Practices reported combined shortages of more than 20 oncology drugs.
Oncology drug shortages may "seriously" affect more than half of community practices in the U.S., according to results of an observational study.
In a survey of more than 90 community oncology practices, greater than 50% reported drug shortages caused cancer care delivery problems, including changes to more toxic and/or less effective treatments, delayed therapy and ethical dilemmas on who should receive impacted medications.
"Drug shortages are not just abstract supply chain issues. They're directly impacting cancer care delivery and patient care. They're even affecting enrollment in clinical trials," lead author Lauren Ghazal, PhD, FNP-BC, assistant professor and researcher at University of Rochester School of Nursing, told Healio.
"We know this can impact survival and quality of life, not only for patients but also their family members, stressing the urgency of developing system-level and policy solutions. We know individual practices can't solve this alone."
More than 200 drug shortages occur every year in the U.S., according to study background.
Since 2005, the country has had an average of 12 oncology drug shortages annually, including a high of 26 in 2011.
Healio previously reported on a National Comprehensive Cancer Network survey in 2023 that showed 93% of cancer centers had a carboplatin shortage and 70% did not have enough cisplatin at the time.
"It became a huge issue," senior author Elaine L. Hill, PhD, professor in the department of public health sciences at University of Rochester Medical Center, told Healio.
Hill became interested in the topic in 2017.
"It had been ongoing for many, many years," she explained. "Some of the drugs of interest have curative intent, and so the fact that they are in shortage has potential implications for patients. I wanted to take it further than just quantifying how often it happens, or why it happens, which has been done in the supply side of health economics. I was really interested in what happens for patients, and how providers have to make challenging decisions in the face of drug shortages."
Researchers conducted an observational study with data from a prospective cancer care delivery investigation led by the University of Rochester NCORP Research Base.
In all, 93 community practices completed baseline surveys, which were collected between Oct. 7, 2020, and June 3, 2024.
Researchers defined practices being "seriously affected" by drug shortages as those that had to change to a less effective or more toxic treatment, delayed treatment or had a medication error or near miss.
The number of practices seriously affected by drug shortages served as the primary endpoint. Cancer care delivery issues and strategies used to alleviate them served as secondary endpoints.
In all, drug shortages seriously affected 52.7% of practices within the previous 3 months.
"We had anticipated that maybe 20% of practices would report having a serious problem for their patients," Hill said. "To have over 50% of our practices report at baseline was just much higher than we expected."
Most affected practices were based in the Midwest (46.9%) or South (24.5%).
Practices reported a combined 23 specific drug shortages.
"I definitely underestimated that," Ghazal said. "What I thought we would see is maybe eight to 10, but 23 -- I remember sitting with that for a little bit. It's like, wow, imagine if that all came at once as a clinician and what that decision-making would be."
Among affected practices, the most common drug shortages included carboplatin (46.9%), leucovorin (42.9%) and cisplatin (36.7%).
More than half (50.5%) of practices reported having an ethical dilemma when planning for a drug shortage. These included prioritizing who should get medications and needing input from legal and ethics departments to help make decisions.
Drug shortages prevented 11.8% of practices from enrolling patients in clinical trials and forced 15.1% to use different treatments in those investigations.
Compared with unaffected practices, seriously affected practices had a significantly higher rate of changing to an equally effective treatment (36.7% vs. 15.9%; P = .03), not having a suitable alternative (34.7% vs. 13.6%; P = .02), changing to a less-effective treatment (14.3% vs. 2.3%; P = .04) and having substantial resource expenditures (70.8% vs. 50%; P = .02).
Seriously affected practices also had a numerically higher rate of treatment delays (20.4% vs. 6.8%), transferring a patient to another practice (4.1% vs. 0%) and increased costs (61.2% vs. 45.5%).
The most common strategies to alleviate the impact of drug shortages included using alternative or substituting drugs, stockpiling medications and creating action plans.
Researchers acknowledged study limitations, including its cross-sectional, retrospective design.
Hill repeatedly described the findings as "baseline" and emphasized the importance of longitudinal data they are collecting.
"We try to understand how many patients [are affected], and we ask questions about how many infusions they're offering over a period of time for each drug so we can get a rate of problems for patients," Hill said.
She also wants to gather more details on ethical dilemmas, considering how many practices reported them.
"We put a couple questions in about ethical dilemmas, but I wish that was a repeating question throughout the longitudinal data so that then we could better capture that," Hill said. "I do think that's a burden for clinicians, but also for families, and understanding transparency around that [is important]. I think so much more work could be done just on that question alone."
Investigations into whether location or size of practice could impact access to drugs during shortages are warranted too.
"Being able to understand how any large practice that's stockpiling might have downstream implications for a smaller practice that's not able to would require different data," Hill said. "It's plausible in the grand scheme of supply and demand that when there's a shortage, if some sites are able to stockpile, not only does it reduce access for sites that cannot, but it also increases the cost and the prices for acquiring any supply that does exist."
Ultimately, Hill and Ghazal highlighted the need for policy interventions to mitigate the impact of drug shortages.
"During that cisplatin shortage, people switched to carboplatin and then that became in shortage," Hill said. "Now there's not another alternative after that. Each shortage can have downstream effects for the next-line drug. There's a whole cascade of events, so then you get to a place where there's a lack of a suitable alternative.
"I think that's a place where we definitely want to be thinking about policy solutions, because practices are unlikely to be able to address this," she added. "You can't anticipate what the next shock will be. How do we prevent that cascade from the beginning? I think that is something I would like to consider for future work."
Hill noted issues surrounding supply-side structures that also could be addressed.
"Most of these drugs are generics, and they often are sourced from single manufacturers," she said. "Therefore, if a plant gets shut down, or there are concerns about reimbursement because there's not a huge economic incentive to produce these drugs, there's a number of concerns on that side of the equation that could be addressed through policy."