• Internal medicine journal · Mar 2012

    No evidence or no alternative? Taking responsibility for off-label prescribing.

    • N Ghinea, W Lipworth, I Kerridge, and R Day.
    • Australian Institute of Health Innovation, University of New South Wales, Australia. n.ghinea@student.unsw.edu.au
    • Intern Med J. 2012 Mar 1;42(3):247-51.

    AbstractRecombinant 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.© 2012 The Authors. Internal Medicine Journal © 2012 Royal Australasian College of Physicians.

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