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.

Using inpatient electronic medical records to study influenza for pandemic preparedness

“…We examined oxygen delivery as well as ordinal endpoints in hospitalizations with influenza diagnosis codes. Although we found that up to 40% of influenza non‐ICU hospitalizations had evidence of supplemental oxygen use, we understand that oxygen use may be underestimated if only procedure codes are relied upon 26 . We were unable to identify BiPAP in this study, which was not unexpected, as billing practices may bundle this with other care and our study identified oxygen delivery based on diagnosis and procedure codes.…”

“…Although we found that up to 40% of influenza non‐ICU hospitalizations had evidence of supplemental oxygen use, we understand that oxygen use may be underestimated if only procedure codes are relied upon. 26 We were unable to identify BiPAP in this study, which was not unexpected, as billing practices may bundle this with other care and our study identified oxygen delivery based on diagnosis and procedure codes. We expect that both oxygen supplementation and BiPAP use are included in nursing documentation within many EMR systems, and thus it may be possible to extract such information as needed.…”

COVID‐19 pharmacotherapy utilization patterns during pregnancy: International Registry of Coronavirus Exposure in Pregnancy

“…Our findings reveal similar patterns of use found in other, nonpregnant populations with COVID‐19, which showed that COVID‐19‐specific medications were received more frequently among patients with severe disease than in those with lower severity. 13 , 14 Given the general trend of increased medication use with increased disease severity, future research on the effectiveness and safety of COVID‐19 therapeutics in pregnancy will need to carefully adjust for confounding by indication.…”

SARS-CoV-2 Pandemic and Food Safety Oversight: Implications in Canada and Coping Strategies

“…Inspectors had to learn to use new technologies to conduct reviews offsite [67,68]. It is still unknown how effective these inspections were.…”

“…At the systems level, some research was conducted on federally coordinated systems which would allow for proactive risk surveillance. A nation such as Canada would require public health surveillance systems capable of monitoring the occurrence of serious illnesses as well as assessing the use, safety and effectiveness of treatments [68]. The Sentinel model in the United States is often mentioned as a significant case study.…”