Safety Monitoring of Medicinal Products: Guidelines for Setting Up and Running a Pharmacovigilance Centre
(2000; 28 pages) [French]
Table des matières
Afficher le documentINTRODUCTION
Afficher le document1. WHY PHARMACOVIGILANCE?
Afficher le document2. DEFINITION AND AIMS
Ouvrir ce répertoire et afficher son contenu3. HOW TO START A PHARMACOVIGILANCE CENTRE
Fermer ce répertoire4. REPORTING OF ADVERSE DRUG REACTIONS
Afficher le document4.1 Reporting form
Afficher le document4.2 Reporting by whom?
Afficher le document4.3 What to report?
Afficher le document4.4 Mandatory or voluntary reporting?
Ouvrir ce répertoire et afficher son contenu5. SPECIAL ISSUES IN REPORTING
Ouvrir ce répertoire et afficher son contenu6. PRACTICALITIES IN THE ORGANISATION OF A PHARMACOVIGILANCE CENTRE
Ouvrir ce répertoire et afficher son contenu7. ASSESSMENT OF CASE REPORTS
Ouvrir ce répertoire et afficher son contenu8. USE OF THE DATA
Ouvrir ce répertoire et afficher son contenu9. RELATIONS WITH OTHER PARTIES
Afficher le document10. OTHER SOURCES OF INFORMATION
Afficher le document11. FUNDING
Afficher le documentREFERENCES
Afficher le documentGLOSSARY
Afficher le documentCAUSALITY CATEGORIES
Afficher le 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.

vers la section précédente
vers la section suivante
 
 
Le Portail d'information - Médicaments essentiels et produits de santé a été conçu et est maintenu par l'ONG Human Info. Dernière mise à jour: le 29 octobre 2018