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
Close this folder4. REPORTING OF ADVERSE DRUG REACTIONS
View the document4.1 Reporting form
View the document4.2 Reporting by whom?
View the document4.3 What to report?
View the document4.4 Mandatory or voluntary reporting?
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
 

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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