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WHAT INFLUENCES DRUG USE BY CONSUMERS SESSION NOTES PURPOSE AND CONTENT This module discusses the various factors that influence drug use by consumers. The factors are grouped into different levels of influence. The module provides participants with a framework which links individual drug use behaviour to the multi-layered environment which shapes it. The framework described provides a basis to analyse drug use problems. It can also assist the development of interventions aimed at changing drug use behaviour and the environment in which drug use takes place, in order to bring about more appropriate drug use. OBJECTIVES At the end of this module, participants will be able to: 1. Identify factors that determine drug use by consumers at each of the five defined levels of influence. 2. Recognise the relative importance of the factors with respect to efforts to promote rational drug use by consumers. PREPARATION 1. Read the Session Notes. 2. Reflect on drug use problems in your country and the factors that influence them at each of the five levels mentioned below. 3. Read the two case studies included in Activity 1 at the end of this module. © World Health Organization 2002 What influences drug use by consumers Session Notes A. INTRODUCTION These Session Notes set out factors that influence drug use by consumers. The factors are each described in detail according to their level of influence: the family level; the community; the health-service institution; the national level; the international level. This list is not meant to be exhaustive. Rather, it aims to provide a framework for analysing drug use problems. Factors shaping consumers’ use of drugs differ greatly depending on the setting. Influences on this behaviour are multiple and complex, and vary for each drug use problem studied. B. THE FAMILY LEVEL Individual ideas about how medicines should be used affect consumer drug use. Ideas held by those people with whom one lives and interacts in the private sphere also shape it. Influential people can include members of the immediate family and those in extended family networks. Important factors at this level are mentioned below. B1. Perceived need for drugs There is global evidence that people today think they need to take medicines to restore health, even for self-limiting disorders such as colds and diarrhoea. This is true regardless of the fact that medicines often only alleviate symptoms and do nothing to cure the underlying condition. Evidence suggests that people have lost trust in the body’s ability to fight disorders without the ‘help’ of medicines. Studies on drug use by consumers show that people think they should take medicines immediately at the onset of illness to prevent it from becoming worse. Statements made by people living in rural villages within the Karakoram Mountains in Pakistan illustrate this belief “Medicine is needed for every illness. If medicine is not used, the illness will become serious." "All illnesses need medicine. No illness will be cured without medicine." "Medicine is to the sick, what water is to the thirsty." "If we don't get medicine, how will we get cured?" Rasmussen ZA et al. (1996) Enhancing Appropriate Medicine Use in the Karakoram Mountains. Community Drug Use Studies. Amsterdam, Het Spinhuis. 2 What influences drug use by consumers Session Notes People don’t only take medicines to treat symptoms of ill health. They also increasingly believe that medicines are needed to stay healthy. Preventive use of drugs is a topic often neglected in discussions on appropriate medicine use. However, drug sales increasingly tend to involve such products. Vitamins are the most common type of preventive medicines. B2. Ideas about efficacy and safety People use medicines according to their own ideas about drug safety and efficacy. Educational efforts which aim at enhancing appropriate use of medicines by consumers should be based on an understanding of people’s notions about these issues. Anthropological studies have given us much insight into people’s perspectives on medicines. The following trends have been documented: Ideas about efficacy are related to the colour and shape of medicines. People believe that efficacy of medicines differs by the form of administration, for example, injections are perceived to be more potent than oral drugs. Safety and efficacy of medicines are not only determined by attributes of the medicines but also by the compatibility between the medicine and the person taking it. So a medicine that is effective for me, may not be effective for you. People’s choice of medicines depends on the cause attributed to an illness and its perceived severity. People use methods based on past experiences: if medicine proved effective they are likely to use it again. People believe that new medicines are more effective. These ideas ultimately help shape drug use practices. How beliefs influence use In Sierra Leone, Bledsoe and Goubaud (1985) found that medicines’ efficacy is linked to colour symbolism. Red medicines, for example, are thought to be good for the blood. In Uganda, Birungi (1994) describes the popularity of injections. People believe that medicine injected into the bloodstream does not leave the body as quickly as that administered orally. Oral medicine is compared to food, which enters the digestive system and eventually leaves the body through defecation. Senah (1997) describes how people in Ghana consider heat to be the main cause of measles. Heat causes constipation and stomach sores in children. To treat measles people give Septrin (cotrimoxazole) syrup, multivite syrup, calamine lotion, akpeteshie (local gin) and a herbal concoction given as an enema to ‘flush out’ the heat. 3 What influences drug use by consumers Session Notes The box illustrates a few of the mentioned trends. Colour and dosage form in fact appear to be factors which universally affect notions of drug safety and efficacy. People’s choice of medicine usually also depends on the cause they attribute to the illness and its perceived severity. If illnesses are thought to be caused by witchcraft, it is likely that a traditional healer will be used rather than medicines bought at a local shop. However, if the illness is believed to be caused by bodily imbalance related to hot-cold notions, for example, then one may decide to treat the imbalance symptoms with medicines. More severe disorders may be brought to the attention of health workers or traditional healers, depending on what the cause of illness is believed to be. Efficacy and safety of medicines tend not only to be related to these factors. Whether or not a medicine works also depends on its suitability for the patient taking it. In the Philippines people use the concept hiyang to explain why a medicine did not work for a particular patient. They say “Clearly the medicine was not hiyang for him/her” (was not suitable, did not ‘fit’). In Indonesia and Thailand similar concepts exist to explain why medicines work for some patients but not for others. People’s ideas about a medicine can actually affect its efficacy. This fact has been documented in numerous studies on the ‘placebo effect’. This research has shown that placebos (harmless substances that look like the actual medicine but contain no active ingredient), can cause psychological and physiological effects. Placebos’ efficacy has also been proven in double-blind trials on new drugs. In these trials, approximately one-third of the participants responded to the placebo. B3. Uncertainty resulting in poly-therapy People are often uncertain about the cause of disorders as well as the most effective treatment. For that reason, they tend to use several therapies at the same time. Often they combine modern and