Farmacovigilancia

VIGILANCIAThe IMPORTANCE
of PHARMACOVIGILANCE
Safety Monitoring of medicinal products

World Health Organization 2002

WHO Library Cataloguing-in-Publication Data
The Importance of Pharmacovigilance. (Safety monitoring of medicinal products) 1. 2. 3. 4. 5. Drug monitoring Pharmaceutical preparations - adverse effects Adverse drug reaction reporting Product surveillance, PostmarketingLegislation, Drug I.Series (NLM classification: QV 38)

ISBN 92 4 159015 7

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© World Health Organization 2002
Publications of the World Health Organization enjoy copyright protection in accordance with the provisions of Protocol 2 of the Universal Copyright Convention. All rights reserved. The designations employed and the presentation of the material in this publication do notimply 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. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the WorldHealth Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters.

Typeset and printed in the United Kingdom.

The IMPORTANCE
Safety Monitoring of medicinal products

of PHARMACOVIGILANCE

World Health Organization 2002

WHO Collaborating Centre forInternational Drug Monitoring

TABLE OF CONTENTS
Contents Preface Chapter 1 Introduction Chapter 2 A Short History of Involvement in Drug Safety Monitoring by WHO Chapter 3 Partners in Pharmacovigilance Chapter 4 Pharmacovigilance in Drug Regulation Chapter 5 Pharmacovigilance in Clinical Practice Chapter 6 Pharmacovigilance in International Health Chapter 7 Conclusion and considerations for thefuture Glossary References Page 3 4 5 9 15 24 28 35 40 44

PREFACE
The Quality Assurance and Safety: Medicines team in WHO aims to assure the safety of medicines by ensuring reliable and timely exchange of information on drug safety issues, promoting pharmacovigilance activities throughout the Organization and encouraging participation in the WHO Programme for International Drug Monitoring. Thisteam is developing a series of publications on Safety Monitoring of Medicinal Products. This text was developed in consultation with the WHO Collaborating Centre for International Drug Monitoring and the national pharmacovigilance centres participating in the WHO Programme for International Drug Monitoring. The draft was widely circulated and discussed at two informal consultations withinternational experts in pharmacovigilance. The WHO Department of Essential Drugs and Medicines in Geneva held these consultations. Contributions were made by: Ms N Arthur, Irish Medicines Board, Dublin, Ireland Dr A Bentsi-Enchill, Vaccine Assessment and Monitoring, WHO, Geneva Dr M R Couper, Quality Assurance and Safety: Medicines, WHO, Geneva Dr P Duclos, Vaccine Assessment and Monitoring, WHO, Geneva DrI R Edwards, WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden Mr T Fushimi, Ministry of Health, Labour and Welfare, Tokyo, Japan Dr K Hartigan-Go, Makati City, Philippines Dr P Folb, University of Cape Town, Cape Town, South Africa Dr N A Kshirsagar, GS Medical College and KEM Hospital, Mumbai, India Dr J K Lazdins-Helds, Product Research and Development, WHO, Geneva...