[Adverse drug reactions: a pilot study on patient reporting through patient associations].
BACKGROUND
The expected evolution of monitoring systems for health products, aims at increasing the involvement of patients into health products safety system. As a result, it seems necessary to consider the ability for patients to directly report their own adverse events.


METHODS
A pilot study has been undertaken by Afssaps (Health Agency) for 23 patient associations using a reporting form specially created for patients.


RESULTS
According to the analysis of the first 200 reports, received from June 2006 to August 2007, the reported adverse events are mostly serious in terms of consequences on patients' quality of life and expected. The quality of information shows that the proposed tools are adequate and could be used in case of a future change in legislation allowing patient reporting of adverse events.


CONCLUSIONS
The patient, eventually helped by his association, may provide contributory safety information, especially regarding side effects affecting daily life.
Nasrallah-Irles
Daphney
D
Afssaps, Service de l'Evaluation et de la Surveillance du Risque et de l'Information sur les Médicaments, Saint-Denis, France.
Castot
Anne
A
Thomas
Laure
L
Babai
Samy
S
Delorme
Bernard
B
Le-Louët
Hervé
H
D004358:Drug Therapy / Q000523:psychology* / Q000592:standards; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D008991:Monitoring, Physiologic; D010361:Patients / Q000523:psychology; D011788:Quality of Life; D012449:Safety