A COVID-19-ready public health surveillance system: The Food and Drug Administration's Sentinel System

Abstract

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.

Keywords: COVID-19; electronic health records; medical claims; real-time monitoring; real-world data; surveillance.

FIGURE 1

Proportion of COVID‐19 hospitalizations with administration of select medications, by week, February 20, 2020‐January 10, 2021, HCA Healthcare Sentinel System data. The gray bars represent COVID‐19 hospitalizations independent of medication administrations. The US Food and Drug Administration issued an emergency use authorization (EUA) for remdesivir on May 1, 2020. ²⁶ Preliminary results from the RECOVERY trial on dexamethasone were released June 16, 2020 ²⁷ [Colour figure can be viewed at wileyonlinelibrary.com]