traditional remedies. If the condition is serious they may consult a variety of modern and traditional health providers. B4. Drug consumption roles Drug use is not only defined by people’s ideas about medicines. It is also determined by the role people play in the process of buying, administering and deciding about medicine use. Drug consumption is rarely an autonomous act. Within families, different members play different roles in it. Culture’s influence on women’s roles In the Philippines (Hardon, 1991) mothers decide whether or not they should buy and give medicines to their children. Men are usually not involved in decision-making on the treatment of common childhood illnesses. Instead, women consult with neighbours and relatives on treatment options. Mothers and wives in this country manage household expenses and the family’s income. They don't have to consult their husbands about costs. Husbands take a more active role only when a health problem becomes severe. Box continued… 4 What influences drug use by consumers Session Notes In Pakistan (Rasmussen et al., 1996), women are constrained in their efforts to treat children's health problems. They cannot go to the bazaar or hospital in town to obtain drugs, as local, cultural norms forbid such mobility for women. For this reason, husbands, sons or other family members must buy medicines. As a consequence of these gender roles, men in this country are involved in decisions about children's treatment. They often receive information on a medicine’s use at the bazaar or health facility and tell this information to their wives who actually administer the drugs. B5. The cost of medicines Cost is a major factor shaping drug use at the family level in developing countries. Drug prices play an important role for patients not covered by insurance schemes in industrialised countries as well. When presenting a prescription containing different medications at a pharmacy, consumers must decide which medicines they can afford. In developing countries fifty to ninety percent of medicines are paid ‘out-of-pocket’. Payments for medicines represent the largest out-of-pocket household health expenditure in poorer countries. In parts of Africa, Asia, and Eastern Europe drugs account for up to eighty percent of household health expenditures. People frequently waste money on drugs. Often they are not aware of cheaper, generic alternatives or they do not realise that many medicines are ineffective. Interventions which enable people to find cheaper alternatives for medicines, by teaching them how to identify the active component of a drug, and how to compare prices, can draw on strong community interest. This is because they confront medicines’ high cost, a crucial, daily concern for people who are poor. Public health workers are sometime surprised that people pay for medicines in the private sector when they could obtain them for free at public health centres. Studies show that people are willing to pay for what they consider to be good and effective remedies. Research documents that people believe that more expensive medicines (usually brand name products) are more effective than cheaper ones. B6. Literacy levels of consumers Literacy determines the extent to which people have access to written information. Package inserts, where they do accompany drugs, are rarely understandable for nonand semi-literates. People who cannot read do at times ask others, who can, to explain what is written on and in medicine packages. And sometimes children are the ones to read texts for their mothers. Posters also often have written texts as the main message, which limits their role in populations with high illiteracy levels. B7. The power of medicines At the family level, medicine use is also influenced by the pharmaceutical efficacy of medicines. Analgesics are popular because they relieve pain symptoms; cough syrups because they stop the cough; antibiotics because they cure infections. Some medicines are even more “powerful”. They cause dependencies. Tranquillisers are an example of such medicines. 5 What influences drug use by consumers Session Notes C. THE COMMUNITY LEVEL The community is the immediate context in which individuals and families deal with their health problems. People talk to each other about therapies, creating and reinforcing existing drug use cultures, and they rely on local sources of drugs. Factors that influence drug use at the community level include: C1. Drug use cultures Drug-use studies often find a clear, local, drug use culture in communities. A set of medicines is used routinely to treat the most common health problems. People know what medicines are needed for these problems and they obtain them at local drug stores, general shops or the market. For example, in Uganda, most people use chloroquine as first-line treatment for malaria. They buy it at general stores. If you ask them why they use this drug, they will be surprised by the question. To them, it is normal to use it; it brings down the fever. You must determine local, drug use cultures before you carry out any community education programmes. C2. Drug supply systems The community drug supply system plays an important role in drug use by consumers. Which medicines can consumers obtain in and around their communities? How can they gain access to drugs? These are crucial questions to be answered. Public health administrators often assume that people get medicines at public health facilities, such as local primary health-centres, which stock essential drugs. However, this is usually not the case. Most studies on community drug use show that people tend to rely on informal and private channels for their drug needs. Using these outlets they can buy medicines without a prescription. Purchases can also be made at convenient times, as these private and informal channels have long hours and are open at the weekend. Before developing community drug use interventions it is important to gain insight into drug distribution channels. The figure below outlines the drug supply channels used by consumers in an urban, poor community in the Philippines. One can see that eighty percent of medicines is obtained from the private sector, either directly from town pharmacies or through sari-sari (neighbourhood) stores. 6 What influences drug use by consumers Session Notes Community drug distribution channels: an example from the Philippines Town Drugstores (35%) Neighbourhood stores (40%) Clinics (2%) Hospital (1%) M ED I CI N ES (n=1324) Doctors (7%) Household stocks and free-clinics (8%) Neighbours and relatives (5%) Neighbourhood Source: Hardon AP (1991) Confronting Ill Health: Medicines, Self-Care and the Poor in Manila. Quezon City, Health Action Information Network. C3. Information channels Not only is there high demand for medicines in communities, information on medicines is also a valued commodity. The information people can obtain about drugs also shapes drug use. Often, the brand name printed on the medicine package is the only information available for drugs bought at the pharmacy. These packages rarely include information inserts. Radio and television programmes provide other possible information sources about medicines. Educational sessions organised as part of primary health care programmes and community health workers who give advice on appropriate treatment of common disorders are another source. In addition, drug sellers in small shops or markets and traditional healers who have incorporated pharmaceuticals into their therapeutic regimes pass on drug information. Magazines and comics, reused prescriptions and popular health books are all sources as well. Primary health care programmes that aim to enhance appropriate use of medicines often ignore the messages relayed to consumers through mass