title: No evidence or no alternative? Taking responsibility for off-label prescribing.
abstract: Recombinant activated factor VII (rFVIIa) is registered for patients with rare haematological disorders, but is used 'off-label' in many other situations, including intracranial haemorrhage, cardiac surgery, trauma, transplantation and prostatectomy. Lack of systematic evidence to support these off-label uses has not slowed the growth of off-label prescribing of rFVIIa. We use the case of rFVIIa to illustrate the issues raised by off-label prescribing, and the kind of impasse that can arise when views about evidence, expertise and clinical necessity are in conflict. We argue that clinicians, hospital drug committees and regulators all need to acknowledge the complexity of prescribing decisions, and ensure that decisions to prescribe off-label are sufficiently justified.
authors.affiliation: Australian Institute of Health Innovation, University of New South Wales, Australia. n.ghinea@student.unsw.edu.au
authors.forename: N
authors.initials: N
authors.lastname: Ghinea
authors.forename: W
authors.initials: W
authors.lastname: Lipworth
authors.forename: I
authors.initials: I
authors.lastname: Kerridge
authors.forename: R
authors.initials: R
authors.lastname: Day
mesh_terms: D000329:Advertising / Q000941:ethics / Q000331:legislation & jurisprudence; D001315:Australia; D003657:Decision Making; D004345:Drug Industry / Q000941:ethics / Q000331:legislation & jurisprudence; D019317:Evidence-Based Medicine; D015942:Factor VIIa / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D006470:Hemorrhage / Q000188:drug therapy / Q000209:etiology; D006490:Hemostatics / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D006801:Humans; D040541:Marketing / Q000941:ethics / Q000331:legislation & jurisprudence; D056687:Off-Label Use / Q000941:ethics* / Q000331:legislation & jurisprudence; D010358:Patient Participation; D017410:Practice Guidelines as Topic; D010818:Practice Patterns, Physicians'; D011306:Prescription Fees; D011994:Recombinant Proteins / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D012941:Social Responsibility
chemical_list: D006490:Hemostatics; D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa