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全球主动不良事件监测系统的比较。

A comparison of active adverse event surveillance systems worldwide.

作者信息

Huang Yu-Lin, Moon Jinhee, Segal Jodi B

机构信息

Department of Health Policy and Management, Johns Hopkins University Bloomberg School of Public Health, Room 644, 624 N. Broadway, Baltimore, MD, 21205, USA.

出版信息

Drug Saf. 2014 Aug;37(8):581-96. doi: 10.1007/s40264-014-0194-3.

Abstract

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.

摘要

药品上市后不良药物事件(ADEs)监测通常依赖自发报告。最近,监管机构已将注意力转向更多利用现有数据进行监测的先发制方法。我们进行了一项环境扫描,以识别全球范围内利用现有数据检测ADEs的主动监测系统。我们提取了有关这些系统的结构、数据和功能的数据。我们综合各系统的信息以识别这些系统的共同特征。我们识别出九个主动监测系统。两个系统位于美国——美国食品药品监督管理局哨兵计划(包括迷你哨兵计划和联邦合作伙伴协作)以及疫苗安全数据链(VSD);两个在加拿大——加拿大药物效应观察研究网络(CNODES)和安大略省疫苗与免疫监测(VISION);两个在欧洲——通过整合挖掘临床记录和生物医学知识探索与理解药物不良反应(EU - ADR)联盟以及疫苗不良事件监测与沟通(VAESCO)。此外,还有亚洲药物流行病学网络(AsPEN)和上海药品监测与评估系统(SDMES)。我们在英国识别出两个系统——药品警戒与风险管理(VRMM)部门以及药物安全研究单位(DSRU),一个独立的学术单位。这些监测系统大多使用行政索赔数据或电子病历;大多数代表监管机构开展药物警戒工作。使用通用数据模型或集中式模型来获取现有数据。这些系统要么仅使用国家数据构建,要么通过与其他国家合作构建。然而,利用现有数据的主动监测系统仍然很少见。北美和欧洲的人口覆盖范围最大;亚洲国家也取得了显著进展。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4532/4134479/ff762fd21554/40264_2014_194_Figa_HTML.jpg

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