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.”
