Division of Therapeutics Research and Infectious Disease Epidemiology, Department of Population Medicine, Harvard Medical School, Harvard Pilgrim Health Care Institute, 401 Park Drive, Suite 401 East, Boston, MA, 02215, USA.
Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Drug Saf. 2024 Oct;47(10):931-940. doi: 10.1007/s40264-024-01447-z. Epub 2024 Jun 28.
While many pregnant individuals use prescription medications, evidence supporting product safety during pregnancy is often inadequate. Existing electronic healthcare data sources provide large, diverse samples of health plan members to allow for the study of medical product utilization during pregnancy, as well as pregnancy, maternal, and infant outcomes. The Sentinel System is a national medical product surveillance system that includes administrative claims and electronic health record databases from large national and regional health insurers. In addition to these data sources, Sentinel develops and maintains a sizeable selection of analytic tools to facilitate epidemiologic analyses in a way that protects patient privacy and health system autonomy. In this article, we provide an overview of Sentinel System infrastructure, including the Mother-Infant Linkage Table, parameterizable analytic tools, and algorithms to estimate gestational age and identify pregnancy outcomes. We also describe past and future Sentinel work that contributes to our understanding of the way medical products are used and the safety of these products during pregnancy.
虽然许多孕妇会使用处方药物，但用于支持妊娠期间产品安全性的证据往往不足。现有的电子医疗保健数据源提供了大量不同的健康计划成员样本，以允许在妊娠期间研究医疗产品的使用情况，以及妊娠、产妇和婴儿的结局。Sentinel 系统是一个国家医疗产品监测系统，包括来自大型国家和地区健康保险公司的行政索赔和电子健康记录数据库。除了这些数据源之外，Sentinel 还开发和维护了大量分析工具，以保护患者隐私和医疗系统自主性的方式促进流行病学分析。在本文中，我们提供了 Sentinel 系统基础设施的概述，包括母婴链接表、可参数化的分析工具以及估计胎龄和识别妊娠结局的算法。我们还描述了过去和未来的 Sentinel 工作，这些工作有助于我们了解医疗产品的使用方式以及这些产品在妊娠期间的安全性。
