Jonville-Bera Annie Pierre, Gautier Sophie, Micallef Joëlle, Massy Nathalie, Atzenhoffer Marina, Grandvuillemin Aurélie, Drici Milou-Daniel
Service de pharmacosurveillance, centre régional de pharmacovigilance, centre Val de Loire, CHRU de Tours, 37000 Tours, France.
Service de pharmacologie, centre régional de pharmacovigilance Nord Pas de Calais, CHRU de Lille, 59000 Lille, France.
Therapie. 2023 Sep-Oct;78(5):467-475. doi: 10.1016/j.therap.2023.03.002. Epub 2023 Mar 7.
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) pandemic virus was a "health crisis" and a significant burden also for the French pharmacovigilance system. It took its toll in 2 phases, the first being in early 2020 when very little was known, and during which the missions of the 31 Regional Pharmacovigilance Centers (RPVCs) from university hospitals were to detect adverse reactions of drugs used in the context of the disease. Whether as a possible aggravating role on COVID-19, or displaying a different safety profile during its course, or to assess safety of curative treatment, this phase preceded that of the arrival of dedicated vaccines. Then the RPVCs' missions were to detect, as early as possible, any new serious adverse effect leading to a potential signal that would modify the benefit/risk ratio of a vaccine and require the implementation of health safety measures. During these two distinct periods, signal detection remained the core business of the RPVCs. Each RPVC had to organize itself to handle an unprecedented surge of declarations and requests for advice, from health care professionals and patients alike. "Leading" RPVCs, who were in charge of monitoring vaccines, had to deal with an extraordinary workload (still going on to this date), to generate in real-time and on a weekly basis, a summary of all the adverse drug reaction (ADR) reports as well as an extended analysis of the different safety signals. The organization put in place at the beginning of the health crisis, adapted to the context of the vaccines, allowed to meet the challenge of real-time pharmacovigilance monitoring, and to identify many safety signals. Efficient "short-circuits exchanges" with the French Regional Pharmacovigilance Centers Network (RPVCN) were paramount to the National Agency for the Safety of Medicines and Health Products (ANSM) to develop an optimal collaborative partnership. The French RPVCN has shown at this occasion both agility and flexibility, swiftly adapting to vaccine- and media-related unrest, and demonstrated its effectiveness in the early detection of safety signals. This crisis also confirmed the superiority of manual/human signal detection over automated ones, as the most effective and powerful tool to date to rapidly detect and validate a new ADR and enable to elaborate rapid risk reduction measures. To maintain the performance of French RPVCN in signal detection and to monitor all drugs as they should, and as expected by our fellow citizens, a new funding model should be considered.
严重急性呼吸综合征冠状病毒2（SARS-CoV-2）大流行病毒对法国药物警戒系统而言是一场“健康危机”，也是一项重大负担。它分两个阶段造成影响，第一阶段是在2020年初，当时人们对该病毒知之甚少，在此期间，来自大学医院的31个地区药物警戒中心（RPVC）的任务是检测在该疾病背景下使用的药物的不良反应。无论是作为对新冠肺炎可能的加重作用，还是在病程中表现出不同的安全性，亦或是评估治疗性治疗的安全性，这个阶段都先于专用疫苗的到来。然后，地区药物警戒中心的任务是尽早检测任何新的严重不良反应，这些反应会导致潜在信号，从而改变疫苗的获益/风险比，并需要实施健康安全措施。在这两个不同时期，信号检测一直是地区药物警戒中心的核心业务。每个地区药物警戒中心都必须进行自我组织，以处理来自医护人员和患者前所未有的申报和咨询请求激增情况。负责监测疫苗的“牵头”地区药物警戒中心不得不应对超常的工作量（至今仍在持续），要实时且每周生成所有药物不良反应（ADR）报告的摘要以及对不同安全信号的详细分析。在健康危机初期建立的组织架构，适应了疫苗背景，得以应对实时药物警戒监测的挑战，并识别出许多安全信号。与法国地区药物警戒中心网络（RPVCN）进行高效的“短路式交流”，对于国家药品和健康产品安全局（ANSM）建立最佳合作关系至关重要。法国地区药物警戒中心网络在此次事件中展现出了敏捷性和灵活性，迅速适应了与疫苗和媒体相关的动荡局面，并证明了其在早期检测安全信号方面的有效性。这场危机还证实了人工/人力信号检测优于自动化检测，是迄今为止快速检测和验证新的药物不良反应并制定快速风险降低措施的最有效、最强大的工具。为了保持法国地区药物警戒中心网络在信号检测方面的表现，并按照我们的公民所期望的那样对所有药物进行监测，应该考虑一种新的资金模式。
