Expand Document  |  Expand Chapter  |  Full TOC  |  Printable HTML version
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
Open this folder and view contents3. HOW TO START 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
 

1. WHY PHARMACOVIGILANCE?

The information collected during the pre-marketing phase of a medical drug is inevitably incomplete with regard to possible adverse reactions (for definition see Glossary):

• tests in animals are insufficiently predictive of human safety

• in clinical trials patients are selected and limited in number, the conditions of use differ from those in clinical practice and the duration of trials is limited

• information about rare but serious adverse reactions, chronic toxicity, use in special groups (such as children, the elderly or pregnant women) or drug interactions is often incomplete or not available.

Pharmacovigilance is needed in every country, because there are differences between countries (and even regions within countries) in the occurrence of adverse drug reactions and other drug-related problems. This may be because of differences in:

• drug production

• distribution and use (e.g. indications, dose, availability)

• genetics, diet, traditions of the people

• pharmaceutical quality and composition (excipients) of locally produced pharmaceutical products

• the use of non-orthodox drugs (e.g. herbal remedies) which may pose special toxicological problems, when used alone or in combination with other drugs.

Data derived from within the country or region may have greater relevance and educational value and may encourage national regulatory decision-making. Information obtained in a certain country (e.g. the country of origin of the drug) may not be relevant to other parts of the world, where circumstances may be different. When information from a region itself is not available, it may take longer before a problem becomes known to drug regulatory authorities, physicians, pharmacists, patients and pharmaceutical companies.

On the other hand, international monitoring such as the WHO International Drug Monitoring Programme may provide information on possible safety issues which may not yet have emerged within the country’s data. Pharmacovigilance is needed for the prevention of drug-induced human suffering and to avoid financial risks associated with unexpected adverse effects. In conclusion, medicines on the market need continuous monitoring in every country.

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