WHO DRUG INFORMATION VOLUME 6 • NUMBER 4 • 1992 PROPOSED INN LIST 68 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 in English, French and Spanish. Annual subscription: Sw. fr. 60.— Airmail rate: Sw.fr. 72.— Price per copy: Sw.fr. 20.— © World Health Organization 1992 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. ISSN 1010-9609 World Health Organization, Geneva WHO Drug Information Volume 6, 1992: Index A Didanosine and HIV, (1) 15 Diethylene glycol, (4) 169 ACE inhibitors, (1) 15 Dithranol, (3) 123 fetotoxicity, (2) 56 Doxycycline, (1) 37 dialysis anaphylaxis, (2) 56 Drug control, (3) 131 Acetylsalicylic acid, (4) 149 Drug information centres, (3) 106 Aciclovir, (1) 29, (2) 69 Drug surveillance, (2) 75 Advertising standards, (1) 14 Allopurinol, (2) 45 Aluminium diacetate, (2) 71 E poisoning, haemodialysis, (4) Epinephrine, (2) 73 Anaphylaxis, (3) 110 Erythromycin, (1) 32, (2) 68, (3) 123 Anthraquinone, (4) 168 Essential drugs lists, rare diseases (4) 147 Antibiotic resistance, (4) 160 Etretinate, (3) 124 Anticoagulants, (4) 153 Expensive drugs, cost containment, (3) 106 Antihistamines, (4) 165 Artemether, (1) 6 Ascaris therapy, (3) 98 F Atovaquone, (4) 168 Fenfluramines, (3) 110 Finasteride, (4) 168 Fluoxetine, (3) 110 B Foscamet sodium, (1) 16 Benzathine benzylpenicillin, (1) 30, (2) 67 Benzoyl peroxide, (3) 121 Benzyl benzoate, (2) 72 G Benzylpenicillin, (1) 30, (2) 67 Germander, (2) 57 Beta-adrenoreceptor agonists, (4) 153 Glafenine, (2) 57 asthma, (1) 17, (2) 56 Good Clinical Practice for pharmaceutical Bioavailability, (1) 1 products, (4) 170 Bioequivalence, (1) 1 Group-A streptococci, (2) 55 Biological standardization, (1) 38 Growth hormone, (3) 111 standards, (1) 38 Bufexamac, (2) 56 H Heparins, (4) 151 C Herbal medicines, (3) 103 Calamine lotion, (2) 70, (3) 121 HIV & tuberculosis, (2) 51 Ceftriaxone, (1) 31 Hydrocortisone, topical use, (1) 19 Chloramphenicol, meningitis, (2) 45 (2) 73, (3) 124 multiresistance, (4) 160 Chlorofluorocarbon restriction, (1) 15 I Chlorphenamine, (3) 121 Cinchophen, (2) 57 Immunity, vitamins and trace elements, (4) 161 Ciprofloxacin, (1) 31 Immunization, rubella, (3) 103 Clinical trial protocol, (4) 1855 Importation, illegal, (2) 57 Contraceptive, injectable, (4) 167 Infections, post-operative wound, (2) 53 Isoniazid, tuberculosis, (1) 12 oral, (4) 166 lUDs, (1) 6 Corticosteroids, immunosuppression, (1) 15 varicella, (2) 57 Counterfeiting, workshop (2) 41 L Counterfeits, (1) 3 Lucidine, (4) 168 D M Dapsone, (3) 122 M. leprae vaccine, (1) 7 Declaration of Helsinki, (4) 186 Magnesium, (4) 158 Dialysis anaphylaxis/ACE inhibitors, (2) 56 1 WHO Drug Information Volume 6, Index 1992 Melarsoprol, (2) 47 Meta-analysis, (4) 145 S Metamizole sodium, (1) 16 Salicylic acid, (2) 71 Methoxsalen, (3) 125 Selenium sulfide, (3) 127 Methylrosanilinium chloride, (2) 70 Spectinomycin, (1) 35 Metronidazole, (1) 33 Stereoisomerism, (4) 163 Miconazole, (1) 33 Streptomycin, tuberculosis, (1) 12 Micronutrients, (4) 161 Sulfamethoxazole/trimethoprim, (1) 35 Mumps vaccines, (4) 164 Sumatriptan, (3) 111 Mupirocin, (2) 68 Sunscreens, (3) 128 N T Non-steroidal anti-inflammatories, (4) 160 Tacrine, (2) 58 Noscapine, (1) 16 Tar products, (3) 128 Nystatin, (1) 34 Temafloxacin, (3) 112 Tetracycline, (1) 36, (3) 129 Thiazides, (4) 156 O Thrombolytic therapy, (4) 150 Ofloxacin, leprosy, (3) 99 Tiabendazole, (2) 69 Opioids, pain, (3) 99 Tibolone, (3) 112 Oral rehydration, (2) 46 Triazolam, (3) 112 Trimethoprim, (1) 35 P Tuberculosis & HIV, (2) 51 chemotherapy, (1) 12 Paediatric prescribing, (4) 163 Typhoid vaccines, (1) 9 Pain, opioids, (3) 99 Parental attitudes, (3) 108 Permethrin, (2) 72 V Pertussis vaccination, (1) 