Pharmacoepidemiol Drug Saf. 2025 Sep;34(9):e70217. doi: 10.1002/pds.70217.
ABSTRACT
BACKGROUND: Assessing medication safety in the pediatric population can take many forms, but given the shortcomings of traditional methods, there has been a shift toward leveraging real-world data to bolster these efforts.
OBJECTIVES: To characterize demographics, enrollment, and health characteristics among pediatric members in the Sentinel Distributed Database (SDD).
METHODS: Using administrative healthcare data from the SDD between January 1, 2000, and May 8, 2023, we used descriptive statistics to characterize the demographics, enrollment, and select health characteristics of pediatric members in the following age groups: 29 days-< 24 months (infants), 2-< 6 years (young children), 6 -< 12 years (older children), 12-< 18 years (early adolescents), and 18-21 years (late adolescents).
RESULTS: Older children (6-< 12 years of age) represented the largest pediatric age group in the SDD, with over 46 million members, though there were between 27.5 and 45.4 million members in each of the other age groups as well. Estimates of common health conditions and medication use were in line with current national estimates.
CONCLUSIONS: The FDA’s Sentinel Distributed Database accurately captures key aspects of pediatric health and can be used as an adjunct to current methods to assess and monitor the safety of approved medical products in the pediatric United States population.
PMID:40947306 | DOI:10.1002/pds.70217
