1 Action Programme on Essential Drugs and Vaccines E S S E N T I A L D R U G S MONITOR N o 24 (1997) Essential Drugs Monitor The Essential Drugs Monitor is produced and distributed by the WHO Action Programme on Essential Drugs. It is published in English, French, Spanish and Russian, and has a global readership of some 200,000 to whom it is free of charge. The Monitor carries news of developments in national drug policies, therapeutic guidelines, current pharmaceutical issues, educational strategies and operational research. WHO s Action Programme on Essential Drugs was established in 1981 to provide operational support to countries in the development of national drug policies and to work towards the rational use of drugs. The Programme seeks to ensure that all people, wherever they may be, are able to obtain the drugs they need at the lowest possible price; that these drugs are safe and effective; and that they are prescribed and used rationally. All correspondence should be addressed to: The Editor Essential Drugs Monitor World Health Organization CH-1211 Geneva 27, Switzerland Fax: I N T H I S I S S U E : Newsdesk 2 3 More effective care for those in emergency situations Swiss move to cut prescribing costs Advance in leprosy treatment And more... Public Education 4 Health and the media Networks 5 20 Throughout the world there are networks which are committed to ensuring rational use of drugs. Here we look at some of them how they began, their motivations and achievements, and what lessons others can learn from them. Drug Regulation Survey assesses transparency of drug regulatory authorities Research 22 Treating diarrhoea: French study highlights problems Training 23 Involving communities in managing health units Netscan, Meetings & Courses Published Lately Rational Use 28 Focus on Santa Fe Province, Argentina E D I T O R I A L VER the past two decades a O growing network of action groups has become a powerful force in the global campaign for better use of drugs. The groups vary in size from a revolving network of committed medical practitioners with no more than volunteers at a time all in the same country to a global coalition of 180 action groups in 70 countries. United in a single cause, their strength lies in their global reach, and in the breadth of their membership from academics, practising doctors and pharmacists, to regulators, students and individual consumers. This broad composition underscores the fact that everyone from the drugs expert to the vulnerable consumer has a vital role Networking for action n e t w to play in ensuring rational drug use and equitable access to essential drugs. This issue of the Essential Drugs Monitor looks at how individual groups have evolved, highlights their achievements, and asks what lessons have been learned over the years. Several groups are working to improve prescribing practices through a revamp of undergraduate medical and pharmacology courses, or by compiling scientifically validated comparative therapeutic information. Others monitor the marketing practices of the pharmaceutical companies. Some networks aim at strengthening research skills in developing countries; sharing information gained and gaps identified. One campaigning group, the Pakistan Network, evolved from a one-off campaign against a dangerous drug. Another, the German BUKO Pharma-Kampagne, emerged as an offshoot of a Third World solidarity movement, while the Accíon Internacional por la Salud network in Bolivia grew out of efforts to learn the lessons from a failed attempt to establish an essential drugs programme in the early 1980s. Each group has developed innovative ways of communicating with its own membership and with the public at large. Strategies include newsletters, s o T r , media campaigns, conferences and seminars, internet discussion groups, and street theatre. One group, the Medical Lobby for Appropriate Marketing (MaLAM), adopted the Amnesty International idea of a coordinated letter campaign. One notable achievement was the initiative to establish a Medicinal Drugs Bank in Bolivia to help nongovernmental organizations procure essential drugs. The outcome of this venture was a reduction of up to 800% on the price of drugs. Some groups measure their success in terms of an improved dialogue with pharmaceutical manufacturers, others by their formal representation on government decision-making bodies and their role in drawing up national drug policies or evidence-based pharmacotherapy information. Many groups are engaged in educational development work and progress is inevitably long-term. Under these circumstances a network can be a tower of strength providing an ideas bank and a source of encouragement for committed individuals. On a day-to-day basis, the most pressing concern identified by many networks is their own shortage of funds. One group which was run on a shoestring from a campaigner s home for the first 10 years maintains that the constant search for new sources of funding has become a major constraint on the time available for campaigning. Another, points out that, although its organizational structure is light and much of the work decentralised, funding for k core activities is essential for the survival of the network. Other groups those that can offer educational services, for example are better placed to generate some of their own funds through training courses or consultancies. An encouraging trend highlighted by one campaign group is the growing pressure from governments, health insurers and consumers for better value for money through the use of a scientifically selected range of generic drugs. However, groups elsewhere are concerned at the increasing trend towards privatisation of health care and at the impact of the global liberalisation of trade and deregulation of drugs. The Pakistan Network points out that deregulation has led to an end to price controls on drugs and resulted in unrestricted imports of non registered pharmaceutical products. Linking forces to monitor trends in trade, review clinical practice, and to strengthen research and education, can make a major contribution to ensuring that public health needs and equity underlie pharmaceutical policies. This needs the continuation of a global network which in the words of one NGO must be strong and durable like a good fishing net: strong knots, good links, light in weight, extendable and flexible.
2 2 N E W S D E S K Photo: WHO/A. Tietweld Breakthrough in care of emergency victims EW WHO guidelines are set N to overcome a serious, longstanding problem for those caring for emergency victims. Until now rapid international transport of the most effective painkillers, such as morphine and pethidine, has been virtually impossible, because these severely addictive narcotic drugs are governed by strict international conventions. The drugs require prior import documents from the recipient country but obtaining A comforting hand for a victim of war in Afghanistan. Now action by WHO is set to reduce the suffering of those caught up in emergency situations them often takes too long to meet the urgent needs of relief work. Control authorities may well be rendered inactive by the emergency situation, or are unable to issue import documents for people in the disaster-stricken areas. Consequently all humanitarian aid agencies, including WHO, have abandoned the provision of narcotic drugs in their emergency medical supplies. But lack of these medicines results in additional human suffering, by depriving those in need of adequate pain relief and sedation. The problem has been escalating as psychotropic drugs like sedatives and tranquilisers, although less addictive than narcotics, are increasingly being regulated in a similar way by national authorities. WHO therefore brought the issue to the attention of the International Narcotics Control Board in an effort to find a solution. Faster, more effective pain relief As a result of the WHO initiative the new model guidelines were drafted at a consultation in Geneva in September They will assist national authorities in simplifying their regulatory procedures for donations of controlled medicines. The guidelines allow selected suppliers of these drugs acting at the request of recognised humanitarian relief agencies to make international shipments in emergency situations without prior export/import authorisations, following procedures acceptable to control authorities and the International Narcotics Control Board. The Geneva meeting was attended by representatives of several national regulatory authorities, relevant UN agencies and relief organizations. The guidelines were further discussed and approved at an international consultation of national drug regulatory authorities in Bahrain in November 1996, and are now being implemented on a trial basis. Copies of the Model Guidelines for the International Provision of Controlled Medicines for Emergency Medical Care are available, free of charge, in English and French, from: World Health Organization, Programme on Substance Abuse, 1211 Geneva 27, Switzerland. Mexican workshop on teaching therapeutics ECOMMENDATIONS on incorporating principles of good pres- R cribing into Mexican medical curricula were among many made at a workshop entitled Challenges in teaching therapeutic treatment in the year 2000, held in October The workshop attracted 35 pharmacology professors from 25 of Mexico s medical faculties for two days of lively, wide ranging discussions. HAI Mexico and the host, Free City University Plantel Xochimilco, jointly organized the event. Participants debated the strengths and weaknesses in current pharmacology teaching, and resolved to establish a Committee to promote education in rational drug use. One of the Committee s first tasks will be to convince medical faculties to introduce specific therapeutic materials into their curricula. Until recently essential drugs and rational drug use have had little prominence in Mexico s medical schools. Strengthening the curricula inputs on both will be among the Committee s priorities, as will dealing with national drug policy New advertising rules for Viet Nam NDER new regulations Vietnamese U companies will not be able to advertise medicines for the treatment of tuberculosis, cancer, diabetes, mental disorders, sexually transmitted diseases, sleeping disorders or stimulants. Advertisements for other medicines and cosmetics will be allowed to run for a maximum of five days in a daily newspaper, on 50 radio broadcasts for five days or on 40 television programmes for eight days. Any promotional workshops must be organized in collaboration with an approved Vietnamese pharmaceutical agency, such as the Pharmacists Association, the Medical Association and hospitals. The Ministry of Health is also banning advertisements of medicines and cosmetics not registered with the Vietnamese authorities or whose licences have expired or been cancelled. Source: Scrip No. 2235, May issues and promoting the essential drugs concept. Participants resolved to work through the Association of Faculties of Schools of Medicine in Mexico to incorporate the principles of good prescribing into the country s medical curricula. With the Association s agreement, the Committee will define the criteria necessary to have pharmacology accredited in medical and pharmacy schools. Guidelines will be drawn up to ensure follow-up of prescribing practice among doctors every five years. A pharmacy in My Duc District. Viet Nam s new law on advertising is designed to protect all consumers Photo: A. Battersby Latin American rational use issues on the Net HE bi-annual electronic publication of the Information Bulletin T on the Appropriate Use of Medication will be available on the LANIC (Latin American Network Information Center: farmacos). The Bulletin will appear in February and September. It will include details of advances in theory and practice relating to the appropriate use of medicines, such as research developments, interventions and their results, and legislative changes in Latin American countries. Other issues covered by the Bulletin are: communication between health service providers and recipients, pharmaceutical product marketing, pharmaceutical industry news, costing systems, medication quality control, sideeffect warnings, the role of pharmacists, self-medication, traditional medicine, and home remedies. Readers will also receive details of conferences and publications of interest. In another initiative LANIC will keep a directory of people interested in promoting the rational use of drugs. This directory will be continuously updated and will include the name, address, address, publications and other areas of interest for each person. To include information in the Bulletin (10 August 1998 is the deadline for the September edition), or the directory contact: Nuria Homedes, 1100 N. Stanton, Suite 110, El Paso, TX 79902, USA. Tel: ; fax: , Low-cost edition of BNF HE British National Formulary T (BNF), an invaluable reference for those prescribing, dispensing and administering medicines, is to be published in a low-cost edition every September. The Formulary describes all medicines on the UK market, (including those used for tropical diseases) with special reference to their uses, cautions, contraindications, side effects, dosage and relative costs. Published jointly by the British Medical Association and the Royal Pharmaceutical Society of Great Britain, the first cheaper edition came out in September 1997 and is available from TALC, P.O. Box 49, St Albans, Herts AL1 5TX, UK. Price 5 plus postage and packing ( 2.75 surface or 3.75 airmail).
