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[实践中的药物警戒]

[Pharmacovigilance in practice].

作者信息

Spreux A, Baldin B, Chichmanian R M

机构信息

Centre régional de pharmacovigilance et d'information sur le médicament, CHU de Nice, hôpital Pasteur, France.

出版信息

Transfus Clin Biol. 1999 Jul;6(4):254-9. doi: 10.1016/s1246-7820(99)80036-6.

Abstract

Directed by the French Agency for the Safety of Health Products (AFSSAPS), the French pharmacovigilance system is in charge of the surveillance of drugs after they have been provided by AFSSAPS with official marketing authorizations that are in France either 'new drug approval certificates' (AMM) or 'temporary utilization authorizations' (ATU). About 3,700 pharmaceutical products are concerned which are used either for treatment (all drugs and remedies, inclusive plasma-derived blood products), prevention (vaccines, oral contraception), diagnosis (contrast products, ...), or to modify a physiologic function (general or local anesthetics). At the national level, the main actors of the system are AFSSAPS and its National Commission, the 31 Regional Centers of Pharmacovigilance, all the health professionnals, and the pharmaceutical laboratories. Health professionnals are held to notify any suspected serious or unexpected adverse effects as quickly as possible. The analysis of data collected by the national report bank permits alerts and inquiries about drug safety. Furthermore regional centers of pharmacovigilance are responsible for drug information. The French pharmacovigilance system works in cooperation with the European Agency for the Evaluation of Medicinal Products.

摘要

在法国卫生产品安全局(AFSSAPS)的指导下,法国药物警戒系统负责对药品进行监测,这些药品需已获得AFSSAPS颁发的官方上市许可,在法国即“新药批准证书”(AMM)或“临时使用授权”(ATU)。约3700种药品涉及其中,它们用于治疗(所有药物和疗法,包括血浆衍生血液制品)、预防(疫苗、口服避孕药)、诊断(造影剂等)或改变生理功能(全身或局部麻醉剂)。在国家层面,该系统的主要参与者包括AFSSAPS及其国家委员会、31个地区药物警戒中心、所有卫生专业人员以及制药实验室。卫生专业人员必须尽快报告任何疑似严重或意外的不良反应。对国家报告库收集的数据进行分析,以便发出药物安全警报并进行调查。此外,地区药物警戒中心负责提供药物信息。法国药物警戒系统与欧洲药品评估局合作开展工作。

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