media drug promotion by manufacturers. In the Philippines, Hardon (1991) found that the most commonly used medicines in self-care were those promoted most frequently on the local radio station during times when women listened while performing household 7 What influences drug use by consumers Session Notes chores. The station aired three to four of these advertisements per hour. Advertisements typically started with a problem statement: someone suffers from cough, cold or headache. Then the message follows: take drug X, with the subsequent reassurance that "the drug is safe" or "doctors prescribe the drug". D. THE HEALTH INSTITUTION LEVEL Health institutions, including health centres and hospitals in the private and public sectors, influence consumers’ drug use. A number of factors are relevant at this level, including: D1. Consulting health workers Contrary to your expectations perhaps, household drug use studies in developing countries suggest that most medicines are taken without advice from health workers. Of particular importance are the findings of community-based studies conducted in Thailand, the Philippines, Pakistan, and Ghana (Hardon and Le Grand, 1993). In these studies, researchers visited families at regular intervals to record the occurrence of common health problems, such as cough and diarrhoea, and the chosen therapy. The findings suggest that a large proportion of common health problems is treated by family members without first seeking health worker advice. Roughly half of the self-care cases were treated with modern pharmaceuticals (Hardon and Le Grand 1993, Rasmussen, 1996). Consumers’ advice-seeking behaviour Researchers conducted a household survey in four Thai villages covered by a primary health care programme that promoted the use of herbal medicines in self-care. One hundred and twenty families participated in the two-month study in which a total of 1,755 cases of illness were recorded. The study found that people in the four villages only consulted a health professional in 7% of the illness episodes. Seventy percent of the illnesses were initially treated by self-care. Approximately half of the cases were treated with modern pharmaceuticals and the other half with herbal remedies. Le Grand A, Sringernyuang L (1989) Herbal Drugs in Primary Healthcare. Amsterdam, Royal Tropical Institute. In the Philippines, household surveys were conducted in a rural community and two urban communities. During a five-month period, the rural study recorded 422 illness episodes for infants. Eighty percent of these episodes were treated without medical advice. About half were treated with modern pharmaceuticals, including a number of potentially hazardous prescription drugs. In the urban communities, 1,411 illness episodes were recorded during the study period. In this area, 92% of the episodes were treated without consulting a doctor. In approximately half of these cases pharmaceuticals were used. Hardon A (1991) Confronting Ill Health: Medicines, Self-Care and the Poor in Manila. Quezon-City, Health Action Information Network. Hardon AP (1987) The Use of Modern Pharmaceuticals in a Filipino Village: Doctor's Prescription and SelfMedication. Social Science and Medicine 25(3):277-292 Box continued… 8 What influences drug use by consumers Session Notes A household survey was conducted in two villages covered by a NGO primary health care programme (AKHS) and two control communities in Pakistan’s Karakoram Mountains during a period of seven months. A total of 897 illness episodes were recorded. In the primary health care (PHC) communities 44% of the recorded illness episodes were treated without health worker advice; in the control communities this percentage was slightly higher, 52%. Self-care practices included the use of traditional and herbal remedies, the use of modern pharmaceuticals and no treatment. In the PHC communities 16% of the recorded illness episodes were treated with modern pharmaceuticals without health worker advice. This number was 11% for the control communities. Rasmussen ZA et al. (1996) Enhancing Appropriate Medicine Use in the Karakoram Mountains. Community Drug Use Studies. Amsterdam, Het Spinhuis. In Ghana, an urban-rural comparative study found less self-medication in urban settings than in rural communities. About half of the 58% of illness episodes treated by self-care in two rural areas received pharmaceuticals while the other half received herbal remedies. In the two urban communities, 57% of the cases were treated using a doctor's prescription. Wondergem PW, Senah KA, Glover EK (1989) Herbal Drugs in Primary Health Care, Ghana. Amsterdam, Royal Tropical Institute. D2. Quality of prescribing The quality of health workers’ prescribing has a strong impact on consumers’ use of drugs. This is true, even if in terms of volume, most medicines are taken without health worker advice. The quality of prescribing plays a crucial role with serious health conditions when people do tend to consult health workers. It also affects the treatment of less severe conditions as people tend to remember the given advice and use it in later episodes of self-medication. In the Philippines it was observed that people keep prescriptions in their homes for re-use (Hardon, 1991). Studies conducted by members of the International Network for Rational Use of Drugs (INRUD) document how health workers practice poly-pharmacy. A study conducted in Indonesia found that the average number of drugs used to treat illnesses presented to the health worker was 3.8, both for children under five and for the over five age group. Patients seem to receive a similar mix of vitamins, analgesics and antibiotics irrespective of their disorders. Health workers’ prescribing of multiple medicines reinforces to consumers that they need a pill for every ill; and that a cure is unlikely without medical intervention. In some countries, professional organisations have been created to inform health workers about rational prescribing and rational drug use. Health institutions can also adopt an essential drugs list and prescribing guidelines in order to increase rational use of medicines. D3. Quality of the consultation Numerous studies on compliance (Homedes and Ugalde, 1993) suggest that people rarely take medicines as prescribed. Some obvious examples include the use of antibiotics and antituberculosis medications in inadequate dosages. People also 9 What influences drug use by consumers Session Notes follow irregular drug regimes for chronic conditions such as hypertension and diabetes. Non-compliance can be related to the health worker-consumer interaction. If the health worker does not explain the need to complete treatments, the dosages required, and ways to handle side-effects, then compliance with the prescribed regime is less likely. In a study of 69 hypertensive and diabetic patients in Zimbabwe, Nyazema (1984) found that sixty percent of the patients did not understand their diagnosis and the prescribed drugs. A study of 119 patients in the Dominican Republic found that fifty percent was unable to recall the dosage, frequency or interval of use (Ugalde et al., 1986). This was particularly problematic among those who were elderly, those with minimal literacy skills and when multiple prescriptions were given. While non-compliance generally has a negative connotation, Conrad (1985) points out its positive aspects. From a consumer perspective non-compliance could be seen as a way of self-regulating medicine use, rather than disagreeing with prescribed treatment. D4. Quality of dispensing Medicine dispensing is strictly regulated in industrialised countries. Those who dispense drugs must complete certain levels of training depending on the types of medicines they dispense. It is increasingly recognised that