3 3 N E W S D E S K Swiss initiative to cut prescribing costs ealth professionals and insurance H companies in the Swiss region of Fribourg are running a project designed to improve the quality and cut the cost of prescribing. Pilot programmes suggest that savings can be as much as 10 20%. Those involved in the project believe that the quality/price ratio of prescribing could be improved and significant savings achieved. Medical practitioners, pharmacists and health insurance companies have set up 11 groups, each involving a pharmacist and up to six doctors. Each group will analyse the doctors prescriptions over the course of a year, using information from the pharmacist owned prescription invoicing centre, Ofac, and scientific literature published by the Swiss New Zealand: controversy hits advertising campaign N intensive multimedia campaign A by New Zealand s pharmaceutical industry against the costcutting policies of the medicines subsidy agency, Pharmac, has had a shaky reception so far. Doctors groups have taken a stand against it, and Pharmac has submitted a complaint to the Advertising Standards Authority. The Research Medicines Industry Authorities campaign includes television advertising, full-page advertisements in the main newspapers, and mailings to doctors and homes. The campaign follows Pharmac s announcement of plans to further rein in pharmaceutical spending, including tenders for off-patent products. Various doctors associations expressed reservations about the campaign. The General Practitioners Association said GPs supported Pharmac in its efforts to supply cheaper drugs to patients. And the Pegasus Medical Group, which represents more than 200 Christchurch family doctors, said the pharmaceutical industry had misjudged the attitudes of family doctors, and expressed concern that the advertisements would frighten people, and just serve to confuse the issue for patients. Meanwhile the Change of address NYONE interested in receiving further details of the inventory of A projects aimed at improving the use of medicines in the Netherlands (see EDM-23 pg. 14) should contact: Mr. Drs. G.A.L. Kocken at the Dutch Institute for Effective Use of Medication, Stichting DGV, Postbus 3089, 3502 GB Utrecht. Tel: , fax: , Pharmaceutical Society. The groups say that statistics show significant differences in prescriptions written by doctors for the same ailment. The group asks whether the doctor has made the best choice in terms of available products, and, if necessary, suggests prescribing a different drug. It also looks at whether certain products might have an unsatisfactory quality/price ratio. A coordinating committee of two doctors and two pharmacists has been set up to monitor results from the groups, and assess whether they correspond to the aims of the Swiss law on health insurance. Results are expected in autumn Source: Scrip No.2257, August Medical Association called for a truce, urging the two sides to discuss the problems openly. A formal complaint Pharmac has submitted a formal complaint to the Advertising Standards Authority, claiming that the advertisements were misleading and play on people s fears, and set up a phoneline to reassure people who are worried by the ads.. Pharmac also put out figures comparing the prices of the 27 top selling medicines in New Zealand and Australia, claiming that New Zealand was being ripped off, and that the figures made the advertising campaign all the more obnoxious. Pharmac claims that it would save NZ$38 million annually on payments of NZ$122 million for the products in question if they were priced at the same level as in Australia. (They are ACE-inhibitors, calcium antagonists, beta-blockers, anti-asthmatics and SSRI antidepressants). Source Scrip: No. 2286, November Kuwait s choice HE Faculty of Pharmacy at the T University of Kuwait has chosen the new edition of Managing Drug Supply as the textbook for its first year introductory pharmacy course. The book, extensively revised in collaboration with DAP and other WHO programmes, provides up-to-date descriptions of the process of drug selection, procurement, distribution and use. (See EDM-22 Published Lately for more details). Pacific Islands collaborate on supply HE Ministers of Health of the T Pacific met in August 1997 in Rarotonga, Cook Islands, to discuss issues relating to the supply and management of pharmaceuticals and medical supplies within the context of the development of essential drugs policies in the Pacific. The resulting Rarotonga Agreement reflects the commitment of the Pacific Island countries to further collaboration with the aim of strengthening the availability of safe and effective drugs. The conference agreed to identify and take action to overcome obstacles to the implementation of bulk purchasing schemes for pharmaceuticals and other health supplies, and to address related issues such as quality assurance and drug information exchange, through agreements between interested countries in the Pacific. A practical recommendation made during the meeting was the proposed development of a plan of action for joint activities to improve drug supply ince 1981 multidrug therapy S (MDT), the combination of three powerful antileprosy drugs, has cured more than 8.5 million leprosy sufferers, and the global strategy to eliminate the disease is working extremely well. Now a comprehensive multicentre trial has shown that for a special class of early paucibacillary (PB) leprosy where patients have one skin lesion a single dose of three drugs in combination is sufficient to bring about a cure. Apart from patient satisfaction with the new treatment, the implications in terms of reducing the workload on health staff and reducing health service costs are appreciable. The single dose consists of rifampicin (600mg), ofloxacin (400mg) and minocycline (100mg). It is expected that the simplified treatment will be introduced into countries depending on the needs of the national leprosy programmes. For PB leprosy patients with more than one skin lesion, the standard treatment (600mg rifampicin once a month and 100 mg dapsone daily) will continue to last for six months. The multicentre trial, which management, with an emphasis on product quality and specifications, the selection of accredited suppliers or manufacturers, detailed tender procedures, and the estimation of requirements for and financing of drug supplies. The first follow-up activity, organized with technical support from the WHO Regional Office for the Western Pacific, was a workshop on drug supply management and quality assurance held in Nadi, Fiji, in November It was attended by representatives from 17 out of the 21 Pacific Island countries. The recommendations adopted at the workshop serve as useful indicators of the progress made in implementing the Rarotonga Agreement. Among these was a decision to establish a drug information network between Pacific Island countries; to explore liaison between the smaller Island States and Fiji, so that drugs could be obtained from the Fiji bulk purchase scheme; and to conduct a survey to identify products to be quality tested by Australia s Therapeutic Goods Administration. Treating leprosy: more good news led the Seventh Expert Committee on Leprosy to approve the simplified treatment, was initiated and supported by the United Nations Development Programme, the World Bank and WHO s Special Programme for Research and Training in Tropical Diseases. The Expert Committee, which met at WHO Headquarters in Geneva from 26 May 3 June 1997, also agreed on shortening the treatment for the more severe multibacillary (MB) leprosy from 24 months to 12. For further information contact: World Health Organization, Action Programme for the Elimination of Leprosy, 1211 Geneva 27, Switzerland. Leprosy patients in an upland township of Ethiopia take the multidrug pills which will cure them Photo: WHO/J. Maurice
4 4 P U B L I C E D U C A T I O N Health and the media: getting the message across SIAN LONG, SANTOSH GNANAKAN, DARLENA DAVID* HE Christian Medical Journal of India found an unusual, enjoyable and very T useful way to celebrate its 100th anniversary. Staff organized a four-day workshop on the promotion of health issues in the media, which attracted NGO training and medical officers, health project directors and newsletter editors from all over India. Held in New Delhi in November 1996, the event was hosted jointly by the Christian Medical Association of India (CMAI) and the Appropriate Health Resources and Technology Action Group (AHRTAG). Creative use of information Lively group sessions generated much creative energy and focused on: folk media, (including puppet shows and songs); newsletters; developing a dynamic resource centre; and generating ideas for stories about community health and primary health care. Professionals in the fields of journalism and public relations shared information on writing press releases (see box) and hosting press conferences. Two volunteers deftly answered questions from journalists at a mock press conference. All those intending to put their new found skills into practice were asked to inform CMAI of their successes and difficulties, so that their experiences can benefit others. * Sian Long coordinates the AIDS Programme at AHRTAG, Santosh Gnanakan and Darlena David work with the Communication Centre of the Christian Medical Association of India, Lot No.2, A-3, Local Shopping Centre, Janakpuri, New Delhi , India. N E W S D E S K WHO and NGOs strengthening partnership News has to be: Press releases New a first time occurrence Unique no one else is telling the story Topical for example on the occasion of an anniversary, such as World Health Day Surprising it must get the journalist s attention Interesting it has to impact the readers Controversial it can interest by raising controversy Remember: if your press release is not three or four of these things, then it is not news. A press release has three main components: The headline The first paragraph, which includes the what, where and when Some explanatory information, including statistics and a quote At the end in bold put where to obtain more information A press release should be on one side of a piece of paper and never be more than two pages long. N the past five years the series of I United Nations Summits have clearly illustrated the immense influence of nongovernmental organizations (NGOs) in global policy development. This influence was again apparent when representatives from over 130 NGOs attended a consultation to review the new global health policy Health for All in the 21st Century. Convened by WHO s Policy Action Coordination Team, the meeting was held in Geneva in May It brought together not only NGOs working in public health but also in sectors with indirect influence on health issues, such as education, agriculture, business and environment, and organizations that address inter-related issues, such as human rights and gender. WHO s major aims for the meeting were to consult NGOs on global health policy development; to identify the potential roles of NGOs in implementing policy; and to identify, strengthen, and create new structures for NGOs to collaborate with WHO at all levels. The NGOs agreed to work for the adoption of a universal Health for All Value System. Its essential features include championing the importance of health as a human right, based on principles of social justice; and promoting ethics, equity, solidarity and sustainability as well as a gender perspective in all health policies. Specific priorities, such as promoting the advancement of women and increasing the participation of women in decision making, have direct effects on health status. NGOs shared a wealth of experience in approaches to influencing policy and practice related to women s health, with far-reaching effects on policies and programmes on improving the well-being of women, men and children. A clear message: health is everybody s business There was common agreement among NGOs on the need to promote a vision of health as being central to sustainable development. They deplored the fact that 1.5 billion people around the world still do not have access to basic health services. Eradication of poverty is essential in all efforts to achieve a good standard of health care. A Global Health Watch system, to be managed and operated by an NGO group and modelled after Amnesty International s work on human rights, was proposed as a new collaborative structure. This could serve a crucial function in stimulating the political will necessary to quickly translate policy into action, and to monitor how well governments, NGOs and the private sector are fulfilling Health for All responsibilities. There was general agreement that WHO could work more effectively with NGOs in the future if it was able to work with a broad range of multisectoral NGOs, and not just the narrow range of organizations now admitted into official relations with WHO. This would mean a review of existing criteria and arrangements for official relations with WHO, as well as strengthening WHO s current NGO liaison office to promote expanded partnerships and working relations. A report of the Consultation, A New Global Health Policy for the Twenty-first Century: An NGO Perspective, is available free of charge from: World Health Organization, Policy Action Coordination Team, 1211 Geneva 27, Switzerland. Leave wide margins and a lot of space, because journalists like to write on the same sheet of paper. If possible send pictures or illustrations that are interesting, relate to the news and are preferably in black and white. Papers are short of visual material. Remember: give the facts simply and clearly. Leave the creative writing to the journalist. An example of the training materials used at the New Delhi workshop Participants at the workshop discussed appropriate use of cartoons For further information contact: Christian Medical Association of India, Plot No.2, A3, Local Shopping Centre, Janakpuri, New Delhi, , India. Credit: Christian Medical Association
5 5 MaLAM: networking for scientific integrity in drug promotion PETER MANSFIELD, JOEL LEXCHIN* N late 1981 a young Australian medical student, Peter Mansfield, went I to Bangladesh to do a student elective. In such a context of severe poverty scientific medical care can achieve great good. In villages where everyone has known young children who have died, parents will make great sacrifices to buy medicines. Consequently he was horrified when he saw scientific medicine under attack from inappropriate pharmaceutical marketing. Misleading promotion is an emotional issue. However it deserves the same calm rational examination as any other medical issue. The challenge was to conceive and then implement therapy. Out of that challenge grew the Medical Lobby for Appropriate Marketing MaLAM. A number of social processes enable pharmaceutical companies to develop and promote more positive beliefs about their drugs than can be supported by critical appraisal of the evidence. Companies also tend to be more concerned about their images in major markets than their relatively small profits from poor countries. All organizations need feedback to enable them to improve their performance. Pharmaceutical companies need more honest feedback from health professionals. Consequently, MaLAM was designed to provide an open, participatory forum for dialogue between health professionals and pharmaceutical companies. Arising from this dialogue publication of international MaLAM editions, usually focusing on promotion in developing countries, began in November Consequently, MaLAM has found that the Amnesty International concept of coordinated letters is very cost-effective. Monthly editions usually include a newsletter, MaLAM International News, and a letter to a pharmaceutical company about one or more of its promotional claims. Each letter includes a summary of the relevant scientific literature and invites the company to justify or improve its claims. Subscribers also receive a support letter that they can sign and post to the company to request a copy of its reply. Successes... Over the 14 years since it started MaLAM has grown from 53 subscribers, mostly in Australia, to over 6,000 in more than 30 countries. Editions have been available in French since 1986, courtesy of the Paris-based PIMED (Pour une information médicale éthique et le développement). The first major success was a letter in 1986 requesting evidence to support the promotion of a mixture of arsenic, strychnine, vitamins and alcohol for stress in Pakistan. The manufacturer announced a withdrawal immediately. By 1991 pharmaceutical companies had promised to withdraw 11 drugs after receiving MaLAM letters. The most important of these was a chloramphenicol/ streptomycin combination that had been the top selling over-the-counter product for diarrhoea in the Philippines. It is often difficult to assess how large a role MaLAM played in causing improvements. However, the temporal relationships are usually clear. Besides changing companies behaviour, MaLAM has also been successful at giving individual, isolated doctors and pharmacists a sense that they are not powerless; that even the small action of signing a letter can have significant consequences. People feel that they are contributing to worthwhile changes and this, in no small measure, has accounted for the growth of the MaLAM network. As well as linking scattered individuals MaLAM has also been part of a growing international network of organizations that work in different ways to achieve the same goals. The recent An advertisement from the Medical Publishers Association in Australia. While the pressure to advertise increases, MaLAM is working to ensure that all drug promotion is ethical example of the promotion of a drug for postpartum lactation suppression provides an excellent example of this cooperation. MaLAM received a copy of an advertisement from Pakistan encouraging women to use the drug to stop breast-feeding. This advertisement triggered a MaLAM letter to the company responsible for the promotion. At the same time, Public Citizen s Health Research Group was vigorously lobbying the United States FDA to get this use removed from the product s official list of indications; a British health activist was filing a protest about other advertisements with the International Federation of Pharmaceutical Manufacturers Associations; and the HAI network was also active in the international arena on this issue. The end result of this multinational and multi-method effort was that the company has ceased promoting the drug for this indication worldwide. The anti-breastfeeding drug promotion issue is also an example of how MaLAM has been able to dialogue with some drug companies. While the campaign against the Pakistani promotion was underway, contact between Peter Mansfield and the Managing Director of the Australian subsidiary of the company responsible eventually led to a meeting between three MaLAM Board members and senior executives. This took place at the company s international headquarters in October The two-day meeting saw a wide ranging discussion about all aspects of the company s policies on drug promotion. The company demonstrated an impressive new capacity to listen to outsiders concerns. Medical Observer, Australia But not without problems... While MaLAM has certainly had its share of successes, it also illustrates the problems inherent in small organizations operating in an international context. With a Board that includes members from Australia, Canada, France and Pakistan, just coordinating teleconference Board meetings is a major task. But the problems go deeper than that. For the first 10 years Peter Mansfield basically ran the organization out of his living-room. But as it expanded the living-room was no longer adequate and there was more work than one person could possibly do. Although there was Australian funding between 1992 and 1996 and more people available to work for MaLAM, a change in government meant the end of that money. MaLAM has been forced to cut back its operations, so that for the past year MaLAM editions have been appearing sporadically. The search for new sources of funding has also been taking up valuable time that otherwise would be going into producing MaLAM editions. From the beginning the success of MaLAM has depended on its subscribers. However, as they are scattered around the globe it has been very difficult to keep in contact and to get timely feedback from them. MaLAM editions are distributed by local individuals and organizations. This eases the burden for the people in Australia but means that there has to be effective communication with these local distributors a task that is sometimes difficult to achieve. Without some accurate knowledge about how well MaLAM editions are being distributed it is hard to plan for the network s rational growth. Encouraging trends... There is a trend towards a more sophisticated market which will reward quality by favouring drugs that come with reliable information so as to produce the best health outcomes. Rising consumer and government concern about paying for sub-optimal care is creating pressure for better prescribing. Quality use of medicines activities, the evidence-based medicine movement, improving medical education and the ancient but everrelevant ideal of doing the best for the patient are all part of this trend. MaLAM gains strength from this trend but also tries to accelerate it. MaLAM has been successful, but in order to become more effective it will have to become a more effective network. * Peter Mansfield is Director and Joel Lexchin is President of MaLAM. For further information on MaLAM s activities contact: Dr Peter Mansfield, MaLAM, PO Box 172 Daw Pk SA 5041 Australia. Tel/fax: ,
