For pharmacists, drug shortages often pose a real-life version of the ethical thought experiment known as the “trolley problem,” where one must decide whether to sacrifice one person to save a larger number. It usually starts with a runaway trolley on course to kill five people on the track, but a bystander can choose to pull a lever to divert it to another track where the trolley would instead kill just one person. Do you pull the lever or do nothing?

Brian Spoelhof, PharmD, BCPS, BCCCP, the manager of pharmacy medication utilization strategy at UVA Health, in Charlottesville, Va., recounted such a dilemma during a panel on the ethics of drug shortages at the ASHP Midyear 2024 Clinical Meeting & Exhibition, in New Orleans.

In December 2019, Dr. Spoelhof had to deal with the worst shortage of his then eight-year career: one affecting vincristine, a critical treatment for leukemias, lymphomas and brain tumors in adult and pediatric patients that has no alternative therapy.

“We were at the point where we were starting to discuss whether we would have to withhold appropriate therapy for certain patients, and I was very stressed,” Dr. Spoelhof recalled.

During the vincristine shortage, he said his institution got through with solutions such as dose rounding and “pairing” of patients. “We worked with our schedulers to take two patients who had doses that would total the amount in a vial, so that we could make sure we used every single drop,” Dr. Spoelhof said. “You do whatever you can to balance everything out, reviewing your utilization, reducing any inappropriate or less appropriate use, and trying to get more supply from whatever resources you have. But there were many times when [our supply] got to near zero, and we had to have conversations about what we would do if we had to decide to withhold therapy.

“I still remember one conversation I had with a pediatric oncology nurse who said, ‘Why don’t we just stop treating the adults and give the rest to the kids?’ I’d been working on drug shortages for many years at that point, but nothing can prepare you for a question like that.”

That wasn’t the only time Dr. Spoelhof was struck by the ethical high stakes posed by drug shortages. At dinner with his wife in downtown Charlottesville one evening, he noticed a little girl of about 6 or 7 years of age in a pink and purple jacket, walking with her family. “She was happy, playing, living her best life. But what caught my attention was her evident patchy alopecia from chemotherapy,” he said. “And in that moment, I wondered if her life was in our hands. I broke down and cried, realizing what the true weight was on our shoulders when we managed drug shortages.”

Although he had navigated these scarcities for eight years, Dr. Spoelhof said, “my process had been very formulaic and scientific. But now I was wondering if it lacked the humanity that it deserved, and if I had always made the right decision.”

Effect on Patient Care

A 2017 JAMA paper cited by Dr. Spoelhof underscores the high stakes involved. The study evaluated outcomes resulting from a 2011 shortage of norepinephrine (2017;317[14]:1433-1442). In 26 hospitals that had endured at least one-fourth of the shortage, the drug’s use among patients with septic shock decreased from 77% to 56%, while phenylephrine use increased from 36% to 54%. “Now, I am sure there were very thoughtful discussions to make sure that there was appropriate use of phenylephrine in the right patients, but despite that, there was a mortality increase from 35.9% to 39.6%,” he said. “That’s one additional death for every 27 patients, and the magnitude of that [increase] is greater than the benefits of some standard therapies, like thrombolytics for pulmonary embolism and aspirin for myocardial infarction.”

Guiding Principles

A deeper understanding of ethics and moral philosophy is essential to establish a consistent and coherent ethical drug shortage management strategy, Dr. Spoelhof advised. “We should question our initial instincts and approach the situation rationally and with caution. Traditional drug shortage mitigation techniques are influenced by implicit bias, or may inadvertently cause disparities in health equity.”

In a June 2023 article in The Lancet, Ezekiel Emanuel, MD, and Govind Persad, PhD, discussed a “shared ethical framework to allocate scarce medical resources” stemming from the COVID-19 pandemic, involving five “substantive values”: maximizing benefits/minimizing harms, mitigating disadvantage (ensuring equity), equal moral concern (not identical treatment), reciprocity and “instrumental value” (Lancet 2023;401[10391]:1892-1902).

Each value has potential negative implications as well, Dr. Spoelhof noted. “If you’re talking about maximizing benefit, whether that is prioritizing those who are most likely to survive or try to prevent the most mortality, that is often driven by prognostics.” Yet prognostics are an inherently biased measure due to systemic medical injustice. “You must recognize that even though this is a rational approach, you may be prioritizing affluent individuals,” he said. “So, you may argue, let’s prioritize the disadvantaged instead, which is also a valid approach. But if the prognostics are negative in that case, you may not get the maximum benefit from the available drug.”

Avoid Indiscriminate Rationing

Equal moral concern, which could take a “first come, first serve” or random assignment approach, is indiscriminate. “First come, first serve always goes to the people who have the most access and health literacy,” Dr. Spoelhof said. “So maybe do a lottery? Have fun trying to do that with drug shortages. It’s not very practical.”

The last values, reciprocity and instrumental value, focus on “giving back to those who give to you,” he said. “You might give a vaccine first to the nurses because they’ve given everything to the hospital, or you prioritize your front-line healthcare workers because of the need for them to provide care.” These values are more relevant in a context such as scarce vaccines during the COVID-19 pandemic than in the setting of an IV fluids or oncology drug shortage.

Respect Patient’s Autonomy

Drug shortages are in many ways the antithesis of modern bioethics, Dr. Spoelhof noted. “For example, if we want to respect patients’ autonomy, we want to give them the ability to make decisions. It’s hard to do that when you have an independent group drug shortage task force making those decisions for them,” he said. “Beneficence is about doing best for patients and not causing harm; you can’t do that if you don’t have the drugs you need to do it.” (See sidebar, “3 Foundational Guiding Principles.)

To guide these difficult discussions, it has become increasingly common for hospitals and health systems to include representation from bioethics on their drug shortage committees, said Eric Tichy, PharmD, the vice chair of pharmacy formulary for the Mayo Clinic Health System, in Rochester, Minn., and a past chair of the End Drug Shortages Alliance. “Most institutions have ethics committees that address a variety of ethical issues, and typically a representative from that committee might also participate in the drug shortage committee. Because we have been dealing with these shortages for so long, the process of getting those people engaged has become easier.”

How to Add Ethics Experts

There are various ways health systems can include ethics experts in drug shortages discussions, such as inviting outside ethics advisors to attend committees tasked with navigating supply chain challenges (sidebar, “Bringing in Experts”). UVA has a slightly different structure, with an internal drug shortage expert who sits on the system’s ethics committee.

“However you set up your framework, you need to establish governing principles for ethical drug allocation,” Dr. Spoelhof said. “This includes transparency—don’t hide the fact that there’s a shortage.”

Make sure that your principles are both relevant and enforceable. “That’s always a challenge: If they’re not enforceable, you are going to get the providers who are the loudest getting the drug for their patients, while those who are trying to follow the rules are behind.”

It’s important to allow for discussion and appeals, he added. “Whatever principles you put in place are not going to allow for every scenario.”

Finally, these discussions should involve a large and diverse group, including community representation, “because that can help to pick up on implicit biases that you may not recognize.”

The sources reported no relevant financial disclosures.