(201) Characterizing Pediatric Members in The Sentinel Distributed Database

Sunday, August 28, 2022

8:00 AM – 1:45 PM CEST

Location: Hall C

Publication Number: 1246

Presenting Author(s)

Ashley I. Martinez, PharmD, PhD
– Research Scientist, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, Massachusetts, United States

Co-Author(s)

Emmanuel Ojo, MPH
– Research Analyst, Harvard Pilgrim Health Care Institute, Harvard Medical School Department of Population Medicine, United States
Kimberly Barrett, MPH
– Research Analyst I, Harvard Pilgrim Health Care Institute, Harvard Medical School Department of Population Medicine, United States
Samantha Smith, BA
– Research Assistant, Harvard Pilgrim Health Care Institute, Harvard Medical School Department of Population Medicine, United States
Danijela Stojanovic, PharmD, PhD
– U.S. Food and Drug Administration, Silver Spring, MD, United States

Background: The US FDA’s Sentinel Distributed Database (SDD) primarily consists of administrative claims data from national and regional health plans, representing 800 million person-years from all 50 US states.

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

Methods: From January 1, 2000, to May 31, 2021, we used five data partners to describe common health conditions, prescription medications, and healthcare utilization in members’ first year in each group: neonates (0 - 28 days; characteristics assessed only through 28 days) infants/toddlers (29 days - < 24 months), young and older children (2 - < 6 and 6 - < 12 years), and early and adolescents (12 - < 18 and 18 - 21 years). We also described demographics and length of continuous enrollment in the SDD.

Results: We identified 5,979,901 neonates, 10,273,860 infant/toddlers, 14,281,513 young children, 18,965,761 older children, 19,773,853 early adolescents, and 18,151,176 late adolescents in the SDD. In all age groups, ~48% of members were female, and the median (IQR) length of continuous enrollment ranged from 16.9 (7.5 – 35.9) to 21.9 (9.5 – 46.0) months. In their first year, members had four ambulatory encounters and filled three prescriptions on average.

Allergies appeared in the top five most frequently observed health conditions in all age groups (1.7-13.8%). Gastroesophageal reflux disease was the most common condition observed in neonates (3.7%) and made the top five among infants/toddlers (8.5%). Otitis (4.8-35.1%), sinusitis (6.5-8.7%), and asthma (4.0-6.2%) were also common from infancy through early adolescence. Mental health conditions were more common in older ages: attention deficit and hyperactivity disorder was highly evident from 6-21 years (3.5-6.3%), while anxiety (5.7%) and depression (4.6%) surged in late adolescence.

The most dispensed prescriptions starting in infancy were antibiotics (27.9-41.4%) and glucocorticoids (11.4-19.5%), while antiasthmatics and antihistamines were common until age 18 (8.3-12.3% and 6.9-9.7% respectively). Medications for mental health conditions, including stimulants (4.9-6.4%) and antidepressants (4.1-7.0%) were common among children 6 - < 18 and 12 – 21 years respectively.

Conclusions: The Sentinel Distributed Database contains a substantial number of pediatric members, with representation from all 50 US states. Member enrollment spans more than 20 years, and more than half of members are continuously enrolled for ≥1 year. While capture of health conditions and prescription medication appears low among neonates, capture among other age groups is similar to other sources. Future researchers should consider the SDD as a valuable data source when investigating pediatric medication exposures and health outcomes.