6 6 INDEPTH: rational pharmacotherapy HE International Network for the Development of Pharmacotherapy Teaching (INDEPTH) is an informal, non profit network T of pharmacotherapy teaching institutions and experts, which promotes education and research on rational drug use. Its aim is to ensure that all prescribers are equipped with the necessary knowledge and skills to select and use appropriate drug therapy. EVOLUTION OF INDEPTH The seeds of the INDEPTH network were sown at the first international course on pharmacotherapy at the University of Groningen (RuG) in the Netherlands in The course was organized in collaboration with WHO s Action Programme on Essential Drugs, to train teachers of therapeutics in the principles of problem-based pharmacotherapy teaching. Developed by the University to improve prescribing practices, the teaching model is published by WHO as the Guide to Good Prescribing 1 (see EDM- 20). On the final day of the first course, an informal network emerged, with the aim of keeping the participants informed of each other s work. The courses have prompted an increasing number of universities to seek RuG support in curriculum development. Meanwhile, through the network, RuG started helping universities to develop problem-based pharmacotherapy teaching. Applications for the course also increased rapidly, and RuG began to support the start up of regional courses in collaboration with other universities, such as the newly established course at the University of Cape Town, South Africa. INDEPTH grew out of a demand for collaboration in educational research on rational pharmacotherapy. Members required a more structured network, not only to find partners in educational research and share expertise, but also to help identify sources of financial support for research projects. The need had always been there: a recent study of 3,689 articles on research in medical education published between 1975 and 1994 concluded that lack of theory-based research, failure to build on previous research, under-reporting, and the high percentage of studies based on a single institution may be due to the scattered nature of the literature and the lack of external funding. INDEPTH brings together people who want to develop and research rational pharmacotherapy, both in universities and elsewhere. It does not have a formal membership structure and members are not bound by any of its recommendations. Although it does have a secretariat and an 11-member Executive Board with regional representation. The Board determines network priorities and operates a network budget. However, decisions are made on the basis of a broad consensus a crucial factor in keeping the network running as an equal partnership. INDEPTH also has a three-member Steering Committee to carry out Executive Board decisions, and a Scientific Board a consultative body of experts who advise on the content of summer courses, curriculum development and research projects, as well as in-service training and research programmes. The network s activities are part of the work of the WHO Collaborating Centre for Clinical Pharmacology and Drug Policy Science. COMMUNICATION Initially the network communicated with its membership through letters and . Now, in response to the continuing increase in membership, INDEPTH Participants and staff at the 4th INDEPTH Training Course on Teaching Rational Drug Therapy, held in August 1997 is to publish a bi-annual newsletter, available by post or . A web site has also been established at and a mail server is currently being tested. Meanwhile, in collaboration with HealthNet, INDEPTH is also planning to set up an electronic conference on pharmacotherapy education. FINANCIAL SUSTAINABILITY Almost half of INDEPTH income comes from donations mainly from European donors. The rest is generated by the network s own programmes. There is no membership fee. A sustained effort has been made to establish good relationships with donors reinforcing their role as shareholders in our cause. Efforts have also been made to ensure donor accountability and demonstrate that fundraising is structured to maximise the amount of Photo: Faculty of Medical Sciences, Univ. of Groningen income available for network activities. INDEPTH funds the remainder of its activities through its own operations. It organizes customised training courses on rational pharmacotherapy teaching commissioned by (inter) governmental agencies. It assists national drug programmes and professional associations by developing training programmes for prescribers. INDEPTH also receives a small contribution from each regional course organized by individual network members. In addition INDEPTH makes use of a number of innovative schemes including the virtual loan system. This allows the network to re-use its financial resources, so that each dollar pays for more than a dollar s worth of activities. Seed funding may be provided for a regional training course, for example. But if the course makes a profit, the seed funding is returned to INDEPTH possibly to fund a future training course elsewhere. Sometimes, reimbursement takes the form of services instead of funds. The network can provide financial or technical support to a pharmacotherapy curriculum development and research programme in Portugal, for example. In return, it might require the beneficiary to translate WHO s Guide to Good Prescribing into Portuguese. COMPLEMENTARY WORK INDEPTH s work complements that of other organizations which carry out research to identify problems in the prescribing and use of drugs. Its work also supports that of governmental bodies and other organizations responsible for drug regulations and managerial strategies to prevent irrational drug prescribing. INDEPTH also complements the educational work of consumer organizations, and collaborates with WHO both at the regional level and through its Action Programme on Essential Drugs. LESSONS LEARNED Many medical schools are researchoriented and educational activities are often not regarded as important. As a result, funding for educational research remains limited. And without data to convey the economic and health-related impact of rational pharmacotherapy teaching, it is difficult to convince donors of the need for funding. Another lesson we have learned is that all potential donors have their own agendas and geographic areas of focus. Some countries may be favoured more than others. These donor preferences are sometimes difficult to explain to our members. Finally, the system of training people through short-term summer courses although important is not sufficient to bring about changes in the undergraduate and postgraduate pharmacotherapy training curricula. Summer course participants need support in the form of on-site follow-up assistance and seed funding an intervention which would cost more than just donor sponsorship for a course participant. Unless this help is provided, the universities will fail in their efforts to change the pharmacotherapy curriculum. A new in-service training course on rational pharmacotherapy, funded mainly by the European Union, was launched in Portugal in November The new course is for doctors, pharmacists and nurses working in state or university hospitals. The programme is a joint venture involving the Portuguese Government, the Universities of Coimbra and Lisbon, and INDEPTH. The programme follows parallel but separate courses for physicians, pharmacists and nurses. The first course was targeted to health professionals from four hospitals in Coimbra. The training programme was on-site and lasted five days. Patient examples and case studies were derived from hospital archives. The programme included a daily seminar on topics including generic drugs and prescribing, post marketing surveillance, drug registration and patents, the rational pharmacotherapy model, and cost-monitoring. Meanwhile, daily workshops enabled participants to discuss different aspects of the WHO model of rational pharmacotherapy, through the patient case studies. Although the course is tailored to individual professional groups, there are some joint sessions. This is a pilot programme which will be used by hospitals in Lisbon and Oporto during There are also plans to start training general practitioners, beginning with a pilot project in the Dao or Alentejo regions. For further information contact: Dr Yunus Kocabasoglu, Coordinator of INDEPTH, INDEPTH Secretariat, A. Deusinglaan 1, Kamer 617, 9713 AV Groningen, the Netherlands. Tel , fax: , Reference De Vries TPGM, Henning RH, Hogerzeil HV, Fresle DA. Guide to Good Prescribing. Geneva: World Health Organization; WHO/DAP/94.11.
7 7 The International Network for Rational Use of Drugs Photo: WHO/D.A. Fresle he International Network for Rational Use of Drugs (INRUD) is an T action research network in which multi-institutional and multidisciplinary country core groups develop, test and disseminate interventions to improve the use of medicines in developing countries; develop useful drug use research tools; and carry out targeted training and skills development. By focusing on changing medication use behaviour the INRUD approach complements the work of other networks. Key principles are listed in Box 1. The network was conceived as a research initiative on the effectiveness of rational drug use interventions during a meeting of African and Asian clinical pharmacologists with participants from Management Sciences for Health (MSH), Harvard Medical School and the Karolinska Institute. INRUD was explicitly designed as a network of interested individuals rather than institutional relationships between organizations. This framework facilitated involvement of individuals in universities, government departments, NGOs, and the private sector. Initially, an ad hoc planning committee selected seven countries, based on country visits, evaluation of country background papers and proposed action plans. Since then, the network has expanded its membership to 10 country core groups, technically supported by six academic and technical assistance organizations (see Box 2). At its inaugural meeting in 1990, the planning committee was replaced by an elected Network Committee (one person from each country and an additional social scientist from the Asian region and the African region), coordinated by Management Sciences for Health. The Network Committee decides by consensus, at an annual meeting or by ad hoc polling, on all important policies related to the governing of INRUD, including which activities are to receive greater priority and how the overall growth of the network will proceed. Research proposals are reviewed and approved by at least DAVID LEE* A session at the Promoting Rational Drug Use Course held in Dar es Salaam in September INRUD runs the courses in collaboration with the Action Programme on Essential Drugs, one of its many partners two members of the committee. The Network Coordinator and staff at Management Sciences for Health are responsible for day-to-day decisions about communication, logistics and expenditures. Full or regional network annual meetings of country core group coordinators, support group members, as well as ad hoc technical support visits have played an important role in strengthening country core group commitment to the INRUD focus. Within INRUD countries, meetings are held periodically. The INRUD News, fax and electronic mail communications also contribute to maintain the interest and commitment of network members. The network has been financially supported through various sources. The Danish Agency for International Development (Danida) has provided financial support for network development and expansion since Core funds support the work of the secretariat and Harvard Support Group in maintaining the INRUD Bibliography database, and publication and distribution of the INRUD News. These funds also cover country core group communication costs, seed support for Promoting Rational Drug Use (PRDU) courses, development of training materials, short-term training of INRUD core group members, and provision of seed funding for research. Beginning in 1998, the United States Agency for International Development (USAID) will contribute core funding from the Rational Pharmaceutical Management (RPM) Project to support INRUD coordination and work related to rational use of antimicrobials and slowing the emergence of antimicrobial resistance. WHO country programmes and the Action Programme on Essential Drugs sponsor PRDU course participants and fund INRUD specific research projects. The Action Programme also provides course trainers and training materials. Among others, the Swedish International Development Agency (SIDA), the Dutch Ministry of Foreign Affairs, the Australian Agency for International Development (AusAID), UNICEF, World Bank funded essential drugs projects and various private sector organizations have supported training activities. Long-term sustainability is an important concern. Since 1995 INRUD country core groups have assumed primary responsibility for organizing and running the regional PRDU courses. These have generated modest revenue for host country core groups to support small scale studies and strengthen local research infrastructure. Several of the country core groups have been quite successful in running similar revenue-generating rational drug use training courses at national level. Some groups are highly successful at developing proposals for fully funded drug use intervention research. Until country core groups attain a sufficient degree of self-funding, network support and formal expansion will continue to depend on major international donor contributions. The INRUD experience shows that researchers in developing countries can produce well-designed drug use intervention studies, many of which were presented in the First International Conference on Improving Use of Medicines in Chiang Mai, Thailand (see Box 3, and more details are included in EDM-23). Key elements that contributed to successful experiences include: an initial structured and focused training approach on appropriate research methodology, including relevant qualitative and quantitative methods; continuing technical assistance to strengthen research proposals; availability of seed funding or assistance in raising required research funds; continued ad hoc assistance in data analysis, presentation and report preparation. To date, there has been greater support for study design and proposal development, and comparatively less ad hoc support to data analysis and report preparation. There are proposals underway to address the need for more attention on data analysis and report writing through targeted and focused workshop activities. The recent call for research preproposals issued by INRUD in collaboration with WHO/DAP, ARCH, and RPM, (see EDM-23 report on the International Conference on Improving Use of Medicines) is expected to lead to another generation of intervention studies. It will be an excellent opportunity to train junior staff and further strengthen core group capabilities. A more structured approach to support all phases of research (proposal development, data analysis, report writing and dissemination), will be applied. This type of collaboration with other networks should optimise the use of resources available to each member organization. Box 1 Key INRUD principles an interdisciplinary focus, linking clinical and social sciences; emphasis on understanding behavioural aspects of medicines use, particularly the beliefs and motivations of providers and consumers; well-designed research studies to understand these behavioural factors, leading to reproducible interventions to improve drug use. Box 2 INRUD core groups and support groups Country core groups Africa Ghana Nigeria Tanzania Uganda Zimbabwe Asia Bangladesh Indonesia Nepal Philippines Thailand Support groups Karolinska Institute Division of International Health Care Research, Sweden University of Newcastle Discipline of Clinical Pharmacology, Australia World Health Organization Action Programme on Essential Drugs, Switzerland World Health Organization Division of Child Health and Development (control of diarrhoeal and respiratory diseases), Switzerland Harvard Medical School Drug Policy Group, USA Management Sciences for Health, USA (network coordination)...cont d on pg. 8
