使用哨兵系统检查孕期医疗产品的使用情况和结果。

IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY Drug Safety Pub Date : 2024-10-01 Epub Date: 2024-06-28 DOI:10.1007/s40264-024-01447-z
Jennifer G Lyons, Mayura U Shinde, Judith C Maro, Andrew Petrone, Austin Cosgrove, Maria E Kempner, Susan E Andrade, Jamila Mwidau, Danijela Stojanovic, José J Hernández-Muñoz, Sengwee Toh
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引用次数: 0

摘要

虽然许多孕妇会使用处方药,但支持孕期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,可用于研究怀孕期间医疗产品的使用情况,以及怀孕、孕产妇和婴儿的结局。哨兵系统(Sentinel System)是一个全国性的医疗产品监测系统,包括来自全国性和地区性大型医疗保险公司的行政索赔和电子健康记录数据库。除这些数据源外,哨兵系统还开发并维护了大量分析工具,以保护患者隐私和医疗系统自主权的方式促进流行病学分析。在本文中,我们将概述哨兵系统的基础设施,包括母婴关联表、可参数化的分析工具以及估算孕龄和确定妊娠结局的算法。我们还介绍了哨兵系统过去和未来的工作,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孕期的安全性。
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Use of the Sentinel System to Examine Medical Product Use and Outcomes During Pregnancy.

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.

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来源期刊
Drug Safety
Drug Safety 医学-毒理学
CiteScore
7.60
自引率
7.10%
发文量
112
审稿时长
6-12 weeks
期刊介绍: Drug Safety is the official journal of the International Society of Pharmacovigilance. The journal includes: Overviews of contentious or emerging issues. Comprehensive narrative reviews that provide an authoritative source of information on epidemiology, clinical features, prevention and management of adverse effects of individual drugs and drug classes. In-depth benefit-risk assessment of adverse effect and efficacy data for a drug in a defined therapeutic area. Systematic reviews (with or without meta-analyses) that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. Original research articles reporting the results of well-designed studies in disciplines such as pharmacoepidemiology, pharmacovigilance, pharmacology and toxicology, and pharmacogenomics. Editorials and commentaries on topical issues. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Drug Safety Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.
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