A COVID-19-ready public health surveillance system: The Food and Drug Administration's Sentinel System.
Pharmacoepidemiol Drug Saf
; 30(7): 827-837, 2021 07.
Article
in English
| MEDLINE | ID: covidwho-1192592
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
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Product Surveillance, Postmarketing
/
United States Food and Drug Administration
/
Public Health Surveillance
/
Health Information Management
/
COVID-19
Type of study:
Observational study
/
Prognostic study
Topics:
Vaccines
Limits:
Humans
Country/Region as subject:
North America
Language:
English
Journal:
Pharmacoepidemiol Drug Saf
Journal subject:
Epidemiology
/
Drug Therapy
Year:
2021
Document Type:
Article
Affiliation country:
Pds.5240
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