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The Enhanced Danger of Physicians’ Off-Label Prescribing During a Public Health Emergency

dc.contributor.author Coleman, D
dc.contributor.author Rosoff, P
dc.date.accessioned 2020-08-07T15:10:23Z
dc.date.available 2020-08-07T15:10:23Z
dc.date.issued 2020
dc.identifier.issn 2053-9711
dc.identifier.uri https://hdl.handle.net/10161/21293
dc.description.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>
dc.language en
dc.publisher Oxford University Press (OUP)
dc.relation.ispartof Journal of Law and the Biosciences
dc.relation.isversionof 10.1093/jlb/lsaa031
dc.title The Enhanced Danger of Physicians’ Off-Label Prescribing During a Public Health Emergency
dc.type Journal article
duke.contributor.id Coleman, D|0136486
duke.contributor.id Rosoff, P|0099553
dc.date.updated 2020-08-07T15:10:22Z
pubs.organisational-group Duke Law School
pubs.organisational-group Center for Child and Family Policy
pubs.organisational-group Duke Science & Society
pubs.organisational-group Duke
pubs.organisational-group Sanford School of Public Policy
pubs.organisational-group Initiatives
pubs.organisational-group Institutes and Provost's Academic Units
pubs.organisational-group School of Medicine
pubs.organisational-group Pediatrics, Hematology-Oncology
pubs.organisational-group Pediatrics
pubs.organisational-group Clinical Science Departments
pubs.publication-status Published


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