Departments of Medical Informatics, Erasmus University Medical Centre, Rotterdam, The Netherlands; Dutch Medicines Evaluations Board, Utrecht, The Netherlands.
Pharmacoepidemiol Drug Saf. 2013 Oct;22(10):1046-53. doi: 10.1002/pds.3494. Epub 2013 Aug 15.
"Additional" risk minimisation measures (aRMMs) can be necessary to optimise the benefit-risk balance of a drug. Evaluation of effectiveness of these measures has become mandatory with the new European Union (EU) pharmacovigilance legislation in force since July 2012. The aim of this study was to classify the aRMMs in the EU with a special emphasis on the possibilities to analyse the effectiveness of these aRMMs in existing electronic healthcare databases (EHDs).
European Public Assessment Reports were reviewed to identify key elements of the aRMMs. Researchers categorised the key elements based on the objectives, i.e. knowledge change or behavioural change and sub-categorised the behavioural changes. They assessed for each key element if it would be eligible for analysis in existing EHDs.
68 drugs with aRMMs contained 801 key elements of which 57% aimed at behavioural changes. 22% of all key elements, all aimed behavioural changes, were assessed eligible for analysis in existing EHDs. These mainly concerned recommendations targeted at healthcare professionals regarding drug prescription, e.g. dose recommendations, contraindications or the need to perform laboratory tests for patient monitoring.
Only a limited proportion of key elements of the aRMMs could potentially be monitored in existing EHDs as these data sources cannot capture all the required data. Due to difference between existing EHDs, not necessarily all available EHDs are appropriate for every drug or aRMM. To facilitate rapid evaluation of aRMM implementation and timely adjustments, industry and regulatory authorities should agree well-defined key elements of aRMMs leading to unambiguous actions of the target group.
“附加”风险最小化措施（aRMM）可能是优化药物的风险效益平衡所必需的。自 2012 年 7 月生效的新的欧盟（EU）药物警戒立法以来，评估这些措施的有效性已成为强制性要求。本研究的目的是对欧盟的 aRMM 进行分类，特别强调在现有电子医疗保健数据库（EHD）中分析这些 aRMM 有效性的可能性。
审查了欧洲公共评估报告，以确定 aRMM 的关键要素。研究人员根据目标（即知识变化或行为变化）对关键要素进行分类，并对行为变化进行细分。他们评估了每个关键要素是否有资格在现有的 EHD 中进行分析。
包含 aRMM 的 68 种药物共有 801 个关键要素，其中 57%的目标是行为变化。所有关键要素中有 22%（全部为行为变化）被评估为有资格在现有的 EHD 中进行分析。这些主要涉及针对医疗保健专业人员的药物处方建议，例如剂量建议、禁忌症或需要进行实验室检查以进行患者监测。
由于这些数据源无法捕获所有必需的数据，因此只有 aRMM 的关键要素的有限比例可能在现有的 EHD 中进行监测。由于现有 EHD 之间的差异，并非所有现有的 EHD 都适合每种药物或 aRMM。为了促进对 aRMM 实施的快速评估和及时调整，行业和监管机构应就导致目标群体明确行动的 aRMM 的明确关键要素达成一致。
