A comparison of active adverse event surveillance systems worldwide.
A comparison of active adverse event surveillance systems worldwide.
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DOI：
10.1007/s40264-014-0194-3
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发表时间：
2014-08
期刊：
影响因子：
4.2
通讯作者：
Segal, Jodi B.
中科院分区：
文献类型：
--
作者：
Huang, Yu-Lin;Moon, Jinhee;Segal, Jodi B.
上市后的药物不良事件监测(ADE)通常依赖于自发报告。最近，监管机构将注意力转向了更具先发制人的方法，即利用现有数据进行监控。我们进行了一次环境扫描，以确定世界各地使用现有数据检测ADE的活跃监测系统。我们提取了有关系统的结构、数据和功能的数据。我们综合了各个系统的信息，以确定这些系统的共同特征。我们确定了九个活跃的监视系统。两个系统设在美国-FDA哨兵倡议(包括迷你哨兵倡议和联邦合作伙伴合作)和疫苗安全数据链(VSD)；两个是加拿大-加拿大观察药物效应研究网络(CNODES)和安大略省疫苗和免疫监测(VISION)；两个是欧洲-通过综合挖掘临床记录和生物医学知识来探索和了解药物不良反应(EU-ADR)联盟和疫苗不良事件监测和沟通(VAESCO)。此外，还有亚洲药物流行病学网络(ASPEN)和上海药物监测与评价系统(SDMES)。我们确定了英国的两个系统--药品警戒和风险管理部门(VRMM)和药物安全研究单位(DSRU)，这是一个独立的学术单位。这些监测系统大多使用行政声明或电子医疗记录；大多数代表监管机构进行药物警戒。使用公共数据模型或集中式模型来访问现有数据。这些系统是单独使用国家数据或与其他国家合作建立的。然而，使用现有数据的主动监控系统仍然很少。北美和欧洲的人口覆盖率最高；亚洲国家取得了良好的进步。本文的在线版本(doi：10.1007/s40264-0140194-3)包含补充材料，授权用户可以使用。
Post-marketing drug surveillance for adverse drug events (ADEs) has typically relied on spontaneous reporting. Recently, regulatory agencies have turned their attention to more preemptive approaches that use existing data for surveillance. We conducted an environmental scan to identify active surveillance systems worldwide that use existing data for the detection of ADEs. We extracted data about the systems’ structures, data, and functions. We synthesized the information across systems to identify common features of these systems. We identified nine active surveillance systems. Two systems are US based—the FDA Sentinel Initiative (including both the Mini-Sentinel Initiative and the Federal Partner Collaboration) and the Vaccine Safety Datalink (VSD); two are Canadian–the Canadian Network for Observational Drug Effect Studies (CNODES) and the Vaccine and Immunization Surveillance in Ontario (VISION); and two are European–the Exploring and Understanding Adverse Drug Reactions by Integrative Mining of Clinical Records and Biomedical Knowledge (EU-ADR) Alliance and the Vaccine Adverse Event Surveillance and Communication (VAESCO). Additionally, there is the Asian Pharmacoepidemiology Network (AsPEN) and the Shanghai Drug Monitoring and Evaluative System (SDMES). We identified two systems in the UK—the Vigilance and Risk Management of Medicines (VRMM) Division and the Drug Safety Research Unit (DSRU), an independent academic unit. These surveillance systems mostly use administrative claims or electronic medical records; most conduct pharmacovigilance on behalf of a regulatory agency. Either a common data model or a centralized model is used to access existing data. The systems have been built using national data alone or via partnership with other countries. However, active surveillance systems using existing data remain rare. North America and Europe have the most population coverage; with Asian countries making good advances. The online version of this article (doi:10.1007/s40264-014-0194-3) contains supplementary material, which is available to authorized users.
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