8 8 INRUD... cont d from pg. 7 Box 3 The Pakistan Network Major INRUD activities Development and dissemination of research tools Action Programme on Essential Drugs. How to Investigate Drug Use in Health Facilities. WHO/ DAP/93.1. World Health Organization, INRUD Social Scientists Working Group. How to Use Applied Qualitative Methods to Design Drug Use Interventions. Working draft. December INRUD Bibliography. Annual update. Training Regional Courses on Promoting Rational Drug Use in Asia and Africa, in collaboration with local institutions and WHO/DAP (two per year). Selected rational drug use interventions by INRUD researchers: Lecture-based in-service training on the clinical management of malaria by medical assistants; Interactional group discussions to reduce the use of injections in public health facilities; Small group face-to-face training versus formal seminars to improve appropriate use of drugs in the management of diarrhoea; Printed information only compared to counselling with printed handouts to reduce prescription costs in a teaching hospital; Educational interventions (workshops, posters and workshops combined with posters) to improve dispensing practices; Prescribing audit with feedback to improve prescribing of antimalarials and antimicrobial agents in regional and teaching hospitals; Standard treatment guidelines with or without prescription audit on prescribing for diarrhoea and acute respiratory infections; National standard treatment guidelines to improve drug use in rural health units; National generics legislation on prescribing for acute respiratory and urinary tract infections in hospitals. * David Lee is INRUD Coordinator, Management Sciences for Health, 1515 Wilson Blvd., Suite 710, Arlington, VA , USA. Tel: , fax: , msh.org ZAFAR MIRZA* 1990 campaign in Pakistan A against the use of loperamide drops, implicated in a number of child deaths, was the catalyst for the establishment of a new network to promote rational drug use. The loperamide campaign became an international issue and led to the eventual banning of this drug in over 100 countries. Meanwhile, in Pakistan, questions were already being asked about the availability of other problem drugs and the general state of drug regulation in the country. At the time, there were about 10,000 registered pharmaceutical products and no enforcement of prescription law. In response, the country office of OXFAM set out to harness a broad, wellcoordinated, and effective campaign to reform pharmaceutical policies by promoting rational drug use and the essential drug concept. This led to the establishment in 1991 of the Association for Rational Use of Medication in Pakistan, more widely known as the Pakistan Network. Building on experience... As an international NGO, OXFAM had experience of similar campaigning work in Africa. At that time, OXFAM was involved in running a Rational Health Campaign in the UK and had been a close observer during the struggle for pharmaceutical reform in Bangladesh in As a result, OXFAM was aware of the importance of advocacy in this area. Meanwhile, the emergence of a democratic government in Pakistan after more than a decade of military rule around the time of the loperamide incident provided a window of opportunity for change. The idea was to establish a non profit organization with the help of committed health professionals and individuals. Initial consultations identified a number of people who were already advocating rational drug use and eager to cooperate with others in an effort to improve the situation. A National Council was established in early 1991 followed by the appointment of a national coordinator. An appeal for joint action was sent to potential allies, including heads of pharmacology and pharmacy in all universities and medical colleges in Pakistan; social and health activists; schools of public health; public health specialists; development journalists; health-related NGOs, and other health-related agencies. Contacts were also established with both Federal and Provincial Ministries of Health. Through OXFAM, we were able to get in touch with international and national groups and networks active in advocacy work for rationalisation of pharmaceutical products and policies affording opportunities for shared expertise, commitment and global solidarity. A key aspect of international networking in this area is the indispensibility of each partner, irrespective of their size or geographic location. Valuable global networking partners include: Health Action International, the Medical Lobby for Appropriate Marketing (MaLAM), INRUD, the Asia-Pacific Regional Office of Consumers International, Gonoshasthia Kendra (Bangladesh), BUKO-Pharma (Germany), Wemos (Netherlands), Essential Drugs Programme (UK), WHO s Action Programme on Essential Drugs and the United Nations Children s Fund (UNICEF). A quarterly newsletter was launched in 1992, with an initial circulation of several hundred, and attracted considerable attention. The size of the print run increased with every subsequent issue providing an opportunity both for advocacy and for increasing the number of supporters. Today it is published bimonthly and has some 10,000 subscribers. The target audience includes not only individual subscribers but also policy makers, ministries of health and pharmaceutical manufacturers. Other activities include a programme of seminars and workshops. They range from national workshops on Rational use of medication in children and the role of the mass media and Consumer protection to small meetings with supporter groups in remote areas of the country. Gains and challenges... What has been achieved over the past seven years? Most importantly, the issue of pharmaceutical policy reform is now high up on the political agenda in Pakistan. This is the result of lobbying, media contacts, operational research, and follow-up campaigns on issues such as drug pricing and registration, the sale of problem drugs, and the non availability of essential drugs. The Pakistan Network now enjoys formal representation on many Government working committees, including the working committee on development of a national drug policy and the Prime Minister s National Steering Committee on Health. In addition, the Network played a key role in the development of the first National Essential Drugs List. Elsewhere, acting as a watchdog for the pharmaceutical market, the Network has succeeded in getting many drugs banned or repackaged or in putting a stop to their unethical promotion. One of the challenges we face today is to ensure that inadequate drug policies are scrapped or reformed and that rational A Network newsletter cartoon promoting the view that not all visitors to a clinic or hospital should leave with a drug: doctors should exercise their right to prescribe a no drug therapy drug use policies are implemented and carefully monitored. An even bigger challenge is to safeguard the principle of universal access to essential drugs in the wake of a structural adjustment programme in Pakistan, involving liberalisation of trade, deregulation and privatisation. Within the pharmaceutical industry, liberalisation and deregulation have resulted in fewer constraints on drug registration in Pakistan a trend that has also been noted in Latin American countries. Deregulation has also brought an end to price controls on drugs and led to unrestricted imports of non registered pharmaceutical products. These are daunting challenges which call for new approaches and strategies. And they will be further exacerbated once the current transitional period expires and Pakistan must comply fully with the new Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) of the World Trade Organization (WTO) (see EDM-22). The success of efforts to ensure timely access to essential drugs will depend on a thorough understanding of all these influences and on the ability to forge new alliances both national and international. However, the greatest challenge lies in ensuring the sustainability of initiatives such as the Pakistan Network. The time has come to start planning ways of generating our own funds and moving away from dependency on donor support a gradual shift that has proved initially promising. Our vision for the future includes gradually moving towards generating our own resources and to becoming a consumer organization resource centre. * Zafar Mirza is Executive Coordinator of The Network, Association for Rational Use of Medication in Pakistan, P.O.Box 2563, 60-A, Street 39, F-10/4, Islamabad, Pakistan. Tel: , fax: , Credit: The Network
9 9 Health Action International: networking for rational drug use BAS VAN DER HEIDE, CATHERINE HODGKIN* EALTH Action International (HAI) is a unique coalition of consumer, H development and health NGOs working together to promote a more rational use of drugs. HAI was founded in 1981 by 50 people from health, development and consumer organizations. They shared a concern about the misuse of pharmaceuticals, and about unsatisfactory standards of industry promotion and marketing. At that time organizations and individuals working to promote the rational use of drugs were often isolated and hampered by lack of information and resources. They had no voice at an international level and few opportunities to work together and learn from each other. HAI was established to rectify this situation. HAI provided a balance in discussions traditionally dominated by government and industry. It was described as an international antibody to the worst effects of international pharmaceutical marketing. Over the last 17 years HAI has grown to be a powerful voice for rational drug use and consumer interests. Increasing campaign impact through the network In industrialised countries a well organized consumer movement can raise concerns directly with the regulatory authority and challenge them to act. A recent example is the US group Public Citizen s actions relating to the inappropriate use of bromocriptine as a lactation suppressant. In 1993 Public Citizen filed a petition with the Food and Drug Administration calling for the removal of the indication, which the manufacturer then agreed to do. HAI circulated a briefing paper and relevant documentation to network participants enabling them to pursue the issue. Within one month of the US withdrawal of the indication, the issue had been raised in the press, and with regulatory authorities and the company itself in countries as diverse as Australia, Burkina Faso, Germany, Italy, Korea, Latvia, Mauritius, the Netherlands, Pakistan, Switzerland, Tanzania, Thailand and Zimbabwe. A few milestones of a growing network 1981 HAI is launched. First HAI meeting in Geneva HAI Asia network is launched with the Penang Declaration on Rational Health Policies First HAI meeting in Africa HAI publishes the first edition of Problem Drugs in three languages First regional meeting in Latin America HAI international meeting in Geneva brings together 51 participants from 35 countries First HAI meeting in Eastern Europe Start of HAI Africa Programme. HOW DOES IT WORK? The HAI network is built around the simple idea that if many organizations and individuals pool their expertise, skills, resources and experience, and cooperate to achieve a common goal, they become a powerful force. This is the case even if their financial resources are small and their organizational structure limited. Cooperation between groups in industrialised and developing countries is important, particularly when it comes to influencing policy at international level or monitoring the standards set by multinational companies. There is no excess of organizational baggage; only people who actively participate are part of the network. The strong consensus among HAI participants about the central themes, and the mutual respect between HAI participants, are binding forces. Network membership gives leverage and encouragement to individual participants to persevere in what is often seen as an uphill struggle. The HAI network today consists of around 180 consumer, health and development groups working in 70 countries. The groups are varied ranging from powerful NGOs to small groups of isolated health workers or concerned individuals. There are three coordinating centres, in Asia, Latin American and Europe, and plans to establish a coordination centre in Africa within the next few years. The centres maintain close contact with each other and with HAI participants in six continents. They are there to serve the needs of the groups, to respond to developments at national or regional level, and to coordinate international advocacy and campaigning. Participants meet at regional or international meetings to discuss common concerns and develop joint strategies. HAI groups are autonomous and selfreliant, and drugs are often only one component of their work. One of the key functions of the HAI network is to share information about national consumer campaigns and regulatory actions. The network newsletter HAI News is published six times a year. In addition regional and national newsletters are produced and information is increasingly available on-line. HAI key contacts also receive targeted mailings on the topics most relevant to their areas of work and interest. WHAT DOES THE HAI NETWORK DO? HAI works through research, action campaigns, training and advocacy to promote a more rational use of drugs. RESEARCH Action oriented research provides the material which makes HAI groups effective. HAI participants have helped to quantify and document problems which would otherwise not have come to light. Examples include research into drugs which are exported but not marketed in Europe; and research into the quality of drug promotion. CAMPAIGNING INFORMATION SHARING Information sharing has been a key element of HAI s work. Apart from the regular newsletters HAI publishes material to support the network s activities. For ACCESSIBLE In 1981 HAI started with an inter- national campaign to withdraw diphenoxylate and clioquinol (antidiarrhoeal drugs). Subsequent targets have focused on specific drugs or categories of problem drugs: such as highdose estrogen/progesterone products, anabolic steroids, dipyrone and appetite stimulants. The work on specific drugs and categories of problem drugs continues to be of SAFE importance, but increasingly the groups involved in HAI concentrate on longer-term policy change. HAI groups see that strengthening drug regulation and national drug policy is one highly effective way of promoting a more rational use of drugs. example, Problem Drugs 1 (a publication highlighting different kinds of drugs known to carry significant health risks) has been used all over the world both as a campaigning tool and to train health workers. HAI members provide high quality information to the public and to the medical profession. In 1992 HAI produced Med-Sense, a pill-box with information on drug issues as well as specific classes of drugs. It has been translated and adapted and is used by health and consumer groups in many countries. Collaboration and information EFFECTIVE...cont d on pg. 10 Essential drugs always the winners. A clear message from HAI-Peru Credit: AIS/Peru
10 10 HAI... cont d from pg. 9 sharing with other networks, such as the International Society of Drug Bulletins and MaLAM, the Medical Lobby for Appropriate Marketing, is important to the effective running of the network. Mutual support and joint planning, where appropriate, enable the various actors to maximise their impact. TRAINING Training workshops are organized, often on a regional basis, to allow groups to learn from each others successes and failures. In 1998 HAI plans to organize two training seminars, one in West Africa and one in Southern Africa. ADVOCACY Advocacy for policies which will ensure access to drugs, promote equity and protect consumers interests is central to HAI s work. HAI participants are involved in policy development and policy advocacy at national and international level. Recently the impact of the General Agreement on Tariffs and Trade (GATT) and the World Trade Organization (WTO) on the availability of essential drugs has been the focus of one international advocacy campaign. In Geneva HAI advocates meet regularly with delegates attending the World Health Assembly. They argue for strong leadership from WHO on drug issues as well as debating national developments with delegates. ACHIEVEMENTS Since HAI s foundation more than 15 years ago considerable progress has been made. The essential drugs concept has gained wide acceptance. Steps have been taken to encourage the distribution of independent information on drugs, and some of the worst drugs have been withdrawn. HAI has been one of the forces behind these changes and has played an important role, especially in the field of policy advocacy, and in promoting consumers interests. Today there is an increasing acceptance that consumer advocates have a place in drug policy discussions, and that what is at issue is not the safety of drugs, but the safety of people using them. FACILITATING FACTORS In understanding the factors which have helped HAI to become a successful, influential and sustainable network it is important to remember its informal, collaborative nature. The informality allows people to take what they need and to contribute what they can. The qualities of a good fishing net: strong knots, good links, light in weight, extendible and flexible, these are the qualities which make a network strong and durable. Funding has been one constraining factor. HAI does not have major institutional costs because its structure is light and much of its work is decentralised. Groups participating in HAI are funded separately, and many of them work on a voluntary basis. However, funding for the coordinating offices core activities and for the national groups is essential for the network s survival. Securing this funding has been a major challenge, and uncertainty about finance has often hindered planning. However, funding for the global programme of the three regional offices has been secured up to What makes a network effective? clearly shared goals mutual trust and solidarity between participants active participation decentralised activities coordination which facilitates the work of participants flexibility and the ability to react quickly expertise and experience which can be shared within the network cooperation and collaboration with others resources for key activities Threats and pitfalls lack of money loss of focus inability to agree on important strategies over domination by a few partners tendency to centralise power and responsibility EuroPharm Forum: involving pharmacists in improving patient care UROPHARM Forum is a collaboration between the European E Forum of Pharmaceutical Associations and the WHO Regional Office for Europe. Founded in 1992, the Forum promotes the integration of WHO s Health for All (HFA) policy into basic, postgraduate and continuing pharmaceutical education, and also formulates policy statements on specific health issues of relevance to the network. It works through dialogue and cooperation between national pharmaceutical associations and WHO s Regional Office in Copenhagen. Pharmaceutical associations from 31 of the 51 Member States in the European Region are members and several international pharmaceutical organizations have observer status. Promoting health From the outset the focus has been on projects in support of implementing the LOOKING AHEAD HFA targets and policies, and to show the benefit of involving pharmacists in improving patient care. The Forum currently has five main operational projects: Asthma Services; CINDI (hypertension control); Diabetes Care; Smoking Cessation; and Ask About Your Medicines. The last activity focuses on the pharmacist s advisory role in the safe and economical use of prescribed and over-the-counter medicines. The project encourages patients to ask basic questions about their There is still much work to be done by HAI and others in this field. Increas- ing privatisation and the deregulation of many prescription drugs have already led to changes in emphasis in consumer organizations work. Debt and the economic problems facing many developing countries mean that health care services are under increasing pressure. In spite of guidance given by WHO, few countries have acted effectively to control drug promotion, and in many developing countries drug regulatory control is rudimentary. In industrialised countries, an increasing number of prescription drugs are being given overthe-counter (OTC) status. As a result, consumer organizations have begun to pay more attention to advertising standards for OTC products and the availability of independent information about them. HAI also sees the need to continue to monitor new trends in drug promotion, and to campaign for effective control of promotion and marketing. Re-educating prescribers and consumers to prescribe and use drugs more rationally is a longterm goal. This is a slow and gradual process which requires creativity and ingenuity. In spite of the progress that has been made, many people in the world have no access to essential drugs, and drugs continue to be inappropriately used. In the future HAI will continue to campaign for access and equity, and to challenge practices which are against consumer interests. * Bas van der Heide is the coordinator for HAI-Europe and Catherine Hodgkin worked for HAI for 10 years and is now a freelance consultant. For further information about HAI and its work contact: For Europe and Africa: HAI-Europe, Jacob van Lennepkade 334-T, 1053 NJ Amsterdam, the Netherlands. Tel: , fax: , For Asia: HAI/ARDA/CI-ROAP, P.O.Box 1045, Penang, Malaysia. Tel: , fax: , For Latin America: AIS Latin America: Oficina de Coordinacion AIS LAC, Aptdo , Lima, Peru. Tel/fax: Reference A HAI international meeting in Geneva in 1992 endorsed WHO s Ethical Criteria for Medicinal Drug Promotion and launched HAI s own publication on this subject, Promoting Health or Pushing Drugs Chetley A. Problem Drugs. Amsterdam: HAI; drugs. Belgium, Denmark, Finland, Malta, the Netherlands, Portugal, Spain and the UK are among the countries participating in the project. The Forum has also helped to set up twinning projects between pharmaceutical associations in Western Europe and those in Central and Eastern Europe, where the pharmaceutical sector is undergoing rapid change. It also organizes international symposia on topics of interest to members. EuroPharm Forum Newsletter published and distributed twice a year updates members and subscribers on activities. The EuroPharm Forum secretariat is situated at the WHO Regional Office for Europe, Programme for Pharmaceuticals, Scherfigsvej 8, DK-2100 Copenhagen, Denmark. For further information contact: Ida Gustafsen, the Professional Secretary. Tel: ; fax: ; Photo: HAI
