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

AIM: To study the prevalence of prescribing medicines for off-label (OL) use and unlicensed (UL) medicines for children during hospitalisation in 2021 and to assess changes compared to 2011.

METHODS: The study included all patients aged under 18 years old 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 to 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<0.001). The proportion of patients receiving at least one UL medicine prescription decreased from 53% in 2011 to 30% (age-adjusted proportion) in 2021 (P<0.001). 76% of hospitalised children were still prescribed either OL prescription or UL medicine in 2021.

CONCLUSION: The prescriptions for OL use and UL medicines were less prevalent in 2021 than 2011, but still a majority of hospitalised 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.