(2000; 28 pages) [French]
4.1 Reporting form
A case report in pharmacovigilance can be defined as: A notification relating to a patient with an adverse medical event (or laboratory test abnormality) suspected to be induced by a medicine.
A case report should (as a minimum to aim at) contain information on the following elements:
1. The patient: age, sex and brief medical history (when relevant). In some countries ethnic origin may need to be specified.
2. Adverse event: description (nature, localisation, severity, characteristics), results of investigations and tests, start date, course and outcome.
3. Suspected drug(s): name (brand or ingredient name + manufacturer), dose, route, start/stop dates, indication for use (with particular drugs, e.g. vaccines, a batch number is important).
4. All other drugs used (including self-medication): names, doses, routes, start/stop dates.
5. Risk factors (e.g. impaired renal function, previous exposure to suspected drug, previous allergies, social drug use).
6. Name and address of reporter (to be considered confidential and to be used only for data verification, completion and case follow-up).
Reporting should be as easy and cheap as possible. Special free-post or business reply reporting forms, containing questions 1-6 mentioned above, can be distributed throughout the target area to healthcare professionals at regular intervals (for example, four times a year).
It may take the yearly distribution of hundreds of thousands of forms to harvest only some hundreds of case reports. It may be effective to include reply-paid reporting forms in the national formulary, drug bulletin or professional journals. Also telephone, fax and electronic mail or internet may be easy means of reporting where reliable technology is available and accessible.