pharmacists have an important role to play in providing information on medicines, in order to complement the information given by doctors. Pharmacies are also important targets for drug promotion campaigns. In developing countries untrained pharmacy workers tend to dispense medicines in shops owned by pharmacists. These workers have little background knowledge about medicines. However, they are important sources of information on a wide range of medicines (including prescription-only drugs). Medicines are often dispensed in little sachets with little information about the drug’s content, use and precautions. Often package inserts meant to inform consumers about a medicine are not given to them when the drug is purchased. Medicines dispensed at markets or informal drug stores usually include no written information at all. Often they are wrapped in newspaper and sold by the tablet. D5. Regular supply People judge health centres by their capacity to ensure a regular supply of medicines. Often when consulting health workers in developing countries, people find there are no drugs available. Because consumers know that public health centres often lack medicines, they may go immediately to pharmacies and informal drug shops when they or someone in the family becomes ill. 10 What influences drug use by consumers Session Notes D6. Cost of medicines Often fees for medicines in public health services are relatively low. People pay more in the private sector. They are willing to do so because medicines in the private sector are believed to be more effective. E. THE NATIONAL LEVEL Medicines represent the second largest government health expenditure. In most developing and transitional economies spending on pharmaceuticals is second only to personnel costs. Getting the best health care value for such expenditures is vital. Government policies on provision of essential medicines through public health channels and regulation of the private sector’s drug supply, and promotion all affect consumers’ drug use. E1. Implementing essential drugs policies Rational drug selection, good procurement practices, reliable quality assurance and efficient distribution systems comprise central elements of essential drugs policies, as we have seen in the previous module. The World Health Organization estimates that the implementation of essential drugs programmes has given two-thirds of the world’s population access to essential drugs. Today nearly all countries have an essential drugs list. In 1999, 71 countries reported to WHO that the list guides drug procurement in the public sector (WHO, 2000). However, drug supply in the private sector is generally not regulated by the essential drugs policy. This is a problem as studies show people rely heavily on private and informal sources of medicines. The Philippine market, for example, includes more than 14,000 medicines. Many of these drugs are inessential, expensive, unsafe and ineffective. Most of them can be bought over-the-counter even if they are registered as prescription-only products. It is impossible for rational drug use programmes to inform consumers about all 14,000 medicines on the market. Essential drugs policies tend to emphasise drug procurement and supply, and appropriate prescribing by health workers. Promotion of rational drug use by consumers is not a priority in many countries. E2. Drug promotion Drug promotion creates demand for medicines in various ways. Firstly, it defines illness conditions that need treatment. It also promotes the idea that medicines are the best remedy as opposed to non-drug alternatives. Lastly, it tends to emphasise a medicine’s efficacy while minimising possible health risks. 11 What influences drug use by consumers Session Notes Companies spend vast amounts of money (an estimated one-third of sales revenues) on marketing. This is double the amount spent on research and development (Mintzes, 1998). Campaigns to promote the rational use of medicines have much less money to spend. In the absence of effective regulations on drug promotion, community interventions to promote rational drug use will have limited impact. Drug promotion to consumers is becoming an increasingly important component of drug companies’ marketing strategies (Mintzes, 1998). In the past, most consumer advertisements promoted over-the-counter medicines. More recently, companies have started promoting prescription drugs to consumers. Direct-to-consumer advertising (DTCA) for prescription drugs is allowed in the United States and New Zealand. It is now under consideration by regulatory authorities in Europe and elsewhere. The pharmaceutical industry has devised ways to create consumer demand for prescription products even where DTCA for prescription medicines remains illegal. (See the case-study provided in the activity at the end of this module.) Undercover promotion to consumers Pharmaceutical companies attempt to interest mass media journalists in their medicines. For example, one study reported that even though journalists tend to be sceptical about information from industry sources, in practice they often use industry materials for articles on medicines (van Trigt, 1995). The researcher found that drug manufacturer, Glaxo, informed Dutch journalists about its new, antimigraine drug sumatriptan (Immigran) at a scientific meeting before the product was officially registered. The announcement led to a series of newspaper and magazine articles that reported on the “new drug against migraine, not yet available in the Netherlands” and stated the “new antimigraine drug is effective”. This media coverage led to a discussion in the Dutch parliament on ‘clandestine advertising’. The same debate is now taking place in the United Kingdom. Here an incontinence campaign initiated by the company Pharmacia and Upjohn is the focus. Television advertisements used in the campaign encourage women with bladder control problems to see their doctors although DTCA is illegal. (See Annex 1 for more information on this controversy.) In an interesting twist, some of these ‘disease awareness’/DTCA campaigns are strongly supported by patient groups. This may be linked to the fact that patient groups (both national and international) are increasingly and sometimes solely funded by the pharmaceutical industry. The WHO's Ethical Criteria for Medicinal Drug Promotion (WHO, 1988), adopted at the 1988 World Health Assembly, call for promotion of prescription and over-thecounter drugs to contain reliable claims without misleading or unverifiable statements. The criteria also say that promotion should not contain omissions that could lead to health risks. They emphasise that promotion should not be disguised as educational or scientific activities. Ten years later, WHO reported that the criteria have only been adopted to a ‘modest’ degree in national drug policies. Criteria for drug promotion are only mentioned in 17 of 42 national drug policies and their implementation remains weak (WHO, 1998). A separate study done in Australia, for example, analysed 140 advertisements to the public and found that only 29% provided warnings or cautions about possible health risks (Watson, 1995). 