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
 

3.1 Basic steps in setting up a Pharmacovigilance Centre

Prepare a plan according to the points below for the establishment of the pharmacovigilance system.

1. Make contacts with the health authorities and with local, regional or national institutions and groups, working in clinical medicine, pharmacology and toxicology outlining the importance of the project and its purposes.

2. Design a reporting form (see § 4.1) and start collecting data by distributing it to hospital departments, family practitioners, etc.

3. Produce printed material to inform health professionals about definitions, aims and methods of the pharmacovigilance system.

4. Create the centre: staff, accommodation, phone, word processor, database management capability, bibliography etc.

5. Take care of the education of pharmacovigilance staff with regard, for example, to:

• data collection and verification
• interpreting and coding of adverse reaction descriptions
• coding of drugs
• case causality assessment
• signal detection
• risk management.

6. Establish a database (administrative system for the storage and retrieval of data; see also § 7.1).

7. Organise meetings in hospitals, academia and professional associations, explaining the principles and demands of pharmacovigilance and the importance of reporting.

8. Promote the importance of reporting adverse drug reactions through medical journals, other professional publications, and communications activities.

9. Maintain contacts with international institutions working in pharmacovigilance, e.g. the WHO Department of Essential Drugs and Medicines Policy (Geneva) and the Uppsala Monitoring Centre, Sweden (see page 24 for all contact details).

to previous section
to next section
 
 
The WHO Essential Medicines and Health Products Information Portal was designed and is maintained by Human Info NGO. Last updated: December 6, 2017