvement over multiple sites over a relatively short period of time. The Breakthrough Series is designed to help organisations close that gap by creating a structure in which interested organisations can easily learn from each other and from recognized experts in topic areas where they want to make improvements. A Breakthrough Series Collaborative is a short-term (6 - to 15-month) learning system that brings together a large number of teams from hospitals or other health and disability services to seek improvement in a focused topic area. Collaboratives range in size from 12 to 160 teams. This Collaborative would have 21 teams; one from each of the DHBs. Each team typically sends five of its members to attend Learning Sessions (three face-to-face meetings over the course of the Collaborative identified as LS on diagram 3.1), with additional members working on improvements in the local organisation. Some collaborative processes have found that an orientation session for teams before the Learning Sessions start is of great value. Teams in such Collaboratives have achieved dramatic results, including reducing waiting times by 50 percent, reducing worker absenteeism by 25 percent, reducing ICU costs by 25 percent, and reducing hospitalisations for patients with congestive heart failure by 50 percent. In addition, IHI has trained over 650 people in the Breakthrough Series methodology, thus spawning hundreds of Collaborative initiatives throughout the health care world.15 A final, followup Conference to better ensure sustainability of the improvement results achieved, is held approximately 7 months after the completion of the last learning session. Further information about how the Collaborative process works can be found at Appendix 1 to this report. 15 www.ihi.com Prepared by: Page 15 of 17 10th November 2006 Scoping the Priorities for Quality in the Health and Disability Sector Timeframes The Collaborative Process 15 Diagram 3.1 Sept ‘07 Sept – Nov ‘07 May also have Orientation Session for teams during this time Oct ‘07 June‘07 Bar Coding Development Method Dec ‘07 Feb‘08 May ‘08 Dec ‘08 The method for development of the Bar Coding system is not identified in this report. A separate process is being developed by the Ministry of Health. This process will be closely co-ordinated with the Collaborative process to ensure that the workplace changes that are required for the successful implementation of the bar coding system are achieved through the Collaborative in readiness for the implementation of bar coding. Consumer Consumers need to be involved in this programme, from its commencement, involvement in in the following ways. this programme Consumers will provide expertise on improvement strategies and will Exclusions Prepared by: form part of faculty and expert group Each participating team from the DHBs will be required to have a consumer member Consumers will be invited to participate in focus groups to inform the diagnostic process in each of the DHBs Private health care organisations Page 16 of 17 10th November 2006 Scoping the Priorities for Quality in the Health and Disability Sector Action required at levels of organisation The Ministry will be responsible for Development and issue of national policy Development of a nationally coordinated implementation plan Oversight of implementation including project management for the Collaborative process Development and implementation of the bar coding system Safe and Quality Use of Medicines Group could perhaps sponsor the programme and provide substantial input to the Expert Group The DHBs will be responsible for DHB level policy development that reflects national policy Providing the right people to participate in the Collaborative Providing local project management resource Providing and overtly displaying leadership, guidance and support for the programme. The Collaborative teams from the health and disability services will be responsible for:16 being dissatisfied with the status quo and being ready for ambitious change having a commitment to a rigorous diagnosis of the current system seeking improvements that will deliver the greatest benefits to patient safety through medication management agreeing to make measurable changes within six months to improve medication management seeking to develop service improvement skills investigating all relevant processes, patterns and structures that impact on medication management applying creativity and eagerness to willingness to test improvements having a willingness to address cultural issues at an executive level. 16 Adapted from the Victorian Patient Flow Collaborative requirements. Prepared by: Page 17 of 17 10th November 2006