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Recent estimates showed that patients aged 18 years or younger comprised approximately 14% of the population in the Sentinel Distributed Database (SDD). To conduct studies among pediatric patients that could support regulatory decisions, it is vital to understand the composition of this population. The FDA initiated this study to better understand the characteristics of this population, including demographics, vaccination status, medical comorbidities, major congenital malformations, medication administration, prescription claims, healthcare utilization, and available follow-up time in the SDD from January 2000 to May 2023.
Results indicate that the total volume of pediatric enrollees in the SDD from 2000-2023 ranged from about 16 million newborns (0-28 days) to about 46 million older children (6-11 years of age), with representation from all 50 U.S. states’ commercial and Medicaid health plans. The data span more than 20 years, and more than half of pediatric patients are continuously enrolled in their health plan for at least one year. The SDD is a valuable data source that can support investigations of pediatric medication exposures and health outcomes.