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Safety Monitoring of Medicinal Products: Guidelines for Setting Up and Running a Pharmacovigilance Centre
(2000; 28 pages) [French]
Table des matières
Afficher le documentINTRODUCTION
Afficher le document1. WHY PHARMACOVIGILANCE?
Afficher le document2. DEFINITION AND AIMS
Ouvrir ce répertoire et afficher son contenu3. HOW TO START A PHARMACOVIGILANCE CENTRE
Ouvrir ce répertoire et afficher son contenu4. REPORTING OF ADVERSE DRUG REACTIONS
Ouvrir ce répertoire et afficher son contenu5. SPECIAL ISSUES IN REPORTING
Ouvrir ce répertoire et afficher son contenu6. PRACTICALITIES IN THE ORGANISATION OF A PHARMACOVIGILANCE CENTRE
Ouvrir ce répertoire et afficher son contenu7. ASSESSMENT OF CASE REPORTS
Ouvrir ce répertoire et afficher son contenu8. USE OF THE DATA
Ouvrir ce répertoire et afficher son contenu9. RELATIONS WITH OTHER PARTIES
Afficher le document10. OTHER SOURCES OF INFORMATION
Afficher le document11. FUNDING
Afficher le documentREFERENCES
Afficher le documentGLOSSARY
Afficher le documentCAUSALITY CATEGORIES
Afficher le documentWHO CONTACTS
 

2. DEFINITION AND AIMS

Pharmacovigilance is concerned with the detection, assessment and prevention of adverse reactions to drugs. Major aims of pharmacovigilance are:

1. Early detection of hitherto unknown adverse reactions and interactions

2. Detection of increases in frequency of (known) adverse reactions

3. Identification of risk factors and possible mechanisms underlying adverse reactions

4. Estimation of quantitative aspects of benefit/risk analysis and dissemination of information needed to improve drug prescribing and regulation.

The ultimate goals of pharmacovigilance are:

• the rational and safe use of medical drugs
• the assessment and communication of the risks and benefits of drugs on the market
• educating and informing of patients.

Spontaneous reporting - a regional or country-wide system for the reporting of suspected adverse drug reactions - is the primary method in pharmacovigilance. In addition, other methods of data-collection exist or are under development (see § 8.5 and 10).

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