12 What influences drug use by consumers Session Notes E3. Financing and reimbursement One of the big differences between consumers in industrialised countries and most of those living in developing countries is the cost of drugs. In industrialised countries, prescribed medicines’ costs tend to be covered by social security or private insurance schemes. At the national level, insurance companies’ reimbursement policies play an important part in shaping drug use. In some countries, such as the Netherlands and the United Kingdom, the government decides which medicines will be reimbursed, thus ensuring equitable access to essential drugs. In the United Kingdom, the National Institute for Clinical Excellence (NICE) is charged with determining which new drugs should be available in the National Health Service. In developing countries, medicines are available in public health services. To obtain them, people must often pay a user fee. This cost is sometimes proportional to the amount of medicine received. However, access to medicines in the public sector is limited. The majority of medicine purchases occur in the private sector in most countries. Drug costs are an important factor in consumers’ decisions on how to treat illness episodes, as we have seen. E4. Consumer and patient advocacy Consumer advocacy influences drug use at the national level of health care. Advocacy initiatives include monitoring implementation of essential drug policies, informing health workers and consumers about the rational use of medicines, and highlighting unethical drug promotion practices. However, many developing countries, particularly in sub-Saharan Africa and the Western Pacific region do not have consumer organisations. Those that do exist may not be powerful enough to influence policy. In the advocacy module we describe consumer advocacy in more detail. Patient organisations tend to focus on the medicine needs of specific patient populations. At times they push governments to allow new drugs on the market and lobby for these drugs to be reimbursed. In such campaigns patient groups are allies of drug manufacturers. E5. The media The media can play a key role in raising awareness on problems with drugs. They tend to publicise serious health hazards related to drugs, when these are brought to their attention. Also, unethical promotion is an issue which journalists tend to pick up. However, their influence is not always beneficial. They may sensationalise the “discovery and potential efficacy of new untried and often unregistered drugs and they are frequently used by the pharmaceutical industry to covertly promote products in the guise of what has come to be known as “advertorials”. Moreover, the pharmaceutical industry is often a significant advertiser and broadcasting companies, newspapers and journals may be hesitant to publish information perceived by the industry to be negative. 13 What influences drug use by consumers Session Notes E6. Public education on medicines to consumers Few countries have effective public education programmes. Often the programmes are limited in coverage and content. For example, there may be educational programmes on malaria treatment, but not on other diseases. School curricula are often put forward as an ideal medium for public education on medicines. Only a few countries, though, have such curricula. F. THE INTERNATIONAL LEVEL Globalisation is what everyone is talking about these days. A module on what influences drug use would not be complete without mentioning how the international level affects drug use by consumers. The most important factors at this level include: F1. Multilateral agreements involving drugs As we have seen in the previous module, the adoption of essential drugs policies and strategies by the World Health Assembly have increased access to essential drugs globally. National governments implementing these policies emphasise availability of essential drugs in the public sector and rational prescribing by public health workers. Promoting rational use of medicines by consumers, who depend largely on the private and informal sector for their drug needs, should receive more attention. This course is an important step in more seriously promoting rational drug use by consumers. F2. Global trade regulation and access to drugs Globalisation and the international regulation of trade are becoming increasingly linked to health policy. Concerns about the consequences of globalisation and international trade agreements and what were described as the ‘non-level playing field’ on which they were developed, were first raised during the 1996 World Health Assembly. The lack of financial access to patented HIV/AIDS medicines in developing countries and alliances between health and development groups in both developed and developing countries have brought these issues to the forefront of national and global agendas. The World Trade Organization’s (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) obliges all WTO Member States to provide twenty years of patent protection for medicines. Industrialised countries should have implemented TRIPS by 1996, developing countries had to introduce national regulation on intellectual property by the year 2000 and least developed countries have until 2006 to do so. 14 What influences drug use by consumers Session Notes Effects of TRIPS: public interest NGO concerns Increased patent protection leads to higher drug prices. The number of new essential drugs under patent will increase but the drugs will remain out of reach to people in developing countries because of their high prices. Enforcement of WTO rules will have a negative effect on local manufacturing capacity and will remove a source of generic, innovative, quality drugs on which poorer countries depend. It is unlikely that the TRIPS Agreement will encourage adequate research and development for diseases of developing countries or transfer of technology. Developing countries are under pressure from industrialised countries and industry to implement patent legislation that goes beyond the obligations of the TRIPS Agreement. This is so-called ‘TRIPS plus’ protection. ‘TRIPS plus’ is patent legislation that provides stronger protection of intellectual property than the TRIPS Agreement or does not include public health safeguards such as compulsory licensing or parallel imports that are provided for in TRIPS. Industrialised countries and the World Intellectual Property Organization (WIPO) offer expert assistance to help countries become TRIPS compliant. But this technical assistance does not take into account the specific needs of the health sector of developing countries, and both are under strong pressure to advance the point of view of large pharmaceutical companies that own patents. F3. Donor support Donors sometimes shift their interests in projects on drug issues. This also affects the use of medicines by consumers. During the last decade donors have moved away from supporting vertical programmes, such as the essential drugs programme. Instead, they favour health reform and sector-wide approaches. Health reform policies affect local-level implementation of essential drugs programmes. They generally promote collaboration with the private sector, the introduction of user fees and decentralisation of health care decision-making, including drug procurement and supply. There have been several recent efforts to mobilise resources in order to increase access to specific, greatly needed medicines and vaccines in developing countries. Examples of this trend include the Global Alliance for Vaccines and Immunisation (GAVI), the Medicines for Malaria Venture public-private partnership to enhance malaria drug supply, and the UNAIDS initiative to collaborate with pharmaceutical companies in an effort to increase access to HIV-related medicines. These initiatives can potentially increase access in developing countries to urgently needed medical technologies. However, questions remain concerning sustainability and the capacity of health services to make the medicines available and ensure proper use of the drugs by consumers. An interagency committee including a wide range of NGOs and UN agencies has published Guidelines for Drug Donations (WHO/EDM/PAR/99.4) which aim to ensure appropriate supply and rational use of donated drugs. 