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Updating the French method for the causality assessment of adverse drug reactions.
Therapie ; 68(2): 69-76, 2013.
Article en En | MEDLINE | ID: mdl-23773347
The Imputability Working Group (CRI) updated the French drug reaction causality assessment method. This tripartite group is made up of staff from the French network of regional pharmacovigilance centres, pharmaceutical companies, and the French National Agency for the Safety of Medicines and Health Products (ANSM). After reviewing the strengths and weaknesses of the previous method, several ideas for improvement were proposed: a better-worded and more discriminating scale for certain chronological and semiological criteria, a larger scale for the intrinsic score (increased from 5 to 7 levels), a new bibliographical scale to differentiate between expected and unexpected adverse drug reactions, and a new informativeness scale.
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Sistemas de Registro de Reacción Adversa a Medicamentos / Farmacovigilancia Tipo de estudio: Etiology_studies Límite: Humans País/Región como asunto: Europa Idioma: En Revista: Therapie Año: 2013 Tipo del documento: Article País de afiliación: Francia

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Sistemas de Registro de Reacción Adversa a Medicamentos / Farmacovigilancia Tipo de estudio: Etiology_studies Límite: Humans País/Región como asunto: Europa Idioma: En Revista: Therapie Año: 2013 Tipo del documento: Article País de afiliación: Francia