title: Retapamulin prescriptions and monitored off-label use.
abstract: BACKGROUND
  Retapamulin, a topical pleuromutilin that selectively inhibits bacterial protein synthesis, is approved for treatment of impetigo and secondarily infected traumatic lesions in adults and in children older than 9 months of age.
  
  
  OBJECTIVE
  A 5-year study was conducted to monitor prescription use in children younger than 9 months of age.
  
  
  METHODS
  Annual prescription events were monitored in the UK Clinical Practice Research Datalink (CPRD) and the Clinformatics™ DataMart Multiplan (IMPACT), a product of OptumInsight Life Sciences, Inc. (Eden Prairie, MN, USA), from the USA.
  
  
  RESULTS
  In the CPRD, of 148 prescriptions, three (2 %) were identified in children aged less than 9 months between years 2008 and 2011. In IMPACT, of 59,210 claims for retapamulin in children, 1,951 (3.3 %) were categorized as definitive, or uncertain for, less than 9 months of age between 2007 and 2011.
  
  
  CONCLUSIONS
  Retapamulin prescription events in children aged less than 9 months were relatively low compared with other recent estimations of off-label pediatric medicines. Our report provides a framework for future investigations and discussions that may facilitate off-label reporting schemes and promote pediatric drug safety.
authors.affiliation: WorldWide Epidemiology, Quantitative Sciences, GlaxoSmithKline, LLC, Collegeville, PA, USA, linda.m.mundy@gsk.com.
authors.forename: Linda M
authors.initials: LM
authors.lastname: Mundy
authors.forename: Tim
authors.initials: T
authors.lastname: Sampson
authors.forename: John W
authors.initials: JW
authors.lastname: Logie
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D019086:Bridged Bicyclo Compounds, Heterocyclic / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004224:Diterpenes; D006801:Humans; D007169:Impetigo / Q000188:drug therapy*; D007223:Infant; D008875:Middle Aged; D056687:Off-Label Use
chemical_list: D019086:Bridged Bicyclo Compounds, Heterocyclic; D004224:Diterpenes; C508887:retapamulin