(232) Characterizing Pediatric Members in the Sentinel Distributed Database: An Update with Data from Medicaid

Background: The US FDA’s Sentinel Distributed Database (SDD) primarily consists of administrative claims data from national and regional health plans, representing 1.1 billion person-years from all US states and territories, including more than 300 million from Medicaid.

Objectives: To better understand pediatrics in the SDD, we described members aged 0 - 21 years.

Methods: Thirteen Sentinel Data Partners contributed data from 2000-2023. We described demographics, enrollment, healthcare utilization, common health conditions, and prescription medications in each pediatric age group: neonates (0 - 28 days; characteristics assessed only through 28 days), infants/toddlers (29 days - < 24 months), children (2 - < 6 and 6 - < 12 years), and adolescents (12 - < 18 and 18 - 21 years).

Results: We identified about 16.6 million (M) neonates, 27.6M infant/toddlers, 36.8M young children, 46.7M older children, 45.4M early adolescents, and 35.5M late adolescents in the SDD. 49-51% of each age group were female. The median (IQR) length of continuous enrollment ranged from 432 (214 – 1,004) in late adolescents to 708 (320 – 1,455) days in older children, with non-Medicaid data being more right-skewed. Healthcare utilization peaked in infancy and was slightly higher in Medicaid data (mean 7.5 ± 7.1 & 7.7 ± 8.6 ambulatory encounters; 1.9 ± 2.5 & 2.6 ± 3.2 unique dispensed prescriptions in non-Medicaid and Medicaid data, respectively).
Allergies were common in all age groups (2.8-17.3%), whereas gastroesophageal reflux disease peaked in neonates and infants/toddlers (3.1 & 7.8%). Otitis (4.2-31.0%), sinusitis (4.7-6.3%), and asthma (4.3-7.0%) were also common from infancy through early adolescence. Attention deficit and hyperactivity disorder was highly evident from 6-21 years (3.5-7.8%), while anxiety (6.6%) and depression (5.3%) surged in late adolescence.
The most dispensed prescriptions starting in infancy were antibiotics (26.3-41.7%) and glucocorticoids (11.0-22.6%), while antiasthmatics and antihistamines were common until age 18 (9.6-13.8% and 11.1-15.7%). Stimulants (4.9-6.4%) and antidepressants (4.1-7.0%) were common among children 6 - < 18 and 12 – 21 years. Non-narcotic analgesics were common for every age group (6.8-14.2%), while 5.5% and 11.2% of early and late adolescents were dispensed at least one narcotic analgesic.

Conclusions: The SDD contains a substantial number of pediatric members, with representation from all 50 US states’ commercial and Medicaid health plans. Data spans more than 20 years and more than half of members are continuously enrolled for ≥1 year. Future researchers should consider the SDD as a valuable data source when investigating pediatric medication exposures and health outcomes.