title: Compounded medicines and 'off label' prescribing - a case for more guidance.
abstract: BACKGROUND
  Interest by prescribers and pharmacists in the provision of individualised pharmaceutical therapy in the form of compounded medicines has grown in recent times. However, there have also been a number of case reports of patient harm associated with these medicines.
  
  
  OBJECTIVE
  To highlight areas for clinicians and pharmacists to consider when prescribing or dispensing compounded medicines, which are consistent with quality use of medicines principles.
  
  
  CONCLUSIONS
  Regulators of pharmaceutical products have expressed concerns with the production, marketing and use of compounded medicines dispensed by pharmacists. This has prompted debate over the need for more regulation of these products. We propose an expansion of off label prescribing guidelines to include a risk based assessment of pharmaceutical quality, a consumer information/education strategy and the development of a code of practice for pharmacists engaging in compounding. These strategies recognise a shared responsibility among prescribers, dispensers and regulators to achieve contemporary quality, safety, and efficacy standards and support the quality use of compounded medicines.
authors.affiliation: Faculty of Pharmacy, University of Sydney, New South Wales. romanof@pharm.usyd.edu.au
authors.forename: Romano A
authors.initials: RA
authors.lastname: Fois
authors.forename: Barry T
authors.initials: BT
authors.lastname: Mewes
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: McLachlan
authors.forename: Iqbal
authors.initials: I
authors.lastname: Ramzan
mesh_terms: D001315:Australia; D017277:Drug Approval / Q000331:legislation & jurisprudence; D004339:Drug Compounding / Q000009:adverse effects / Q000592:standards*; D004348:Drug Labeling / Q000331:legislation & jurisprudence*; D006801:Humans; D010818:Practice Patterns, Physicians' / Q000592:standards; D014481:United States