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
Open this folder and view contents4. REPORTING OF ADVERSE DRUG REACTIONS
Open this folder and view contents5. SPECIAL ISSUES IN REPORTING
Open this folder and view contents6. PRACTICALITIES IN THE ORGANISATION OF A PHARMACOVIGILANCE CENTRE
Close this folder7. ASSESSMENT OF CASE REPORTS
View the document7.1 Data-processing
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
 

7.1 Data-processing

In the early stages case-reports can be managed manually. When reporting increases, a computer system enabling the processing and retrieval of cases according to suspected drugs and adverse reactions is generally advisable.

The computer system used should include a hierarchical drug file allowing drugs to be recorded according to product name, generic name and therapeutic category. Similarly a hierarchical adverse reaction terminology should be employed. Hierarchical systems for the recording of drugs and adverse reactions are necessary to allow for specific recording of detailed case information while still permitting retrieval of information at higher levels.

As far as possible internationally recognised terminologies and classifications of drugs (ATC, INN) and adverse reactions (e.g. WHOART, MedDRA) should be used, to facilitate international comparisons of results and international transfer of data. Special care should be taken to attain compatibility with the reporting requirements of the WHO Drug Monitoring Programme. Detailed instructions on how to organise computerised data for submission to the WHO database are obtainable from the Uppsala Monitoring Centre. It may not be cost-effective to design a computer system for the management of adverse reaction reports from scratch. Commercial programmes are available which have been appropriately tested and can be customised according to local needs including local languages.

to previous section
to next section
 
 
The WHO Essential Medicines and Health Products Information Portal was designed and is maintained by Human Info NGO. Last updated: December 6, 2017