11 11 ISDB: dedicated to ensuring reliable drug information ELLEN T HOEN* HE independent drug information movement began in response to developments in the pharmaceutical field after the Second World War. At T that time the flow of new drugs increased and large pharmaceutical companies were being established. In the increasingly competitive pharmaceutical sector, aggressive marketing and promotion became an inevitable part of the drug manufacturers survival strategy. At the same time there was a tremendous lack of unbiased, comparative drug information to help physicians make valid therapeutic choices. Groups of doctors and pharmacists who felt that they needed much more critical and reliable information tried to fill this gap through the creation of independent drug bulletins. One of the first was the Medical Letter, launched in the USA in Every network or organization has its midwife a person or group of people who are the motivating force behind it. Long before the International Society of Drug Bulletins (ISDB) was formally established, bulletin editors were in regular contact coming together at international meetings, exchanging information and training, and discussing ways to improve their journals. The publication of the first European drug bulletin, the UK Drug and Therapeutics Bulletin, in 1962 (initially an anglicised version of the Medical Letter) served as an example for others in Europe to follow. The idea of an international organization of independent drug bulletins originated in Madrid in 1985, during a WHO-organized drug information meeting attended by representatives from many bulletins. A constitution was drafted and ISDB officially came into being in The Society s main aims are: to encourage and further the development of independent drug bulletins; to promote international exchange of good-quality information concerning drugs and therapeutics. A shift in focus... ISDB s creation meant that a structure was in place to facilitate a more systematic development of new bulletins, offer support to young editors and disseminate the basic principles of independent drug information. ISDB stimulated editors to engage in activities outside their own publication or organization and encouraged new bulletins to join an international network. Over the last decade, as it has worked to grow and to promote its goals, ISDB has had its share of success and problems. At the same time the focus of bulletins has been shifting, with increasing recognition of the need to better inform the public. Engaging in policy discussion is now seen as a priority. This is particularly true in countries where most drugs are directly purchased by consumers, and where drug markets tend to offer a rather irrational selection of medicines. Many of the people producing drug bulletins are involved in drug policy advocacy work, even though this is not necessarily covered by their bulletins. Today ISDB has more than 50 full members and 30 corresponding members in 33 countries. The bulletins vary in circulation, target groups and appearance from glossy 80-page journals to basic four-page newsletters. A number of them have web sites through which they publish and provide references to other useful information sources. Full members have to be independent and produce good quality drug information at least four times a year. Corresponding members include bulletins that have just started or organizations that support the goals of ISDB but do not produce a journal. What most bulletins seem to have in common is that they have a small, over worked, under resourced staff. For most editors, producing their bulletin is just one element of their work, and therefore the amount of time they have for international activities is adversely affected. An even greater burden was placed on the bulletin providing the ISDB secretariat, as it was responsible for keeping people motivated and maintaining projects around the world. ISDB therefore established a formal coordinating office in Paris in November 1997 to facilitate communication, encourage continuation of work and ensure long-term sustainability. A network s sustainability depends on the one hand on the motivation and availability of its members, and on the other on having the financial resources to carry out activities. ISDB has obtained its financing through its members (membership fees and donations from bulletins towards specific activities), but now the organization is growing there is a need for additional sources of revenue. Most new members are starting bulletins that can contribute little to the organization s costs. To ensure continued success ISDB is in the process of developing long-term funding plans for training, exchange of information and support for developing new bulletins. Significant achievements... Networks such as ISDB have to overcome many difficulties, including constant financial and time constraints. Information on successful aspects of the work tends to get lost in the overall struggle to survive a serious omission as ISDB has achieved a great deal. The Society s existence means that individuals doing the same work but scattered throughout the world do not have to feel alone. It provides successful models of drug bulletins and offers its members the opportunity to use information produced by others. The training provided either through ISDB summer schools or by bulletins themselves has been essential to the development of new initiatives. ISDB is a partner to others involved in improving the rational use of drugs. It provides information resources to numerous networks and organizations, including the drug information community, consumer and campaigning networks, and drug regulators. Through its members, and in some cases through readers, ISDB has provided a platform for carrying out joint studies on drug information issues. Examples include: a 1996 survey on the degree of openness of drug regulatory agencies 1 (see page 2), to which bulletins in 23 countries contributed; a survey of members editorial processes carried out in ; and a study on how informed general practitioners manage mild hypertension 3, based on a survey of drug bulletin readers in seven countries. ISDB has also helped bulletins to gain recognition from scientific bodies. For example, it is consulted by the European Medicines Evaluation Agency (EMEA) as an interested party. Plans are underway for a joint meeting to discuss how to increase access to EMEA information. Such consultation gives bulletins a chance to express their views and needs with regard to information provided by drug regulators. ISDB has also been campaigning for recognition and indexing of drug bulletins by the major medical databases. As this still has a long way to A critiquing session at the first ISDB Asia-Pacific meeting in Malaysia in Bulletin editors analysed each others journals and suggested improvements go, ISDB has started to develop its own index of full member bulletins. One of the main lessons ISDB has learned after a decade in existence is that regular personal contact is one of the cornerstones of the network. No matter how sophisticated modern communication methods are, nothing beats seeing colleagues face-to-face to discuss, share problems and training, make joint plans and build friendships. * Ellen t Hoen is Coordinator of ISDB. For further information contact: ISDB, PO Box 459, Paris Cedex 11, France. Tel: , fax: , References l. Bardelay D. An ISDB survey to assess the degree of transparency of drug regulatory agencies. The International Journal of Risk & Safety in Medicine 1996; 9(3): Broclain D, Chirac P, t Hoen E. An international survey of quality control procedures in independent drug bulletins. Poster presentation at the International Congress on Biomedical Peer Review and Global Communications; September ; Prague, Czech Republic. 3. Avazini F, Tognoni G, Alli C, Colombo F, Herxheimer A. How informed general practitioners manage mild hypertension: a survey of readers of drug bulletins in seven countries. Eur J Clin Pharmacol 1996; 49: Photo: ISDB
12 12 French journal s readers form a network DANIELLE BARDELAY* INCE 199l a network of readers of S the independent French drug bulletin la revue Prescrire has been monitoring the behaviour of medical representatives and the accuracy of the information they provide. The initiative started in 1990 when la revue Prescrire was in its tenth year of publication and had almost 20,000 subscribers. Many readers had written to complain about the poor quality of information given by medical representatives. A few even began to explain why and how they had stopped receiving representatives. In an editorial in September 1990, the editorial board initiated a campaign called One year without medical representatives. Readers were invited to stop seeing industry representatives for a year and to explore other information sources instead 1. The campaign was followed by a lengthy debate between la revue Prescrire and the pharmaceutical industry, and also among subscribers with divergent views. One outcome was the decision taken by a small group of readers and members of the non profit association running la revue Prescrire (Association Mieux Prescrire) to set up a network. Members, mainly GPs and a small number of hospital and community pharmacists, would continue to allow representatives visits but would note their behaviour and the claims they made for their products. Concern about the quality of representatives information was obviously widespread, as the network grew immediately and spontaneously with no new publicity campaign. Since 1991 new candidates have regularly applied to join the monitoring team, all from la revue Prescrire s readership (which probably defines them as motivated professionals). When members see a representative they fill in a standard report form**, noting if the information given orally on indications and the drug s dose regimen differ from the official data sheet. They report whether the representative spontaneously mentions side effects, contraindications and interactions. Members also note the particular arguments used to encourage prescription of the drug (including gifts and paid participation in trials). The forms are collected and analysed at la revue Prescrire s headquarters in Paris. Information on new drugs and any recommendation for major offlicence use is forwarded to the editorial team in the New Products and Vigilance sections. Need for feedback The editorial staff has decided to keep the network to an average of 30 to 40 members. They are replaced every six months to minimise bias and because filling the forms in properly is time consuming. In recent years a growing Findings of the network monitoring forms 1991 to Do the indications match those on the data sheet? yes 77% 65% 64% 69% 79% 84% 75% Does the dose regimen match that on the data sheet? yes 88% 74% 79% 87% 89% 93% 87% Did the representative spontaneously mention side effects? yes 23% 31% 29% 32% 27% 24% Did the representative spontaneously mention contraindications? yes 19% 25% 22% 30% 21% 20% Did the representative spontaneously mention drug interactions? yes 17% 20% 18% 23% 21% 18% Given the type of drug, do you think the representative should have mentioned the above information? 1 yes 65% 79% 83% 73% 73% 75% Was the representative willing to answer your questions? 1 yes 80% 73% 69% 71% 70% 66% Did you find the representative convincing? yes 18% 20% 17% 28% 30% 31% Were there strong inducements to prescribe the drug? 2 yes 24% 19% 15% 18% 20% 33% 1. Questions relating to side effects, contraindications and drug interactions. 2. Arguments used to pressure doctors to prescribe a particular drug, such as implying that refusal would increase patients suffering or decrease their chances of survival. (Gifts and financial inducements are covered elsewhere in the report form). number of pharmacists have applied to join the network They feel they are receiving an increasing amount of misleading information, especially in hospitals where expensive drugs are strongly promoted. For the six months they contribute to the network, observers are not paid but they receive regular circular letters with news and results from other observers. They also receive a present (usually related to drug information) every year as a reward. Observers appreciate having a brief monthly report in la revue Prescrire on the information they have collected. They are also notified of any activities which show how their network is valued by others: the publication of articles on global results, posters, and news of practitioners from other countries wanting to set up similar networks, for example. Minimising bias One of the network s main difficulties is to minimise the possibility of bias. Steps taken to achieve this include: replacing network observers every six months and keeping their names secret; ensuring that observers are scattered throughout at least 16 of France s 22 regions; and only publicly reporting misleading claims when they have been notified in several regions. The main bias probably lies in the selection of monitoring doctors and pharmacists, who (by definition) are particularly interested in rational use of drugs. As a result representatives are likely to offer them more scientific evidence than normal and avoid incentives. The network s findings therefore probably err on the optimistic side. Over the past five years, monitoring results have shown a certain consistency which is cause for concern. Overall, drug indications were extended or changed in about 30% of visits, and the dose regimens in 15%. More serious still, side effects, contraindications and interactions were not mentioned in 75% of visits. Qualitative study showed that off-licence information corresponded either to premature claims, analogies with other drugs, or pure promotional fantasy 2. A more recent study, on the data collected in 1997 (not yet published), shows that information given by medical representatives is of better quality Drugs are commonly marketed through medical representatives and the French monitoring network has attracted interest from many countries when the drug is new, with new indications and few well known side effects. When the drug has been on the market longer, the tendency is to increase the indications and to conceal side effects which have been discovered over the years. Such nuances of behaviour illustrate how difficult it is to present global findings from the network, yet they have also stimulated new ideas on improving methodology. An encouraging experience After seven years experience one can conclude that such a sentry-network is a very valuable way for health professionals to take the initiative in a field where they might be considered passive. Despite unavoidable methodological bias this kind of monitoring network is a great help in identifying problems and initiating counteractions. The recipes for success that others can draw from our experience are the need to: have highly motivated members (which necessitates a careful selection process), working on a voluntary basis; provide members with feedback; value their work; renew observers frequently; ensure strict adherence to methodology; and publish well written conclusions. * Danielle Bardelay is an editor at la revue Prescrire, BP Paris Cedex 11, France. Tel: , fax: , prescrire.org ** Copies of the report form are available in French and English from la revue Prescrire. References 1. Bardelay G. Une année sans VM. Rev Prescrire 1990; 10 (99): Bardelay D, Becel B. Visits from medical representatives: fine principles, poor practice. Prescrire Intern 1995; 4 (18): Photo: Royal Australian College of General Practitioners
13 13 The BUKO pharmaceuticals campaign OUNDED in 1981 as an offshoot of F BUKO, the Germany-based Third World solidarity movement, BUKO Pharma-Kampagne was set up to monitor the activities of German pharmaceutical companies in developing countries and to campaign for the implementation of rational drug policies. At the time, the public consensus was that pharmaceuticals are beneficial and that the activities of German pharmaceutical companies in developing countries should be welcomed. Today partly due to the success of information campaigns by BUKO Pharma-Kampagne the German public is more sceptical about the motives and activities of some of the companies which market drugs in the Third World. BUKO s pharmaceutical campaigns focus either on individual companies or on specific groups of drugs. The organization maintains that rational drugs policies are essential, especially in poorer countries, where both public and private health resources are scarce and surveillance of the pharmaceutical market is weak. Companies must be held responsible for their marketing activities and pressurised to withdraw irrational drugs. This is what Pharma-Kampagne does, using a variety of methods. They range from the publication of information and advocacy materials, including a regular newsletter, and the organization of seminars and conferences, to a street theatre group which develops an annual presentation based on the latest campaigning issue. The theatre group, all volunteers, go on tour in an old renovated bus to 10 cities entertaining the public, and educating them at the same time. The pharmaceutical campaigns are underpinned by thorough research on drugs and the pharmaceutical industry carried out by experts in the fields of pharmacology and medicine. International standard textbooks serve as reference literature as well as regulations laid down by institutions such as the United States Food and Drug Administration (FDA). Through the international network Health Action International (HAI), of which BUKO Pharma-Kampagne is a member, the organization is in contact with active groups in 70 countries. These groups often highlight the marketing of inappropriate drugs within their countries or the use of misleading advertisements or false drug information. In the past, many groups within the German Third World solidarity movement actively supported the pharmaceutical campaigns. Today, our supporters are increasingly limited to health professionals and medical or pharmacology students who become interested in this work and actively support it either by campaigning or by donating money. The public image and status of BUKO Pharma-Kampagne the only campaign group of its kind in Germany has changed from that of a left-wing activist group campaigning against the pharmaceutical industry to a respected information centre on the Photo: Gesundheitsladen München A serious message transmitted in a fun way: a play about irrational drug use is performed for children in Munich inappropriate and unethical marketing of drugs. The attitude of many pharmaceutical companies has also changed, although their marketing policies are still often far from acceptable. In the face of public criticism following successful campaigns against some companies in the late 1980s, the pharmaceutical industry launched a public relations campaign in the print and broadcasting media. The industry also set up an organization, the German Pharma Health Fund, to improve the public image of their activities in the Third World. Whereas in the 1980s the industry was dismissive of the