WHO Drug Information Vol. 02, No. 3, 1988
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WHO DRUG INFORMATION VOLUME 2 • NUMBER 3 • 1988 RECOMMENDED INN LIST 28 INTERNATIONAL NONPROPRIETARY NAMES FOR PHARMACEUTICAL SUBSTANCES WORLD HEALTH ORGANIZATION • GENEVA WHO Drug Information WHO Drug Information provides an cerned with the rational use of overview of topics relating to drug drugs. In effect, the journal seeks development and regulation that to relate regulatory activity to are of current relevance and im therapeutic practice. It also aims to portance, and will include the lists provide an open forum for debate. of proposed and recommended In Invited contributions will portray a ternational Nonproprietary Names variety of viewpoints on matters of for Pharmaceutical Substances general policy with the aim of sti (INN). Its contents reflect, but do mulating discussion not only in not present, WHO policies and ac these columns but wherever re tivities and they embrace socio levant decisions on this subject economic as well as technical mat have to be taken. ters. WHO Drug Information is publish The objective is to bring issues that ed 4 times a year in English and are of primary concern to drug French. regulators and pharmaceutical manufacturers to the attention of a Annual subscription: Sw. fr. 50.— wide audience of health profes Airmail rate: Sw. fr. 60.— sionals and policy-makers con Price per copy: Sw. fr. 15.— C World Health Organization 1988 Publications of the World Health Organization Authors alone are responsible for views expressed enjoy copyright protection in accordance with in signed contributions. the provisions of Protocol 2 of the Universal The mention of specific companies or of certain Copyright Convention. For rights of reproduc manufacturers' products does not imply that they are tion or translation, in part or in toto, applica endorsed or recommended by the World Health tion should be made to: Chief, Office of Organization in preference to others of a similar na Publications, World Health Organization, ture which are not mentioned. Errors and omissions 1211 Geneva 27, Switzerland. The World excepted, the names of proprietary products are Health Organization welcomes such applica distinguished by initial capital letters. tions. The designations employed and the presen tation 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 concern ing the delimitation of its frontiers or boun daries. ISSN 1010-9609 Vol. 2, No. 3, 1988 World Health Organization, Geneva WHO Drug Information Contents AIDS therapy: prospects reassessed 136 Antibiotic audit in a hospital setting 137 Child-resistant packaging General Policy Topics and elderly patients 137 The WHO Certification Scheme: Drugs or psychotherapy in neurotic performance and potential 121 disorder? 137 Transfer of topically-applied drugs 138 Bioequivalence of generic drugs 138 Points of View Importation ban on skin-lightening Towards a single pharmaceutical market soaps and creams 138 for the European Community 123 Accelerated availability of new drugs for serious conditions 138 Reports on Individual Drugs Task force on counterfeit drugs 139 Acetylsalicylic acid in vascular disease 125 Acetylsalicylic acid in pregnancy 127 Regulatory Matters BCG vaccines: influence of manufacturing techniques 128 Drugs for Human Use Mycobacterium BCG: counting by Antibiotics: final monograph for over- firefly luciferase assay 128 the-counter topical products 140 Vitamin A supplements and diarrhoea 129 Buprenorphine: reduced dosage 140 Targeted vidarabine inhibits viral Cianidanol: definitive withdrawal 140 replication in chronic hepatitis B 129 Clomipramine: approved for obsessive Nitrates and tolerance 129 compulsive disorders 140 Etretinate: retinal abnormalities 130 Clomethiazole: revised product Beta-blockers in post-infarction information 141 patients 130 Deferoxamine mesilate: revised A role for methotrexate in product information 141 rheumatoid arthritis? 130 Diclofenac: revised product Halofantrine in falciparum malaria 131 information 141 Community administration of Diltiazem: hypersensitivity warning 141 ivermectin 132 Expiry dates: proposed amendment Oral rehydration therapy and child to the food and drug regulations 141 mortality 132 Further requirements for tamper- Effect of influenza immunization resistant packaging 142 on mortality 132 Heat-treated factor VIII: restricted First clinical study of a birth use 142 control vaccine 133 Human blood and blood products: testing for HIV antibody 142 General Information Isoniazid/protionamide/dapsone: Poliomyelitis eradication by the year hepatic toxicity 142 2000 adopted as WHO goal 134 Isotretinoin: restricted use 142 Cost and benefit in cancer care 134 Isoxicam: marketing suspension Guidelines for drug donations 135 extended 143 Physician dispensing: a conflict of Nifedipine: sublingual absorption interest? 