title: Licensing and labelling of drugs in a paediatric oncology ward.
abstract: OBJECTIVE
  Paediatric drug prescriptions are known for their high percentages of off-label and unlicensed use. In paediatric oncology data available are scarce. The aim of this paper is an analysis of the licensing and labelling status of all prescribed medication over a 2 week period in a Dutch paediatric oncology centre.
  
  
  METHODS
  An analysis of the delivery of medication by the hospital pharmacy to patients admitted to the paediatric oncology centre was carried out.
  
  
  RESULTS
  In total 268 precriptions were filed for 39 patients. In 87% of children unlicensed medication was used. Fifty-nine per cent of the children received at least two unlicensed drugs. In total 72% of the drugs were used licensed and on-label was found in 57% of the prescriptions. There was a trend that in younger children percentages were lower. International and local guidelines necessitated in many cases unlicensed use, e.g. intrathecal prednisolone, low dose medication such as heparin, ethanol and vancomycin for locking intravenous devices and higher intravenous vancomycin dosages. There were no major differences with respect to type of malignancy.
  
  
  CONCLUSIONS
  Our figures are substantially higher than the figures reported from adult oncology. Comparison with other paediatric reports are cumbersome, due to different percentages of diseases in the reports and other rules to dispense medication in the outpatient setting. Our data are in line with reports mentioning the higher percentages of unlicensed and off-label use. Our data further underpin the need for more research on suitable formulations, dosages, safety and efficacy in these children.
authors: Department of Paediatric Oncology, Emma Children Hospital AMC, University of Amsterdam, Amsterdam Medicines Evaluation Board, The Hague, The Netherlands. h.vandenberg@amc.uva.nl
authors: Henk
authors: H
authors: van den Berg
authors: Nanda
authors: N
authors: Tak
mesh_terms: D000293:Adolescent; D000367:Age Factors; D000970:Antineoplastic Agents / Q000600:supply & distribution* / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004348:Drug Labeling / Q000331:legislation & jurisprudence*; D011307:Drug Prescriptions; D006761:Hospitals; D006801:Humans; D007223:Infant; D007880:Legislation, Drug; D008495:Medical Oncology / Q000639:trends; D009426:Netherlands; D056687:Off-Label Use / Q000331:legislation & jurisprudence*; D010372:Pediatrics / Q000639:trends; D004364:Pharmaceutical Preparations / Q000600:supply & distribution*; D010818:Practice Patterns, Physicians' / Q000592:standards*
chemical_list: D000970:Antineoplastic Agents; D004364:Pharmaceutical Preparations