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.
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.
Prescribing Stewardship
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.
Opinion 9.6.6 from the American Medical Association (AMA) Code of Medical Ethics explicitly states that physicians have an ethical obligation to prescribe “based solely on medical considerations, patient need and reasonable expectations of effectiveness for the particular patient.” Clinical situations for which there are no approved therapies, such as COVID-19 and its immune-mediated complications, therefore, would be considered off-label by definition.
Opinion 1.2.11 states that usage of “an existing intervention in a novel way” still should be “on the basis of sound scientific evidence and appropriate clinical expertise.”
Whether the use of hydroxychloroquine for COVID-19 meets these standards is unclear at present. An observational study in New York City of 1,376 patients receiving a short course of hydroxychloroquine did not demonstrate a difference in intubation or death between groups.4 Several formal, randomized, controlled trials are in progress at the time this piece was written.
It is critical, as a community, for us to advocate to protect access of hydroxychloroquine and other immunosuppressive drugs for rheumatology patients with established indications, such as hydroxychloroquine, which is well established as part of standard-of-care management for systemic lupus erythematosus and inflammatory arthritis. Discontinuation because of reduced access to medication puts patients at risk of disease activity flares, with the potential for real morbidity and mortality outcomes.
Acute treatment of flares often requires escalation in the intensity of the immunosuppressive regimen, with the addition of steroids and other agents, adding increased infection risks for patients already at higher baseline risk for severe COVID-19 complications. For these reasons, the ACR explicitly recommends against holding or discontinuing any medications for rheumatic disease to mitigate COVID-19 risk.5
As rheumatologists, we are not strangers to the ethical considerations of off-label uses. We routinely treat rare diseases, many of which have no approved therapies. The hydroxychloroquine case, however, highlights the corollary stewardship role we are uniquely positioned to play as the COVID-19 pandemic continues and the urgent race to identify effective treatments intensifies.
Hydroxychloroquine will not be the last of our drugs to be considered for repurposing. We are not the gatekeepers of access to these drugs per se, but we and our patients will continue to be clear stakeholders in the distribution of finite supplies in a world of continuously increasing demand.
Redeployment of Healthcare Workers
Resource and personnel shortages have forced increasing numbers of healthcare systems and practices throughout the U.S. and around the world to consider deploying providers in areas and settings outside their typical scopes of practice. Redeployment on such a wide scale has not been considered for any recent disaster and highlights obligations that institutions and systems have to ensure proper support for frontline providers as they discharge their duties.
Opinion 8.3 of the AMA Code of Medical Ethics broadly summarizes the specific obligations of physicians in situations of epidemic, disaster or terrorism as follows: “Because of their commitment to care for the sick and injured, individual physicians have an obligation to provide urgent medical care during disasters. This obligation holds even in the face of greater than usual risks to physicians’ own safety, health or life.”
The opinion also states, however, that this obligation is counterbalanced by the understanding that the physician workforce is a resource and not unlimited.
Institutions, therefore, must continually re-evaluate and balance the risks to providers against the need to be available to provide services in the future. Implicit is an obligation for healthcare systems to protect and support treating providers and to operate with a policy of communicating in a clear and transparent manner about these efforts in real time.
Protective Measures
The specific types and extent of measures taken to protect physicians are often determined by individual institutions. We believe such measures should carefully account for the following considerations to preserve the safety, and enhance the effectiveness, of our workforce:
The personal and family health status of deployed physicians, particularly those who have conditions that increase their own risk for adverse outcomes due to SARS-CoV-2 infection, should be given fair consideration. Specific examples associated with such increased risk include pregnancy, advanced age, cardiovascular or metabolic conditions, and the use of immunosuppressive drugs for existing comorbidities. A significant number of healthcare personnel with confirmed COVID-19 reported at least one underlying medical condition.6 Personal risk aside, many physicians also worry about transmitting infection to vulnerable family members.
Despite the demographically defined lower-risk category that trainees usually occupy, consideration should also be given to health status of trainees and their home contacts.
Structural features in redeployment schemes can incorporate safeguards to protect vulnerable physicians and those for whom risk is not well-defined. Some healthcare systems have tiered their redeployment plans based on such factors as age, comorbidities and proximity to internal medicine training. Deployments in these schemes are based on workforce needs, reserving frontline deployment of higher risk physicians only when absolutely necessary. High-risk providers are instead having their efforts directed to low-exposure support roles, including logistics, occupational health physician oversight and telemedicine to balance redeployment with preventing excess morbidity and mortality due to limited outpatient clinical operations within our own specialty.7
Refresher courses for general in-patient medical practice may be built into redeployment schemes in the form of online didactics or case-based materials. Redeployments often require providers to apply skills or knowledge that some may not have used for several years or that have not yet been tested or consolidated by experience. Sometimes, these assignments are offered as voluntary opportunities. In other cases, redeployment of trainees, including early graduation from medical school, leaves limited choices for these groups. Many retired physicians and healthcare workers also have offered to re-enter the workforce to address the increased demands during the pandemic.8
Some institutions have planned for internal medicine hospitalists to be paired with redeployed specialists, much like the traditional, attending resident oversight structure in post-graduate medical training. Trainees from internal medicine already assume these roles, and those outside internal medicine can readily adapt within this structure.
