Weekly Review: Ethics, Law & Policy – Staff, Stuff, Space & Systems – August 31, 2020

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Weekly Review: Ethics, Law & Policy – Staff, Stuff, Space & Systems – August 31, 2020

Weekly Review: Ethics, Law & Policy – Staff, Stuff, Space & Systems – August 31, 2020

Resource Allocation

This article by Webb, Shah & Fernandez Lynch addresses ethical issues in allocating access to unproven but promising drugs that become available through Pre-Approval Access (PAA) programs and Emergency Use Authorization (EUA). PAA programs allow access to unapproved drugs for individuals or groups of patients meeting specific criteria who have exhausted alternatives, and EUA allows more widespread use in treatment for unapproved drugs when potential benefits outweigh known and likely risks. These pathways have historically been rare, but they have been highly relevant during the current pandemic, including for remdesivir and, most recently, convalescent plasma, both of which were available through PAA and later granted an EUA. In allocating scarce supplies of drugs under these programs, the authors argue that priority should be tied to participation in clinical trials in order to promote data collection, but that attention must be paid to issues of voluntariness and distrust. They also emphasize the need to ensure a diverse range of sites, including those serving marginalized populations. The approach is in grounded in fundamental bioethical principles (nonmaleficence, beneficence, and justice) and also seeks to minimize population-level harms by avoiding interference with trials that can help determine the safety and efficacy of such drugs.

Facilities

This CDC MMWR Report by Hatfield et al. on facility-wide testing in nursing homes provides potential insights on controlling transmission among residents and personnel. Testing performed by health departments in facilities that had not had a known case of COVID-19 found 0.4% prevalence, while testing in facilities that had a prior case found 12% prevalence. The results indicate that rapid implementation of facility-wide testing following identification of a case is likely to identify additional unrecognized cases; however, implementing such testing in low-incidence areas without an identified case may not be an optimal strategy. Alternatives to facility-wide testing in the latter scenario include focusing on highest-risk populations, point-of-care testing, sample-pooling, self-collection of samples, or wastewater surveillance.

This article by McGarry, Grabowski & Barnett addresses staffing and PPE shortages in nursing homes, finding that 1 in 5 report a severe PPE shortage or a staff shortage, with no meaningful improvement in rates from May to July 2020. Shortages were more likely in facilities with reported COVID-19 cases (resident or staff), facilities serving more Medicaid recipients, and facilities with lower quality scores. These characteristics raise significant equity issues, particularly in light of the disproportionate burden of morbidity and mortality faced by nursing home residents and the stark disparity facing facilities serving more disadvantaged populations.

|2020-08-31T08:33:23-04:00August 31st, 2020|COVID-19 Literature|0 Comments

About the Author: Daniel Orenstein

Daniel Orenstein
Daniel G. Orenstein, JD, MPH, is Visiting Assistant Professor of Law at the Indiana University Robert H. McKinney School of Law in Indianapolis. He teaches in the areas of administrative law, public health law, and health care law and policy. His research focuses on public health law, policy, and ethics, and he was previously Deputy Director of the Network for Public Health Law Western Region, where much of his work centered on emergency preparedness and response, including resource allocation and government authority during declared emergencies, as well as vaccination policy.

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