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

• This nationwide Italian survey reveals that off-label prescribing in Italian pediatric hospitals is primarily driven by institutional specialization-especially NICU presence-rather than hospital size, with digital tracking and research units linked to better regulatory compliance. • A significant portion of facilities lack awareness of their off-label prescribing rates, highlighting the need for standardized oversight and national policy alignment to ensure safer pediatric drug use.