Skip to main content

FDA Sentinel System's Coronavirus (COVID-19) Activities

FDA’s Sentinel System is engaged in numerous activities to protect and promote public health during the COVID-19 pandemic, ranging from monitoring the use of drugs, describing the course of illness among hospitalized patients, and evaluating the treatment impact of therapies actively being used under real-world conditions. Descriptions of efforts led by the Center for Drug Evaluation and Research are shown below. Please visit the links to learn more about each area of activity and also visit:

FDA’s Official COVID-19 Drugs Page

Sentinel Projects

Characteristics and Medication Use Patterns of Pregnancies With COVID-19 Ending in Live-Birth in the Sentinel System

Pregnant women are at high risk for developing severe illness related to coronavirus disease 2019 (COVID-19). We adapted the “COVID-19 infectiOn aNd medicineS In pregnancy” (CONSIGN) study protocol as part of an international collaboration to examine medication use patterns among pregnancies in the United States.

We identified eligible women aged 12–55 years with documented live-birth deliveries in the Sentinel Distributed Database (SDD) who had at least one qualifying diagnosis for COVID-19 or a positive-confirmed test for SARS-CoV-2, by trimester of COVID-19 infection. We conducted two sets of analyses comparing medication groups and COVID-19 treatment utilization in the 30 days prior to or after COVID-19 among pregnancies with COVID-19 to: (1) pregnancies without COVID-19 during six months prior to or during pregnancy; and (2) non-pregnancy episodes with COVID-19.

Details
Utilization of Proton Pump Inhibitors (PPIs), Single-Agent H2 Receptor Antagonists (H2RAs), and Famotidine in Patients with Gastroesophageal Reflux Disease (GERD): A Descriptive Analysis

In this report, we identified new and prevalent users of proton pump inhibitors (PPIs), single-agent H2 receptor antagonists (H2RAs), and famotidine who had a diagnosis of gastroesophageal reflux disease (GERD) in the Rapid Sentinel Distributed Database (SDD). We also estimated the incidence of COVID-19 and COVID-19-related adverse outcomes among these individuals.

The study period includes data from April 1, 2020 to December 15, 2020. We distributed this request to seven Sentinel Data Partners (DPs) on June 3, 2022.

Details
Dexamethasone Dose for COVID-19 in a Large U.S. Hospital Network From April 2020 to May 2023

While potential harm from high doses of systemic dexamethasone for clinical management of COVID-19 is an important concern, little is known about real world dexamethasone dosing in patients hospitalized with COVID-19 in the United States. We conducted a descriptive study to assess dexamethasone daily dose in adults with COVID-19 in a large US hospital network, overall and by respiratory support requirements, extracted using semi-structured nursing notes.

Details
Characterization of COVID-19 Vaccine Data in the Sentinel System

COVID-19 vaccination has been delivered in a wide range of settings, from healthcare delivery visits to state sponsored vaccination fairs. Therefore, complete capture of vaccination status may benefit from using multiple code types, such as claims and CVX (vaccine administered) state-based Immunization Information Systems (CVX-IIS) codes, to enhance the ascertainment.

This poster aims to characterize the availability and code type of COVID-19 vaccine data in the Sentinel Distributed Database (SDD). It was presented at the 2024 ISPE Annual Meeting.
 

Details
Patterns of Prescribing and Dispensing Medicines Among Non-Hospitalized Pregnant Women with COVID-19: a Prospective Meta-Analysis Pooling Findings from Healthcare Databases in Europe and North America

There is a significant void in our understanding of the specific medications utilized by pregnant women with COVID-19 in real-world outpatient settings. Existing evidence refers to small populations or inpatient prescriptions only.

This poster estimates medicines use prevalence by pregnancy trimester in non-hospitalized pregnant women with COVID-19 and compare it with pregnant women without COVID-19 and non-pregnant women with COVID-19. It was presented at the 2024 ISPE Annual Meeting.
 

Details
Comparing the Risk of Adverse Infant Outcomes Among Pregnancies with and without COVID-19 in the Sentinel System

COVID-19 may increase the risk of developing severe illness among pregnant patients. Several studies have described clinical characteristics and complications among pregnancies with COVID-19, but data on the impact of maternal COVID-19 on adverse infant outcomes is limited. 

This presentation implements the CONSIGN protocol (COVID-19 infection and medicines in pregnancy), as part of an international collaboration across Europe, USA, and Canada, to examine the risk of adverse outcomes in infants delivered by pregnant patients with COVID-19 compared to pregnant patients without COVID-19. It was presented at the 2024 ISPE Annual Meeting.
 

Details
COVID-19 Related Changes in Healthcare Utilization Among Insured Persons in the U.S. and its Impact on Pharmacoepidemiologic Research

COVID-19 pandemic containment measures in the U.S. resulted in changes in the provision and utilization of health services. Validity of pharmacoepidemiologic studies using claims data from this time may be impacted.

This poster investigates the impact of changing healthcare utilization on ascertainment of study variables by replicating a known positive association using 2018-2022 data. It was presented at the 2024 ISPE Annual Meeting.

