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Safety Monitoring of Medicinal Products: Guidelines for Setting Up and Running a Pharmacovigilance Centre
(2000; 28 pages) [French]
Índice de contenido
Ver el documentoINTRODUCTION
Ver el documento1. WHY PHARMACOVIGILANCE?
Ver el documento2. DEFINITION AND AIMS
Abrir esta carpeta y ver su contenido3. HOW TO START A PHARMACOVIGILANCE CENTRE
Abrir esta carpeta y ver su contenido4. REPORTING OF ADVERSE DRUG REACTIONS
Abrir esta carpeta y ver su contenido5. SPECIAL ISSUES IN REPORTING
Abrir esta carpeta y ver su contenido6. PRACTICALITIES IN THE ORGANISATION OF A PHARMACOVIGILANCE CENTRE
Abrir esta carpeta y ver su contenido7. ASSESSMENT OF CASE REPORTS
Abrir esta carpeta y ver su contenido8. USE OF THE DATA
Abrir esta carpeta y ver su contenido9. RELATIONS WITH OTHER PARTIES
Ver el documento10. OTHER SOURCES OF INFORMATION
Ver el documento11. FUNDING
Ver el documentoREFERENCES
Ver el documentoGLOSSARY
Ver el documentoCAUSALITY CATEGORIES
Ver el documentoWHO 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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