Dermatoethics: Self-prescribing Plaquenil during the COVID-19 pandemic.

Case scenario

I am a dermatologist with elderly parents who have many comorbidities. I moved them in with my family during the COVID-19 pandemic so I can look after them. I was contemplating prescribing hydroxychloroquine for them to have on hand if they become ill. I heard that others are stocking up on this medication because it might ameliorate the coronavirus infection. If my parents acquire the COVID-19 infection, I am concerned this medicine will not be available. What should I do?

Write the prescription for both of my parents to have the medication at home in case we need it. As a physician and a daughter, wife, and mother, I have a right to protect myself and my family.

Do not write the prescription because it might contribute to a nationwide shortage for others who require this medication.

Write a prescription for one parent, but not both, so we have at least enough of the medicine to start treatment if needed. As a physician and a daughter, wife, and mother, I have a right to protect myself and my family.

Call their primary care physician and ask for the physician to call in this prescription for them.

Discussion

Prescribing a medication for future use has consequences. This medication is in demand for both chronic debilitating diseases and for an acute pandemic. This action may contribute to a shortage that could affect the lives of others and might therefore be considered unethical and an assault on distributive justice. In addition, in prescribing this medication for your healthy family members, you might be considered by some to not be fulfilling your nonmaleficence duty as a physician for others in your community who might need this medication.

However, this is a complex ethical scenario because there are conflicting ethical (and professional) obligations involved. The physician in question also has a strong personal obligation to protect her family and herself. This needs to be weighed against her professional obligation to her patients, her community, and society at large. Therein lies the ethical tension that exists for health care providers during pandemics of potentially fatal infections. One could legitimately ask why she should not act in the best interests of her parents (or her own health and well-being, without which her medical skills would be useless).

On March 28, 2020, the U.S. Food and Drug Administration issued an Emergency Use Authorization allowing hydroxychloroquine sulfate and chloroquine phosphate to be used for hospitalized patients with COVID-19 (Hinton, 2020). Evidence in support of the efficacy of hydroxychloroquine has been limited to ongoing clinical trials investigating these and other drugs; results have been shown to be promising but preliminary (Centers for Disease Control and Prevention [CDC], 2020a). Hydroxychloroquine has been limited to nonrandomized clinical trials (Gautret et al., 2020) and in vitro analyses (Yao et al., 2020). Nevertheless, as the number of COVID-19–related hospitalizations increases and resource shortages become apparent (Mehta et al., 2020), the pursuit of efficacious pharmacologic intervention is a high priority in an effort to speed the recovery of critically ill patients, free ventilators, and decrease the mortality rate.

As demand for hydroxychloroquine has grown, pharmaceutical companies are donating millions of doses of the drug at the request of the U.S. government (Mahase, 2020). Nonetheless, drug shortages have made filling prescriptions impossible for some patients who need hydroxychloroquine for chronic conditions, such as systemic lupus erythematosus and rheumatoid arthritis (Mehta et al., 2020). In addition, there have been reports of physicians hoarding hydroxychloroquine for themselves and their families, which further contributes to shortages (Gabler, 2020). In response, the U.S. Food and Drug Administration CDC, American Medical Association (AMA), and several state medical boards have issued statements or guidelines regarding appropriate medication prescription and use (Table 1, Table 2; American Medical Association, 2020a, Centers for Disease Control and Prevention, 2020b, Hinton, 2020, Iowa Board of Pharmacy, 2020, Michigan Department of Licensing and Regulatory Affairs, 2020, Piercey, 2020, State Medical Board of Ohio, 2020, State of New York, 2020). In many jurisdictions, laws and regulations are taking precedence over any ethical ambiguity (AMA, 2020b).

Table 1

Sources and guidelines on prescribing hydroxychloroquine.

Source	Guideline for prescribers
FDA (Hinton, 2020)	1. Hydroxychloroquine sulfate may only be used to treat adult and adolescent patients who weigh ≥ 50 kg and are hospitalized with COVID-19, and for whom a clinical trial is not available or participation is not feasible. 2. For clinical trials, see https://clinicaltrials.gov/
CDC (2020b)	Recommendations for clinicians and public health officials:1. Educate patients on the serious risks of misusing chloroquine products. 2. Counsel patients on the importance of taking medications only as prescribed and as directed by health care providers.
AMA, APHA, and ASHP joint statement (AMA, 2020b)	“The joint statement is in response to reports of physicians and others prophylactically prescribing, medications currently identified as potential treatments for COVID-19 (e.g., chloroquine or hydroxychloroquine, azithromycin) for themselves, their families, or their colleagues. There also are reports that some pharmacies and hospitals have been purchasing excessive amounts of these medications in anticipation of potentially using them for COVID-19 prevention and treatment. The organizations strongly oppose these actions.Stockpiling these medications—or depleting supplies with excessive, anticipatory orders—can have grave consequences for patients with conditions such as lupus or rheumatoid arthritis if the drugs are not available in the community. The health care community must collectively balance the needs of patients taking medications on a regular basis for an existing condition with new prescriptions that may be needed for patients diagnosed with COVID-19. Being just stewards of limited resources is essential.”

APHA, American Pharmacists Association; American Society of Health-System Pharmacists; AMA, American Medical Association; CDC, Centers for Disease Control and Prevention; COVID-19, coronavirus disease 2019; FDA, U.S. Food and Drug Administration.

Table 2

Examples of state guidelines regarding prescribing and dispensing potential COVID-19 treatments.

