By Stacey Kusterbeck
Drug shortages are causing significant ethical dilemmas in cancer care, both in clinical practice and research, and there is reason to think that these concerns will not go away soon. Shortages often are long-lasting. Of 15 oncology drugs with shortages between 2023 and 2025, 12 had shortages lasting more than two years, according an analysis of the U.S. Food and Drug Administration’s (FDA) Drug Shortage Database.1
Another group of researchers surveyed 96 community oncology practices about the effect of drug shortages, including ethical dilemmas.2 “We knew from anecdotal reports and news media articles that oncology drug shortages were creating serious disruptions in cancer care. But there wasn’t a national, systematic picture,” says Elaine Hill, PhD, the study’s principal investigator and a professor in the Department of Public Health Sciences at the University of Rochester.
The researchers wanted to know how drug shortages are affecting cancer care outside of academic medical centers — how widespread drug shortages are, how practices are responding in real time, and what it means for patient care. Thirty percent of oncologists reported not having access to an adequate alternative drug. More than half of National Cancer Institute Community Oncology Research Program practices were affected by 23 shortages. Seriously affected practices were more likely to report a lack of suitable alternatives and substantial resources spent.
Half of oncology practices reported ethical dilemmas related to a drug shortage, such as having to decide which patients would get access to scarce drugs. “That’s an incredibly heavy burden for providers,” says Lauren Ghazal, PhD, FNP-BC, another of the study authors and an assistant professor in the School of Nursing at University of Rochester. Practices also responded that treatment substitution dilemmas arose because, in some cases, the only available option was less effective or more toxic.
Pharmacists and oncologists also face challenges regarding decision-making for curative intent vs. palliative care and prioritizing available infusional chemotherapy. “Ethicists would be valuable members of the care team to help clinicians make decisions about these difficult issues,” says Ghazal.
Drug shortages also interfere with clinical trial enrollment. “Some sites reported the need to pause or modify clinical trial enrollment due to shortages,” notes Ghazal.
If a drug that is part of the study plan is not available, it may compromise the study’s validity or result in the study being suspended or terminated, says Stacey Page, PhD, chair of the Conjoint Health Research Ethics Board at the University of Calgary. “Drug shortages can compromise the conduct of research in the same way shortages would impact clinical care,” says Page. Researchers have an ethical obligation to respect participant welfare and ensure that people are not disadvantaged or harmed by study participation. Therefore, as part of the consent process, potential participants should be told about foreseeable circumstances under which the study could be discontinued. “Participants who no longer have access to a study drug should be transitioned back to standard of care, as they would be at the end of a study,” adds Page.
On the clinical side, oncology drug shortages are having a disproportionate effect on community and safety net hospitals, where creative solutions are needed to maximize limited resources of oncology drugs.3 “Stockpiling can work for institutions that can afford it,” according to Kevin Knopf, MD, MPH, a clinical assistant professor of medicine and member of the Institute for Health Policy Studies at University of California, San Francisco.
Most physicians do not spend much time contemplating ways to mitigate drug shortages, however. Mainly, doctors are just frustrated at not having access to drugs their patients need. “It’s very hard to practice oncology when you can’t access chemotherapy drugs that are generic because of the low profit margin. Some of these drugs are essential drugs to cure patients. It seems odd that this would happen in a nation as rich as the United States, but the perverse economic incentives of cancer pharmacology are responsible,” says Knopf.
Ethicists should be aware that clinicians may need to make decisions about who should receive curative chemotherapy and who should not. “Ethicists should also familiarize themselves with how the economic aspects of cancer care can actually harm patients in an unethical way — by creating larger gaps between the rich and poor in access to and quality of care. While a single-party payer system would largely solve these problems, this is unlikely to happen in the United States. Trainees should understand how the economics of cancer care delivery can cause ethical dilemmas and harm patients,” argues Knopf.
Drug shortages also lead to unsafe practices and compromised care. Nearly a quarter (24%) of practitioners were aware of at least one medical or medication error related to a drug, supply, or device shortage in the previous six months, according to a survey conducted in 2023 by the Institute for Safe Medication Practices (ISMP) and ECRI.4 “When a medication is unexpectedly unavailable due to shortage, a new medication or formulation may be purchased quickly, without going through all the due diligence processes within the organization,” says Shannon Bertagnoli, PharmD, lead medication safety specialist for publications at ISMP. Without a comprehensive process to evaluate any safety concerns, critical steps can be missed when a new product is introduced. For instance, healthcare providers may get confused if labeling or packaging looks like another product. Products may not have appropriate warnings enabled in systems and products may be administered differently.
