Safety Monitoring of Medicinal Products: Guidelines for Setting Up and Running a Pharmacovigilance Centre
(2000; 28 pages) [French]
Table of Contents
View the documentINTRODUCTION
View the document1. WHY PHARMACOVIGILANCE?
View the document2. DEFINITION AND AIMS
Close this folder3. HOW TO START A PHARMACOVIGILANCE CENTRE
View the document3.1 Basic steps in setting up a Pharmacovigilance Centre
Open this folder and view contents4. REPORTING OF ADVERSE DRUG REACTIONS
Open this folder and view contents5. SPECIAL ISSUES IN REPORTING
Open this folder and view contents6. PRACTICALITIES IN THE ORGANISATION OF A PHARMACOVIGILANCE CENTRE
Open this folder and view contents7. ASSESSMENT OF CASE REPORTS
Open this folder and view contents8. USE OF THE DATA
Open this folder and view contents9. RELATIONS WITH OTHER PARTIES
View the document10. OTHER SOURCES OF INFORMATION
View the document11. FUNDING
View the documentREFERENCES
View the documentGLOSSARY
View the documentCAUSALITY CATEGORIES
View the documentWHO CONTACTS
 

3. HOW TO START A PHARMACOVIGILANCE CENTRE

A new pharmacovigilance centre can start operating very quickly. The development of a pharmacovigilance system, however, from the first and uncertain stage to becoming an established and effective organisation, is a process that needs time, vision, dedication, expertise and continuity. The most promising location for a new pharmacovigilance centre may depend on the organisation and development of the healthcare system in the country and other local issues.

A governmental department (health authority, drug regulatory agency) can be a good host for a pharmacovigilance centre. However, any department in a hospital or academic environment, working in clinical pharmacology, clinical pharmacy, clinical toxicology or epidemiology, may be a suitable starting point for pharmacovigilance. The reporting of adverse drug reactions may start locally, perhaps in one hospital, then extend to other hospitals and family practices in the region, and progress step by step into a national activity. In some countries professional bodies such as the national medical association may be a good home for the centre.

When the centre is a country-wide organisation from the start, it should be remembered that much effort, especially in effective communications, will be needed before a substantial proportion of practitioners are contributing.

When a centre is part of a larger organisation (for example, a poison control unit, a clinical pharmacology department, or a hospital pharmacy) providing administrative continuity, it can get going as long as there is one professional (e.g. a physician or pharmacist) available who is primarily responsible for pharmacovigilance.

Whatever the location of the centre, pharmacovigilance is closely linked to drug regulation. Governmental support is needed for national co-ordination. Pharmacovigilance is nobody’s individual privilege. Good collaboration, co-ordination, communications and public relations are needed for coherent development and for the prevention of unnecessary competition or duplication.

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