criticism from Pharma- Kampagne, today they set great store by maintaining an ongoing dialogue. Although this improved communication has led to few real changes, the work of Pharma-Kampagne is now being taken seriously by the industry and some managers now publicly state that the ethical demands on pharmaceutical marketing are justified. The success of Pharma-Kampagne hinges on three key factors: the scientific validity of its claims, its financial independence, and public support. However, it is becoming increasingly difficult both to raise funds and to find medical or pharmacology experts who can be consulted without a fee. Public funding is declining and people are far more selective about the kind of donations they make during a period of economic recession. Donations are easier to secure for a specific aid project such as the construction of a health centre in a poor country, than for awareness-raising or education work. Up to now the BUKO Pharma- Kampagne has successfully maintained its donor base but some contributions were not paid this year. However, in spite of the critical financial situation, the enthusiasm and commitment of its staff are constant. For further information contact: BUKO Pharma-Kampagne, August-Bebel-Str. 62, D Bielefeld, Germany. Tel: , fax: E-DRUG: the InterNetwork OLLEAGUES in developing countries often find international C journals, telephone and fax calls too expensive. Normal postal services may be slow and unreliable. Many people have already discovered the usefulness of electronic mail ( ) as an affordable communication tool. Now can be used to get quick answers to essential drugs queries, and to exchange information with colleagues in other countries. But the question is how? The Internet provides a solution in the form of an electronic conference. This basically means that everyone interested in a certain subject, such as essential drugs, agrees to send messages to one central computer which then distributes the same message to ALL people who have subscribed to that conference. The answers go back to the same computer, which resends the messages to all subscribers. The central computer for the essential drugs electronic network is E-DRUG E-DRUG s objective is to support the essential drugs concept by improving and speeding up communication between all health professionals interested in this field. It was started in 1995 by a small group of consultants working in the area of essential drugs who used to communicate, and by Satellife, a Boston-based NGO that promotes access to health workers in developing countries using the HEALTHNET network. Currently some 550 people in 77 countries subscribe to E- DRUG, free of charge. While it began in English, a French version has just started (E-MED, see box). A Spanish version (E-MEDICAMENTOS?) could also be launched if there is enough interest. The network has little formal structure, but subscribers must agree to abide by certain ethical rules (no messages for commercial gain, no offensive language, etc.), and are requested to contribute as professionals. E-DRUG is moderated on a rotating basis by four volunteers, who try to standardise submissions and ensure consistent quality. Moderators sometimes invite people to respond to questions. Simple questions are intercepted and sent to pharmacists who have volunteered to answer them directly. It must be realised that E-DRUG is a public discussion forum: all people with can in principle subscribe, even those opposed to essential drugs! Reaching health workers E-DRUG has been specially designed for colleagues in developing countries without access to interactive Internet (the World-Wide-Web or WWW). It can be accessed using off-line, ordinary e- mail messages. A technical user manual explaining all this is available from Healthnet/Satellife. In addition, for people in developing countries who have to pay for each incoming message (on average five per day) E-DRUG-digest has been developed. The Healthnet computer automatically sends a collation of E-DRUG messages when it has reached a 27 Kbyte size. How to subscribe To subscribe to the E-DRUG electronic conference send an to (Do NOT send it to healthnet.org>: that address is reserved for E-drug messages only!) Leave the subject line blank (or put anything you like there), and write: subscribe e-drug (or e-drug-digest) in the text space. E-DRUG people For those who want to contact specific people, a list, Who is where on in essential drugs? has been developed. With new technology has come E-DRUG, linking colleagues around the world who have an interest in the essential drugs concept More than 300 people are included, with their addresses, and often with their specific areas of interest related to essential drugs. To obtain a copy, send the message get e-drug whoed030.txt to (omit the quotation marks). * For further information contact: Wilbert Bannenberg, compuserve.com E-MED allows French speakers to join Database The new French language version of E-DRUG, known as E-MED is already receiving a great deal of interest. If you would like to add your voice you can subscribe by: sending an to: for your message write: inscrivez moi à E-MED you will then receive information on what you need to do to join the conference. Photo: Ministry of Health, Zimbabwe
14 14 SIGN pointing to the future for clinical guidelines JAMES PETRIE, JULIET HARLEN* he Scottish Intercollegiate T Guidelines Network (SIGN) was established in 1993 by the Academy of Medicine in Scotland (see EDM-22) 1. The network sponsors and supports independent and professionallyled development of evidence-based clinical guidelines for the National Health Service. SIGN s methodology for guideline development is designed to ensure that guidelines are scientifically valid 2 and will produce the health gains and costs predicted 3. They must also be valued by the medical profession, so that they are adopted into local medical practice. SIGN s constitution as a network of involved professional organizations now including dentistry, nursing, pharmacy, professions allied to medicine, patients and management is central to the achievement of these aims. Use of the network enables SIGN to fulfil criteria identified as essential to the development of valid guidelines: that they are developed by multidisciplinary groups; and that a systematic review is undertaken to identify and critically appraise the scientific literature. A SENSE OF OWNERSHIP jor difficulties in defining evidence and making recommendations. The selection of a chairperson and the balance of representatives of the medical professions, health service managers and patient groups to form the guideline development group, must be very carefully considered. Failure to do so may seriously undermine the development process. The SIGN secretariat is able to call for advice and obtain nominations from all the member organizations. In this way it ensures that all relevant professions have an The composition of SIGN guideline development groups varies depending on the topic under review. The selection of a limited number of topics for inclusion in the SIGN programme follows a formal application procedure. This is designed to establish the need for the guideline (considering the burden of disease, the existence of variation in practice, and the potential to improve clinical outcomes), and the quality of evidence available to support guideline recommendations. Experience has shown that the selection of inappropriate topics may lead to mainput into and feel ownership over the choice of guideline topic and the guideline development processes. SYSTEMATIC LITERATURE REVIEW The involvement of users is crucial both to the validity of guideline recommendations and to their acceptance by practitioners. However, SIGN has learned that many clinicians are lacking in the skills (or confidence in those skills) required to undertake a rigorous and critical appraisal of the scientific literature. Many experienced health care professionals appear to be reluctant to question the validity of published studies. They are also unsure of how to evaluate the quality of evidence provided by various types of studies, from meta-analyses of randomised controlled trials to descriptive studies. Organizing guideline development through a network such as SIGN means that the resources of a central secretariat are available to assist development groups in overcoming these difficulties. The secretariat is able to undertake the literature search for the groups, thus ensuring consistent standards. It also oversees the critical appraisal process, to ensure that the literature is evaluated against rigorous criteria for validity, and that the systematic review is itself meticulously documented. Training in critical appraisal skills is offered to key group members. And further advice and support is available throughout the guideline development process. GRADING RECOMMENDATIONS ON STRENGTH OF EVIDENCE It has been demonstrated that although nationally developed guidelines are most likely to be scientifically valid, they are much more likely to be valued, and thus SIGN guidelines can be found on the web page and single copies downloaded free of charge effective in changing medical practice, if there is local involvement in the development process. SIGN national guidelines are therefore intended only as a starting point from which local protocols are derived for implementation into practice. The recommendations for best practice in the national guidelines are therefore linked explicitly to the evidence from which they are derived. They are graded according to the strength of that evidence, giving local groups the information they need to select and prioritise recommendations for implementation. Of course, SIGN s member organizations not only have an important contribution to make, they also have considerable expectations of SIGN. To satisfy these, SIGN guidelines must be seen to make a measurable contribution to improvement in patient outcomes and/ or the use of health service resources. SIGN alone cannot either achieve or satisfy these requirements and therefore makes use of other networks to ensure that: SIGN guidelines are of the highest quality. Close liaison with other organizations developing guidelines or undertaking systematic reviews, such as the Cochrane Collaboration or the UK National Health Service Centre for Reviews and Dissemination, enables knowledge and experience to be shared, and ensures that work is not duplicated. SIGN guidelines are implemented into local practice. As discussed above, local ownership over the implementation of guidelines is essential to their successful adoption into practice, and is best achieved through local leadership and accountability. Present thinking is that a national network such as SIGN does not have a large part to play in local implementation. However, this position will be kept under review as knowledge and experience of guideline development and implementation accumulate. the effects of implementation are monitored. Links with local and national audit projects are important here. SIGN guidelines include a minimum data set designed to facilitate audit, both of outcomes and processes of care. this experience is fed back into the development process. The strength of a network is its ability to incorporate the views of a large range of stakeholders. This ensures that not only is a single control loop in place to see that the organization s initial objectives and targets are met, but that double loop learning is employed to reconsider those objectives and redefine standards in the light of experience. Note in particular that the initial pilot editions of SIGN guidelines will be reviewed two years after publication, or sooner if new evidence is published. An important outcome of the guideline development process is the highlighting of areas where further research is needed to fill gaps in the evidence base. SIGN guideline development groups now benefit from the accumulated experience of more than 45 guidelines, either published or in preparation, enabling an incremental improvement in their quality in terms of adherence to criteria for validity 4. However, if quality is defined in terms of fitness for purpose, then the key criterion must relate to the needs of guideline users rather than the concerns of guideline developers. It is here that the concept of networking is of most benefit. SIGN s wide constituency offers an ideal opportunity for it to be a true learning organization, proactive in obtaining external views on its work, receptive to new ideas, and quick to feed from experience into practice. * James Petrie is Chairman of SIGN and Professor of Clinical Pharmacology and Head of the Department of Medicine and Therapeutics at the University of Aberdeen, Scotland, UK. Juliet Harlen is Head of the SIGN Secretariat. For further information contact: Juliet Harlen at SIGN, Royal College of Physicians, 9 Queen Street, Edinburgh EH2 1JQ, Scotland, UK. Tel: , fax: , web site: home.htm References 1. Petrie JC. Clinical guidelines in Scotland: a SIGN of the times. WHO Essential Drugs Monitor 1996; 22: Clinical Resource and Audit Group. Clinical guidelines: A report by a working group set up by the Clinical Resource and Audit Group. Edinburgh: Scottish Office, Institute of Medicine. Field MJ, Lohr KN, eds. Guidelines for clinical practice: from development to use. Washington DC: National Academic Press, Scottish Intercollegiate Guidelines Network (SIGN). Criteria for appraisal of national guidelines. Edinburgh: Scottish Intercollegiate Guidelines Network, 1995.
15 15 The Cochrane Collaboration N an influential book published more than 20 years ago 1 Archie Cochrane I drew attention to our great collective ignorance about the effects of health care, and explained how evidence from randomised controlled trials (RCTs) could help us to use resources more rationally. He recognised that people who want to take more informed decisions about health care do not have ready access to reliable reviews of the available evidence. The Cochrane Collaboration has evolved in response to this challenge. Contributors in many countries and specialities prepare and maintain systematic reviews of RCTs, and reviews of other evidence when appropriate. This international endeavour aims to ensure that, in due course, all areas of health care which have been evaluated using RCTs will be covered. The reviews prepared and maintained by the Collaboration are disseminated using electronic media through The Cochrane Database of Systematic Reviews. MORE RELIABLE REVIEWS OF RESEARCH EVIDENCE NEEDED It is unreasonable to expect people such as clinicians, policy makers or patients who want reliable information about the effects of health care to unearth all the relevant evidence from reports of original research. These are far too numerous and too dispersed to be of practical use. Most people must rely on reviews of the primary research as a way of coping with the information overload confronting them. Reviews thus occupy a key position in the chain which should link the results of research at one end, to improved outcomes of health care at the other. Unfortunately, the quality of reviews leaves much to be desired. This is because many reviewers do not approach their task systematically, with a respect for scientific principles, in particular, the control of biases 2 and random errors 3,4,5. The poor quality of most reviews has meant that advice on some highly effective forms of health care has been delayed for many years, and that other forms of care have been recommended long after controlled research has shown them to be either ineffective or actually harmful 6. Cochrane recognised that people who wanted to take more informed decisions in health care did not have ready access to reliable evidence. The Cochrane Collaboration has developed in response to Cochrane s call for systematic, up-to-date reviews of all relevant RCTs of health care. His hope that the methods used to prepare and maintain systematic reviews of RCTs in pregnancy and childbirth would be adopted and developed by other specialities was reflected in the decision to found a centre named after him. The centre was created as part of the new Research and Development Programme established to support the National Health Service in the UK. In the months after the centre opened at the end of 1992, people all over the world expressed strong support for its aims. The concept and reality of the Cochrane Collaboration emerged naturally as a result of this global support. The organization and development of the Collaboration is now guided by discussions at annual colloquia, involving participants from all over the world. HARNESSING ENTHUSIASM The task of the Cochrane Collaboration is to prepare, maintain and disseminate systematic, up-to-date reviews of RCTs of health care, and, when A new mother and her baby in an Ethiopian maternity unit. It was the systematic reviews of randomised controlled trials in pregnancy and childbirth which fuelled Cochrane s hope that such practice would spread to other areas of medicine RCTs are not available, reviews of the most reliable evidence from other sources. Although a massive effort is required to build, maintain and disseminate the database of such systematic reviews, it has become clear that the collaborative spirit required to make efficient progress already exists. A willingness to collaborate with others is a fundamental prerequisite for getting to grips with Cochrane s agenda. Thus, although those contributing to the Collaboration are named in its electronically published output, the Cochrane Collaboration itself belongs to all of the contributors, collectively. Experience of preparing and updating systematic reviews on the scale needed is still limited, and the time required to prepare valid reviews is often grossly underestimated. The key to the Collaboration s success is thus to find: the means of harnessing the specific interests and enthusiasm of individuals who support the overall objectives of the Collaboration; and to find ways of providing the various kinds of support which they need to prepare and maintain systematic reviews. Although the Cochrane Collaboration is still at an early stage of its development, its basic structure and methods of working have been established. Each reviewer is a member of a collaborative review group, which consists of individuals sharing an interest in a particular topic (stroke, for example). Collaborative review groups have often grown out of an ad hoc meeting of people who realise that they share an interest in preparing and maintaining systematic reviews of RCTs relevant to a particular problem; but review groups have also emerged in other ways. Members of the group seek funding and other support for their activities from whichever sources they consider appropriate. Each group is coordinated by an editorial team. This is responsible for assembling an edited module of the reviews prepared by review group members for incorporation in and then dissemination through the Cochrane Database of Systematic Reviews. In addition, the team selects reviews contained in the main Database for compilation in one or more specialised databases. Although most groups focus on health problems breast cancer, for example the Collaboration addresses other dimensions of interest through field coordination. A field may refer to a category of health service users (children, for example), a group of health professionals (intensivists, for example), a setting for health care (such as less developed countries), or a class of interventions (physical therapies, for instance). The work of collaborative review groups and field coordination is facilitated in a variety of ways by the work of Cochrane Centres. The characteristics of each Cochrane Centre reflect the interests of the individuals associated with it and the resources made available to them; but the centres share a responsibility for helping to coordinate and support the other elements of the Cochrane Collaboration, and for exploring ways in which the Collaboration can be developed. Cochrane Database reviews Each review incorporated in the database consists of: a cover sheet, giving the title and citation details of the review, the names, addresses and other contact details of the reviewer(s) and the editorial team responsible for the collaborative review group to which the reviewer(s) belong(s), and the sources of support for preparing and updating the review; a structured report of the review, consisting of an introduction/ statement of objectives; information about the materials and methods used; the results of the systematic review; and a discussion section; full citations of reports of the studies incorporated in the review, and of reports of those studies that were potentially eligible, but which the reviewer(s) decided to exclude (with reasons for the exclusions); tabulation of the characteristics of the trials included in the review, including the information relevant to an assessment of the methodological quality of each of the studies included; tabulation of the review results, with presentation of statistical syntheses (meta-analyses), when these were both possible and appropriate; contact details for obtaining further information about relevant unpublished and ongoing trials. Because the Database is updated and amended as new evidence becomes available and errors are identified, electronic media offer obvious advantages for disseminating and interrogating its contents. The complete Database is distributed online and on CD-ROM. Smaller, specialised databases derived from the main Database are being compiled and published on floppy disk. At present, opportunities for criticising reviews before they are published in print are restricted by the number and competence of the referees selected by editors. After a review has been printed, opportunities for published criticism are usually limited to the few letters that editors can accept for publication, or to book reviews, which are often unhelpfully brief and non specific. It is also frustrating that there is no straightforward way in which the authors of printed reviews can amend...cont d on pg. 16
