Uppsala Monitoring Centre, Uppsala, Sweden.
Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.
Drug Saf. 2018 Feb;41(2):203-212. doi: 10.1007/s40264-017-0594-2.
Patient reporting in pharmacovigilance is important and contributes to signal detection. However, descriptions of methodologies for using patient reports in signal detection are scarce, and published experiences of how patient reports are used in pharmacovigilance are limited to a few individual countries.
Our objective was to explore the contribution of patient reports to global signal detection in VigiBase.
Data were retrieved from VigiBase in September 2016. Drug-event-combination series were restricted to those with >50% patient reports, defined as reporter type "Consumer/non-health professional" per E2B reporting standard. vigiRank was applied to patient reports to prioritize combinations for assessment. Product information for healthcare professionals (HCPs) as well as patient information leaflets (PILs) were used as reference for information on adverse drug reactions (ADRs). Staff from the Uppsala Monitoring Centre and the Netherlands Pharmacovigilance Centre Lareb categorized the combinations. Potential signals proceeded to a more in-depth clinical review to determine whether the safety concern should be communicated as a "signal."
Of the 212 combinations assessed, 20 (9%) resulted in eight signals communicated within the World Health Organization (WHO) programme for international drug monitoring. Review of PILs revealed insufficient ADR descriptions for patients and examples of poor consistency with product information for HCPs. Patient narratives provided details regarding the experience and impact of ADRs and evidence that patients make causality and personal risk assessments.
Safety concerns described in patient reports can be identified in a global database including previously unknown ADRs as well as new aspects of known ADRs. Patient reports provide unique information valuable in signal assessment and should be included in signal detection. Novel approaches to highlighting patient reports in statistical signal detection can further improve the contribution of patient reports to pharmacovigilance.
在药物警戒中，患者报告十分重要，有助于信号检测。然而，用于检测信号时使用患者报告的方法描述却很少，并且药物警戒中使用患者报告的经验发表也仅限于少数几个国家。
我们的目的是探索患者报告在 VigiBase 中的全球信号检测中的作用。
数据于 2016 年 9 月从 VigiBase 中检索。药物-事件组合系列仅限于那些超过 50%为患者报告的药物-事件组合，按照 E2B 报告标准定义为报告类型为“消费者/非卫生专业人员”。应用 vigiRank 对患者报告进行优先级排序，以评估组合。产品信息（针对医护人员）和患者信息传单（PILs）被用作不良反应（ADR）信息的参考。来自乌普萨拉监测中心和荷兰药物警戒中心 Lareb 的工作人员对组合进行分类。潜在信号会进行更深入的临床审查，以确定是否应将安全问题作为“信号”进行沟通。
在所评估的 212 种组合中，有 20 种（9%）导致了世界卫生组织（WHO）国际药物监测计划中通报的 8 个信号。审查 PILs 发现，针对患者的 ADR 描述不足，且与医护人员产品信息的一致性较差。患者叙述提供了有关 ADR 经历和影响的详细信息，以及患者进行因果关系和个人风险评估的证据。
可以在包括先前未知 ADR 以及已知 ADR 新方面的全球数据库中识别出患者报告中描述的安全问题。患者报告提供了有价值的信号评估信息，应包括在信号检测中。突出统计信号检测中患者报告的新方法可以进一步提高患者报告对药物警戒的贡献。
