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. 2008 Sep-Oct;63(5):385-92.
doi: 10.2515/therapie:2008060. Epub 2009 Jan 21.

[Adverse drug reactions: a pilot study on patient reporting through patient associations]

[Article in French]
Daphney Nasrallah-Irles  1 , Anne Castot, Laure Thomas, Samy Babai, Bernard Delorme, Hervé Le-Louët
Affiliations

[Adverse drug reactions: a pilot study on patient reporting through patient associations]

[Article in French]
Daphney Nasrallah-Irles et al. Therapie. 2008 Sep-Oct.

Abstract

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.

Conclusion: The patient, eventually helped by his association, may provide contributory safety information, especially regarding side effects affecting daily life.

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