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WHAT INFLUENCES DRUG USE BY CONSUMERS TRAINER’S NOTES (FOR USE WITH MANUAL) PURPOSE AND CONTENT This session aims at encouraging participants to identify the various factors which influence drug use by consumers. The factors they identify are grouped into layers of influence: the family level; the community; the health-service institutions; the national level; the international level. The module thus provides participants with a framework which links individual drug-use behaviour to the multi-layered environment which shapes drug use. The framework presented forms the basis for an analysis of drug-use problems; and the development of interventions which aim at changing drug use behaviour as well as at changing the environment in which drug use takes place, to enable more appropriate use of drugs. OBJECTIVES At the end of the session, participants will be able to: 1. Identify factors that determine drug use by consumers in each of the five levels of influence (individual/family/community/health care institutions/the national level/international level). 2. Recognise the relative importance of the factors with respect to efforts to promote rational use of drugs by consumers. PREPARATION Participants are expected to: 1. Read Chapters 1 and 2 of the Manual “How to investigate the use of medicines by consumers”. 2. Reflect on drug-use problems in their country and the factors that influence them at each of the five levels. 3. Read the two case-studies in Activity 1. What influences drug use by consumers Trainer’s Notes The trainer needs to: Select three drug-use stories: The session can start with three very short stories on a specific type of drug use. Examples of short ‘drug-use stories’ are given below. If possible, the stories are presented by participants themselves. Try to identify two participants who have done drug use studies, or who work in communities and thus have good insight into what people do with drugs. Ask them if they are willing to present a drug-use story (duration around 3 minutes). Discuss in detail with the two selected participants what they will present. And prepare a short drug-use story yourself as well. It is best if the stories present different types of drug use practices and can help participants in identifying a wide range of factors. Clarify that the presentation should only describe in detail what people do, not why they do so. The ‘why’ will be discussed in the session. Make sure there are two flipcharts in the front of the meeting room, with thick markers. These will be used to list factors which influence drug use by consumers raised by participants in response to the drug-use stories. Get a good overview of the factors by level By reading Chapter 2 of the Manual, the facilitator can make sure (s)he is familiar with factors which influence drug use by consumers by layer of influence. This will enable him/her to make a good synthesis of the factors which are identified during the session. Prepare for the activity Make sure that participants receive a copy of the Activity the evening before the session takes place. Read the case studies given in Activity 1 carefully, and prepare a brief summary to be presented when introducing the activity. Make sure core library texts (see listing) are available for distribution The core readings should be available for distribution. Distribute them at the end of the session when people are filling in their evaluation forms. The trainer should briefly explain why the readings are “core”. CORE LIBRARY WHO (1988) WHO Ethical Criteria for Medicinal Drug Promotion. Geneva, World Health Organization. Mintzes B (1998) Blurring the boundaries. New trends in drug promotion. HAI-Europe, Amsterdam. 2 What influences drug use by consumers Trainer’s Notes ORGANISATION AND KEY POINTS OF THE SESSION Structure and timing of the session 1. Introducing the session - 5 minutes 2. Three drug-use stories - 15 minutes 3. Participatory identification of factors which influence drug use by consumers - 25 minutes 4. Family and community level factors - 30 minutes Break - 15 minutes 5. Short summing up of health institution level factors - 5 minutes 6. National level factors, including drug promotion - 30 minutes 7. Activity - 50 minutes plus 20 minutes feedback 8. Summing-up - 5 minutes VISUAL AIDS 1. Title slide 2. Objectives 3. The session 4. Layers of influence 5. The family level 6. Perceived safety and efficacy 7. Gender roles and medicines 8. The community level 9. Community drug distribution 10. The health institution level 11. Extent to which health worker advice is sought 12. The national level 13. Drug promotion 14. WHO ethical criteria on drug promotion 15. Ethical criteria adoption 16. OTC advertising: IOCU study 17. Increase in promotion towards consumers 18. Top DTCA expenditures 19. The international level 20. Zyban: Information from the Internet 21. Activity tasks 22. DTCA discussion questions 23. Discussion questions: drugs used as abortifcients 3 What influences drug use by consumers Trainer’s Notes 1. INTRODUCING THE SESSION (5 MINUTES) Introduce the session by explaining its objective (OH 2) The main objective is: Identify factors which influence drug use by consumers, by level of influence Explain why this objective is important: it helps to link individual drug-use behaviour to the multi-layered environment which shapes drug use. It further forms the basis for an analysis of drug-use problems; and the development of interventions to change drug-use behaviour as well as at changing the environment in which drug use takes place, to enable more appropriate use of drugs. Ask participants now to listen carefully to three drug-use stories. We are now going down to the real-life situation of medicine-use in communities: day-to-day medicine use. Tell participants that there will be no opportunity in between for responses, but that we will discuss all stories at once. Explain that the stories will be used to identify factors which influence drug-use practices. Mention the five layers of influence(OH 4): family level; the community; the health-service institutions; the national level; the international level. 