Authors
Daishi Hirano, Yuki Kataoka, Kota Sakaguchi, Takashi Watari
Published in
European journal of pediatrics. Volume 185. Issue 10. Sep 23, 2026. Epub Sep 23, 2026.
Abstract
Children are particularly vulnerable to medication-related harm. However, most previous research has focused on prescribing errors, leaving incidents occurring during downstream stages of the medication-use process insufficiently well characterized. We determined the epidemiology of pediatric medication-related incidents in Japan and examined factors associated with severe patient harm. This retrospective cross-sectional study analyzed nationwide incident reports from the Japan Council for Quality Health Care (JCQHC) Safe Master database involving patients aged 0 to 19 years reported between 2013 and 2024. Incidents were classified by medication-use stage and error type. Severe incidents (severity grade ≥ 3b) were identified, and associated factors were evaluated by multivariable modified Poisson regression to estimate adjusted prevalence ratios (aPRs) and 95% confidence intervals (CIs). Among the 54,310 incident reports, 546 pediatric medication-related incidents were identified, including 178 (32.6%) that were severe. Incidents occurring during preparation and administration accounted for 67.9% of all incidents and were associated with a higher prevalence of severe harm among reported incidents (aPR, 2.03; 95% CI, 1.38-2.98). Extravasation occurred in 35 incidents, of which 29 (82.9%) were severe. Nurse-related incidents were associated with a lower prevalence of severe harm than physician-related incidents (aPR, 0.55; 95% CI, 0.42-0.72). Patient age, time of day, neonatal intensive care unit (NICU) location, physician experience, and workload were not significantly associated with severe harm.
Preparation and administration were frequently reported medication-use stages and were associated with a higher prevalence of severe harm. Pediatric medication safety strategies should extend beyond prescribing toward system-level interventions targeting preparation, administration, and monitoring.
• Children are particularly vulnerable to medication-related harm, and previous pediatric medication safety research has focused predominantly on prescribing errors. • Evidence regarding severe medication-related incidents occurring during downstream medication-use stages remains limited, particularly from nationwide studies.
• In this 12-year nationwide Japanese study, incidents occurring during medication preparation and administration (not prescribing) were associated with a higher prevalence of severe harm among reported incidents. • Severe extravasation occurred predominantly in younger children, highlighting monitoring of intravenous access sites as a key target for pediatric safety.
PMID:
42773260
Bibliographic data and abstract were imported from PubMed on 23 Sep 2026.
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