The Enhanced Danger of Physicians’ Off-Label Prescribing During a Public Health Emergency
Abstract
<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>
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https://hdl.handle.net/10161/21293Published Version (Please cite this version)
10.1093/jlb/lsaa031Publication Info
Coleman, 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.This is constructed from limited available data and may be imprecise. To cite this
article, please review & use the official citation provided by the journal.
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Show full item recordScholars@Duke
Doriane Lambelet Coleman
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
Philip Martin Rosoff
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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