WHO DRUG INFORMATION VOLUME 7 • NUMBER 3 • 1993 RECOMMENDED INN LIST 33 INTERNATIONAL NONPROPRIETARY NAMES FOR PHARMACEUTICAL SUBSTANCES WORLD HEALTH ORGANIZATION • GENEVA WHO DRUG INFORMATION WHO Drug Information provides an overview of topics relating to drug development and regulation that are of current relevance and importance, and includes the lists of proposed and recommended International Nonproprietary Names for Pharmaceutical Substances (INN). Its contents reflect, but do not present, WHO policies and activities and they embrace socioeconomic as well as technical matters. The objective is to bring issues that are of primary concern to drug regulators and pharmaceutical manufacturers to the attention of a wide audience of health professionals and policy-makers concerned with the rational use of drugs. In effect, the journal seeks to relate regulatory activity to therapeutic practice. It also aims to provide an open forum for debate. Invited contributions will portray a variety of viewpoints on matters of general policy with the aim of stimulating discussion not only in these columns but wherever relevant decisions on this subject have to be taken. WHO Drug Information is published 4 times a year and can be ordered from: Distribution and Sales, World Health Organization, 1211 Geneva 27, Switzerland. Annual subscription: Sw. fr. 60.— Airmail rate: Sw.fr. 72.— Price per copy: Sw.fr. 20.— ©World Health Organization 1993 Publications of the World Health Organization enjoy copyright protection in accordance with the provisions of Protocol 2 of the Universal Copyright Convention. For rights of reproduction or translation, in part or in toto, application should be made to: Chief, Office of Publications, World Health Organization, 1211 Geneva 27, Switzerland. The World Health Organization welcomes such applications. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the Secretariat of the World Health Organization concerning the legal status of any country, territory, city, or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Authors alone are responsible for views expressed in signed contributions. The mention of specific companies or of certain manufacturers' products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature which are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. WHO Drug Information Contents General Policy Topics Regulatory Matters Role of the International Conference of Drug Antihyperlipidaemic agents: paraesthesia and Regulatory Authorities 97 neuropathy 123 Atovaquone as an alternative treatment for Pneumocystis pneumonia 123 Personal Perspectives Bovine brain gangliosides: marketing Patient's rights and the therapeutic dialogue 99 suspension recommended 124 Antiretroviral therapy: recommendations for use 124 Reports on Individual Drugs Short-acting hypnotics: a comparative Dapsone-pyrimethamine: dual therapy in HIV assessment 125 infection? 101 Identification codes for tablets and capsules 126 Diethylstilbestrol: a human carcinogen 103 Misoprostol: unsafe in pregnancy 126 Tacrine: a first step towards management of Propofol: adverse neurological events 127 Alzheimer's disease 104 Bismuth subsalicylate: association with Folic acid and spina bifida 106 Reye's syndrome 127 Poliovirus vaccines: the case for a Tacrine approved for the symptomatic relief supplemental dose 108 of Alzheimer's disease 127 Quality control of propylene glycol 127 General Information Essential Drugs Guillain-Barré syndrome: immunoglobulins or Viral hepatitis 128 steroids 110 Hepatitis B vaccine 130 Artemisinin and its derivatives: use as Hepatitis B immune globulin 131 antimalarials 111 Human immunoglobulin 132 Tuberculosis preventive therapy in HIV- Hepatitis A vaccine 132 infected individuals 113 Advertising in medical journals 115 Antiarrhythmic agents: the problems of clinical Recent Publications assessment 116 Quality control of essential drugs in developing Biological products and transmissible countries: standardized methods 134 pathogens 118 Sickle cell disease: a trend towards less Recommended International invasive management 120 Nonproprietary Names: List 33 135 General Policy Topics Role of the International Conference • discuss contemporaneous issues of international relevance. of Drug Regulatory Authorities The objective is, above all, to offer practical support One of the primary functions of the World Health to decision-makers in drug regulatory authorities. Organization is to serve as the directing and The conferences have been looked upon with coordinating agency in international health work. benevolence by the governing bodies of WHO, and Among a wide range of technical functions, WHO's they have been actively supported by an increasing Constitution requires the secretariat to "develop, number of Member States that arrange to be establish and promote international standards for represented at the meetings. It is gratifying that the food, biological, pharmaceutical and similar conferences have now been formally recognized by products". In no other domain does the Organiza­ the World Health Assembly in which resolution tion work in such direct collaboration with the WHA45.28 defines WHO's role in intergovern­ governments of Member States. Currently, over mental harmonization of drug registration and 160 countries have designated a senior official to control. The resolution urges all Member States to be responsible for disseminating technical advice support and participate in sessions of the ICDRA received from WHO on the safety and efficacy of concerning the harmonization process. It also drugs, and who also arranges for WHO to be kept invites the pharmaceutical industry "to continue to informed of national drug regulatory decisions that collaborate with drug regulatory authorities and with are of international relevance and concern. It is this WHO, where appropriate, in order to ensure that initiative that has established WHO as the inter­ the advantages of harmonization benefit all national focus for drug regulatory affairs and has concerned". helped to establish and maintain the International Conferences of Drug Regulatory Authorities The ICDRA has helped to create a commitment (ICDRA). within drug regulatory authorities to address international responsibilities. Certain obligations The first of these conferences was convened in towards collaboration are manifest. They include Annapolis in the USA in 1980, as a joint initiative of the need to exorcise trade in counterfeit, spurious the WHO Secretariat and officials of the US Food and substandard products; to assure broad and Drug Administration. For the first time within a international respect for good manfacturing global context, representatives of drug regulatory practices in all circumstances; to establish efficient authorities in both developed and developing approaches to drug registration and other aspects countries were provided with a forum for debate. of control in all countries; and to sensitize law Conferences have since been held biennially, each enforcement and customs authorities to their role in one being sponsored by the Ministry of Health of a control mechanisms. host country and the agenda is proposed by a regionally-representative group of drug regulatory Other concerns are more recent. One sign of officials and the WHO Secretariat. changing times is a general acceptance of the need to validate all data that contribute to the drug At the first meeting, both the acronym ICDRA and development process. Hence the need to develop the objectives of the conference were established. globally-recognized standards of good clinical and The principle aims are to: good laboratory practice. This need is uncontested, but the requirements will have to be interpreted with • promote collaboration between national drug sensitivity and with concern for practicability. There regulatory authorities; is always a danger that overzealous commitment to standards may serve only to frustrate the process • forge a consensus on matters of mutual interest; that they are intended to protect. • facilitate timely and adequate exchange of Extensive discussion within the ICDRA has resulted technical information; and in better understanding of underlying problems. At the same time, in the course of debate, the frailty of of WHO's Ethical Criteria for Medicinal Drug the drug registration process in many countries has Promotion and the responsibilities of the various become evident. This has stimulated WHO to parties involved, including pharmaceutical develop Guiding Principles for Small Drug companies, consumers and governments, in Regulatory Authorities and to complement this text assuring standards of promotional practice. with a computer software package for drug registration. One of the most encouraging These are but examples of the work and influence experiences of ICDRA, thus far, has been the of the ICDRA. In fact, the agenda of each meeting frequency with which discussion of one topic has is overloaded to the extent that much time is brought into focus other important subjects. devoted to small parallel workshop discussions, each of which has a global focus. Topics that have Regulatory authorities, like pharmaceutical captured attention range from the assessment and companies,