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
Fermer ce répertoire4. REPORTING OF ADVERSE DRUG REACTIONS
Afficher le document4.1 Reporting form
Afficher le document4.2 Reporting by whom?
Afficher le document4.3 What to report?
Afficher le document4.4 Mandatory or voluntary reporting?
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
 

4.2 Reporting by whom?

Professionals working in healthcare are the preferred source of information in pharmacovigilance, for example family practitioners, medical specialists and pharmacists. Dentists, midwives, nurses and other health workers may also administer or prescribe drugs and should report relevant experiences.

In addition pharmacists and nurses can play an important role in the stimulation of reporting and in the provision of additional information (for example, on co-medication and previous drug use).

Pharmaceutical manufacturers, being primarily responsible for the safety of their products, have to ensure that suspected adverse reactions to their products are reported to the competent authority. If adverse reactions are reported directly by patients to the national or local centre, it is useful to consider the possibility of communication with their physicians for additional information and data verification.

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Le Portail d'information - Médicaments essentiels et produits de santé a été conçu et est maintenu par l'ONG Human Info. Dernière mise à jour: le 29 octobre 2018