Psychological Toll
We last faced tension between training and protecting our charges during the early years of HIV/AIDS spread.9 That tension was due not only to uncertainty regarding transmission and personal safety, but also to the psychological toll due to excess patient mortality and the futility of contemporaneous medical interventions. These concerns parallel our current challenges with COVID-19 and are arguably in more stark relief.
Our trainees face personal physical risk due to deficiencies in personal protective equipment supply, compounded by the psychological toll of dealing with excess patient mortality from a combination of lack of effective treatments and limitations in available intensive care unit beds and ventilators. Rationing care has become a reality for physicians across the world. This, combined with witnessing patients dying under isolation from their loved ones, is causing untold trauma.
These situations pose some of the most challenging dilemmas one can face as a physician—balancing patient autonomy against the community’s health, other sick patients and the health of providers. These are dilemmas all internists and redeployed physicians alike will experience and may be similarly ill prepared to handle in isolation.
Institutional guidance is critical to providing a principled approach to dealing with these situations. While the COVID-19 pandemic will define a generation of physicians, as the HIV/AIDS epidemic did, deployment plans for specialists and trainees alike should include forward-looking systems to support the expected needs resulting from the pandemic.
Final Thoughts
Beyond science, protocols and traditions, medicine is a humanistic and moral activity at its roots. Physicians will always answer the call to duty, and although the COVID-19 pandemic will pass, how we decide to allocate our medical and human resources will have far-reaching impact beyond the current crisis. We owe it to each other to remind ourselves that in the time of pandemic, a physician can become a patient within the span of a day. We must do all we can to protect the resources we need to effectively fulfill our duties.
David Y. Chen, MD, PhD
David Y. Chen, MD, PhD, is an instructor in medicine in the Division of Dermatology at Washington University School of Medicine, Saint Louis (WashU). He was previously a member of the Center for the Study of Ethics and Human Values at WashU and was involved in formulating a tiered redeployment plan for the Division of Dermatology.
Eric J. Gapud, MD, PhD, is an assistant professor of medicine and director of research for the Vasculitis Center in the Division of Rheumatology at Johns Hopkins University School of Medicine, Baltimore. He is a current member of the ACR Committee for Ethics and Conflicts of Interest.
Eric J. Gapud, MD, PhD
References
- Beauchamp TL, Childress JF. Principles of biomedical ethics, 5th ed. New York: Oxford University Press; 2001.
- Johns Hopkins Coronavirus Resource Center. https://coronavirus.jhu.edu/us-map.
- Gautret P, Lagier J-C, Parola P, et al. Hydroxychloroquine and azithromycin as a treatment of COVID-19: Results of an open-label non-randomized clinical trial. Int J Antimicrob Agents. 2020 Mar 20:105949. [Epub ahead of print]
- Geleris J, Sun Y, Platt, J, et al. Observational study of hydroxychloroquine in hospitalized patients with COVID-19. N Engl J Med. 2020 May 7;NEJMoa2012410. [Epub ahead of print]
- American College of Rheumatology. ACR updates: COVID-19. https://www.rheumatology.org/announcements.
- Burrer SL, de Perio MA, Hughes MM, et al. Characteristics of health care personnel with COVID-19—United States, February 12–April 9, 2020. MMWR Morb Mortal Wkly Rep. 2020 Apr 17;69(15):477–481. http://dx.doi.org/10.15585/mmwr.mm6915e6.
- Rosenbaum L. The untold toll—The pandemic’s effects on patients without COVID-19. N Engl J Med. 2020 Apr 17. [Epub ahead of print]
- Paturel A. Retired doctors want to return to work to fight COVID-19. Here’s what they need to know. Association of American Medical Colleges. 2020 Apr 8. https://www.aamc.org/news-insights/retired-doctors-want-return-work-fight-covid-19-heres-what-they-need-know.
- Wachter RM. The impact of the acquired immunodeficiency syndrome on medical residency training. N Engl J Med. 1986 Jan 16;314(3):177–180.
Editor’s note: This article was written for The Rheumatologist on behalf of the ACR Committee on Ethics & Conflict of Interest. If you have comments or questions about this case, or if you have a case that you’d like to see in Ethics Forum, email us at [email protected].
