Online Reporting of Adverse Drug Reactions: A Study from a French Regional Pharmacovigilance Center
Online Reporting of Adverse Drug Reactions: A Study from a French Regional Pharmacovigilance Center
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DOI：
10.2515/therapie/2014035
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发表时间：
2014-09-01
期刊：
影响因子：
2.6
通讯作者：
Montastruc, Jean-Louis
中科院分区：
文献类型：
--
作者：
Abadie, Delphine;Chebane, Leyla;Montastruc, Jean-Louis
背景在法国，通过网站在线报告是一种新的药物不良反应（ADR）通知方法。法国南比利牛斯地区药物警戒中心（RPVC）于2010年7月建立了基于网络的ADR报告工具，以提高ADR报告率。目标.评估这一新的ADR报告系统的可行性、使用和性能。评估这些在线报告的主要特征。方法.在一项回顾性研究中，我们评价了2010年7月7日（首次在线通知）至2011年12月31日期间向RPVC报告的在线通知的特征（数量、ADR报告和文件处理时间、报告者类型、可疑药物、ADR的“严重性”和性质）。我们对“常规”通知进行了随机抽样，即在同一时期通过传统工具（邮政、传真、电子邮件或电话）自发向RPVC报告的通知进行了比较。结果在18个月期间，在线报告总数为312份。实施新报告工具后，来自门诊医疗保健专业人员的报告数量增加了45%。在线报告平均比“常规”报告提前近一个月（26天）提交给法国医药局。这一差异主要是由于通过在线表格更快的ADR通知过程（使用新工具后，报告期平均缩短了19天）。与“传统”报告相比，在线报告更多来自门诊医疗保健专业人员，更频繁地涉及神经精神药物和神经精神ADR。未观察到ADR的“严重性”差异。结论.在目前的实践中，部署由卫生专业人员使用的在线ADR报告系统是可行的。我们强调这一新的在线报告工具对于增加ADR报告的效率。此外，这是首次发表的研究表明，在线报告工具可以帮助节省ADR报告期和文件处理的时间，这对于生成早期安全性信号至关重要。
Background. In France, online reporting via a website is a new method for notifying adverse drug reactions (ADRs). The French Midi-Pyrenees Regional Pharmacovigilance Center (RPVC) set up in July, 2010 a Web-based ADR reporting tool in order to improve ADR reporting rate. Objectives. To assess feasibility, use and performances of this new ADR reporting system. To evaluate the main characteristics of these online reports. Methods. In a retrospective study, we evaluated characteristics (numbers, ADR reporting and file processing times, type of reporters, suspected drugs, "seriousness" and nature of ADRs) of online notifications reported to the RPVC between July 7th, 2010 (first online notification) and December 31th, 2011. We performed comparisons to a random sample of "conventional" notifications, i.e. spontaneously reported to the RPVC via traditional tools (post, fax, e-mail or telephone) during the same period. Results. The total number of online reports was 312 over the 18-month period. There was a 45% increase in numbers of reports from ambulatory healthcare professionals after the implementation of the new reporting tool. Online reports were transmitted to the French Medicine Agency on average almost one month (26 days) earlier than "conventional" ones. This difference was mainly due to a faster ADR notification process via the online form (on average, the reporting period was decreased by 19 days with the new tool). In comparison to "conventional" notifications, online reports came more often from ambulatory healthcare professionals, and involved more frequently neuropsychiatric drugs and neuropsychiatric ADRs. None difference was observed for "seriousness" of ADRs. Conclusions. It is feasible to deploy an online ADR reporting system used by health professionals in current practice. We underline the efficiency of this new online reporting tool for increasing ADRs reporting. Moreover, this is the first published study demonstrating that an online reporting tool can help to save time on the ADR reporting period and file processing, which is essential to generate early safety signals.