On Monday, the Medical Ethics Discussion Panel hosted Yoram Unguru to discuss the impact of chemotherapy drug shortages on patients. The panel hosts speakers from the Berman Institute of Bioethics to discuss bioethics in their field.
Unguru is an assistant professor at the Berman Institute as well as a pediatric oncologist. He sits on the Working Group on Chemotherapy Drug Shortages in Pediatric Oncology, which is dedicated to mitigating the effects of drug shortages.
According to Unguru, medication shortages are nothing new. Beginning in the 1920s, insulin was a scarce commodity for patients with diabetes and was given out on the whim of one of the discoverers. Then, in the 1930s, the U.S. faced a shortage of penicillin.
However, these shortages are becoming more and more common, particularly in the U.S.; currently, 276 medications are in short supply. About half of these medications are sterile injectables that have been around for decades. Cancer patients are disproportionately affected; about 50 percent of the medications in shortage are chemotherapy medications.
Unguru highlighted the problems that these shortages cause. In one survey, 83 percent of oncologists stated they could not prescribe preferred forms of care due to the shortages. Another survey showed that two thirds of pediatric oncologists believed care was compromised.
Patients may be unable to access the life-saving medication they need. More commonly, however, they are forced to make changes to their treatment by taking a lower dose or altering the timing of treatment. Some patients are forced to delay treatment, while others receive a dose too soon to compensate for impending shortages.
Shortages have another consequence: price. Doctors and patients alike turn to the gray-market, where unauthorized secondary distributors sell medications at more than a 3000 percent markup.
Drug shortages are primarily caused by economic interests, according to Unguru. He noted that a CEO of one company dedicated to mitigating the defecit described how the shortages are the result of economics decisions. Although 4500 children are being diagnosed with cancer each year, shortages remain constant. Unguru put this down to money.Pharmaceutical companies have no motive to produce more of these generic sterile injectables, which are not as profitable to the company as designer drugs.
As an example, Unguru described how IV bags made from saline solution, essentially salt water, have been in short supply since Puerto Rico was hit by Hurricane Maria in 2017. Some groups, like Civica RX, are trying to create affordable generic medications to combat the shortage. Others want to sit down with pharmaceutical companies to negotiate. However, these both take time that both take time that patients may not have.
The Working Group has released several recommendations. The first is to lift the burden from the doctor. Currently, 82 percent of hospitals allow providers to make choices about whether or not to administer scarce medications to the patient. Not only is this inefficient and uncomfortable, but it’s also likely unethical.
He points to subconscious biases that could affect a provider’s decision in allocating medication. He believes that decisions should be left to panels made up of clinicians, patient advocates, bioethicists and other representatives to ensure decisions are ethical as well as practical.
However, moving the decision in drug allocation is more complicated than simply forming panels. When a medication is in short supply, who should receive the medication? Here he turned to the audience for an exercise. In a hypothetical situation, if a hospital was to run out of a standard chemotherapy medication in a week, who should get access to it?
Audience members suggested various strategies, like cutting doses for all patients or looking for alternatives. Others elected to review cases individually and mete out the medication based on the patient’s prognosis and treatment phase. Still others suggested allocating fixed percentages of the medication to each type of cancer.
At the end of the discussion, Unguru pointed out the wide scope of different tactics the audience used. It was representative of how the medical community handled such cases — various working groups simply couldn’t agree on the best method for allocating scarce medications.
All groups agreed that first-come, first-served policies ignored patient need or access issues and instead favored wealthy and knowledgeable patients. Some of the working groups advocated for a lottery-based system, while others favored prioritizing on medical need. Ultimately, however, all groups agreed that drugs should be distributed in order to maximize patient benefit.
The Working Group’s recommendations also encompassed selection criteria. For instance, the group suggests prioritizing treatment with data-driven, proven results over clinical trials. Additionally, patient treatment should not be interrupted or delayed if possible. The group also suggested more creative solutions, like searching for alternative sources or possibly using slightly expired, but still viable, medication.
Most importantly, Unguru stressed the importance of sharing resources. More than 85 percent of hospitals hoard medications in the face of a shortage, further compounding the problem. Sharing medication may ease the collective shortage as well as improve patient care. Unguru also suggests that clinicians and government alike treat drug shortages as a national emergency, freeing up more pathways to source medication.
Unguru emphasized that drug shortage problems are not temporary.
“Nobody is immune from these shortages,” he said, “and they’re not going away any time soon.”