2. THREE DRUG-USE STORIES (15 MINUTES) Present the three short drug-use stories (see “Preparation”). The stories should take around 3–5 minutes each. The facilitator makes sure that the story-tellers do not use up too much time. Examples of drug-use stories are: Drug-use story 1: The use of antibiotics to treat perceived womb-related inflammations in Thailand Studies on women’s health in the north-east of Thailand have shown that women commonly suffer from a condition called ‘mot-luuk ak-seep’. ‘Mot-luuk’ means ‘womb’. ‘Ak-seep’ means ‘inflamed’. The symptoms women mention are backache and lower abdominal pain. Mot-luuk ak-seep is a common condition. Women believe it is caused by inflammation of the womb. They usually treat it in self-medication with a few antibiotic capsules. One specific type of antibiotic is especially popular. It is Gano®, a locally produced brand of Tetracycline. The manufacturer of this brand encourages use for womb-related indications by depicting a drawing of the uterus on the package and on billboards promoting Gano®. 4 What influences drug use by consumers Trainer’s Notes Drug-use story 2: Treatment of malaria with injections and other drugs in Uganda In Uganda an elaborate community drug use study has been done. People in rural communities often treat fever with chloroquine injections. They go to informal drug sellers in their communities for these injections. AIDS prevention campaigns have warned against unhygienic injections. Perhaps as a consequence, people do not trust the injections provided at health facilities anymore. An injection use study found that 60% of families keep syringes and needles in their homes, and they take these to the drug seller when they need an injection. If the chloroquine injection does not work, and the fever continues, people go to the hospital or they try other medicines such as Fansidar®, or Comaquin® (contaning chloroquine). Children are often given Septrin® (cotrimoxazole), a medicine which is commonly used for respiratory conditions. Drug-use story 3: Considering a new medicine to quit smoking, Netherlands A social worker in the Netherlands is home from work, burnt-out. Because of stress she started smoking again, which she regrets. Now she is at home and feeling depressed and exhausted. She is going to a psychotherapist who is helping her tackle the extreme tiredness and depression. He advises her to take a new drug Zyban®. He says that it will help her quit smoking, which she wants, and that this drug also works as an antidepressant. He suggests she asks her doctor about it. Her doctor tells her that she will have to pay for the drug herself, as it is not yet included in the Dutch reimbursement scheme, so her insurance company will not pay for the drug. Zyban® is a new drug he says and relatively expensive. If she wants an antidepressant he can prescribe another drug. The social worker is not sure what to do and searches the internet. She enters “Zyban” in a search machine and is directed to various sites with information on the drug, including possibilities to purchase it. She discusses the issue with a friend. She tells her friend that she is inclined to take the drug, citing information from the internet: It’s a pill which does not contain nicotine. You can start using the pill, without having to stop smoking, and it is relatively cheap cessation therapy – it is more expensive to continue smoking. Her friend cautions her: It is a new drug. Perhaps it is not safe. The social worker then goes to the pharmacy and buys nicotine chewing gum instead. The pharmacist gives her a leaflet about Zyban, and tells her it is new, and perhaps better for her. Optional: use OH 20, which gives the key messages that the social worker found on the internet. 3. PARTICIPATORY IDENTIFICATION OF FACTORS WHICH INFLUENCE DRUG USE BY CONSUMERS (25 MINUTES) The facilitator asks the participants: why do these drug-use practices occur? Which factors influence these drug use practices? Which factors cause the women in the north-east to use antibiotics for perceived womb-related inflammations? Why are 5 What influences drug use by consumers Trainer’s Notes injections so popular in the treatment of fever in Uganda; why is the social worker inclined to take Zyban® even if it will not be reimbursed by her insurance company. Ask co-facilitators to write the factors on two flipcharts or whiteboards which you place left and right in the front of the room. Ask one of them to list all the individual and community factors mentioned. Ask the other facilitator to list the health institution and international level factors. Stop this exercise, when the participation becomes less lively. Do so after around 25 minutes of discussion. 