Off-label prescribing in Italian pediatric practice: insights from a nationwide survey.

ABSTRACT: Off-label prescribing in pediatric care is common due to the lack of age-specific drug formulations, posing risks to safety and efficacy. Understanding how Italian hospitals manage and regulate this practice is essential to improving oversight and promoting safer prescribing. A multicenter, cross-sectional survey was conducted from November 13, 2024, to January 31, 2025, under the Italian Network for Pediatric Clinical Trials (INCiPiT). Fifty facilities participated; 64% of those with < 5000 pediatric admissions had Neonatal Intensive Care Units (NICUs) and birth centers. Off-label prescribing was strongly associated with NICUs, increasing up to 50% following compassionate use refusal. Notably, 25% of centers were unaware of prescribing frequency. Facilities with digital tracking and dedic

SUBMITTER: Arbo A 

PROVIDER: S-EPMC12664833 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature