title: Off-label prescribing in palliative care - a cross-sectional national survey of palliative medicine doctors.
abstract: BACKGROUND
  Regulatory bodies including the European Medicines Agency register medications (formulation, route of administration) for specific clinical indications. Once registered, prescription is at clinicians' discretion. Off-label use is beyond the registered use. While off-label prescribing may, at times, be appropriate, efficacy and toxicity data are often lacking.
  
  
  OBJECTIVE
  The aim of this study was to document off-label use policies (including disclosure and consent) in Australian palliative care units and current practices by palliative care clinicians.
  
  
  METHODS
  A national, cross-sectional survey was conducted online following an invitation letter. The survey asked clinicians their most frequent off-label medication/indication dyads and unit policies. Dyads were classified into unregistered, off-label and on-label, and for the latter, whether medications were nationally subsidised.
  
  
  METHODS
  All Australian palliative medicine Fellows and advanced trainees.
  
  
  RESULTS
  Overall, 105 clinicians responded (53% response rate). The majority did not have policies on off-label medications, and documented consent rarely. In all, 236 medication/indication dyads for 36 medications were noted: 45 dyads (19%) were for two unregistered medications, 118 dyads (50%) were for 26 off-label medications and 73 dyads (31%) were for 12 on-label medications.
  
  
  CONCLUSIONS
  Off-label prescribing with its clinical, legal and ethical implications is common yet poorly recognised by clinicians. A distinction needs to be made between where quality evidence exists but registration has not been updated by the pharmaceutical sponsor and the evidence has not been generated. Further research is required to quantify any iatrogenic harm from off-label prescribing in palliative care.
authors.affiliation: Discipline, Palliative & Supportive Services, Flinders University, Adelaide, Australia. timothy.to@health.sa.gov.au
authors.forename: Timothy H M
authors.initials: TH
authors.lastname: To
authors.forename: Meera
authors.initials: M
authors.lastname: Agar
authors.forename: Tania
authors.initials: T
authors.lastname: Shelby-James
authors.forename: Amy P
authors.initials: AP
authors.lastname: Abernethy
authors.forename: Matthew
authors.initials: M
authors.lastname: Doogue
authors.forename: Debra
authors.initials: D
authors.lastname: Rowett
authors.forename: Danielle
authors.initials: D
authors.lastname: Ko
authors.forename: David C
authors.initials: DC
authors.lastname: Currow
mesh_terms: D000328:Adult; D001315:Australia; D003430:Cross-Sectional Studies; D004335:Drug and Narcotic Control; D005260:Female; D006801:Humans; D008297:Male; D056687:Off-Label Use / Q000941:ethics* / Q000592:standards; D010166:Palliative Care; D010818:Practice Patterns, Physicians' / Q000941:ethics / Q000331:legislation & jurisprudence / Q000592:standards*