title: Off-label and unlicensed use of medicinal products in the neonatal setting in the Slovak Republic.
abstract: 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. Data were collected on hospitalized neonates admitted between 1 April and 30 September 2012 who received pharmacotherapy. Label status of the administered drugs was determined according to the Slovak Summaries of Product Characteristics.
  
  
  RESULTS
  A total of 962 prescriptions referring to 97 different medications was administered to 202 hospitalized newborns (46% premature). Anti-infectives and alimentary drugs were the most commonly prescribed. Of all prescriptions, 43% were identified as off-label and 4.8% as unlicensed. At least one off-label or unlicensed drug was given to 88.6% of patients. Ketoconazole was the most frequent drug used in an unapproved manner. A total of 13.8% of all prescriptions was administered despite contraindication.
  
  
  CONCLUSIONS
  Administration of drugs to newborns in an unapproved manner was common in the participating Slovak neonatal wards, reflecting the lack of appropriate pediatric drug labeling.
authors.affiliation: Department of Pharmacology and Toxicology, Faculty of Pharmacy, Comenius University in Bratislava, Bratislava, Slovakia.
authors.forename: Jana
authors.identifier: http://orcid.org/0000-0003-1073-4617
authors.initials: J
authors.lastname: Schweigertova
authors.affiliation: Department of Neonatology, Teaching Hospital Nitra, Nitra, Slovakia.
authors.forename: Alena
authors.initials: A
authors.lastname: Durisova
authors.affiliation: Department of Neonatology, Children's University Hospital, Bratislava, Slovakia.
authors.forename: Dana
authors.initials: D
authors.lastname: Dolnikova
authors.affiliation: Department of Pharmacology and Toxicology, Faculty of Pharmacy, Comenius University in Bratislava, Bratislava, Slovakia.
authors.forename: Elena
authors.initials: E
authors.lastname: Ondriasova
authors.affiliation: Department of Pharmacology and Toxicology, Faculty of Pharmacy, Comenius University in Bratislava, Bratislava, Slovakia.
authors.forename: Martina
authors.initials: M
authors.lastname: Balazova
authors.affiliation: Department of Pharmacology and Clinical Pharmacology, Faculty of Medicine, Comenius University in Bratislava, Bratislava, Slovakia.
authors.forename: Veronika
authors.initials: V
authors.lastname: Slezakova
authors.affiliation: Department of Pharmacology and Toxicology, Faculty of Pharmacy, Comenius University in Bratislava, Bratislava, Slovakia.
authors.forename: Magdalena
authors.initials: M
authors.lastname: Kuzelova
mesh_terms: D003430:Cross-Sectional Studies; D011307:Drug Prescriptions / Q000706:statistics & numerical data*; D004363:Drug Utilization / Q000706:statistics & numerical data*; D005260:Female; D006785:Hospitals, University; D006801:Humans; D007231:Infant, Newborn; D007363:Intensive Care Units, Neonatal; D008297:Male; D056687:Off-Label Use / Q000706:statistics & numerical data*; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data*; D018154:Slovakia
keywords: Slovak Republic; medicine; newborn; off-label use; unlicensed