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Deprecated: Implicit conversion from float 235.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Pharmacoepidemiol+Drug+Saf 2021 ; 30 (7): 827-837 Nephropedia Template TP
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A COVID-19-ready public health surveillance system: The Food and Drug Administration s Sentinel System #MMPMID33797815
Cocoros NM; Fuller CC; Adimadhyam S; Ball R; Brown JS; Dal Pan GJ; Kluberg SA; Lo Re V 3rd; Maro JC; Nguyen M; Orr R; Paraoan D; Perlin J; Poland RE; Driscoll MR; Sands K; Toh S; Yih WK; Platt R
Pharmacoepidemiol Drug Saf 2021[Jul]; 30 (7): 827-837 PMID33797815show ga
The US Food and Drug Administration's Sentinel System was established in 2009 to use routinely collected electronic health data for improving the national capability to assess post-market medical product safety. Over more than a decade, Sentinel has become an integral part of FDA's surveillance capabilities and has been used to conduct analyses that have contributed to regulatory decisions. FDA's role in the COVID-19 pandemic response has necessitated an expansion and enhancement of Sentinel. Here we describe how the Sentinel System has supported FDA's response to the COVID-19 pandemic. We highlight new capabilities developed, key data generated to date, and lessons learned, particularly with respect to working with inpatient electronic health record data. Early in the pandemic, Sentinel developed a multi-pronged approach to support FDA's anticipated data and analytic needs. It incorporated new data sources, created a rapidly refreshed database, developed protocols to assess the natural history of COVID-19, validated a diagnosis-code based algorithm for identifying patients with COVID-19 in administrative claims data, and coordinated with other national and international initiatives. Sentinel is poised to answer important questions about the natural history of COVID-19 and is positioned to use this information to study the use, safety, and potentially the effectiveness of medical products used for COVID-19 prevention and treatment.