title: A literature review on off-label drug use in children.
abstract: The aim was to compare results of studies performed in different settings worldwide and identify common therapeutic areas to allow for focused interventions, because off-label drug use can be a measure of the lack of knowledge concerning paediatric treatments. A secondary objective was to provide a brief review of efforts to date. A literature review of articles on off-label and unlicensed drug use in children involving general prescription samples was performed using Medline and Embase. In all, 30 studies from 1985-2004 were included. Eleven involved paediatric hospital wards, seven neonatal hospital wards, and 12 the community setting. The off-label and unlicensed classification methods varied, making results difficult to compare. In general, off-label/unlicensed prescription rates ranged from 11%-80%, and higher rates were found in younger versus older patients and in the hospital versus community settings. On the paediatric hospital wards, off-label/unlicensed prescriptions ranged from 16%-62% and most often concerned acetaminophen, cisapride, chloral hydrate, and salbutamol. In the neonatal wards, rates ranged from 55%-80% and often involved caffeine. In the community setting, rates ranged from 11%-37% and the most commonly implicated drugs were salbutamol and amoxicillin.
  
  
  CONCLUSIONS
  A lack of harmonization between the evidence, the information available to doctors, and its use in clinical practice exists and this is part of the reason off-label therapies are so common. Attempts have been made to improve knowledge concerning paediatric treatments, but more focused interventions are needed, also taking into consideration this lack of harmonization.
authors.affiliation: Laboratory for Mother and Child Health, Mario Negri Institute for Pharmacological Research, Via Eritrea 62, Milan, Italy. pandolfini@marionegri.it
authors.forename: Chiara
authors.initials: C
authors.lastname: Pandolfini
authors.forename: Maurizio
authors.initials: M
authors.lastname: Bonati
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D002648:Child; D002675:Child, Preschool; D003153:Community Health Services / Q000706:statistics & numerical data; D004348:Drug Labeling / Q000706:statistics & numerical data; D011307:Drug Prescriptions / Q000706:statistics & numerical data; D006776:Hospitals, Pediatric / Q000706:statistics & numerical data; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007880:Legislation, Drug / Q000706:statistics & numerical data