title: Use of off-label and unlicenced drugs in hospitalised paediatric patients: a systematic review.
abstract: OBJECTIVE
  The aim of this review is to assess the extent of the use of off-label and/or unlicenced drugs among hospitalised children.
  
  
  METHODS
  A systematic search was made in MEDLINE-PubMED for papers published from 1994 to 2012, addressing the prescription of off-label and/or unlicenced drugs for the paediatric population in hospital care.
  
  
  RESULTS
  Of the 829 studies retrieved, 34 met the inclusion criteria. Prescriptions ranged from 12.2 to 70.6 % for off-label and from 0.2 to 47.9 % for unlicensed drugs. The percentage of children who received at least one off-label and/or unlicensed drug ranged from 42.0 to 100 %, with newborns being the population that received most of such drugs. Off-label prescriptions were essential for dose modification (7.1-73.1 %) and unlicensed prescriptions for formulation modification purposes (3.6-100 %).
  
  
  CONCLUSIONS
  These findings show that: (i) off-label and/or an unlicensed prescribing is widespread among the hospitalised paediatric population worldwide, (ii) there is no consensus on a definition of off-label and/or unlicensed drugs and (iii) preterm newborns receive most off-label and/or unlicensed drugs. By shedding new light on off-label and/or unlicensed drug prescribing, these findings will hopefully contribute to generating new, more effective knowledge about the paediatric population's need for quality drugs that are both safe and efficacious.
authors.affiliation: Centre for Cell Biology, University of Aveiro (CBC/UA), Aveiro, Portugal.
authors.forename: Joana
authors.initials: J
authors.lastname: Magalhães
authors.forename: António Teixeira
authors.initials: AT
authors.lastname: Rodrigues
authors.forename: Fátima
authors.initials: F
authors.lastname: Roque
authors.forename: Adolfo
authors.initials: A
authors.lastname: Figueiras
authors.forename: Amílcar
authors.initials: A
authors.lastname: Falcão
authors.forename: Maria Teresa
authors.initials: MT
authors.lastname: Herdeiro
mesh_terms: D002648:Child; D017277:Drug Approval; D004363:Drug Utilization / Q000706:statistics & numerical data*; D006760:Hospitalization / Q000706:statistics & numerical data*; D006801:Humans; D056687:Off-Label Use / Q000706:statistics & numerical data*