Safety Monitoring of Medicinal Products: Guidelines for Setting Up and Running a Pharmacovigilance Centre: 4. REPORTING OF ADVERSE DRUG REACTIONS

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

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

4. REPORTING OF ADVERSE DRUG REACTIONS

Spontaneous reporting - a regional or country-wide system for the reporting of suspected adverse drug reactions - is currently the major source of information in pharmacovigilance.