135 ineffective 143 Biotechnology gains momentum in Nontherapeutic ingredients: disclosure drug development 136 on labelling 143 Vaccine potency testing: information Prenylamine: worldwide withdrawal 144 on laboratories sought 136 Ranitidine: revised product information 144 i Who Drug Information, Vol. 2, No. 3, 1988 Contents (continued) Revised requirements for synthetic Calcium channel blocking agents: thyroid packaging materials 144 hyperplasia 149 Somatropin: possible link with Captan: prohibited in cosmetics 149 leukaemia 144 Cefaclor: restricted use in children 149 Spironolactone: restricted indications 144 Chemonucleolysis: conditions for Suffadoxine/pyrimethamine: revised application 150 product information 144 Ciprofloxacin: interaction with Tiabendazole: under prescription theophylline 150 control 145 Diethylhexylphthalate (DEHP): call Tretinoin: prohibition in cosmetics 145 for reports of adverse effects 150 Triazolam: restrictive measures 145 Estrogen oral contraceptives 150 Herbal tea (Sou Tsian Te): Drugs for Veterinary Use adverse reactions 150 Carcinogenicity testing: safety Slimming pills: cautionary information standards for new veterinary drugs 145 for users 151 Cefoperazone: registration refusal 146 Terfenadine: adverse reaction reports 151 Cefuroxime: approved for use in Xylane-polyhydrogen sulfate: cattle 146 thrombo-embolism 151 Chloramphenicol: prohibited in food- producing animals 146 Essential Drugs Fenbendazole: extension of indications 146 Halofuginone + bacitracin Leprosy affects more than ten million methylenedisalicylate approved 146 people worldwide 152 Maduramicin approved 146 Clofazimine 154 Monensin approved 147 Dapsone 155 Parvovirus vaccine approved 147 Rifampicin 155 Sulfadimidine: carcinogenicity in Ethionamide/protionamide 157 rodents 147 Sulfadimidine: residues in milk 147 Newly Registered Products 158 Trichophyton verrucosum vaccine 147 approved Recent Publications A monthly newsletter on AIDS 161 Advisory Notices Responsibility for drug-induced injury 161 Amsacrine: new preparation Guidelines for the control of recommended 148 Shigella dysenteriae 1 161 Astemizole: indications and Information on veterinary products 161 adverse effects 148 Why report adverse drug reactions? 162 Bemetizide/triamterene: warning of allergic vasculitis 148 Benzodiazepines: warning of dependence liability 148 Recommended International Bromocriptine: pulmonary changes 149 Nonproprietary Names: List 28 163 Buspirone: central nervous system and extrapyramidal effects 149 ii WHO Drug Information Vol. 2, No. 3, 1988 General Policy Topics The WHO Certification the widespread routine use of growth-promoting sub Scheme: performance and stances to increase yields in food-producing animals. potential • The extension of the Scheme to include drug substances as well as finished dosage forms reflects the steadily rising international commerce in these commodities. More countries are manufacturing and During the Forty-first World Health Assembly held in exporting them, while others are becoming more Geneva in May of this year, several substantive active in formulating finished products from drug sub amendments were introduced into the WHO stances imported in bulk. Certification Scheme on the quality of pharmaceuti cal products moving in international commerce (1). The last of these factors, together with the emer These bring within the ambit of the Scheme drug gence of generic manufacturing as an important substances as well as finished dosage forms, and market force in many countries, is contributing to an products intended for veterinary use as well as those important restructuring of the industry. The competi for human use. They also require the competent tive edge that these companies bring to trade in pat authority in the exporting country to provide copies of ent-expired products is welcomed by governments all approved labelling and package inserts, as everywhere as a means of relieving the heavy contained in the product licence, together with the burden of drug costs in the public sector. At the same date of their approval. time, regulatory authorities are confronted with the challenge of ensuring that the safety of patients is With the introduction of the WHO certification never unnecessarily placed at risk by allowing quality procedure in 1975, an international corollary was to be compromised in the interests of economy. established to national systems of product registra Assurance has to be obtained, through prevailing tion. Importing authorities were provided not only