Weekly Review: Ethics, Law & Policy – Staff, Stuff, Space & Systems – August 24, 2020

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Weekly Review: Ethics, Law & Policy – Staff, Stuff, Space & Systems – August 24, 2020

Weekly Review: Ethics, Law & Policy – Staff, Stuff, Space & Systems – August 24, 2020

Supplies

As reported in this Axios article, FDA released a list of medical supplies that remain in short supply. FDA is required to provide this list under provisions of the CARES Act passed in March 2020, based on mandatory reports from manufacturers of potential supply disruptions. Products on the list include a variety of PPE, testing supplies and equipment, and ventilation-related products that are expected to be in limited supply for the duration of the COVID-19 public health emergency due to increased demand.

Further complicating shortages, as reported in this Politico article, access to many scarce supplies and to health care staff is unevenly distributed across the country, with many smaller and poorer facilities facing disparate barriers compared to larger and richer peers. Bidding markets created by scarcity and absence of centralized distribution frameworks have led to facilities (including many in current hot spots for the virus) being outbid for needed supplies and unable to compete for personnel, exacerbating longstanding shortages of health care workers in many areas.

Health Care Workers

This article by Arnetz et al. reports on a study of the association between PPE access and mental health outcomes for nurses using an online survey of approximately 700 Michigan nurses. Several studies and anecdotal reports have pointed to widespread PPE shortages among frontline health care workers nationally, and studies from other countries have indicated mental health problems for frontline staff, especially nurses, due to trauma related to their own infection risk and witnessing illness and deaths among colleagues and patient with the added burden of distancing measures. This study found that more frequent exposure to COVID-19 patients and poor PPE availability were associated with worse mental health outcomes, including anxiety, depression, and PTSD.

Testing

Supply shortages and delays have hampered wide scale testing efforts nationally, but a recently authorized new form of test may provide some relief. As explained in this STAT article the new test, SalivaDirect, allows collection of saliva samples in any sterile container, skipping the use of nasal swabs, some chemical reagents, and other materials that have been in short supply. The test received an Emergency Use Authorization (EUA) from the FDA on August 15.

Also affecting testing, this HHS announcement indicated that FDA will no longer require premarket review of laboratory developed tests (including but not limited to those related to COVID-19). This affects in vitro diagnostic tests designed, manufactured, and used within a single lab, as explained here, meaning the greatest impact will be for large labs or academic medical centers that have such capabilities. Some experts have applauded the move for removing barriers to developing and using new tests, but others worry that it may allow for inaccurate or poorly controlled tests to enter the market.

Resource allocation

This JAMA Internal Medicine research letter from Karaca-Mandic, Georgiou & Sen assesses hospitalizations related to COVID-19 by race/ethnicity in the 12 states that report data for these categories. The authors found that in all 12 states the proportion of Black patients admitted was higher than proportion of Black individuals in the state population. Indiana was among the states with the highest disparity between hospital admissions and state population for Black individuals (28.1% of admissions vs. 9.8% of population). Similar disparities were observed for Hispanic and American Indians and Alaskan Native population in states reporting these categories. This data is consistent with other information regarding significant disparities in the impact and burden of the pandemic and has substantial implications for strategies to direct and allocate available resources to communities that are being most negatively affected.

|2020-08-24T08:08:19-04:00August 24th, 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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