15 What influences drug use by consumers Session Notes F4. Global consumer advocacy As is the case at the national level, consumer advocacy at the global level is vital for rational drug use. Consumer organisations operating in the global arena lobby for rational medicines policies within the formulation of world health policies. They monitor the adoption and implementation of international agreements (see box on TRIPS above). Such groups also publicise inappropriate or harmful activities carried out by the pharmaceutical industry. The global advocacy movement also supports national organisations in their campaigns for structural change and rational drug use. F5. The Internet The Internet is perhaps the most talked about global force today. It acts as a very important source of information on health and medicines for people who can access it. It also serves as a tool for advocacy and networking (see module Advocacy and networking). Its lack of borders and regulation also makes it a popular way to promote drugs on industry-sponsored web sites and sites containing material on specific health conditions. 16 What influences drug use by consumers Session Notes G. CONCLUSION The table below gives an overview of the main factors influencing drug use by consumers, according to their level of influence. You can add to this list based on the class’ discussions and your own analysis of what influences consumers’ drug use in your own country. Level of influence Factors Perceived need for drugs Ideas about efficacy and safety Uncertainty resulting in polypharmacy Division of drug consumption roles Cost of medicines Literacy levels The power of medicines Drug use culture Drug supply system Information channels Extent to which health workers are consulted Quality of health worker prescribing Quality of communication and information provided during consultation Quality of medicine dispensing Regular supply of medicines Cost of medicines Implementation of essential drugs policy Drug promotion Drug financing and reimbursement policies Consumer advocacy The media Public education Family Community Health institution National International 17 Implementation of multilateral agreements affecting drugs Health consequences of global trade agreements Donor support for essential drugs programmes Global consumer advocacy The Internet What influences drug use by consumers Session Notes ADDITIONAL READING Mintzes B (1998) Blurring the Boundaries. New Trends in Drug Promotion. Amsterdam, HAI, Europe. WHO (1988) WHO Ethical Criteria for Medicinal Drug Promotion. Geneva, World Health Organization. REFERENCES CITED IN THE TEXT Birungi H et al. (1994) Injection Use and Practices in Uganda. WHO/DAP/94.18. Geneva, World Health Organization. Bledsoe CH, Goubaud MF (1985) The Reinterpretation of Western Pharmaceuticals among the Mende of Sierre Leone. Social Science and Medicine 21(3): 275-82. Conrad P (1985) The Meaning of Medications: Another Look at Compliance. Social Science and Medicine 20(1): 29-37. van der Geest S (1998) Use and Misuse of Pharmaceuticals: Anthropological Comments. In: Streefland P, ed. Problems and Potentials in International Health: Transdisciplinary Perspectives. pp. 195-21, Amsterdam: Het Spinhuis. Hardon A, Le Grand A (1993) Pharmaceuticals in Communities: Practices, Public Health Consequences and Intervention Strategies. Bulletin 330. Royal Tropical Institute, Amsterdam. Le Grand A, Sringernyuang L (1989) Herbal drugs in primary healthcare. Amsterdam, Royal Tropical Institute. Hardon A (1991) Confronting Ill Health: Medicines, Self-Care and the Poor in Manila. QuezonCity, Health Action Information Network. Hardon AP (1987) The use of modern pharmaceuticals in a Filipino village: doctor's prescription and self-medication. Social Science and Medicine 25(3):277-292. Homedes N, Ugalde A (1993) Patient’s Compliance with Medical Treatments in the Third World. What Do We Know? Health Policy and Planning, 8(4): 291-314. Nyazema NZ (1984) Towards Better Patient Drug Compliance and Comprehension: A Challenge to the Medical and Pharmaceutical Services in Zimbabwe. Social Science and Medicine 28(9): 905-1015.8 Rasmussen ZA et al. (1996). Enhancing Appropriate Medicine Use in the Karakoram Mountains. Community Drug Use Studies. Amsterdam, Het Spinhuis. Senah KA (1997). The Popularity of Medicines in a Rural Ghanaian Community. Community Drug Use Studies, Amsterdam: Het Spinhuis. van Trigt AM (1995). Making News About Medicines [Ph.D Thesis]. University of Groningen, Enschede: FEBO (ISBN: 909008605-6). 18 What influences drug use by consumers Session Notes Ugalde A et al. (1986) Do Patients Understand Their Physicians? Prescription Compliance in a Rural Area of the Dominican Republic. Health Policy and Planning 1(3):250-259. Watson R (1995) A Participatory Evaluation of the Implementation of the WHO Ethical Criteria for Medicinal Drug Promotion in Multiple Countries: Australian Results. Melbourne, Latrobe University. WHO (2000) Progress in Essential Drugs and Medicine Policy, 1998-1999. Health Technology and Pharmaceuticals Cluster, WHO/EDM/2000.2. Geneva, World Health Organization. WHO (1998) WHO Ethical Criteria for Medicinal Drug Promotion: A Strategy for Review and Assessment of Effectiveness. WHO/DAP/1998 (DRAFT 2). Geneva, World Health Organization. Wondergem PW, Senah KA, Glover EK (1989) Herbal Drugs in Primary Health Care, Ghana. Amsterdam, Royal Tropical Institute. 19 What influences drug use by consumers Session Notes ACTIVITY 1 1. The preparation notes for this session requested participants to read in advance the following two case-studies to prepare for Activity 1: 2. Young male students’ use of Viagra as an aphrodisiac. The off-label use of many modern pharmaceuticals as abortifacients. 3. Participants should work in groups and each group should appoint a rapporteur for this activity. 4. The group should decide which of the two case-studies it wishes to discuss. You have one hour to discuss the case. 5. The rapporteur should check that participants have already read the case-studies. If not allow ten minutes for this. 6. The groups' answers to the discussion questions will be presented in plenary by the rapporteur of one group for each case (to be chosen randomly). Members of the other groups can add to and comment on the presentation made. 20 What influences drug use by consumers Session Notes Case-Study I: Direct-to-Consumer Advertising of Prescription Drugs Most countries do not allow advertising or promotion for prescription drugs directly to consumers. In recent years, such regulations have come under challenge as drug companies argue that consumers are entitled to information about new prescription drugs. In the United States and New Zealand, this has resulted in the repeal of a ban on direct-to-consumer advertising (DTCA). As a result, printed periodicals sometimes contain more prescription-drug ads than over-the-counter medicine promotion. For example, a recent issue of the US magazine Life (March 2000) contained ads for nine prescription drugs filling 18 pages. It contained no ads for over-the-counter drugs. Typically, the drug ads comprised at least two pages. This is mainly because they included additional information on the drugs presented in a question-and-answer format, for example: “Can I take other medications with Tamiflu?” All the ads included telephone numbers and website addresses for readers wanting additional information. Even with the extensive information they contained, these DTC ads for prescription drugs cause concern. This is mostly due to the large volume of advertising for a new category of pharmaceuticals called ‘lifestyle’ drugs. These medicines are promoted for indications such as ‘erectile dysfunction’ and ‘social anxiety’. Critics suggest that promotion of such drugs will lead to increased medicalisation of conditions that are not real