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法国药物警戒公共系统与新冠疫情

French Pharmacovigilance Public System and COVID-19 Pandemic.

作者信息

Grandvuillemin Aurélie, Drici Milou-Daniel, Jonville-Bera Annie Pierre, Micallef Joelle, Montastruc Jean Louis

机构信息

Centre régional de Pharmacovigilance, Hôpital François Mitterrand, 14 Rue Paul Gaffarel, BP77908, Dijon, 21079, France.

Regional Pharmacovigilance Center of Nice, Department of Clinical Pharmacology, Université Côte d'Azur, Nice, France.

出版信息

Drug Saf. 2021 Apr;44(4):405-408. doi: 10.1007/s40264-020-01034-y. Epub 2020 Dec 28.

Abstract

The current COVID-19 pandemic is an exceptional health situation including for drug use. As there was no known effective drug for COVID-19 at the beginning of the pandemic, different candidates were proposed. In this short article, we present the French public pharmacovigilance activities during this health crisis. Although COVID-19 is a confounding factor per se, owing to its potential for multi-organ damage including the heart and kidney, the quality of the transmitted data in adverse drug reaction reports, the timeliness of feedback from clinicians, and the real-time pharmacological and medical analysis by the French network of the regional pharmacovigilance centers made it possible to swiftly identify relevant safety signals. The French National Agency of Medicine was thus able to validate the data and convey their findings very early. This decentralized organization based on medical and pharmacological evaluation of case reports has proven to be efficient and responsive in this unique and challenging healthcare emergency.

摘要

当前的新冠疫情是一种特殊的健康状况,包括在药物使用方面。由于疫情初期尚无已知有效的新冠治疗药物,因此提出了不同的候选药物。在这篇短文中,我们介绍了法国公共药物警戒机构在此次健康危机期间开展的活动。尽管新冠本身就是一个混杂因素,因其有可能对包括心脏和肾脏在内的多个器官造成损害,但药物不良反应报告中所传递数据的质量、临床医生反馈的及时性以及法国区域药物警戒中心网络的实时药理学和医学分析,使得迅速识别相关安全信号成为可能。法国国家药品管理局因此能够很早就对数据进行验证并传达其研究结果。这种基于对病例报告进行医学和药理学评估的分散式组织,在这一独特且具有挑战性的医疗紧急情况中已证明是高效且反应迅速的。

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