WHO DRUG INFORMATION VOLUME 8 - N U M B E R 3 1994 RECOMMENDED INN LIST 34 INTERNATIONAL NONPROPRIETARY N A M E S F O R P H A R M A C E U T I C A L SUBSTANCES WORLD HEALTH ORGANIZATION • GENEVA Volume 8, Number 3, 1994 World Health Organization, Geneva WHO Drug Information Contents General Policy Topics Regulatory Matters Ethics and drug promotion: the CIOMS Large-scale HIV vaccine trials deferred 152 consensus 123 Antidepressants and hyponatraemia 152 Azapropazone and photosensitivity 153 Personal Perspectives Blood: safeguards to prevent Revision of the IFPMA code of pharmaceutical transmission of pathogens 153 Bromocriptine: no longer recommended to marketing practices 125 suppress lactation 153 Counterfeit medicines: a growing concern 154 Update on AIDS Felbamate and aplastic anaemia 154 HIV vaccines: advances and setbacks 128 Neuroleptic sensitivity in dementia 155 Zidovudine: redressment of early expectations 130 Nonsteroidal anti-inflammatory drugs: Zidovudine: renewed encouragement 131 relative safety 155 China to work with the European Reports on Individual Drugs Pharmacopoeia Commission 156 Antiarrhythmic agents: more concerns over Move to ban distribution of drug samples 156 risks and benefits 134 Theophylline potentiated by fluvoxamine 156 Oral contraceptives: no apparent association Tiaprofenic acid and severe cystitis 156 with diabetic complications 135 Zidovudine approved to prevent HIV Oral contraceptive use and protection against transmission in pregnancy 157 ovarian cancer 136 Ethical criteria for medicinal drug promotion 157 Postmenopausal use of estrogens: a risk factor for breast cancer 137 Essential Drugs Nicotine substitution therapy 140 Psoriasis 161 Dithranol 162 General Information Salicylic acid 162 Management of acute lymphoblastic leukaemia: Tar products 162 a need for compromise between extended survival and long-term toxicity? 143 Recent Publications Drug toxicity and P-glycoproteins 145 Bioethics: a professional responsibility 164 Drug-resistant pneumococal infections: a fast deteriorating situation 148 Osteoporosis in chronic inflammatory disease: Recommended International a need to reevaluate corticosteroid therapy? 149 Nonproprietary Names: List 34 165 i WHO Drug Information Vol. 8, No. 3, 1994 General Policy Topics There was recognition throughout the consultation Ethics and drug promotion: that progress will be dependent upon the leadership the CIOMS consensus provided by WHO, since the Organization is particularly well placed to develop dialogue on how In 1988, the World Health Organization issued control of advertising can best be integrated into the ethical criteria for medicinal drug promotion in process of drug registration without limiting the response to a request by the World Health capacity to meet other vital objectives of the Assembly. The objective was to ensure that all regulatory process. Indeed, several relevant parties involved with the promotion of medicines activities are already in hand: would seek to support and encourage the improvement of health care through the rational use • WHO is promulgating its Guiding principles for of medicinal drugs. This message was directed not small national drug regulatory authorities, and only to pharmaceutical manufacturers and distri­ preparing complementary model legislation; butors but also to health personnel involved in supplying, dispensing and prescribing drugs; • it has created a model software package to patient and consumer groups; and the media support drug registration, which centres around (including publishers and editors of medical the establishment of an approved scientific data journals). sheet; • it is maintaining its system of information exhange Sensing a need to promote more effective use of on national regulatory decisions, and is producing the criteria, the Assembly subsequently requested Model Prescribing Information; and that a meeting of representatives of the various interested parties be convened "to discuss possible • it is negotiating a more searching factual basis for approaches to further advancing the principles the WHO Certification Scheme on the quality of embodied in [the criteria]". This meeting, jointly pharmaceutical products moving in international organized by WHO and the Council for International commerce. Organizations of Medical Sciences (CIOMS), was held in April 1993. Its report* reflects the spirit of the The criteria serve as a reminder that information meeting. It focuses primarily on the application of needed to assure safe and effective use is an the criteria in developing countries. It does not dwell integral component of every drug product. WHO on the deficiencies of the past. It sets out a remains acutely aware that in the majority of its commitment as agreed between the parties and Member States far too little "independent" factual outlines tasks for the future. It also defines an information about the properties and use of overriding ethical precept: the right to be informed. medicines is available to prescribers, patients and other users of these products. Nor do the resources The nineteen recommendations of the consultation exist in these countries to provide comprehensive are broad in scope. They relate to education and oversight of promotional activities. Much thus communication; the interface between promotion depends upon the observance of voluntary codes of and regulation; the development of national practice and two events have occurred in the wake policies; and international collaboration. It appears of the CIOMS meeting that strike a tone of that all the interested parties accept the validity of encouragement: the criteria and that they are prepared to work collaboratively to further their implementation. The International Federation of Pharmaceutical However, it was generally appreciated that Manufacturers Associations (IFPMA) has challenging problems will continue to emerge, and extensively revised its code of pharmaceutical that the criteria themselves may need to be marketing practices (see also page 125), while the adapted from time to time. International Committee of Medical Journal Editors has emphasized that editors must have full * Forty-seventh World Health Assembly. WHO ethical responsibility for advertising policy, and that criteria for medicinal drug promotion. Report by the advertising must be separate from, and not be Director-General, A47/7, 1994. (See also page 157.) allowed to influence, editorial decisons. 123 General Policy Topics WHO Drug Information Vol. 8, No. 3, 1994 On the other side of the coin, Health Action promotional practice; and consumer groups at International has undertaken a review of the international, national and local levels should promotion of over-the-counter drugs within continue to work with governments and industry to countries acknowledged to maintain the highest promote constructive actions, to monitor com­ standards of regulation*, and it has concluded that pliance with the criteria, and to create a critical existing practices still fail to provide the safeguards awareness of their provisions among consumers. that society might reasonably expect. WHO and CIOMS, it is suggested, should bring these and other parties, including donor organiza­ Meanwhile there is much for WHO to attend to. It tions, into more effective interaction, and consider was agreed at the meeting that — in consultation convening regional meetings as occasion arises. with interested parties — the Organization should periodically review the ethical criteria; monitor their Education of interest groups and the public at large implementation and develop performance indicators on the principles embodied in the criteria is for this purpose; consider what remedial measures recognized to be of critical importance in their should be taken in the event of non-compliance; acceptance and implementation. Reliance is vested and assess the current and potential capacity within in WHO, universities and other interested parties to governments in countries at various levels of develop and issue relevant materials. WHO is also development to implement appropriate drug urged to extend the scope of its Model Prescribing regulation and to control promotional activities. Information and to assume the lead in promoting the provision of therapeutic guidelines for All interested parties, it was proposed, should prescribers in a form that is independent and underscore the importance of incorporating the comparative, and propounds the concepts of the criteria into national drug policies. Similarly, it was ethical criteria. All interested parties are urged to agreed that national industry associations should explore how they might act as clearing-houses for be set up in each country with a view to maintaining specific types of information relevant to appropriate standards on a voluntary basis, and implementation of the criteria. that the international associations should assist in their establishment. More specifically, it was agreed At the conclusion of the meeting it was acknow­ that WHO, together with associations representa­ ledged by consensus that the spirit that had tive of consumers, industry and national medical characterized the proceedings reflected "a common associations should develop and adopt standards commitment to enhance the positive contributions of training and responsibilities of medical of medicinal drugs to the well-being of people in all representatives, and rules for conducting countries, with special concern for those of the sponsored medical symposia,