health problems or that may be responsive to non-drug interventions. The problems caused by DTC promotion of prescription drugs become more acute in developing countries. Below are two examples from the Philippines, where two prescription drugs – orlistat (Xenical), for obesity, and sidenafil citrate (Viagra), for male sexual dysfunction – were recently launched and heavily promoted. Viagra Promotion of Viagra started before the drug was even approved. One newspaper featured a seven-part article on the drug in May 1999. This was about five months before it gained approval. The title of the first article in the series declared “3.5 million Filipinos are impotent”. This estimate was given by a Filipino urologist working on the drug manufacturer’s clinical trials. The Filipino doctor based his projections on the US Massachusetts Male Ageing Study that was conducted from 1987 to 1989. Another article in the series announced “My husband is like Superman”, a quote supposedly from a Filipino whose husband had taken the drug. 21 What influences drug use by consumers Session Notes An organisation called the Philippine Erectile Dysfunction Research Organization (PIDRO) a play on a local slang term for the penis suddenly appeared, comprised of Filipino doctors endorsing Viagra. Its members were interviewed for numerous newspaper stories and appeared on television. In almost all cases, the doctors promoted Viagra as an aphrodisiac. Few doctors referred to the drug’s risks although newspapers eventually began picking up foreign reports of men with heart conditions dying after using Viagra. Unsurprisingly, when the drug finally entered the market, there was initial demand for it as an aphrodisiac. Young male college students began taking it just to see if it would improve sexual performance. After its approval, ads appeared regularly in newspapers with teasers such as “Do you know Ed?” (Ed being erectile disorder). They included some information on the causes of erectile dysfunction and a phone number to call. However, the drug’s name was not mentioned as Filipino law still bans DTC advertising. Regardless, the fact that the ads mention the company’s name already hints at what product is being promoted. Xenical Xenical’s promotion started only after the drug was approved. Like Viagra, the campaign began with newspaper articles talking about a problem: “One in every five Filipinos either overweight or obese”; “Docs warn many Pinoys (Filipinos) growing fat”; “Obesity is a major health threat in RP (Republic of the Philippines).” The articles praise Xenical as if it was a lifesaver and quote both local and foreign ‘experts’. And as happened with Viagra, a new medical group suddenly emerged to endorse its use for the mass media. A Philippine newspaper opened with the headline, “Anti-obesity drug now in RP market.” Underneath was a smaller heading: “Blocks fat absorption, reduces weight in 6 months, has no major side effects”. No mention was made of any of the drug’s adverse effects. In contrast, an ad for the drug appearing in the US Life magazine issue mentioned earlier refers to “gas with oily discharge, increased bowel movements, an urgent need to have them and an inability to control them, particularly after meals containing more fat than recommended.” Other contraindications are mentioned (for example, in pregnancy or patients taking certain other drugs). The ad also warns that Xenical reduces the absorption of some vitamins and recommends a daily multivitamin as a supplement. Creating need Promotion of Xenical and Viagra used ‘advertorials’. These are well-planned and strategically placed newspaper items that do not identify themselves as advertisements. In February 2000, an article appeared exclaiming “Xenical is one of Time’s top 10 scientific wonders of 1999”. The article cited Time magazine’s listing of Xenical among scientific breakthroughs. The story went on to describe Xenical as “one of the most popular diet pills among notable celebrities and politicians and 22 What influences drug use by consumers Session Notes people from the upper echelons of society. Even the top man in the land, President Joseph Estrada at one point admitted he lost several pounds with this wonder drug.” Viagra, on the other hand, was promoted in an April 2000 headline with “Drug’s contribution to medical world cited.” This was based on Viagra being named ‘Drug of the Year’ by Spain’s “prestigious Council of Pharmacist Associations”. It also mentioned that the drug was one of four pharmaceuticals to be placed in the UK’s Millennium Dome. The problem with all this hype stems from the fact that it occurs amid a general lack of accurate health information for Filipinos. It is ironic that the country’s regulations prohibiting the mention of a prescription drug name in an advertisement has led to more deceptive promotional strategies, including advertorials. The promotional campaigns for Xenical and Viagra add to the myths surrounding pharmaceuticals and create artificial needs. Instead of treating erectile dysfunction, Viagra has become an aphrodisiac. Xenical, supposedly reserved only for the obese, has become a ‘diet pill’. Creation of so much artificial demand is costly. The price of both drugs is quite high compared to average Filipino wages. For example, a single Viagra tablet is equivalent to two days of the minimum salary. Discussion questions 1. Make an inventory of the ways in which the prescription drugs Viagra and Xenical are promoted to the public in the Philippines. 2. Consider one of the consequences of DTCA of Viagra in the Philippines, its use as an aphrodisiac by young, male, Filipino students. A. Discuss what factors are related to this misuse of Viagra. (List the factors by level of influence: individual, community, health institution, the national level, and the international level.) B. Define possible solutions for this drug-use problem considering the factors that influence it. 3. DTCA is illegal in the Philippines. Discuss the positive and negative consequences of lifting the country’s ban on DTCA. 23 What influences drug use by consumers Session Notes Case-Study II: Off-label use of drugs to induce abortion Because of the strong influence of the Roman Catholic Church, abortion is not allowed under any circumstance in the country. Yet there is a strong demand for abortion, partly because conservative groups have succeeded in blocking family planning services. This has resulted in many accidental pregnancies. (In some parts of the Philippines, conservative governors and mayors have banned ‘unnatural’ contraceptives from government services). A research project conducted by the University of the Philippines’ Population Institute estimates that 300,000 to 500,000 abortions are induced each year in the country. Most take place in homes or secret clinics. Finding information Abortion’s illegal status has resulted in the emergence of informal channels that disseminate information about abortifacients and abortion services. While the quality of the information and services is often quite poor, many women have no other choice. Medicinal plants have long been used as abortifacients in the country. They continue to be used today. Usually they are referred to as pamparegla or medicines to induce menstruation. In the 1960s, high oestrogen-progesterone preparations (brand names Gestex and Cumorit) were introduced to treat gynaecological problems. However, they somehow acquired a reputation for inducing abortion. People also referred to these drugs as pamparegla. The ‘folk’ use of these hormonal drugs actually came from the biomedical establishment. When hormonal contraceptives were first introduced in the late 1950s, they were not promoted for birth control but rather for ‘menstrual disorders’. The drugs only