As the first drug found effective against the novel coronavirus illustrates, medications to treat the infection are likely to be initially scarce.
Decisions about allocating scarce inpatient medications for coronavirus patients should be guided by a four-part ethical framework, a recent journal article says.
The antiviral drug remdesivir is the only medication that has been shown to be effective in treating hospitalized coronavirus disease 2019 (COVID-19) patients. As is expected in the initial deployment of new COVID-19 therapies, there is a shortage of remdesivir. Healthcare providers have criticized the federal government's distribution of the drug.
The recent journal article, which was published by the Journal of the American Medical Association, calls for the setting of parameters to guide allocation of scarce COVID-19 medications.
"Evidence-based, fair guidelines to allocate scarce drugs for COVID-19 could help physicians make difficult decisions. Transparent guidelines will help promote trustworthiness when not all infected patients can receive a medication that is in short supply," the journal article's co-authors wrote.
The journal article proposes a four-part ethical framework as the foundation for allocating scarce COVID-19 medications:
1. Decreasing mortality is a primary guiding principle because reducing deaths benefits entire communities. Taking an evidence-based approach also is essential, the co-authors wrote. "Allocation policies should be revised as evidence develops. During a shortage, medications should be prioritized for indications for which peer-reviewed, randomized clinical trials have demonstrated efficacy and safety."
2. The preferences of patients should be respected, but their desired course of treatment may not be possible when there is a medication shortage.
3. Fairness should be a guiding principle when allocating scarce medications. Guidelines should avoid discrimination and ease health disparities.
4. Allocation guidelines should be established in a transparent, accountable, and responsive manner. The policies should be crafted to fit the situation such as the status of the pandemic.
"Specific goals derived from this ethical framework can provide practical clinical advice," the co-authors wrote. For example, a portion of scarce medications should be allocated to clinical trials to promote evidence-based findings.
Drug allocation recommendations
The JAMA article makes six recommendations for the allocation of scarce COVID-19 medications:
1. Distribution of scarce medications should be evidence based. Patient groups should be prioritized for a medication if clinical trials have shown the patients benefit from the therapy. When there is a shortage, compassionate use unsupported by evidence should be limited.
2. Discriminatory guidelines and administration of a scarce medication should be avoided. "Prioritization should not exclude patients based on age, disability, religion, race or ethnicity, national origin, gender, sexual orientation, or perceived quality of life," the co-authors wrote.
3. Existing Food and Drug Administration-approved medications should not be denied to patients who depend on them for non-COVID-19 therapy.
4. Evidence should guide decisions about which patients could benefit most or least from a scarce medication. "For example, although older age, diabetes, hypertension, and coronary artery disease are risk factors for poor prognosis in COVID-19, predictors of poor prognosis do not necessarily predict response to a new treatment. Physicians should provide new therapies to patients with these conditions, unless evidence emerges that shows that they do not respond to the therapy or respond less well than patients without these conditions," the co-authors wrote.
5. Fairness should be a consideration, they wrote. "Random allocation, such as by lottery, is the fairest way to allocate a very scarce drug among eligible patients. A 'first-come, first-served' approach should be avoided because it is not random, and it disadvantages those who experience barriers to seeking care. Within a lottery, workers in essential jobs may be given some priority."
6. Rationing scarce medications can prompt emotional reactions from patients and their loved ones, so clinicians should have support in making difficult decisions.
Photo credit: Sonis Photography
Christopher Cheney is the senior clinical care editor at HealthLeaders.
The Food and Drug Administration granted "emergency use authorization" for the first effective coronavirus medication—remdesivir—in early May. Since then, the drug has been in short supply.
An evidence-based approach is crucial in allocating scarce medications ethically.
Fairness is a guiding principle during drug shortages.