4. FAMILY AND COMMUNITY LEVEL FACTORS (30 MINUTES) Invite the participants to now focus on the individual/community level factors. Give a relative quick overview of the factors mentioned, building on the ones identified in the Chapter 2 of the Manual (pp. 7-11). The family level (OH 5) Overhead 5 gives an overview of family level factors. Add on a second overhead additional factors which have been listed on the flipchart. The community level (OH 8) Present OH 8, and add additional factors using an overhead marker. Tell participants that you want to discuss a few of these individual and community factors in more detail – highlighting how these factors constrain or facilitate efforts to encourage rational drug use by consumers. You can pick up issues that emerged in the earlier participatory identification of factors. Option one: discuss gender roles and medicines If the gender roles in provision of medicines have been mentioned in the discussion, discuss these briefly in more detail. Gender roles and medicines (OH 7) The main point to highlight is that when developing health communication interventions you need to know who is involved in administering medicines, deciding on what medicines get bought, and in the buying of medicines. If men are involved in the treatment of childhood illnesses, as is the case in Pakistan, then it is important to target information to them as well as to ‘mothers’ (the usual target of child-health campaigns). Option two: Discuss perceived safety and efficacy and its implications Discuss in more detail the factor ‘perceived safety and efficacy’ of medicines. 6 What influences drug use by consumers Trainer’s Notes Perceived safety and efficacy (OH 6) Drug use studies show a number of important trends. Perceived safety and efficacy: is related to colour, taste, and shape of medicines is related to dosage form depends on perceived compatibility between medicine and the person taking the medicine depends on the perceived cause of the illness. Encourage participants to think through the influence of people’s ideas about medicines for programmes which aim to promote the rational use of medicines. Some medicines, such as cough-cold remedies, only relieve symptoms. They do not cure. Other medicines, such as some tonics, are pharmacologically inert. If people feel better when taking medicines which only relieve symptoms or are pharmacologically inert, is it then justified to develop interventions programmes which discourage the ‘inessential’ use of these medicines? Note that placebos can work. People can feel better after taking medicines which have no pharmaceutical action. In clinical trials, usually around one third of the patients react to placebos. Suggest that perhaps campaigns should focus on discouraging the use of medicines which are harmful and discouraging the use of expensive placebos. There is no harm in using cheap placebos, if they make people feel better? Whole traditions of folkhealing are based on the efficacy of placebos! Doctors want to be able to prescribe placebos, otherwise patients go elsewhere and get drugs which are more dangerous. If you have time, continue to discuss why it is so important that essential drugs programmes consider perceived safety and efficacy of medicines. For example: Option three: Discuss people’s preference for cough-cold syrups In South Africa, provincial public health authorities decided to discontinue the supply of cough-cold syrups used widely in the treatment of childhood coughs and colds, because of their limited therapeutic value and the high expenditures on these drugs. The discontinuation of supply of the cough-cold syrups led to an increase in demand for antibiotic suspensions and analgesic. The public health authorities realised that people think they need to give syrups to children with coughs. They decided to procure one cough syrup and supply it to the health facilities in order to meet the demand for syrups in the treatment of coughs-colds. The syrup has limited therapeutic value, and no adverse effects. Option four: Discuss the popularity of Yachud in Thailand Another example is the use of pre-packaged Yachud in Thailand. Yachud are produced locally in Thailand. They contain a number of different medicines for specific health conditions. For example Yachud for muscle pain typically contains dexamethasone or prednisolone tablets, as well as a relatively unsafe analgesic called phenylbutazone. Some Yachud include the tranquillizer diazepam. The distribution of pre-packed Yachud has been banned in Thailand a few years ago. But consumer demand continued. People consider Yachud to be needed in the treatment of muscle7 What influences drug use by consumers Trainer’s Notes pain. Pharmacies therefore now prepare ‘fresh’ Yachud. When customers ask for it, they put a number of different medicines in little plastic sachets. These last two examples show that changes in drug supply and regulatory actions will not have much effect if not accompanied by consumer-oriented communication activities which explain why the medicines are banned. This is a good moment for break. Tell participants that after the break we will discuss the other layers of influence, focusing on the national level. BREAK (15 MINUTES) The health institution level (OH 10) The national level (OH 12) In the break, review the factors on these overheads and add any additional health institution and national level factors that emerged during the earlier discussion. 5. SHORT SUMMARY OF HEALTH INSTITUTION LEVEL FACTORS (5 MINUTES) Probably you need not spend much time on this level. People are very aware of the factors. Summarise the health institution factors briefly referring to the overhead prepared in the break. The health institution level (OH 10) Optional: Use OH 11 to highlight that health worker advice is often not sought when treating illness episodes. The data presented in this overhead are derived from community surveys focusing on common health problems. Point to variations between countries. Refer to the Manual (pp. 11-13) for sources of these data. 6. NATIONAL LEVEL FACTORS, INCLUDING DRUG PROMOTION (30 MINUTES) Give an overview of national level factors which influence drug use by consumers. Use the overhead prepared in the break. The national level (OH 12) Discuss the factors briefly. 