16 16 Cochrane... cont d from pg. 15 their reports after taking account of valid criticisms. Over the coming years, the Cochrane Collaboration aims to create an iterative system through which successive versions of each review will reflect not only the emergence of new data, but also valid criticisms, solicited or unsolicited, from whatever source. Successive versions of a particular review, together with any intervening criticisms, will be archived electronically. As the Cochrane Collaboration develops, it will make the results of research assessing the effects of health care more easily available to those who want to take better decisions. However, as Cochrane made clear in Effectiveness and Efficiency, reliable evidence about the effects of specific elements of health care, although essential for improving decisions about health care and research, is only part of what is needed for better decision-making. If better decisions are to lead to improved health, then effective mechanisms are needed for implementing them efficiently. Forms of care that have been shown to do more good than harm should be encouraged, while those that do more harm than good need to be discarded. And the many forms of care which have unknown effects should, as far as possible, be provided only as part of research studies to find out whether they help or do harm. In addition, if people are to receive care which is appropriate, then policy makers and decision takers ranging from ministers of health to individual clinicians and patients must consider people s needs, the availability of resources, and priorities. Undue reliance on evidence derived from formal investigations about the effects of specific elements of health care is inappropriate. Nevertheless, even if systematic reviews of well designed evaluations of the effects of care are not sufficient for improving policies and decisions in health care and research, they remain essential if these decisions are to become better informed. For further information visit the Cochrane Collaboration website at mcmaster.ca/cochrane/overview.htm or write to: Cochrane Collaboration, Summertown Pavilion, Middle Way, Summertown, Oxford OX2 7LG, UK. References 1. Cochrane AL. Effectiveness and efficiency. Random reflections on health services. London: Nuffield Provincial Hospitals Trust, Dickersin K, Min YI. NIH clinical trials and publication bias. J Curr Clin Trials 1993; Apr Chalmers TC, Matta RJ, Smith H, Kunzler A-M. Evidence favouring the use of anticoagulants in the hospital phase of acute myocardial infarction. N Eng J Med 1977; 297: Yusuf S, Peto R, Lewis T, Collins R, Sleight P. Betablockade during and after myocardial infarction: an overview of the randomised trials. Prog Cardiovasc Dis 1985; XXVII: Peto R. Why do we need systematic overviews of randomized trials? Stat Med 1987; 6: Liberati A, Apolone G, Nicolucci A, Confalonieri C, Fossati R, Grilli R, Torri V, Mosconi P, Alexanian A. The role of attitudes, beliefs, and personal characteristics of Italian physicians in the surgical treatment of early breast cancer. Am J Public Health 1991; 81: INCLEN: responding to the challenges of health care into the 21st century NE of the primary challenges O facing health policy makers worldwide is how to respond to the growing demand on health care systems when resources are scarce, costs are rising, and many countries have weak economies. Traditionally clinicians and public health practitioners have addressed many of the same issues, but from different perspectives. In all countries the majority of health resources are concentrated in the area of care, thus preventive measures are often neglected, and existing resources are focused on only a small part of the population. The challenge is to bridge the gap between hospital-based medicine and the wider health needs of the population. This is one of the critical health issues facing the developing world today. The International Clinical Epidemiology Network (INCLEN) has established a global resource network to support fundamental changes in the way physicians, medical educators and policy makers around the world think about health and disease. The network comprises medical schools from developed and developing countries, dedicated to multidisciplinary training of a critical mass of physicians. These are doctors who will look beyond the classroom and clinic to recognise, prioritise and address the needs of millions who have no regular access to effective medical services. INCLEN is a leading proponent of the practice of evidence-based medicine oriented toward improving health conditions and health resources allocation worldwide. Now in its eighteenth year, the network s efforts have resulted in the development of 40 Clinical Epidemiology Units in 19 countries. Over 400 physicians and other health specialists have been trained at Masters Degree level in clinical epidemiology, social science, biostatistics or clinical economics. Courses are run at one of the five original training centres in the United States, Canada and Australia, or in the regional training centres that operate in India, the Philippines, Thailand, Indonesia, China, Colombia, Chile and Brazil. The programme s longrange goal is to improve the way medicine is practised globally. This will be achieved by giving physicians the tools with which to analyse the efficacy, efficiency, cost-effectiveness and equity of medical interventions and preventive measures. INCLEN trained faculty are committed to using the best available evidence to make appropriate decisions on health care. They also use their skills to convey this information to policy makers faced with many difficult choices regarding resource allocation. Quality research The first phase of the INCLEN programme created a strong clinical Hamilton Chapel Hill Mexico City Bogotá Santiago Temuco Toronto Philadelphia Bucaramanga Fortaleza Lima Marilla Londrina Rio de Janeiro Tucuman São Paulo Lyon epidemiology foundation within an institution, the second was geared to transferring the locus of training to the regions and enhancing national capacity to further the incorporation of clinical epidemiology into medical education. Using a multidisciplinary approach, the network s units are well situated to help direct the course of health care into the 21st century. With the maturation of the original Clinical Epidemiology Units more decision making will devolve to the regions. The natural result of this regionalisation will be a cultural and national tailoring of the programme to be more responsive to its setting. A third phase of the programme is a growing emphasis on consolidating and focusing the extensive skills within the network on critical health issues. At least four major multicentre studies have either begun or are being planned in the areas of tuberculosis therapy, family violence, appropriate drug use for acute myocardial infarction, and injection practices among HIV/AIDS-infected drug users. Additionally, follow-up studies on an Indian invasive bacterial infection surveillance study are being planned. There is a strong belief that the network s sustainability will hinge upon its longterm credibility as a producer of quality research. INCLEN continues to support the units work by: creating and nurturing links with other members of the global network; facilitating intellectual exchange through a series of international and International Clinical Epidemiology Network Barcelona Chengdu Xi an New Delhi Lucknow Shanghai Ismailia Changsha Nagpur Hangzhou Chennai Khon Kaen Chiang Mai Santo Tomas Vellore Manila Bangkok Cebu Yaounde Addis Ababa Trivandrum Cavite KampalaNairobi Harare Pretoria Semarang Beijing Yogyakarta Surabaya * Clinical Epidemiology * Clinical Epidemiology Resource Units (CEUs) and Training Centres (CERTCs) Newcastle regional meetings; supporting electronic communications; sponsoring attendance at international health fora; and facilitating continuing education programmes throughout the network. Developing collaborative relationships with other organizations and programmes is seen as fundamental to success. The Council on Health Research for Development, International Health Policy Programme, The Cochrane Collaboration, UNICEF and medical education networks are among the groups INCLEN currently works with. Such collaboration is another means by which the INCLEN network is striving to broaden its outreach and maximise impact. INCLEN faculty all over the world are having an impact on medical education, medical practice and broader health issues. The network can play a major role in rationalising cost-effectiveness and technical efficiency of interventions, so that decision makers can understand what works and at what cost. With its multidisciplinary profile, it has the capacity to address the most significant health challenges in every culture, namely the conflicts between equity, equality, access, cost-effectiveness and limited resources in health. For further information contact: INCLEN Inc., 3600 Market Street, Suite 380, Philadelphia PA ,USA. Tel: , fax: ,
17 17 The AIS Network in Bolivia Photo: AIS Bolivia CCIÓN Internacional por la Salud in Bolivia grew out of an initial A attempt by the Government of Bolivia to establish an essential drugs programme. The launch in 1983 of the Institute of Essential Drugs (INASME) was an unprecedented experiment in Bolivia, a developing country which cannot afford to squander scarce economic resources on non essential drugs. This especially applies to products of unproven efficacy, which may have been banned elsewhere. The venture failed, however, because there was insufficient public information on the benefits of the scheme to motivate the public, health workers and prescribers to support its aims. Other key factors included fear of damage to business interests and lack of adequate training for the health workers involved. A major problem was the lack of a clearly enunciated drugs policy within the framework of primary health care, along the lines advocated by WHO. Learning from experience... In 1985, a small group of Bolivian health professionals and other health workers launched an independent study of the Government initiative, with the aim of documenting the experiment and highlighting the lessons to be learned. The next two years were spent on operational research and educational work to promote the rational use of drugs and the need for an alternative not necessarily medicinal approach to health care. In January 1987, the group joined with other movements in Peru, Brazil and Chile, in affiliating to Health Action International (HAI) thereby becoming the operational branch of HAI in Bolivia. The first activity was the production of Medicinal Drugs: Situation in Brazil, Chile and Peru, a book produced OSCAR LANZA, RODRIGO URQUIETA* through collaboration within the HAI network in Latin America (AIS Latin America). From the outset, AIS Bolivia has provided independent scientific and technical information on progress in primary health care and rational use of drugs using fora such as lectures, meetings, seminars and media opportunities. However, these activities were restricted by lack of financial support. In 1988, a bi-monthly information bulletin was launched, followed by a poster campaign and the organization of workshops, conferences and meetings. Meanwhile AIS encouraged the organization of new groups of volunteers in other regions throughout Bolivia rapidly establishing itself as a respected campaigning organization. Pooling resources... An early AIS initiative was to suggest pooling of the efforts of nongovernmental organizations interested in joint procurement of generic/ essential drugs. This led to the establishment of a Medicinal Drugs Bank, which achieved a reduction of up to 800% on the price of drugs thus helping to promote wider access to health care. Once up and running, the drug bank became an autonomous organization. This new organization, Essential Medical Supplies (IME), is continuing efforts to ensure that essential drugs are AIS volunteers promoting integrated primary health care and the rational use of drugs at a local market in the Highlands available within the nongovernmental sector in Bolivia. After five years of voluntary work and an ever-increasing workload, a central coordinating office was established in 1990 to oversee the activities of 12 regional branches throughout the country. A data centre and library were set up, offering free admission, and daily radio broadcasts were prepared in Spanish and the three national languages to promote rational drug use. However, volunteers still underpin the vast majority of AIS activities. The volunteer activists of AIS Bolivia are motivated by a commitment to community service. Although unpaid, they benefit from training courses at health schools, universities, and other institutions giving them access to fellowships, operational research, publications, and collaboration with national and international supporters of the AIS Bolivia network. The Bolivia network benefits from the support of volunteers from Médecins pour le Tiers Monde (Belgium), E-changer (Switzerland), and Frères sans Frontières (Switzerland). Its work also attracts European student volunteers who, with the backing of their universities, agree to work on a short-term basis for AIS Bolivia. The work of AIS Bolivia has influenced the attitudes not only of health workers, health professionals and students but also of the health authorities in both urban and rural areas. One example is the campaign against unethical drug promotion. Ten years of effort bore fruit in 1996 with the adoption of Bolivian legislation incorporating the principles articulated in WHO s Ethical Criteria for Medicinal Drug Promotion. Financing and sustainability... At the outset the operation and maintenance of the network were made possible through the determination and integrity of its founder members. Financial support was subsequently provided by organizations including WHO, Médico Internacional (Germany), Interamerican Foundation (USA), OXFAM (UK), and NOVIB (Netherlands). AIS is currently making efforts to become self-financing through the sale of some consultant AIS taking its campaign to the public services to a variety of organizations and institutions. Networking... AIS Bolivia works closely with the world consumer protection movement through Consumers International, of which AIS Bolivia is an active member. AIS has also fostered the development of other campaigning organizations including the consumers rights defence committee (CODEDCO, Bolivia), the Bolivian branch of the International Baby Food Action Network (IBFAN), and the Foundation for Nature and Life (FUNAVI), which is concerned with the impact of industry and technology on health and the environment (including the impact of the disposal of drugs and packaging). Lessons learned... One of the key lessons learned has been the need for widespread public support if a campaigning initiative is to be successful. A technically sound programme, based on the latest scientific and technical data, can succeed only if it is relevant for the people involved. Scientific and technical information must be made available to the public in a simple and accessible format empowering them to take responsibility for their own health. There are also a number of inherent weaknesses to be overcome in building this kind of campaigning network. They include: indifference to the issues involved; the risk of threats from interested parties; individual members motivated by material gain or in search of a springboard for a political cause; and the inevitable lack of continuity involved in using volunteers. * Oscar Lanza is Coordinator General, AIS-CODEDCO-IBFAN-FUNAVI Bolivia and Rodrigo Urquieta is Projects Officer AIS-CODEDCO-FUNAVI Bolivia. For further information contact: AIS Bolivia, P.O.Box 568 (Apartado Postal), La Paz Bolivia. Tel./fax: , Photo: AIS Bolivia
