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

Abstract

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. 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. 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< .001). The proportion of patients receiving at least 1 UL medicine prescription decreased from 53% in 2011 to 30% (age-adjusted proportion) in 2021 (P< .001). About 76% of hospitalized children were still prescribed either OL prescription or UL medicine in 2021. The prescriptions for OL use and UL medicines were less prevalent in 2021 than 2011, but still a majority of hospitalized children were prescribed either medicine for OL use or UL medicine in 2021. This indicates a persisting need for approved medicines in children suggesting that revision of EU Paediatric Regulation 2007 is necessary.