Drug shortages have been a challenging problem for many years, but they have become even more prevalent in recent years as a result of supply chain challenges and regulatory changes. In 2023, there were a few particularly severe shortages of chemotherapy drugs that are used for many different cancers. “These shortages were experienced across the country, with individual hospitals and individual clinicians struggling to know how best to proceed — both in caring for patients and communicating with patients and the public about these shortages,” says Jonathan M. Marron, MD, MPH, HEC-C, director of clinical ethics at the Harvard Medical School Center for Bioethics and a clinical ethicist at Boston Children’s Hospital.
To address these concerns, a task force at the American Society of Clinical Oncology developed practical guidelines for the oncology community about dealing with these shortages.1 “Notably, shortages are not new, nor is the idea of needing ethically informed guidance for dealing with them,” notes Marron. The task force members drew upon guidelines and frameworks that have been helpful in navigating shortages in the past, both in oncology and more generally. Some of these come from the “A4R” (accountability for reasonableness) framework, which aims to provide a series of ethically sound principles for allocation of scarce resources. In applying this to the current drug shortages, the task force considered ethical process principles (such as the engagement of relevant stakeholders, consistency, equity, transparency, and clarity of communication) as well as allocation principles.
“In doing so, we hope to make clear to clinicians and the public how challenging this is — it is truly an impossible situation for all involved — but one that must still be dealt with,” says Marron. An allocation plan that includes many details and subtleties quickly becomes unwieldy and difficult to implement. Similarly, the different patient populations and organizational culture of different institutions may inform slight differences in the allocation process that is developed there. “But one common consideration is the importance of planning. Having a plan for development and implementation of an allocation plan in advance of the shortage is much preferred over having to develop it ‘on the fly,’” says Marron.
The current crisis of unexpected drug shortages affecting patients with a wide variety of disorders is, unfortunately, not a new situation. “The medical profession has been facing these types of unanticipated scarcities for decades,” says Philip M. Rosoff, MD, professor emeritus of Pediatrics & Medicine at Duke University School of Medicine and former chair of Duke Hospital’s Ethics Committee.
Actions by the federal government, largely through the Food and Drug Administration (FDA), have failed to address the myriad supply chain and manufacturing business challenges that result in shortages, adds Rosoff. Regulations require that sole-source producers must notify the FDA of an impending shortage, which could be the result of a manufacturing problem or a business decision to cease production. However, there is no current mechanism to compel a company to continue to produce a medicine. “Thus, under current conditions, the options available to clinicians and healthcare institutions are limited,” Rosoff explains. “Lamentably, a key feature of these shortages is that they almost always occur without prior warning, so the ability to be proactive is limited.”
Limiting off-label use of medications potentially could decrease demand.2,3 “It is a sad fact that significant usages of many drugs are not supported by quality medical evidence,” says Rosoff. In theory, institutions and clinics could try to anticipate shortages and stockpile certain drugs. “This is both impractical and untenable for several reasons,” asserts Rosoff. “Furthermore, stockpiling is inherently unfair.” Some institutions, because of the depth of their financial resources, would be able to do a better job of building up their own supplies than others — thus improving their own situation while exacerbating the scarcity for other institutions.
Instead, hospitals and clinics could proactively adopt policies to anticipate drug shortages and implement approaches that fairly and equitably distribute the available supplies to patients who need the drugs most. At Duke University Hospital, Rosoff led a team that developed such a policy. “In more than a decade of experience with a multitude of drug shortages, we have had excellent results and minimal pushback from patients, families, administrators, and physicians,” reports Rosoff.4,5
Notably, the policy emanated from the hospital ethics committee. “Medical ethicists have a major role to play in this mess,” says Rosoff.
Ethicists also can serve as mediators and facilitators when disputes arise; but ideally, the policy addresses this situation. Duke University’s policy includes an appeals mechanism for allocation decisions, both for patients and families and clinicians. “Openness and clarity and honesty help minimize anger at being denied a drug,” says Rosoff.
In the bigger picture, ethicists can advocate for policy changes to fix a broken system. “If we accept the fact that drugs are integral to the improvement of lives caused by disease, then permitting the continuation of a drug manufacturing system that chronically deprives patients of medications that can relieve their suffering and even save their lives is intrinsically unethical,” asserts Rosoff.
- Hantel A, Spence R, Camacho P, et al. ASCO ethical guidance for the practical management of oncology drug shortages. J Clin Oncol 2023; Dec 7:JCO2301941. doi: 10.1200/JCO.23.01941. [Online ahead of print].
- Rosoff PM, Coleman DL. The case for legal regulation of physicians’ off-label prescribing. Notre Dame Law Review 2013;86:649-691.
- Coleman DL, Rosoff PM. The enhanced danger of physicians’ off-label prescribing during a public health emergency. J Law Biosci 2020;7:lsaa031.
- Rosoff PM. Unpredictable drug shortages: An ethical framework for short-term rationing in hospitals. Am J Bioeth 2012;12:1-9.
- Rosoff PM, Patel KR, Scates A, et al. Coping with critical drug shortages: An ethical approach for allocating scarce resources in hospitals. Arch Intern Med 2012;172:1494-1499.
