Epidemiology Department, Bayer AG, Berlin, Germany.
OXON Epidemiology, Madrid, Spain.
Pharmacoepidemiol Drug Saf. 2018 Jul;27(7):695-706. doi: 10.1002/pds.4434. Epub 2018 Apr 16.
An important element of risk management is the planning and implementation of risk minimisation measures (RMMs) and the evaluation of their effectiveness by process or outcome indicators. The aim of this review is to summarize the characteristics of risk minimisation (RM) effectiveness studies in Europe and provide an overview of RMMs and their effectiveness.
This was a qualitative review of RM effectiveness studies in the European Union electronic Register of Post-Authorization Studies (EU PAS Register); data extracted included study design, population, sample size, data sources, drug information, RMMs, study period, indicators, and their reported effectiveness.
Of the 872 records in the EU PAS Register, 19 studies evaluating the effectiveness of RMMs were included. Eleven were cross-sectional surveys and 8 used secondary data sources. Eighty-nine percent (17/19) evaluated additional RMMs (used when routine RMMs are considered insufficient), and 36% (7/19) evaluated changes in routine RMMs (applicable to all medicinal products). A total of 42 effectiveness indicators were identified: 18 process and 24 outcomes. Half of the indicators (21/42) were successful; 2% (1/42) indicators were partially successful; 17% (7/42) indicators were inconclusive. Effectiveness of the remaining 31% (13/42) indicators could not be determined owing to limited information. The United Kingdom was the most frequent country for the conduct of RM effectiveness studies.
Most of the included studies evaluated additional RMMs. Half of the effectiveness indicators (process and/or outcome) were reported as successful. This review provides evidence to support the development of future guidance on the effectiveness of RM in Europe.
风险管理的一个重要内容是规划和实施风险最小化措施（RMM），并通过过程或结果指标来评估其效果。本综述的目的是总结欧洲风险最小化（RM）效果研究的特点，并提供 RMM 及其效果的概述。
这是对欧盟药品上市后研究电子注册系统（EU PAS 注册系统）中 RM 效果研究的定性综述；提取的数据包括研究设计、人群、样本量、数据来源、药物信息、RMM、研究期间、指标以及报告的效果。
在 EU PAS 注册系统的 872 条记录中，有 19 项评估 RMM 效果的研究被纳入。其中 11 项为横断面调查，8 项使用了二级数据源。89%（17/19）评估了额外的 RMM（当常规 RMM 被认为不足时使用），36%（7/19）评估了常规 RMM 的变化（适用于所有药物）。共确定了 42 个有效性指标：18 个过程指标和 24 个结果指标。一半的指标（21/42）是成功的；2%（1/42）的指标是部分成功的；17%（7/42）的指标是不确定的。由于信息有限，其余 31%（13/42）指标的有效性无法确定。开展 RM 效果研究最多的国家是英国。
大多数纳入的研究评估了额外的 RMM。一半的有效性指标（过程和/或结果）被报告为成功。本综述提供了证据，支持在欧洲制定关于 RM 效果的未来指南。
