Off-label and unlicensed medicine prescribing in university hospital paediatric wards in Finland: A prospective study

Abstract

Aims: The aim of this research is to study the prevalence of prescribing medicines for off-label (OL) use and unlicensed (UL) medicines for children during hospitalization in 2021 and to assess changes compared with 2011. Methods: The study included all patients aged <18 years who were treated in the neonatal intensive care unit (NICU) or general paediatric ward of Kuopio University Hospital (KUH), Finland, during 4 weeks in April and May 2021. Their background data and daily information on medicine prescriptions were collected from patient records. The prescriptions were classified as OL, UL or on-label/approved. The type of OL category was defined. Results: Altogether, 165 children aged 0–17 years (median 3.2 years) were treated in the paediatric wards (46 in the NICU and 119 in the general ward). In total, 1402 prescriptions were made for 153 children (93%). The proportion of OL and UL prescriptions decreased significantly from 55% in 2011 to 45% (age-adjusted proportion) in 2021 (P