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
 

4.1 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.

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