The Enhanced Danger of Physicians’ Off-Label Prescribing During a Public Health Emergency
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<jats:title>Abstract</jats:title> <jats:p>The COVID-19 pandemic represents a major challenge to both technologically advanced and resource-poor countries. There are currently no effective treatments for severe disease other than supportive care and advanced life support measures, including the use of mechanical ventilators. With the urgency and necessity bred from desperation, there have been many calls to utilize unproven therapies, such as hydroxychloroquine, for which little evidence of efficacy exists. We have previously argued that such off-label use, while legal, is problematic (and even dangerous) and have suggested several regulatory remedies that could protect patients and advance their interests while preserving the reasonable authority of physicians to do what they and their patients think is the best course of action. In this essay we ask whether the special conditions existing in a public healthcare crisis, such as the current pandemic, would justify a relaxing of our argument and permit ongoing unregulated off-label use. We outline at least four areas of concern, all of which can be exacerbated by the widespread distress and despair amongst doctors, patients and other stakeholders. We contend that, if anything, these conditions warrant even more caution and scrutiny of this practice.</jats:p>
Published Version (Please cite this version)10.1093/jlb/lsaa031
Publication InfoColeman, D; & Rosoff, P (2020). The Enhanced Danger of Physicians’ Off-Label Prescribing During a Public Health Emergency. Journal of Law and the Biosciences. 10.1093/jlb/lsaa031. Retrieved from https://hdl.handle.net/10161/21293.
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Professor of Law
Doriane Coleman is a Professor of Law at Duke Law School, where she specializes in interdisciplinary scholarship focused on women, children, medicine, sports, and law. Her recent work has centered on sex, including its evolving definition and its implications for institutions ranging from elite sport to medicine and, of course, to law. A first article in this series, Sex in Sport , is at 80 LAW & CONTEMPORARY PROBLEMS 63-126 (2017), and a second, Re-affirming the Value of the Sports Exceptio
Professor Emeritus of Pediatrics
My main interests are clinical ethics with a concentration on the equitable allocation of scarce resources (rationing). In this area, I have done work on planning for pandemic influenza and allocation of drugs during shortages. Before retirement I played a major role in the Clinical Ethics Service at Duke Hospital and chair the hospital's Ethics Committee.
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