Safety Monitoring of Medicinal Products: Guidelines for Setting Up and Running a Pharmacovigilance Centre
(2000; 28 pages) [French]

Abstract

This booklet aims to provide practical guidelines and information for the setting up of new Pharmacovigilance Centres...Criteria for this development are not only the functioning of the centre in question itself, but also the presence of an effective drug regulatory body in the country that has the will and the potential to react to signals emanating from the centre and to take proper regulatory measures. WHO considers this point as vital: a pharmacovigilance system must be backed up by the regulatory body...

Table of Contents

	INTRODUCTION
	1. WHY PHARMACOVIGILANCE?
	2. DEFINITION AND AIMS
	3. HOW TO START A PHARMACOVIGILANCE CENTRE
		3.1 Basic steps in setting up a Pharmacovigilance Centre
	4. REPORTING OF ADVERSE DRUG REACTIONS
		4.1 Reporting form
		4.2 Reporting by whom?
		4.3 What to report?
		4.4 Mandatory or voluntary reporting?
	5. SPECIAL ISSUES IN REPORTING
		5.1 Central or decentralised reporting?
		5.2 Stimulation of reporting
		5.3 Under-reporting
	6. PRACTICALITIES IN THE ORGANISATION OF A PHARMACOVIGILANCE CENTRE
		6.1 Staff
		6.2 Useful equipment (includes)
		6.3 Continuity
		6.4 Advisory Committees
		6.5 Information service
		6.6 Communications
		6.7 Poison Control and Drug Information Centres
	7. ASSESSMENT OF CASE REPORTS
		7.1 Data-processing
	8. USE OF THE DATA
		8.1 Hypothesis generation and strengthening
		8.2 Drug regulation
		8.3 Information
		8.4 Education and feedback
		8.5 Limitations regarding the use of the data
	9. RELATIONS WITH OTHER PARTIES
		9.1 The Drug Regulatory Authority
		9.2 Pharmaceutical companies
		9.3 Professional medical and pharmaceutical associations
		9.4 World Health Organization
		9.5 National pharmacovigilance centres
		9.6 Academia
		9.7 Media and consumer organisations
	10. OTHER SOURCES OF INFORMATION
	11. FUNDING
	REFERENCES
	GLOSSARY
	CAUSALITY CATEGORIES
	WHO CONTACTS

Safety Monitoring of Medicinal Products: Guidelines for Setting Up and Running a Pharmacovigilance Centre

World Health Organization

Published by

the Uppsala Monitoring Centre
(the UMC), WHO Collaborating Centre for
International Drug Monitoring
Stora Torget 3, S-75320 Uppsala,
Sweden

Tel: +46 18 65 60 60
Fax: +46 18 65 60 80
E-mail: info@who-umc.org
Internet: www.who-umc.org

ISBN 91-630-9004-X

This document is not a formal publication of the World Health Organization (WHO) and all rights are reserved by the WHO Collaborating Centre for International Drug Monitoring (the UMC). The document may nevertheless be freely reviewed, abstracted, reproduced or translated into any other language (but not for sale) provided that full acknowledgement is given to the source.

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