Prescribing for off-label use and unauthorized medicines in three paediatric wards in Finland, the status before and after the European Union Paediatric Regulation

The European Paediatric Regulation aims to reduce off-label use of medicines in paediatric pharmacotherapy. Prescribing for off-label use and unauthorized medicines was common in the paediatric wards of the Kuopio University Hospital in 2001. To evaluate the possible impact of the Regulation on the prevalence and the frequency on such prescribing, we repeated the study in 2011 as it was conducted 10 years earlier.In this prospective study, the prescriptions for patients below 18 years of age were reviewed during a 2-week period in each of the three wards; neonatal intensive care unit, general paediatric ward and paediatric surgical ward in April and May 2011. The medicine's authorizing status of all prescriptions was determined according to the approved summary of product characteristics valid during the study in Finland. Data concerning unauthorized medicines were also recorded and classified.Out of the entire study population of 123 patients, 119 received a total of 1054 prescriptions in 2011. The proportion of patients with at least one prescription for off-label use or for an unauthorized medicine was significantly higher, 79% (n = 97) in 2011, compared to 58% in 2001 (P < 0·001). For newborns, significantly more prescriptions were for off-label use in 2011 than in 2001 (51% vs. 22%; P < 0·001). The proportion of prescriptions for unauthorized medicines was significantly higher in children below 2 years of age than in older children in both years (21% vs. 5% in 2011 and 24% vs. 3% in 2001, P < 0·001).The prescribing for off-label use and unauthorized medicines was more prevalent in 2011 than in 2001. This indicates that the recent legislation has had only minor or no impact on the authorizing status of medicines commonly used in paediatric inpatients in specialized care.