State	Guideline/statement
Iowa (Iowa Board of Pharmacy, 2020)	• “Prescribing hydroxychloroquine, chloroquine and azithromycin for COVID-19 prophylactic use is discouraged and not recommend by the Boards at this time.” • “Prescribing hydroxychloroquine, chloroquine, and azithromycin for yourself, family, friends and co-workers in anticipation of a COVID-19 related illness can significantly impact drug supplies, which may negatively impact the health of existing patients who are established on these medications for the treatment of indicated disease states as approved by the FDA. Further, such prescribing may lead to improper use of these medications which can cause harm. Prescribers should exercise caution and refrain from prophylactic prescribing in light of the State of Public Health Disaster Emergency.” • “Prescribers should include the diagnosis code or diagnosis with prescriptions issued for hydroxychloroquine, chloroquine, and azithromycin. Including this information may prevent communications from the pharmacy which in turn will expedite the time to treat.” • “Prescribers should limit the amount prescribed of hydroxychloroquine, chloroquine, and azithromycin, unless otherwise deemed appropriate by the prescriber (e.g., 14-day supply, etc.).”
Michigan (Michigan Department of Licensing and Regulatory Affairs, 2020)	“The Michigan State Medical Society and the Michigan Pharmacists Association recognize the need to maintain adherence to appropriate prescribing and dispensing of prescription drugs…”“…reminder that prescribing hydroxychloroquine or chloroquine with the intent to stockpile the drug may create a shortage for patients with lupus, rheumatoid arthritis, or other ailments for which chloroquine and hydroxychloroquine are proven treatments. Any prescription medicine that may be effective in treating COVID-19 must be reserved for Michigan’s sickest and most vulnerable patients.”
New York (State of New York, 2020)	“No pharmacist shall dispense hydroxychloroquine or chloroquine except when written as prescribed for an FDA-approved indication; or as part of a state approved clinical trial related to COVID-19 for a patient who has tested positive for COVID-19, with such test result documented as part of the prescription. No other experimental or prophylactic use shall be permitted, and any permitted prescription is limited to one fourteen day prescription with no refills.”
Ohio (State Medical Board of Ohio, 2020)	“Unless otherwise approved by the board’s executive director, no prescription for chloroquine or hydroxychloroquine may be dispensed by a pharmacist or sold at retail by a licensed terminal distributor of dangerous drugs unless all the following apply:(1) The prescription bears a written diagnosis code from the prescriber; and (2) If written for a COVID-19 diagnosis, the diagnosis has been confirmed by a positive test result, which is documented on the prescription and both of the following apply:(a) The prescription is limited to no more than a fourteen-day supply; and (b) No refills may be permitted unless a new prescription is furnished.” “UPDATED 3/26/20 – the Pharmacy Board’s Executive Director, in consultation with the Pharmacy Board President have authorized the dispensing of chloroquine or hydroxychloroquine for presumptive positive patients for either of the following:• For use as part of a documented institutional review board-approved clinical trial to evaluate the safety and efficacy of the drugs to treat COVID-19. Prescriptions must include documentation that the patient is enrolled in a clinical trial. • For the continuation of inpatient treatment for COVID-19 using chloroquine or hydroxychloroquine for patients discharged from a hospital. The prescriber shall be required to notate on the prescription that the patient has been discharged from the hospital and the prescription shall be for no more than a fourteen-day supply.”
Tennessee (Piercey, 2020)	“We want providers and pharmacists to act with their best discretion to ensure patients continue to receive appropriate treatment in times of shortages. We discourage inappropriate prescribing or hoarding of this medication for prophylaxis or treatment of COVID-19, which may limit access for patients that require these medications for therapy for approved indications.”

FDA, U.S. Food and Drug Administration.

If written for a COVID-19 diagnosis, the diagnosis has been confirmed by a positive test result, which is documented on the prescription and both of the following apply:

The AMA’s Medical Code of Ethics states that it is acceptable for physicians to treat themselves and family members in limited circumstances, including emergency settings and for short-term minor problems (AMA, 2020c). However, stockpiling a medication and thereby depleting the supply reserved for clinical trials, patients with an indicated use, and potentially dying hospital patients could be considered unethical and a violation of the bioethical principles of justice and nonmaleficence. As physicians, we have professional responsibilities to our patients and others to do what is considered right, especially during difficult times such as now.

The prophylactic use or knowledge of having a reserve stash of an untested drug could create a false sense of invulnerability to the disease and therefore (although unlikely) might undermine the prescribed behavior recommended to curtail the spread of the disease, such as social distancing. In addition, optimal dosing and treatment time has not been established, and hydroxychloroquine has the potential side effect of QT prolongation. Without a formal medical evaluation, thorough patient history, and physical examination, patients receiving the drug may be at increased risk of adverse effects that outweigh the potential benefits of the drug in combating COVID-19 infections.

Finally, what if this physician decided to prescribe hydroxychloroquine for any patient who asked for it because she believed it might be beneficial based on limited data and in vitro activity against other severe acute respiratory syndrome coronaviruses? Would she not be carrying out a beneficent act? At this point in time, based on the AMA's stance and the legal edicts of at least 22 states, the physician in our case scenario could be committing an illegal act, regardless of her ethical intentions.

Analysis of case scenario

There is no one correct answer to this scenario. Those of us in the health care workforce are at a greater risk, and we do have an ethical and even moral imperative to protect ourselves and our family. Therefore, answers A, C, and D are not without justification. Answer B, however, upholds the ethical principles of nonmaleficence and distributive justice. Theoretically, one should not write a prescription for the worried well and contribute to a possible shortage of a needed medication.

Bottom line

This is a complex issue for which there is no clear right or wrong answer. Each physician will have to weigh the pros and cons of whether this is ethical or potentially unethical.

Conflict of Interest

None.

Funding

None.

Study Approval

The author(s) confirm that any aspect of the work covered in this manuscript that has involved human patients has been conducted with the ethical approval of all relevant bodies.