Modern principles governing the actions of individuals and institutions in patient care are often centered around four core principles formulated by Beauchamp and Childress: respect for autonomy, beneficence, non-maleficence and justice.1 Situational contexts in which these principles are in tension compel their reprioritization. And catastrophic externalities, such as the COVID-19 pandemic, impose special circumstances that must be considered to enable providers to discharge their duty to provide care in accordance with these principles.
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Explore This IssueJuly 2020
SARS Coronavirus-2 (SARS-CoV-2), the novel infectious agent responsible for COVID-19, was first identified in human patients only at the end of 2019. As of June 3, 6,445,457 people worldwide have been infected, and 381,175 have died, corresponding to a mortality rate of slightly over 7% in tested-positive cases.2 Roughly a third of known cases are in the U.S., and 106,696 patients have died here, despite our advanced medical science, technology and capabilities.
The unusual infectivity of SARS-CoV-2 coupled with a high burden of asymptomatic transmission and the complex pathophysiology of this novel virus have exposed limitations and vulnerabilities in our technology, resources and healthcare delivery infrastructure.
Provider redeployments and the implications of drug shortages exacerbated by repurposing are two high-profile examples of the many important and unexpected issues increasingly faced by rheumatologists as a result of these stresses on our system. Here, we explore the ethical conflicts and obligations that pertain in these specific cases.
The COVID-19 pandemic has placed rheumatologists in the unique and unexpected position of prescribing stewardship. Increasing evidence indicates some poor outcomes in COVID-19 cases may be due to late immune-mediated sequelae of the viral infection. Clinicians and scientists are recognizing that a number of cytokine interference and immune-modulation agents used in standard rheumatology practice may be beneficial for critically ill COVID-19 patients. Consequently, rheumatologists increasingly find themselves the most common prescribers of known drugs with off-label, life-saving potential.
The initial enthusiasm for hydroxychloroquine for use against COVID-19 resulted in a sudden, high-volume diversion of the drug and threatened access for patients with established rheumatologic indications for their use. This sudden interest was based on encouraging results from small, uncontrolled studies of COVID-19 patients in China and France, particularly the one described by Gautret and colleagues in mid-March 2020.3
Within days, shortages were reported around the country. The national supply of hydroxychloroquine was already particularly vulnerable given its history as a drug with relatively few regular manufacturers and price spikes. The U.S. Food & Drug Administration also authorized emergency use of hydroxychloroquine to treat COVID-19 patients for whom a clinical trial was not available by the end of March 2020, although clinical evidence of effectiveness remained inconclusive. As a result, patients with conditions for which hydroxychloroquine has proved beneficial were placed at risk of being without medication.