Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Building 51, Room 6360, Silver Spring, MD 20993, USA.
Med Care. 2012 Nov;50(11):948-53. doi: 10.1097/MLR.0b013e31826c874d.
After half a century of monitoring voluntary reports of medical product adverse events, the Food and Drug Administration (FDA) has launched a long-term project to build an adverse events monitoring system, the Sentinel System, which can access and evaluate electronic health care data to help monitor the safety of regulated medical products once they are marketed. On the basis of experience gathered through a number of collaborative efforts, the Federal Partners' Collaboration pilot project, involving FDA, the Centers for Medicare & Medicaid Services, the Department of Veteran Affairs, and the Department of Defense, is already enabling FDA to leverage the power of large public health care databases to assess, in near real time, the utility of analytical tools and methodologies that are being developed for use in the Sentinel System. Active medical product safety surveillance is enhanced by use of these large public health databases because specific populations of exposed patients can be identified and analyzed, and can be further stratified by key variables such as age, sex, race, socioeconomic status, and basis for eligibility to examine important subgroups.
经过半个世纪对医疗产品不良事件自愿报告的监测，美国食品和药物管理局（FDA）启动了一个长期项目，以建立一个不良事件监测系统——哨兵系统，该系统可以访问和评估电子医疗保健数据，以帮助在受监管的医疗产品上市后监测其安全性。在通过多项合作努力积累经验的基础上，联邦合作伙伴合作试点项目，涉及 FDA、医疗保险和医疗补助服务中心、退伍军人事务部和国防部，已经使 FDA 能够利用大型公共医疗保健数据库的力量，实时评估正在为哨兵系统开发的分析工具和方法的效用。通过使用这些大型公共卫生数据库，可以加强对医疗产品的主动安全性监测，因为可以识别和分析暴露患者的特定人群，并可以进一步按年龄、性别、种族、社会经济地位和资格基础等关键变量分层，以检查重要亚组。