Nearly one-third (32%) of respondents were unable to provide patients with the recommended drug or treatment for their condition. Of those, 21% thought it resulted in patients receiving a less effective drug. Nearly half (49%) of respondents stated that patient treatments had been delayed. For some patients, this meant interrupted, modified, or delayed chemotherapy regimens (such as reduced doses or treatment being withheld if there was non-curative intent).
When attempting to optimize the limited supply of drug available, clinicians may be faced with ethical dilemmas on how to limit or extend product use safely. Eighty-six percent of respondents reported rationing or restricting drugs, supplies, or equipment in short supply. “When products are used in ways not intended, there’s a heightened risk of adverse outcomes, including medication errors and infections,” says Bertagnoli. When planning for drug shortages, Bertagnoli says that institutions should consider these ethical issues:
- Weighing the potential harm against the necessity to conserve resources.
- Ensuring that decisions are transparent, justifiable, equitable, and prioritize patient safety.
- Establishing clear criteria for rationing drugs, supplies, and equipment.
- Communicating openly with staff and patients about risks and alternative treatment options.
- Ensuring that the mitigation plan does not inadvertently disadvantage a certain population (such as preference given to younger patients instead of older patients).
“The team should be able to consult with ethicists for support during difficult decisions that raise ethical concerns,” says Bertagnoli.
“How do we make the very difficult choices on who has access to these drugs?” In the midst of a very severe shortage of several important oncology drugs, Julie R. Gralow, MD, FACP, FASCO, and colleagues developed an ethical guidance aimed at helping clinicians and institutions to answer this question.5
One key recommendation is to set up a multidisciplinary committee of stakeholders, including ethicists. “The group sets out what the institution’s policies are, to be transparent, equitable, and consistent,” says Gralow, chief medical officer and executive vice president at the American Society of Clinical Oncology. Proactive approaches are necessary. “At the first hint of an impending shortage, you should immediately invoke the opportunity to conserve the drug,” advises Gralow. When determining dosing, which is based on weight and height, providers can round down and not up; providers also can elect to use regimens that conserve drugs (such as slightly higher doses but given less often; e.g., every three weeks instead of every two weeks).
When it gets to the point where a decision has to be made on which patients get a drug, individual clinicians should not face that burden alone. Instead, clinicians should rely on ethical guidance or a committee, says Gralow, and should make decisions based on prioritizing patients where the drug gives them a high chance of a cure, pediatric or young adult patients, or patients who lack good options for alternative regimens. Ethicists can help clinicians to have difficult conversations with patients and families about why the regimen must change as the result of drug shortages. “If the family is presented with information that, while they’ve been told they need 12 doses of a drug but will only get six, understandably, they’ll be upset. If things escalate, the ethicist could be the backup,” says Gralow.
Greater data transparency, improved manufacturing practices, and new legislative efforts are needed for more stable, reliable drug supplies, argue Gralow and colleagues.6 “It is important for clinicians to know that there are groups working on correcting this, and that we are looking at how to solve, long-term, the bigger problem of drug shortages in general with regulatory and business approaches,” says Gralow.
Stacey Kusterbeck is an award-winning contributing author for Relias. She has more than 20 years of medical journalism experience and greatly enjoys keeping on top of constant changes in the healthcare field.
References
1. Socal MP, Acha J, Yang CY, et al. Key drivers and mitigation strategies of oncology drug shortages 2023 to 2025. Cancer J. 2025;31(5):e0791.
2. Ghazal LV, Mohile S, Loh KP, et al. Impact of drug shortages on cancer care delivery within the National Cancer Institute Community Oncology Research Program. JCO Oncol Pract. 2025; Jul 25. doi: 10.1200/OP-25-00057. [Online ahead of print].
3. Reich L, Knopf KB. The oncology drug shortages and its impact on community hospitals. Cancer J. 2025;31(5):e0794.
4. Bertagnoli S, Shastay A, Jew RK. What does the Institute for Safe Medication Practices’ survey tell us about the impact of shortages on patient safety? Cancer J. 2025;31(5):e0789.
5. Hantel A, Spence R, Camacho P, et al. ASCO ethical guidance for the practical management of oncology drug shortages. J Clin Oncol. 2024;42(3):358-365.
6. Westin J, Sherwood S, Hagerty K, Gralow J. Crisis of cancer drug shortages: Understanding the causes and proposing sustainable solutions. JCO Oncol Pract. 2025; Jul 1. doi: 10.1200/OP-25-00381. [Online ahead of print].
