Who Drug Information
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WHO DRUG INFORMATION VOLUME 1 • NUMBER 2 • 1987 PROPOSED INN LIST 57 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 wide audience of health profes Annual subscription: Sw.fr. 40.— sionals and policy-makers con Price per copy: Sw.fr. 15.— World Health Organization 1987 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.1, No.2,1987 World Health Organization, Geneva WHO Drug Information Contents Pharmacovigilance: a decentralized system 55 Pharmacopoeias, compendia and General Policy Topics texts of GMPs 55 Trademarks versus generic names for Chemical analysis unnecessary pharmaceuticals 39 for most drugs 55 Pharmacists' role in infection control 55 Points of view Research on new drugs involving New trends in drug evaluation in Italy 41 human subjects 56 Bleeding and antibiotic treatment 56 Reports on Individual Drugs Blood disorders associated with pirenzepine 56 Ivermectin in onchocerciasis 43 Intravaginal dinoprostone for induction of labour at term 56 General Information Tardive dyskinesia in antipsychotic therapy 57 Continuous cell lines in the Ibuprofen and aspirin safe in over- production of biologicals 46 the-counter use 57 Focus on interferons 46 "Congesting" nasal decongestants 57 Community pharmaceutical services Electrical stimulation devices to treat in Nigeria: towards self-reliance 47 scoliosis 58 Drugs and alternative medicine 47 Sugar in oral liquid medicines 58 Herbal medicines: safe and effective? 48 Drug interference in thyroid testing 58 Continuous subcutaneous insulin infusion 48 Cardiac pacemaker registry 58 A new focus on pharmaceuticals 49 Oxybutynin prescribing "unusually high" 58 New recommended schedule for active Benzodiazepine dependence 59 immunization of infants and children 49 Amitriptyline in diabetic neuropathy 60 Immunization programmes: inappropriate A review of clinical risks 60 application of contraindications 50 Barbiturate anaesthetics and termination Transmission of hepatitis B with jet gun of pregnancy 60 injections 50 Nicardipine, a new calcium antagonist 60 Screening for non-A, non-B Biotechnology patents for pharmaceuticals 60 hepatitis 50 Standardization of rabies immunoglobulin 61 The evaluation of teratogenicity of World Federation of Associations of chemical substances 51 Clinical Toxicology Centres and Definition of a teratogen 51 Poison Control Centres 61 Fetal abnormalities and use of drugs during pregnancy 52 Update on AIDS Reporting congenital malformations 52 Prospects for vaccines ang antiviral therapy 62 Post-marketing surveillance and Zidovudine 72 medical databases 52 Keeping the AIDS virus out of blood supplies 65 3rd International Conference on AIDS: condoms on prgscription? 65 Pharmacoepidemiology 53 Safety of factor VIIK and IX concentrates 65 Drug abuse in the Americas and the Autologous blood transfusion 65 Caribbean 53 Zidovudine avcilable under AIDS Draft guidelines for the investigation treatment resecrch protocol 66 of bioavailability 54 AIDS, condoms and spermicides 66 Research on healthy volunteers 55 (continued) WHO Drug Information Vol. 1, No. 2 1987 Contents (continued) Pharmaceutical Products Approved Advisory Notices Benzodiazepine antagonist 67 Pregnancy warnings in data sheets 80 Diagnostic assay for hepatitis delta agent 67 Clinical evaluation of non-steroidal Biotechnology: a new hepatitis B vaccine 67 anti-inflammatory drugs 80 Other products approved 68 Allergen extracts and anaphylaxis 80 Adverse effects of anti-infective drugs 81 Reports from Regulatory Agencies Anabolic steroids and athletic performance 82 Aminophenazone, Anticholinergic drugs, Barbiturates, Bepridil, Bucetin, Essential Drugs Bupivacaine 69 "River blindness" affects 18 million people 83 Captopril, Carbamazepine, Flunitrazepam Diethylcarbamazine 83 Hydrocortisone (topical preparations), Suramin sodium 85 Mefloquine 70 Accelerated stability studies under Mianserin, Metformin, Nifedipine simulated tropical conditions 86 Paracetamol 71 Sensitivity of Plasmodium falciparum to Phenacetin, Spironolactone, Sulpiride, quinine and mefloquine in Thailand 87 Tartrazine, Other decisions 72 Nigeria adopts an essential drugs list 87 Sudan's new drug policy and essential Regulatory Matters drugs list 88 The future of regulatory affairs in Europe 73 Pharmaceuticals in the European Community 73 Recent Publications Controlled studies not essential for Essential malariology 89 "home medicines" 74 Treatment of cardiac tachyarrhythmias 89 Exports of unapproved drugs: Medicinal products for use in self-medication 89 new legislation 74 Drugs in hospitals 90 Carcinogenicity studies 75 Pharmaceutical regulation in Italy 90 Mutual recognition of toxicological data 76 A handbook of pharmaceutical excipients 90 Good Laboratory Practices 76 Drug information for the health care provider 90 Proprietary medicinal products—Nordic Pharmaceutical administration in Japan 90 guidelines for evaluation reports 76 Treatment of sexually transmitted disease 91 Over-the-counter drug (OTC) review 76 Cancer pain relief 91 Good Manufacturing Practices for Human experimentation: legal and ethical medical devices 77 aspects 91 Sterility testing of parenteral drugs 77 Drug consumption in Norway 91 Mutual recognition of inspection certificates 77 Drug information bulletin from Chile 92 Approved veterinary drugs 77 A magazine from the German Labelling and advertising of new Democratic Republic 92 animal drugs 78 An international society of editors of Generic drugs for animals 78 drug bulletins 92 Product liability and its implications for the practice of pharmacy and medicine 78 Proposed International Nonproprietary Drug Regulatory Index 79 Names: List 57 93 WHO Drug Information Vol. 1, No.2,1987 General Policy Topics Trademarks versus generic aids) such as solvents, preservatives, tablet coat ings and capsule shells that determine the stability names for pharmaceuticals of the product and its time-course of action in the patient. A conflict that requires resolution Preparations containing the same drug substance Generic Names are frequently sold under different trademarks in different countries, and even within the same coun Generic, nonproprietary or common names are try. The Pharmaceutical Trademark Directory selected by national or international nomenclature shows that in 1985 some 60,000 trademarks for committees to designate pharmacologically active drug products were in use in a total of only 36 coun drug substances. As a matter of definition, they tries. cannot be owned by a private party. They are a form of public property which anyone is free to use. Protection of Generic Names The international nonproprietary names (INNs) The INN nomenclature is based on the use of com designated and recommended by WHO offer a mon stems for substances that are chemically or means of identifying each drug substance by a pharmacologically related. Thus each name indi unique, globally applicable and accepted generic cates the chemical or pharmacological genus to name (1). This is of critical importance in facilitating which the substance belongs. For example: and rationalizing communication in medical science as well as in the labelling and advertising of medici • ß-adrenoreceptor-bbcking agents are identified nal products. Since 1953 some 5,500 INNs have by the suffix -olol (pindolol, propranolol, timolol, been selected. These