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10.1002/pds.5240

http://scihub22266oqcxt.onion/10.1002/pds.5240
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33797815!8250843!33797815
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suck abstract from ncbi


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pmid33797815      Pharmacoepidemiol+Drug+Saf 2021 ; 30 (7): 827-837
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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.
  • |Antiviral Agents/therapeutic use[MESH]
  • |COVID-19 Vaccines/administration & dosage/adverse effects[MESH]
  • |COVID-19/epidemiology/*therapy/virology[MESH]
  • |Communicable Disease Control/legislation & jurisprudence[MESH]
  • |Databases, Factual/statistics & numerical data[MESH]
  • |Electronic Health Records/statistics & numerical data[MESH]
  • |Health Information Management/*organization & administration[MESH]
  • |Health Policy[MESH]
  • |Humans[MESH]
  • |Pandemics/prevention & control/statistics & numerical data[MESH]
  • |Product Surveillance, Postmarketing/*methods[MESH]
  • |Public Health Surveillance/*methods[MESH]
  • |United States Food and Drug Administration/legislation & jurisprudence/*organization & administration[MESH]


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