[法国药物警戒系统:结构与使命]

[The French pharmacovigilance system: structure and missions].

作者信息

Welsch M, Alt M, Richard M H, Imbs J L

机构信息

Centre régional de Pharmacovigilance Alsace, Hôpitaux Universitaires de Strasbourg.

出版信息

Presse Med. 2000 Jan 22;29(2):102-6.

DOI:
Abstract

THE NETWORK

The French pharmacovigilance system is composed of a network of 31 regional pharmacovigilance centers located in convenient proximity to health care professionals. CAUSALITY ASSESSMENT: A causality assessment method is compulsory for all persons involved in pharmacovigilance in order to assess the causal relationship between an adverse effect and one or more drugs. PHARMACOEPIDEMIOLOGY: If necessary, an additional evaluation of the causal relationship is performed using pharmacoepidemiology methods. THE NATIONAL COMMISSION: A technical committee and a National Commission of Pharmacovigilance centralizes at the Agence Françiase de Sécurité Sanitaire (or AFSSAPS) and assesses all data in order to provide consensual advise to the relevant authorities on necessary measures, to prevent or reduce a drug-related adverse effect.

摘要

网络

法国药物警戒系统由31个区域药物警戒中心组成的网络构成,这些中心与医疗保健专业人员的距离较近,交通便利。

因果关系评估

对于所有参与药物警戒的人员,必须采用一种因果关系评估方法,以评估不良反应与一种或多种药物之间的因果关系。

药物流行病学

如有必要,可使用药物流行病学方法对因果关系进行额外评估。

国家委员会

一个技术委员会和国家药物警戒委员会集中在法国卫生安全局(即AFSSAPS),对所有数据进行评估,以便就必要措施向相关当局提供协商一致的建议,以预防或减少与药物相关的不良反应。

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