Direction de la surveillance, ANSM, 93100 Saint-Denis, France.
Direction de la surveillance, ANSM, 93100 Saint-Denis, France.
Therapie. 2021 Sep-Oct;76(5):441-447. doi: 10.1016/j.therap.2020.05.011. Epub 2020 May 24.
According to French guidelines on good pharmacovigilance practices, a pharmacovigilance survey is an assessment of the available drug safety data. It is requested by the French national agency for medicines and health products safety (ANSM). The objective is to validate a signal, to characterize it, or to provide strengthened monitoring of a drug.
All the available data were retrieved by ANSM/Regional Pharmacovigilance Centers (RPC) and assessed by a nominate RPC which provides a report for discussion during the monthly Committee between ANSM and the Regional Pharmacovigilance Network (RPN). A descriptive analysis of the minutes available on the ANSM website between 2016 and 2018 has been done: objective, data sources, duration of the survey, number of suspected adverse drug reactions, nature of the drugs and of the signals and recommendations for actions.
Between 2016 and 2018, a total of 115 surveys were discussed concerning 135 drugs, mainly from the nervous system according to the anatomic therapeutic chemical classification (n=31, 27%). They involved a whole pharmacological class for 18 ones. The main objective of the 115 surveys was to provide a strenghtened monitoring for some drugs (72%) or to validate one or more than one signal (28%). Result from surveys allowed to detect one or several new potential safety signals in 63 ones (55%), an off-label-use in 12 (10%) or to characterize some others signals in all the studies. The Committee recommended one or several actions by survey: 67 prolongations (58%) of the survey and regulatory or investigatory actions which included 43 European actions (37%), 37 label changes (32%), 30 national communications (26%) and 29 additional monitoring (25%).
DISCUSSION/CONCLUSION: The current process allows a collegiate, clinical and pharmacological discussion with integration of the regulatory framework. A significant number of new signals are detected and/or validated. This efficient tool which is unique in Europe and is allowed by the decentralized pharmacovigilance which leads to a great reactivity of decision-making. It has to be reassessed and to be adapted continuously to the new challenges of the growing multiplication of signals.
根据法国药物警戒实践良好规范指南，药物警戒调查是对现有药物安全性数据的评估。这是由法国国家药品和保健产品安全局（ANSM）要求的。其目的是验证信号，对其进行特征描述，或加强对药物的监测。
所有可用数据均由 ANSM/地区药物警戒中心（RPC）检索，并由指定的 RPC 进行评估，该 RPC 会提供一份报告，供 ANSM 与地区药物警戒网络（RPN）每月委员会讨论。对 2016 年至 2018 年期间 ANSM 网站上的会议记录进行了描述性分析：目标、数据来源、调查持续时间、疑似药物不良反应的数量、药物性质以及信号，并提出了行动建议。
2016 年至 2018 年间，共讨论了 115 项涉及 135 种药物的调查，主要涉及神经系统（按解剖治疗化学分类，n=31，27%）。其中 18 种药物涉及整个药理学类别。115 项调查的主要目的是加强对某些药物（72%）的监测，或验证一个或多个信号（28%）。调查结果在 63 项研究中发现了一个或多个新的潜在安全信号（55%），12 项研究中发现了一种或多种非标签用途（10%），或对所有研究中的其他信号进行了特征描述。委员会建议通过调查采取一项或多项行动：67 次（58%）延长调查时间，监管或调查行动包括 43 次欧洲行动（37%）、37 次标签变更（32%）、30 次国家通报（26%）和 29 次额外监测（25%）。
讨论/结论：当前的流程允许进行同行评议、临床和药理学讨论，并纳入监管框架。发现并验证了大量新信号。这是一种高效的工具，在欧洲是独一无二的，也是分散式药物警戒所允许的，这导致了决策的快速反应。它需要不断重新评估和适应不断增长的信号数量所带来的新挑战。
