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

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 < .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. CONCLUSION: 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.

Factors associated with medicine use among children aged under 12 years--a population survey in Finland.

PURPOSE: The goal was to determine the prevalence of medicine use and to provide population-based information on factors associated with medicine use, including prescribed and over-the-counter (OTC) medicines, in children aged under 12 years. METHODS: A cross-sectional population survey of a random sample of children aged under 12 years (n = 6000) was carried out in Finland in spring 2007, with a response rate of 67%. A questionnaire was sent to their parents. Current use of medicines prescribed by a physician and use of OTC medicines during the preceding two days were the main outcome measures. RESULTS: The prevalence of current prescribed medicine use was 17%, and the 2-day prevalence of OTC medicine use 17% (vitamins excluded). The use of prescribed medicines was higher among children with illnesses diagnosed by a physician. Additionally, predictors for the use of prescribed medicines were young age among boys, health status worse than good, and the use of any prescribed medicines by a parent. The predictors for the use of OTC medicines by the child were young age and fairly good to poor health status, and the use of OTC medicines by a parent. However, children with any illnesses diagnosed by a physician were less likely to use OTC medicines. CONCLUSIONS: A considerable proportion of children use prescription and OTC medicines in Finland. Young age and health-related factors, morbidity and health status, and parental medicine use predicted children's medicine use. Further studies are needed to examine the association between parents' and children's medicine use.