Off-label drug use among hospitalized children: identifying extent and nature

Objective of the study was to determine the extent and nature of medicinal products used off-label in hospitalized children and to highlight the therapeutic areas with the highest need. Over a 4 week period, data about prescribed drugs to patients under 18 years of age at two paediatric wards in Bratislava (Unit for Infants and Unit for Older Children) were recorded and the drug-licensing status according to valid Summary of Product Characteristics (SPC) was identified. In total, 206 medicinal products containing 70 different generic substances were given to 49 paediatric patients at the Unit for Infants. Of these, 22% were evaluated as off-label. The highest rates were established among the drugs used for diseases of respiratory system and diseases of digestive system. The 68 children had been given at the Unit for Older Children 267 medicinal products resulting in 97 generic substances. In 15.7% of cases medicines were used in off-label manner, mainly due to unapproved paediatric indication and age. This pilot study provided a preliminary survey on drugs administered off-label to paediatric patients in Slovak Republic.