52 Vaccination, pertussis, (2) 52 vaccines, (4) 155 Vaccine immunogenicity, (1) 13 Pharmaceutical Inspection Convention, (3) 96 Vaccine, M. leprae, (1) 7 PIC, (3) 96 mumps, (4) 164 Podophyllum resin, (1) 34 pertussis, (4) 155 Postmarketing surveillance, (3) 95 typhoid (1) 9 Pralidoxime salt, (3) 101 Vitamin A, (1) 11 Prednisolone, (3) 126 Vitamin D, (3) 103 Procaine benzylpenicillin, (1) 30 Propofol, (2) 58 Pyrazinamide, tuberculosis, (1) 12 W Weight-reducers, (2) 58 Q Quinine, (1) 9 Z Zalcitabine, (2) 58 R Zidovudine, (2) 48 Rifampicin, tuberculosis, (1) 12 Ritodrine, (3) 104 Rubella immunization, (3) 103 2 Volume 6, Number 4, 1992 World Health Organization, Geneva WHO DRUG INFORMATION Contents General Policy Topics More on paediatric prescribing in new product labelling 163 Meta-analysis 145 Mumps vaccines and meningoencephalitis 164 Personal Perspectives Non-sedating antihistamines and cardiac arrhythmias 165 Essential drugs: for patients or for Standardized instructions for oral populations? 147 contraceptives 166 Injectable contraceptive approved by FDA 167 Reports on Individual Drugs Haemodialysis and chronic aluminium Acetylsalicylic acid in peripheral poisoning 167 arterial disease 149 Flucloxacillin: cholestatic jaundice 167 Acute pulmonary embolism: a place for Herbal products: more potential carcinogens 168 thrombolytic therapy? 150 Human interleukin-2 for renal cancer 168 Venous thromboembolism: heparins - Atovaquone for treatment of Pneumocystis fractionated and unfractionated - in carinii pneumonia 168 prophylaxis and treatment... 151 Finasteride for benign prostatic hyperplasia 168 ...and for how long are anticoagulants Diethylene glycol: yet another tragedy 169 really needed? 153 Beta-adrenoreceptor agonists and asthma deaths 153 Consultative Document Pertussis vaccines: cellular and acellular 155 Proposed WHO Guidelines for Good Clinical Thiazide therapy: who needs potassium Practice (GCP) for trials on pharmaceutical supplements? 156 products 170 Magnesium and acute cardiac infarction 158 Clinical trial protocol 185 Declaration of Helsinki 186 General Information More reports of multiresistant Salmonella typhi 160 Recent Publications Anti-inflammatory drugs: new insights into Infectious disease: an ominous and adverse gastrointestinal effects 160 unpredictable threat 189 Immunity, vitamins and trace elements 161 Proposed International Non• Regulatory Matters proprietary Names: List 68 191 Stereoisomerism and drug development 163 i WHO Drug Information Vol. 6, No. 4, 1992 General Policy Topics performance of a new drug to national regulatory Meta-analysis authorities when the individual studies lack the Practising doctors need to know how accumulated statistical power to demonstrate a clinically impor­ knowledge on a given set of therapeutic options is tant therapeutic effect with reasonable certainty (3). best translated into appropriate clinical manage­ Even more questionably, it is used as a means of ment. Meta-analysis provides them with an answer arbitration when the results of the individual trials in quantitative terms. It offers an "ultimate" estimate are discordant. of the comparative risks and benefits associated Proponents of meta-analysis readily concede that it with alternative courses of action. In doing so, it is far from a precise statistical tool. Sceptics provides a norm for the practising doctor to follow. question its very legitimacy as a quantitative Its potential influence on the routine practice of technique (4). The complexity of biological re­ medicine is profound. Yet the term has slipped into sponses and their multifactorial determinants the medical lexicon before being securely