title: Off-label and unlicensed medicines to hospitalised children in Norway.
abstract: OBJECTIVE
  The aim of this study was to investigate the use of off-label (OL) and unlicensed (UL) medicines to hospitalised children in Norway, to add to the current knowledge on use of medicines in this vulnerable patient group.
  
  
  METHODS
  The study was performed as a cross-sectional prospective study. Medication was classified as on- or off-label based on the comparison with the SmPC regarding age, indication, dosage, route of administration and handling of the product. UL products were classified as imported or pharmacy produced.
  
  
  RESULTS
  More than 90% of children receiving medicines in our study were given OL or UL medicines. More patients received OL (83%) than UL (59%). Route of administration was the most frequently observed OL category. The vast majority of the OL prescriptions were for 'off-patent' products. One-third of products prescribed were UL.
  
  
  CONCLUSIONS
  The study confirms that medicines to children in hospital to a significant degree are being used outside or without authorisation, in spite of recent paediatric regulatory initiatives. More data are still needed on efficacy and safety of medicines used in children, data to be incorporated in the SmPC. In addition, suitable formulations are needed to ensure optimal dosing and adherence without risky manipulations.
authors.affiliation: Hospital Pharmacy Enterprises, South Eastern Norway, Oslo, Norway.|School of Pharmacy, University of Oslo, Oslo, Norway.
authors.forename: Arna
authors.initials: A
authors.lastname: Teigen
authors.affiliation: Department of Medicinal Product Assessment, Norwegian Medicines Agency, Oslo, Norway.
authors.forename: Siri
authors.initials: S
authors.lastname: Wang
authors.affiliation: Hospital Pharmacy Enterprises, South Eastern Norway, Oslo, Norway.|School of Pharmacy, University of Oslo, Oslo, Norway.
authors.forename: Bich Thuy
authors.initials: BT
authors.lastname: Truong
authors.affiliation: Hospital Pharmacy Enterprises, South Eastern Norway, Oslo, Norway.
authors.forename: Kathrin
authors.initials: K
authors.lastname: Bjerknes
mesh_terms: D000293:Adolescent; D002648:Child; D002673:Child, Hospitalized; D002675:Child, Preschool; D003430:Cross-Sectional Studies; D005260:Female; D006785:Hospitals, University / Q000639:trends*; D006801:Humans; D007223:Infant; D008297:Male; D009664:Norway / Q000453:epidemiology; D056687:Off-Label Use; D004364:Pharmaceutical Preparations / Q000008:administration & dosage*; D011446:Prospective Studies
chemical_list: D004364:Pharmaceutical Preparations
keywords: hospitalised children; off-label; paediatric; unlicensed medicines