user Admin_Adham
3rd Nov, 2025 12:00 AM
Test

Chemotherapy Drug Shortages Become Cancer-Care Reality

Intermittent shortages of various injectable chemotherapy drugs have become a regular part of cancer care, with oncology practices reporting that despite their best efforts to mitigate supply challenges, shortages can be detrimental to patient care.

Between late 2023 and early 2025, there were multiple drug shortages happening simultaneously, said Kathleen Murphy, RN, executive director of Nursing Services at Tennessee Oncology, a large community oncology practice with more than 30 locations around the state. Vinblastine, carboplatin, fludarabine, cyclophosphamide, and etoposide were all on shortage during that period, she said.

“We had to make decisions about who was going to get what drugs because there were not enough to go around,” Murphy said.

That meant prioritizing patients whose disease could be cured vs those for whom treatment would merely extend life, she said.

Forty-five percent of oncologists said that recent shortages of certain chemotherapies have had a severe negative impact on their practice’s quality of care, according to a recent poll of 140 oncologists conducted by Medscape Medical News. Similarly, 42% of respondents said these shortages have had a severe negative impact on patient outcomes.

SUGGESTED FOR YOU

More than a quarter of oncologists who responded to the poll identified shortages of carboplatin and cisplatin as especially problematic. Additionally, 9% cited shortages of the antimetabolites methotrexate and fluorouracil and 5% called out limited access to saline.

The findings line up with a recent survey of 96 National Cancer Institute Community Oncology Research Program community oncology practices.

Those survey results, published in August in JCO Oncology, showed that more than half of practices were seriously affected by shortages across 23 oncology drugs. All practices surveyed reported having mitigation strategies for shortages, including using alterative drugs, stockpiling essential medications, developing action plans, and purchasing drugs off-contract or through secondary markets.

Despite these strategies, half of practices said shortages created ethical dilemmas around prioritizing drug allocations and more than 1 in 10 practices were unable to enroll patients in clinical trials due to drug shortages.

Current Shortage Snapshot

There are currently 22 chemotherapy drugs in shortage in the US, including 15 injectable and seven noninjectable medications, according to the most recent data available from the American Society of Health-System Pharmacists (ASHP). The data shows that chemotherapy drugs are among the top five drug classes with active shortages.

The current list of shortages includes some widely used chemotherapy injectables such as carboplatin and cisplatin. But just because a drug is on the shortage list doesn’t mean that it is having an impact on clinical care, said Michael Ganio, PharmD, senior director of Pharmacy Practice and Quality at ASHP. Medications frequently go in and out of shortage, but supplies may be available in other dosages or from other manufacturers, he explained.

In the case of the current reported carboplatin shortages, while some products have been discontinued, other manufacturers have the same dosage of the product available.

While there are always some shortages ongoing in oncology, the “severity can wax and wane,” Ganio said.

Oncology shortages occur most often among injectable drugs and are usually due to the complexities of manufacturing, Ganio said. Injectable drugs must be made under sterile conditions and require numerous safety and quality tests, making them prone to supply disruption.

These drugs also tend to be generic injectables that are decades old and are sold at relatively low cost. The low profit margins around these drugs have led to significant consolidation among manufacturers, which maximizes disruption if there is a quality issue at a facility that accounts for a large share of that drug’s market, Ganio said.

That was the case in February 2023 when cisplatin went into shortage. One cisplatin manufacturer, which had a significant share of market, had to suspend production because of quality issues and other manufacturers were unable to ramp up production sufficiently to fill the need. Later that year, in April, FDA announced that another backbone chemotherapy drug, carboplatin, was also in shortage. Both drugs were in shortage for over a year, creating significant disruption to cancer care nationwide.

Severe weather can also be a factor in drug shortages. Ganio said those situations are less common but can have a significant impact. Most recently, in September 2024, Hurricane Helene led to the closure of a Baxter manufacturing facility in North Carolina, which is the largest producer of sterile intravenous (IV) fluid in the US. That led to a shortage of IV saline that lasted until August 2025.

Shortages of chemotherapy drugs can be especially challenging, Ganio said, because there are limited substitutions that deliver the same outcomes. Physicians are faced with sacrificing efficacy or taking on more adverse events with some substitutions, if those choices are available at all, he said.

Coping With a Shortage

Murphy said she and her colleagues always look for alternatives when a drug is in shortage but there aren’t always substitutions. That was the case for fludarabine, a chemotherapy drug that has been on the market for more than three decades and is used heavily in patients receiving chimeric antigen receptor (CAR) T-cell therapy or stem cell transplants and patients with blood cancers.

“We had such small supplies that while there were some solid tumor patients that may have benefitted from it, they just couldn’t have it,” she said.

Tennessee Oncology uses a variety of strategies to cope with shortages, including reaching out to other practices and hospitals to obtain needed drugs, switching patients to more expensive oral therapies when they are appropriate, getting early warning of supply disruptions from manufacturers and buying extra supply, putting in place processes to minimize waste when drugs are mixed, and quickly convening subject matter experts to prioritize patients and identify drug alternatives, Murphy said.

“I think one of the lessons we learned was keep your finger on the pulse of what’s going on out there because you do want as much early notice as you can get that something might be happening,” she said.

Kashyap Patel, MD, an oncologist and CEO of Carolina Blood and Cancer Care Associates, said one factor that helped mitigate some of the impact of recent injectable drug shortages is the increasing number of targeted immunotherapies. Rather than treat a patient with a standard platinum-based chemotherapy, there may the option of using a mutation-targeted oral medication, he said.

“What I’m seeing is that in place of chemotherapy, there are patients where we may be able to use targeted therapies. If it was 2015, I think things would’ve been a lot worse. With the advent of targeted therapies and precision medicine, the demand for the platinum group of drugs is slowly shrinking,” Patel said.

Policy Options

The issue of ongoing drug shortages for sterile generic injectable products boils down to economics, said Ted Okon, executive director of the Community Oncology Alliance.

Generic injectable drugs are produced at low profit margins, or in some cases negative margins, with manufacturers only continuing to make the drugs because it fills a production line for a facility that needs to operate on a 24/7 basis, he said. “When you are operating on really small margins, you’re probably not going to have the best quality control,” Okon said.

To address this issue, Okon supports a value-based payment system for these manufacturers where they would get a bonus for maintaining an ongoing supply of quality products and be subject to financial penalties when they don’t. Okon said it’s also critical for Congress to act to remove mandated discounts and rebates from federal programs that further drive down the margins on these drug products.

Julie R. Gralow, MD, executive vice president and chief medical officer at the American Society of Clinical Oncology (ASCO), agrees that the current economics of the generic sterile injectable market are not working. She and ASCO leaders are advocating for a multi-pronged approach that includes creating a market incentive for reliable and quality manufacturing. A pilot program run by the FDA showed the feasibility of identifying quality manufacturers and she said it could be expanded to include more manufacturers and a performance rating.

Other potential parts of the solution include public-private partnerships around drug purchasing, such as Civica-Rx, where drug supplies would be slightly more expensive, but the hospital or oncology practice buyers would get a guaranteed supply. Additionally, ASCO favors encouraging onshoring or “near-shoring” of drug manufacturing in North America.

“Right now, we don’t have a major impact from shortages, but we will again because we haven’t fixed any of the things that have led to some of these more severe shortages in the past,” Gralow said.

Ganio, Gralow, Murphy, Okon, and Patel reported no relevant financial relationships.


Share This Article

Comments

Leave a comment