8 What influences drug use by consumers Trainer’s Notes Probably during the earlier discussion the importance of drug promotion emerged; and the difficulty of countering the “you-need-a-pill” message conveyed in drug promotion. You can use 13-18 to give a brief introduction on drug promotion. Introduction to Drug Promotion (OH 13) 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. 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. For example in the United Kingdom it is estimated that there is 50 times more money available for drug promotion than for public education on medicines. Refer to the document Blurring the Boundaries, which is part of the corelibrary for this session, for sources of all of these data. Highlight that in the absence of effective regulations on drug promotion, community interventions to promote rational drug use will have limited impact. WHO Ethical criteria on drug promotion (OH 14) 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. Ethical criteria adoption (OH 15) Ten years later, the 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). Continue on adoption of ethical criteria with OTC advertising: IOCU study (OH 16) A study done in 11 countries by the International Organization of Consumers Unions reviewed 238 advertisements for over-the-counter medicines. The study found that 9 What influences drug use by consumers Trainer’s Notes most advertisements do not comply with ethical criteria; 75 % of the advfertisements do not mention side-effects or contraindications. Increase in promotion towards consumers Highlight that there is in fact an increase in promotion to consumers. This is explained in the Blurring the Boundaries document that all participants will receive. Increase in promotion towards consumers (OH 17) The document reveals how 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-thecounter medicines. Through regulatory action in fact more and more prescription drugs are becoming OTC drugs. In the past the prescriber was the most important target in drug promotion. Patients were seen to be ignorant. Nowadays, patients are more and more targeted in drug promotion as ‘experts’ in need of information. 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. Even where DTCA for prescription medicines remains illegal, the pharmaceutical industry has devised ways to create consumer demand for prescription products. One of the activity case-studies deals with this. For example, in the United Kingdom an incontinence campaign was initiated by the company Pharmacia and Upjohn. Television advertisements used in the campaign encourage women with bladder control problems to see their doctors although DTCA is illegal. (Refer participants to Annex 1 for more information on this controversy.) 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. Top DTCA expenditures (OH 18) Optional: Use OH 18 to show the DTCA expenditure in the US. Most of these drugs are life style drugs. Close the discussion on drug promotion, and point to the need to get on with the activity. 10 What influences drug use by consumers Trainer’s Notes 7. ACTIVITY 1 (50 MINUTES, 20 MINUTES FEEDBACK) Ask if the participants have read the case studies in Activity 1 (handed out before). Summarise the case studies and then point to the key questions to be answered in discussion groups. If an interesting drug-use problem emerged during the earlier discussion, you can add a case study. Assign groups: two dealing with DTCA and two dealing with abortifacients; and or any groups dealing with problems which emerged. Refer to Activity 1. Ask participants to take the activity in front of them. Tasks in Activity 1 (OH 21) 1. The preparation notes for this session requested participants to read in advance the two case studies for Activity 1. 2. Explain that participants should work in groups and each group should appoint a rapporteur for this activity. 3. The rapporteur should check that participants have already read the case studies. If not allow ten minutes for this. 4. 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. Refer to the discussion questions at the end of each case-study. Discussion questions on DTCA (OH 22) 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: family, 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. 11 What influences drug use by consumers Trainer’s Notes Discussion questions on the off-label use of medicines as abortifacients (OH 23) 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? Point out one group for each case will present briefly their answers to these questions; the other group dealing with the same case is asked to comment and add to the analysis. (20 minutes). Feedback in plenary from group work. 8. SUMMING-UP (5 MINUTES) Stress the need for comprehensive communication strategies which link individual/community oriented interventions with the implementation of comprehensive national drug policies, which regulate drug supply and promotion. Conclude by stressing that the framework presented forms the basis for an analysis of drug-use problems (in the next module); and the development of comprehensive interventions which aim at changing drug use behaviour as well as at changing the environment in which drug use takes place, to enable more appropriate use of drugs (week two of the course). Encourage them to start thinking about the stakeholders which play a role in shaping drug use at the various levels; these actors will need to be involved in/targeted by interventions. Introduce and hand out the core library materials. 12