Details
Characteristics and Drug Utilization in Pregnant Patients With COVID-19: A Propensity Score Matched Analysis

This analysis supports the U.S. Food and Drug Administration (FDA)'s participation in the European Medicines Agency (EMA)-funded project, CONSIGN (COVID-19 infectiOn aNd medicineS In preGNancy)1 , to understand the natural history of COVID-19 in pregnant patients. For other analyses supporting the CONSIGN protocol, please see Risk of Adverse Neonatal Health Outcomes Among Pregnant Patients With and Without COVID-19: A Propensity Score Matched Analysis and Risk of Adverse Maternal Health Outcomes Among Pregnant Patients With and Without COVID-19: A Propensity Score Matched Analysis.

The goal of this analysis was to evaluate the prevalence of medication use among pregnant patients with COVID-19 compared to two 1:1 propensity-score matched comparator cohorts and to describe maternal at-risk conditions and the severity of COVID-19 in the Rapid COVID-19 Sentinel Distributed Database (SDD). 

The study period includes data from January 1, 2020 to December 31, 2022. We distributed this request to seven Sentinel Data Partners on June 30, 2023.

This analysis includes two reports:

  • Report 1: This report includes pregnant patients without COVID-19 as the comparator cohort (Objective 1b of the COVID-19 pregnancy study protocol).
  • Report 2: This report includes non-pregnant patients with COVID-19 as the comparator cohort (objectives 1c and 2b of the COVID-19 pregnancy study protocol).

The analytic package associated with this analysis can be found externally in Sentinel's Git Repository here. The Git Repository serves as Sentinel's version control tracking system for analytic packages and technical documentation.

Details
Risk of Adverse Maternal Health Outcomes Among Pregnant Patients With and Without COVID-19: A Propensity Score Matched Analysis

This analysis supports the U.S. Food and Drug Administration (FDA)'s participation in the European Medicines Agency (EMA)-funded project, CONSIGN (COVID-19 infectiOn aNd medicineS In preGNancy)1 , to understand the natural history of COVID-19 in pregnant patients. For other analyses supporting the CONSIGN protocol, please see Risk of Adverse Neonatal Health Outcomes Among Pregnant Patients With and Without COVID-19: A Propensity Score Matched Analysis and Characteristics and Drug Utilization in Pregnant Patients With COVID-19: A Propensity Score Matched Analysis.

In this request, we completed the following objectives: A) estimated the prevalence of adverse maternal outcomes by trimester of COVID-19 infection and by COVID-19 severity among pregnant patients with COVID-19; B) compared rates of adverse maternal outcomes among pregnant patients with COVID-19 to those without COVID-19 using a 1:1 propensity score (PS)-matched analysis; and C) evaluated the impact of medications used to treat COVID-19 on adverse maternal outcomes by assessing incidence of adverse maternal outcomes among pregnant patients with COVID-19 that had medication use in the 30 days pre-COVID-19 or post-COVID-19 and those not exposed to medications in the 30 days pre- or post-COVID-19.

The study period includes data from January 1, 2020 to November 30, 2023. We distributed this request to seven Sentinel Data Partners on February 8, 2024.

The analytic package associated with this analysis can be found externally in Sentinel's Git Repository here. The Git Repository serves as Sentinel's version control tracking system for analytic packages and technical documentation.

Details
Risk of Adverse Neonatal Health Outcomes Among Pregnant Patients With and Without COVID-19: A Propensity Score Matched Analysis

This analysis supports the U.S. Food and Drug Administration (FDA)'s participation in the European Medicines Agency (EMA)-funded project, CONSIGN (COVID-19 infectiOn aNd medicineS In preGNancy)1 , to understand the natural history of COVID-19 in pregnant patients. For other analyses supporting the CONSIGN protocol, please see Risk of Adverse Maternal Health Outcomes Among Pregnant Patients With and Without COVID-19: A Propensity Score Matched Analysis and Characteristics and Drug Utilization in Pregnant Patients With COVID-19: A Propensity Score Matched Analysis.

The goals of this analysis were to complete the following objectives: A) to estimate the prevalence of adverse infant outcomes by trimester of COVID-19 identification and by COVID-19 severity among pregnant patients with COVID-19; B) to compare rates of adverse infant outcomes among pregnant patients with COVID-19 to pregnant patients without COVID-19 using a 1:1 propensity score (PS)-matched analysis; and C) to evaluate the impact of medications used to treat COVID-19 on adverse infant outcomes by assessing incidence of adverse infant outcomes among pregnant patients with COVID-19 that had medication use in the 30 days pre-COVID-19 or post-COVID-19 and those not exposed to medications in the 30 days pre- or post-COVID-19.

The study period includes data from January 1, 2020 to December 31, 2022. We distributed this request to four Sentinel Data Partners on June 30, 2023.

The analytic package associated with this analysis can be found externally in Sentinel's Git Repository here. The Git Repository serves as Sentinel's version control tracking system for analytic packages and technical documentation.

Details