Background: Frequent prescription of medication in an unapproved manner (off-label or unlicensed) in the neonatal setting is a result of the limited availability of adequately studied drugs in the pediatric population. Given that little information is available on this issue from eastern European countries, the purpose of this study was to describe for the first time the extent and pattern of off-label or unlicensed use of medicines in newborns in the Slovak Republic.
Methods: Cross-sectional study was performed at the Department of Pathological Newborns of Children's University Hospital, Bratislava, and Unit of Pathological Newborns of Teaching Hospital Nitra.