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[从精神活性药物到法国公共卫生法典中的药物警戒(1990 - 2017年)]

[From psychoactive medicines to addictovigilance in French Public Health Code (1990-2017)].

作者信息

Baumevieille Marie, Perri-Plandé Joëlle, Miremont-Salamé Ghada, Daveluy Amélie, Haramburu Françoise

机构信息

Centre d'addictovigilance, service de pharmacologie médicale, CHU de Bordeaux, 33000 Bordeaux, France; Inserm U1219, Bordeaux population health, équipe pharmacoépidémiologie, 33000 Bordeaux, France; Droit et économie pharmaceutiques, UFR des sciences pharmaceutiques, université de Bordeaux, 33076 Bordeaux, France.

Centre d'addictovigilance, service de pharmacologie médicale, CHU de Bordeaux, 33000 Bordeaux, France.

出版信息

Therapie. 2019 Jun;74(3):375-382. doi: 10.1016/j.therap.2018.07.007. Epub 2018 Aug 3.

Abstract

Addictovigilance in the French Public Health Code, in the section related to poisonous substances, refers to a monitoring system developed since 1990: control of psychoactive substances and products, with medicinal use or not, was completed by a specific system focused on evaluation and information on pharmacodependance in 1999. The French medicines agency (Agence du médicament) created in 1993 was involved in this monitoring system; pharmacodependance evaluation was added by law to the missions of the agencies that followed: the Agence française de sécurité sanitaire des produits de santé missions (AFSSAPS, 1998) and the Agence nationale de sécurité du médicament et des produits de santé (ANSM, 2011). "Addictovigilance" first appears in French Law in 2017 whereas it was used by pharmacodependance centers and AFSSAPS since 2007. Legal definition of addictovigilance in the French Public Health Code testified to public authorities action against addictive behavior whatever products status, legal or not. The visibility of addictovigilance is growing on the Internet as well (ANSM website, web portal for reporting adverse health events).

摘要

法国公共卫生法典中与有毒物质相关部分的药物警戒,指的是自1990年起建立的一个监测系统:对具有药用或非药用用途的精神活性物质和产品的管控,在1999年通过一个专注于药物依赖评估和信息的特定系统得以完善。1993年成立的法国药品管理局参与了这个监测系统;药物依赖评估依法被纳入后续各机构的职责范围:法国卫生产品安全局(AFSSAPS,1998年)和法国国家药品与健康产品安全局(ANSM,2011年)。“药物警戒”首次出现在2017年的法国法律中,而自2007年起药物依赖中心和法国卫生产品安全局就开始使用这个词。法国公共卫生法典中药物警戒的法律定义证明了公共当局针对成瘾行为采取的行动,无论相关产品的状态合法与否。药物警戒在互联网上的知名度也在不断提高(法国国家药品与健康产品安全局网站,即报告不良健康事件的网络平台)。

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