Use of the Sentinel System to Examine Medical Product Use and Outcomes During Pregnancy

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 and Sengwee Toh
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Jennifer G. Lyons: Harvard Medical School, Harvard Pilgrim Health Care Institute
Mayura U. Shinde: Harvard Medical School, Harvard Pilgrim Health Care Institute
Judith C. Maro: Harvard Medical School, Harvard Pilgrim Health Care Institute
Andrew Petrone: Harvard Medical School, Harvard Pilgrim Health Care Institute
Austin Cosgrove: Harvard Medical School, Harvard Pilgrim Health Care Institute
Maria E. Kempner: Harvard Medical School, Harvard Pilgrim Health Care Institute
Susan E. Andrade: Harvard Medical School, Harvard Pilgrim Health Care Institute
Jamila Mwidau: US Food and Drug Administration
Danijela Stojanovic: US Food and Drug Administration
José J. Hernández-Muñoz: US Food and Drug Administration
Sengwee Toh: Harvard Medical School, Harvard Pilgrim Health Care Institute

Drug Safety, 2024, vol. 47, issue 10, No 1, 940 pages

Abstract: Abstract 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.

Date: 2024
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DOI: 10.1007/s40264-024-01447-z

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