18 18 Educators for rational drug use Photo: ERDU KUMARIAH BALASUBRAMANIAM* N 1986, Health Action International (HAI) groups in the Asia- I Pacific Region launched a campaign Action for Rational Drugs in Asia (ARDA). The campaign was coordinated by the Asia-Pacific Regional Office of Consumers International. From the outset, ARDA campaigners agreed that a key priority was to improve prescribing practices. However, this was likely to be difficult to achieve in the case of practising physicians who tended to be a conservative professional group. But if medical and pharmacy educators could be convinced of the need to modify undergraduate One of the many workshops organized by ERDU. Bringing together representatives of government, NGOs, academia and the media has been one of the keys to the network s success curricula, they reasoned, this would ensure that future health professionals acquired the skills needed to prescribe drugs rationally and economically. ARDA partners asked the Regional Office of Consumers International to canvas medical and pharmacy educators in the Asia-Pacific Region for their views on education and curricular reforms. On the basis of these views, a background document was prepared for a five-day international consultation on medical and pharmacy education for undergraduates in 1988, involving over 50 participants from 13 countries throughout the world. The participants agreed that the most effective way to implement the conclusions and recommendations of the meeting was by setting up an international network of Educators for Rational Drug Use (ERDU). The major objective of this network is to act as a focal point for rational drug use, recruit allies, and initiate activities at institutional, national and regional levels to spearhead changes within teaching institutions. A new network of educators... Small groups of committed educators were established in several medical ing to Diploma and Fellowship levels. These have now been established by the College of Physicians and Surgeons. The Calcutta group invited key resource people from the region to develop an undergraduate teaching model on some 15 selected topics within clinical pharmacology and therapeutics. This has now been completed and is currently being tested prior to its introduction in medical schools. The ERDU group in the Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) has taken a leading role in facilitating the activities of the network in Southern India. The initial objectives were to sensitise young doctor-trainees to the need for rational drug use and issues related schools in South Asia and brought together at regional training workshops in India and Pakistan, organized by Consumers International in collaboration with medical schools in the region. The idea was to create a critical mass of trainers in rational drug use and the essential drugs concept, who would in turn train other teachers in their localities. The workshops developed different action plans. The Karachi group identified the severe shortage of clinical pharmacologists as the main reason why the teaching of rational drug use had such a low profile in medical schools in Pakistan. The workshop proposed the establishment of graduate courses in clinical pharmacology, leadto unethical drug promotion. An orientation course on rational use of drugs and the essential drugs concept for medical interns was developed by the Pharmacology Department. It soon evolved into a multidisciplinary effort which was well received by interns. Widening the scope... In the course of time it became evident that rationality should be promoted in other areas of medical practice in addition to use of drugs. Rational use of diagnostics was added to the intern programme. It was then apparent that ethical values and communication skills were essential elements for the practice of rational management. These modules were therefore added to develop an integrated programme on quality care. This is now a standardised and structured programme of three days, which has been adopted by several medical schools in India. In a further successful initiative a trainers manual has been prepared by the ERDU network. Entitled Beyond Rational Therapy, the manual has proved an important tool for trainers at various medical schools in the region, who have used it to conduct the programme on quality care for medical interns. Expanding the linkages... During the network s process of evolution it became apparent that unless the consumers and consumer activists, government health ministry officials, and the media were brought together, A doctor examines a child at a rural primary health care project in Tamil Nadu, India. ERDU is working to ensure that all health professionals in the Asia-Pacific Region are trained in rational prescribing Photo: J & P Hubley the demand for irrational drug use would continue. A new level of partnership was therefore forged in the Asia-Pacific Region which brings together medical educators, consumer and Targeting change at an ERDU seminar media representatives and government officials. In June 1992, the Regional Office of Consumers International convened an Asia-Pacific workshop on pharmaceuticals for ministry of health officials. As a result of this meeting, a new partnership was created between government officials, nongovernmental organizations, the academic world, and the media. These groups are now regularly represented at meetings on pharmaceuticals at national and regional levels complementing each other in strengthening the pharmaceutical supply system in the region. Lessons learned... One of the earliest lessons learned was that commitment to a worthy cause by diverse groups of whatever size, attracts public attention, admiration and encouragement. People are surprised to find ivory tower intellectuals from university medical faculties at meetings organized by health activists. However, when the focus is on a common goal, such as providing quality health care, rather than ideological differences, ERDU has shown that a varied group of activists can work productively towards this goal. Other lessons we have learned are that, with a little creative problemsolving, it is possible to work on a shoestring budget; and that, although small core groups of committed individuals can make appreciable changes, sustained efforts are needed over a long period of time. * Kumariah Balasubramaniam is Pharmaceutical Adviser, Consumers International Regional Office for Asia and the Pacific, PO Box 1045, Penang, Malaysia. Tel: , fax: , Photo: ERDU
19 19 From newsletter to network? PAUL SPIVEY, MARTHE EVERARD* HE first Effective Drug Management and Rational Drug Use T course took place in 1992 at The Robert Gordon University School of Pharmacy in Aberdeen, Scotland. Since then the course, which started as a collaborative activity with the Action Programme on Essential Drugs, has trained 88 people (mainly pharmacists) from 33 countries. As a natural consequence of the correspondence that developed between course tutors and participants, the annual newsletter, Aberdeen Course News, was born and with it has grown a small network. The News not only helps to maintain supportive contact between staff and former course participants but also encourages continued links between exstudents. It provides information about the course programme and developments in the School of Pharmacy, and allows the exchange of personal and/or professional information about individuals connected with the course. Because the newsletter has been produced by the course tutor costs have remained low, with distribution limited to course participants. Sustainability is dependent on the course tutor s commitment and on participants continuing to contribute information. Revealing a need The goals of Aberdeen Course News have not changed significantly over time. This is because the financial and human resources have not been available to develop the newsletter into an interactive professional network. On a practical Photo: The Robert Gordon University Smiles all round after the presentation of certificates to the class of 95, by the then President of the Royal Pharmaceutical Society of Great Britain, Ms Ann Lewis, (centre, wearing chain of office) level, however, it has been possible to provide support in some of the participants home countries, such as Bolivia, Eritrea and Ghana. Support consists of visits to contribute to workshops, discussing practical aspects of supply management in specific situations. A sense of joint ownership, regular contributions by members, long-term commitment, and a significant investment of time and resources are required in order to develop from a newsletter into a sustainable and supportive professional network. While the Aberdeen Course News was not created with the intention of setting up such a professional pharmacy network, it revealed a definite need for one. INCAPP: advancing pharmacy practice A new development occurred in 1995 when the School of Pharmacy was designated as a WHO Collaborating Centre for Training in Drug Management and Pharmacy Practice. The small News network was one area of work taken on by the Centre to facilitate the development of pharmacy practice. This was the beginning of INCAPP, the International Network for Cooperation in the Advancement of Pharmacy Practice, which was launched in the same year. The network was established with the approval, in principle, of the Royal Pharmaceutical Society and the heads of schools of pharmacy in the UK. Its overall objective is to promote the quality of pharmacy practice, with a view to guaranteeing the quality and safety of medicines. INCAPP also promotes integrating pharmaceutical care into health services. The network s activities will focus on advocating the role of the pharmacist at national and international level, facilitating continuing education for improving pharmacy practice, and establishing means of communication and discussion (meetings, , website access etc.) between its members. It is envisaged that the Aberdeen Course News will be integrated into INCAPP S overall information strategy. * Paul Spivey was EDM/RDU Course Tutor and Marthe Everard is Manager of the WHO Collaborating Centre, School of Pharmacy, The Robert Gordon University, Schoolhill, Aberdeen AB10 1FR, Scotland, UK. Tel: , fax: , Africa s network of drug regulatory authorities HE first moves to create a T network of African Drug Regulatory Authorities (AFDRAN) were made thousands of miles from that continent, in Berlin in The 23 participants from 20 countries* attending the second Conference of African Drug Regulatory Authorities decided that a network would stimulate and facilitate coordination of their activities. AFDRAN would operate as a network linking a group of people and organizations with a common goal, based on commitment, enthusiasm, professional expertise and exchange of experiences. The network s main objective was to promote good regulatory practices in Africa, where counterfeit and substandard drugs are common and financial constraints on authorities severe. An ambitious agenda... WHO and the German Foundation for International Development were among those providing initial financial and technical support. It was agreed that AFDRAN would work with WHO Collaborating Centres to arrange training programmes in drug registration, inspection and quality control; and would facilitate twinning arrangements between African drug regulatory authorities and those in developed countries in the North and South. Installing in the contact offices of participating countries was a high priority because of Africa s acute communication problems. Other plans were for AFDRAN to develop performance indicators software for drug regulatory control, in cooperation with WHO. AFDRAN participants would also field test, improve and promote the software for drug regulatory authorities. Between April 1994 and October 1995, AFDRAN published the first issue of its Newsletter, and installed and a fax. machine for the secretariat in Kenya. In October 1995 an action plan was drawn up but by November 1996 little had been achieved. This was partly due to communication difficulties and constraints on members time. Also a network meeting planned to take place in Eritrea prior to the International Conference of Drug Regulatory Authorities (ICDRA) did not materialise. Revitalising a flagging network... In November 1996, the Action Programme on Essential Drugs called a satellite meeting of African drug regulatory authorities participating in ICDRA 8 in Bahrain to try to revitalise the network. The meeting agreed that a new executive committee and a coordinator should be elected. It identified priority problem areas, focal points for each problem area, and four sub-regional representatives to participate as members of the executive committee. Zimbabwe s Drug Regulatory Authority was elected to coordinate the network for the following two years. The technical priority areas chosen were: counterfeit and substandard drugs and cosmetics; registration and medicine control procedures, and harmonisation; illicit trade, parallel imports and drug trafficking; and training. A new executive committee met in Zimbabwe in September 1997 and adopted a memorandum of understanding. This will serve during the transitional period until the constitution is approved and adopted at a pre-icdra 9 meeting in What AFDRAN accomplishes in the future depends on its strength its organizational structure, financial resources, leadership, and members commitment. It also depends on the support of WHO, other international organizations, donor agencies and NGOs, as well as the policy support it gets from national governments in the Region. Already AFDRAN has shown that drug regulatory authorities in Africa have a lot to learn from each other. Countries in the Region need to pool knowledge, experiences and resources for their mutual benefit, and to achieve national and collective self-reliance in drug regulation and quality assurance. A well functioning, dynamic and sustainable network could do much to promote such cooperation. For further information contact: Gugu Nolwande Mahlangu, Training Officer, Drugs Control Council, P.O. Box 48517, Union Avenue, Harare, Zimbabwe. Tel: , fax: * Cameroon, Congo, Cote d Ivoire, Eritrea, Ethiopia, Gambia, Ghana, Kenya, Lesotho, Malawi, Mauritius, Mozambique, Namibia, Sierra Leone, Swaziland, Tanzania, Tunisia, Uganda, Zambia and Zimbabwe.
20 20 APUA: an international network to combat antibiotic resistance LLIANCE for the Prudent Use of Antibiotics (APUA) is dedicated to A preserving the effectiveness of antibiotics through research and education about their appropriate use and the problem of resistance. APUA provides a scientific network which facilitates global information exchange and supports country-based efforts to curb antibiotic resistance. Since the 1940s antibiotics have saved millions of lives. But now increasing resistance to them results in people succumbing to diseases that were previously treatable with first line antibiotics. While bacterial resistance was foreseen as a natural evolutionary consequence of antibiotic use, few expected resistant strains to develop so fast, spread so easily and be so multidrug resistant. Today there is general agreement that the alarming rise in antibiotic resistance is linked to overuse and misuse. After prolonged antibiotic use, resistant forms of bacteria can become predominant in local areas and lead to infections which are difficult to treat and/or to the transfer of resistance traits to other bacteria of consequence to public health. Raising consciousness APUA is a grassroots international organization committed to raising public and health professionals consciousness about the impact of antibiotic misuse on local bacterial ecologies. The network supports education and interventions to improve antibiotic use and reverse antibiotic resistance. Its international action programme includes: establishing an interactive website dedicated to the topic of antibiotics was introduced in January 1998; publishing original research findings and expert commentary through the quarterly APUA Newsletter. Published since 1982, the newsletter is distributed to over 7,000 people in 90 countries; providing expert speakers and sponsoring symposia with local branches. During autumn 1997 the Alliance co-sponsored conferences on antibiotic use and resistance in Italy, Mexico and Russia. In May 1998 it is coordinating a symposium, Confronting Antibiotic Resistance: Global Surveillance and Interventions, at the 8th International Congress on Infectious Diseases in Boston. APUA expert speakers from Cuba, Finland, Russia and Saudi Arabia will be present. establishing an international research collaboration and registry on resistance in commensal organisms. This project has been funded by the US National Institute of Health. Interested participants should contact the Alliance; raising public awareness through contributions to regular scientific and popular publications and TV programmes worldwide; conducting a US health provider lecture series which has operated for the past three years and is intended to raise the issue of resistance with providers; publishing a patient brochure on the appropriate use of antibiotics (which won a national award); establishing and collaborating with local chapters on an ongoing basis in: Australia, Bangladesh, China, Cuba, Guatemala, India, Italy, Mexico, Moldova, Poland, Russia, Spain, Turkey and Viet Nam; and developing chapters in Canada, Greece, Korea, Morocco, Nepal, the Philippines, Senegal, South Africa, Taiwan and the UK. Consistent goals APUA was established following a meeting in Santo Domingo, Dominican Republic, in This was the first time that a multinational group from the medical and scientific community declared that antibiotic resistance was a global problem requiring both international attention and local interventions. Over its 17-year history, the Alliance s goal has remained consistent and relevant to improve antibiotic use in order to curb antibiotic resistance around the world. The specific objectives include educating providers and the public about the issue, and encouraging local and international efforts to maintain antibiotic effectiveness. From an initial 200 members in some 20 countries, there are now over 1,000 members in more than 90 countries. Members includes researchers, health practitioners, pharmacists, public health regulators, and others interested in antibiotics and their optimum use. Until 1994, APUA activities were led by its President, Stuart B. Levy, Director of the Centre for Adaptation Genetics and Drug Resistance at Tufts University in Boston. With limited This APUA patient leaflet clearly spells out the dangers of antibiotic resistance resources, a half-day staff member and a board which convened only between one and three times a year, APUA was still able to establish a firm foundation. Membership grew steadily, with more foreign national branches and the regular quarterly publication of the scientific international APUA Newsletter. In 1995 and 1996 strategic planning meetings led to a focused mission and programme agenda, and a recommendation to hire a full time executive director. In 1995 three things happened to promote the growth of the organization. Firstly, the issue of antibiotic resistance became more widely recognised. Secondly, APUA gained more visibility in the media due to outspoken positions on these alarming trends. Finally, successful new funding prompted the board and officers to hire the first fulltime executive director. Charged with fundraising to maintain long-term sustainability, the director is also responsible for forming partnerships with complementary organizations to further the mission and increase the programme s impact. Currently the Alliance is supported by a variety of funding sources private donors, membership fees, corporate sponsorship, and government grants and subcontracts. With increased funding staff numbers have also grown, and their expertise now covers health education, microbiology, medical ethics and clinical medicine. In addition to its research and educational activities, the organization has developed proposals and is seeking funding for the development of: a curriculum for high school and elementary school students; a public media campaign; international guidelines to curb antibiotic resistance; and further research on the economic impact of resistance around the world. APUA is the only organization dedicated to curbing antibiotic resistance, with unique credibility on the issue and an established international network. It is therefore of particular value to organizations interested in collaborating on projects aimed at improving antibiotic use and curbing antibiotic resistance. APUA s leadership is comprised of recognised international medical and scientific experts, including Nobel Prize laureates and members of national academies of medicine and science. Lessons for others The major lessons learned during the development of the Alliance have been: the fundamental importance of dedicated, qualified, committed and enthusiastic leadership from the start; the value of making the best use of limited resources and of tapping involvement from interested individuals and groups; the significance of media attention in providing credibility and helping to raise public awareness of antibiotic resistance; the need for local groups to see antibiotic resistance as part of a global problem; the importance of grassroots involvement of members and branches to ensure a spirit of partnership and relevance of activities to local conditions and capabilities; the necessity to invest in staff and resources in order to develop the organization; the burden that the need for fundraising places on a small non profit organization; the need for start-up funds to invest in promising organizations. For further information contact: Kathleen Young, Executive Director, APUA, P.O. Box 1372, Boston MA , USA.