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
 

4.3 What to report?

In the early stages of any pharmacovigilance system, reports on all suspected adverse reactions - known or not, serious or not - are welcome and useful, because it is necessary to create a notification culture in which the instinctive response to any suspected adverse drug reaction is to report it. Healthcare professionals need to learn how and what to notify, and the staff of the pharmacovigilance centre need to gain experience in assessment, coding and interpretation.

In established pharmacovigilance systems it is common practice to request the reporting of all suspected reactions, including minor ones for new drugs. For established drugs the reporting of serious or unusual suspected adverse reactions is of particular importance, whereas known and minor reactions are of less interest (see Glossary for the definition of a serious reaction). If an increased frequency of a given reaction is suspected this is also a reason for reporting.

Although pharmacovigilance is primarily concerned with pharmaceutical medicines (including radiologic contrast media, vaccines and diagnostics), adverse reactions associated with drugs used in traditional medicine (e.g. herbal remedies) should also be considered. Special fields of interest are drug abuse and drug use in pregnancy (teratogenicity) and lactation.

In addition, the reporting of lack of efficacy and suspected pharmaceutical defects is recommended, especially when there is the possibility of manufacturing problems, counterfeit pharmaceuticals or of the development of resistance (e.g. antibiotics). Pharmacovigilance and poison control are closely related activities, since the problems encountered with accidental or intentional overdose may cast doubt on the safety of a medical drug.

Also, adverse reactions to cosmetics may need to be reported, especially when cosmetics contain obsolete or toxic ingredients (e.g. mercury compounds or corticoids in bleaching creams). If there is no other organisation in the country dealing with the issues, a pharmacovigilance centre may also cover problems related to medical devices and equipment, although different expertise may be needed.

The reporting of adverse events occurring during clinical trials are not covered by these guidelines. Recommendations on how to record and report such events are included in guidelines on good clinical practice for trials on pharmaceutical products (GCP).

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