(2000; 28 pages) [French]
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).