gained approval as contraceptives in the US in 1960. An ad for one of these pills appearing in a Filipino medical journal in 1964 still refers to it as useful for “cyclical therapy”. Until the 1980s, Gestex and Cumorit were listed for “treatment of secondary amenorrhoea of short duration”. These high oestrogen-progesterone (EP) preparations were eventually banned in 1987 by the Philippines’ Bureau of Food and Drugs. Yet for many years, people continued to refer to them as abortifacients even though they were no longer available. Ironically, perceptions of hormonal pills as abortifacients may actually have been reinforced by groups opposed to contraception, including ‘Pro-Life’ groups. Such organisations, often linked to conservative religious and political movements, have attacked hormonal contraceptives as abortifacients in the media. In 1994, one such 24 What influences drug use by consumers Session Notes group placed a large billboard on one of Metro Manila’s main roads that proclaimed, “Contraceptives Abort.” Such campaigns have led to confusion among consumers. Hoping for side-effects In recent years, different kinds of non-hormonal, Western medicines have circulated as abortifacients, often self-administered ones. The antimalarial, quinine, is one such drug. Because the drug is contraindicated in pregnant women, people have turned this risk into an indication. Methotrexate, an anti-cancer drug, was also cited as an abortifacient in the 1980s. Misoprostol (Cytotec) remains the country’s most popular Western medicine used as an abortifacient. It was approved in the Philippines to treat gastrointestinal ulcers induced by the use of non-steroidal, anti-inflammatory drugs (NSAIDs). The drug has gone through various clinical studies and has been found effective as an abortifacient. For that reason it is not supposed to be used by pregnant women. The drug can be dangerous, sometimes causing haemorrhage requiring hospitalisation. It is now cited by many Philippine hospitals as the leading cause of hospital admissions related to incomplete abortions. Conclusion The case of abortifacients in the Philippines shows how real medical need can create an informal information network. Unfortunately, information about abortifacients remains mixed with myths and folklore. This exposes consumers to great risks. Inaccurate information can be traced to abortion’s illegal status in the country, in addition to a general lack of accurate information about medicines. The medical establishment itself may propagate some of the myths since doctors do not have an appropriate forum – scientific meetings for example – to share and evaluate facts about abortion. Ultimately, it is the political environment that determines the degree of consumer access to information. Discussion questions 1. What medicines are used as abortifacients in the Philippines? 2. What are the health risks related to their use? 3. What factors influence misuse of these medicines as abortifacients? 4. What can be done to discourage the use of these medicines as abortifacients? 25 What influences drug use by consumers Session Notes Annex I: Controversy about DTCA in the UK This annex contains a text which highlights issues involved in the current UK controversy about direct-to-consumer advertising of prescription drugs. The newspaper article below reports on the discussion surrounding an industry-initiated incontinence campaign. These readings serve as background for a group discussion on the negative and positive aspects of this type of advertising. Those wanting to learn more about the DTCA debate in the UK should visit the ‘What’s New’ section of Social Audit’s website: http://www.socialaudit.org.uk. This article is reprinted as a fair use. Drug Firm’s TV Adverts Test Industry Rules by Sarah Bosely, Health Correspondent, The Guardian, 18 August 1999. A drug company which has sponsored a series of television commercials to be screened this autumn is being accused of covertly advertising medicines direct to the public. The advertising campaign, which has already begun in print and poster form, is intended to alert the thousands of people who suffer in silent embarrassment from bladder problems to the possibility of treatment, says Pharmacia and Upjohn, one of the leading UK pharmaceutical companies which manufactures a drug to treat the condition. But critics say the campaign is a clever and calculated first step down the slope towards adverts for prescription medicines in Britain, a practice banned by law, which would increase enormously the pressure on GPs to hand out expensive new drugs to patients who had seen them hyped on television. In the US it was the growing number of disease-awareness campaigns such as that being mounted by Pharmacia and Upjohn which led eventually to the Food and Drug Administration allowing products to be advertised by name. The drugs bill in the US has grown by 12 to 14% a year since then, compared with just 5% in the UK. The incontinence campaign features a smiling, carefree, middle-aged woman, and urges those with bladder control problems to ask their doctor about treatment. It features the name and logo of the sponsoring drug company. Already Glaxo Wellcome, manufacturer of the new flu drug Relenza which could be in huge demand over the winter, and of Zyban, which helps people stop smoking, has said it will consider similar "public awareness" campaigns. Astra Zeneca has run 26 What influences drug use by consumers Session Notes such a campaign in France, and might consider mounting one in Britain for a migraine treatment. Pharmacia and Upjohn's incontinence campaign is backed by the Royal College of Nursing, the Patients Association and various patient groups, which all argue that there are thousands of people - mainly women - suffering in agonised silence from a treatable condition. "The particular campaign is a very cleverly chosen one," said John Chisholm, chairman of the GPs committee of the British Medical Association. "I don't know whether it was their idea or there was discussion in the industry about testing the rules. A lot of people suffer and don't realise help is available.” "The question is whether this is the thin end of the wedge opening the door which other people are going to walk through with perhaps more questionable motives." David Gilbert, author of a policy report on prescription drug advertising to the public, said he did not believe the industry was a trustworthy source of impartial information. He believed the campaign was designed to push at the boundaries of what is allowed. "The World Health Organization's Ethical Criteria for Medicinal Drug Promotion objects quite strongly to hidden or disguised promotion, which is what this is," he said. Joe Collier, professor of medicines policy at St George's Hospital School of Medicine, said: "They know what they are doing is creating a concept of need and widening their market and getting access to the public with their name." Roy Sutherwood, Director of public affairs at Pharmacia and Upjohn, said the campaign had the approval of the medicines control agency, which enforces the legislation. "We found fairly widespread enthusiasm for education on this problem," he said. He acknowledged that the relaxation of the law in the US followed such campaigns. "Direct-to-consumer advertising is a separate argument, but I think I'd want to say we can't reasonably contest the right of patients to be better informed about their treatment, and pharmaceutical companies are best placed to ensure that accurate information is given to patients wishing to know more." Claire Rayner, of the Patients Association, who is recording the voice-over on the television adverts, said if advertising to the public was "honest, open and clear", it should not be a problem. 27