(2000; 28 pages) [French]
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.