‘All hands on deck’ needed to navigate oncology drug shortages, says expert panel
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A virtual town hall meeting featuring a panel of regulatory, pharmacy and procurement experts addressed the ongoing shortage of oncology drugs.
The panel discussion, coordinated by National Community Oncology Dispensing Association (NCODA), focused on understanding the current landscape of oncology drug supply, characterizing the substantial effects of the shortage on clinical practice and patient care, and anticipating strategies for handling future drug shortages.
“Today, we’ll discuss what we have learned about the oncology drug shortage,” moderator Sam Abdelghany, PharmD, MHA, BCOP, executive director of oncology pharmacy services at Yale New Haven Health, said in his introduction. “And in the spirit of not letting a good crisis go to waste, we are going to discuss how this experience can help inform our future preparedness.”
Issues of quality
Valerie Jensen, RPh, associate director of FDA’s Center for Drug Evaluation and Research (CDER) drug shortage staff, evaluated the causes of the oncology drug shortage, which centers on the chemotherapy drugs cisplatin, carboplatin and methotrexate.
“Unfortunately, the shortages of oncology drugs that we’ve experienced — especially over the last year — are part of a broader problem with older, generic drugs and, especially, injectables,” Jensen said. “When one firm has a quality issue or problem, it’s very difficult for the other manufacturers — even if there are several manufacturers — to ramp up and meet that supply gap.”
Jensen discussed the unexpected shutdown of one manufacturer, which led to the shortage of cisplatin, followed by shortages in carboplatin and methotrexate. Manufacturing delays also contributed significantly to oncology drug shortages, Jensen added.
When the FDA first became aware of the manufacturer shutdown, it began working with all manufacturers on increasing or expediting supply, reviewing additional sites, and authorizing two new manufacturers of carboplatin and one of cisplatin, according to Jensen. The agency also initiated an import from a Chinese company to a U.S. distributor.
“We very carefully evaluated that product to make sure it was safe for U.S. patients,” she said.
The FDA has also been diligent in disseminating information about the shortages to affected practitioners by providing the most updated information on its website and by communicating directly with ASCO and individual cancer centers, Jensen said.
Impact on clinical practice
Paul Chadwick, chief value and procurement officer at Florida Cancer Specialists and Research Institute, discussed the impact of the drug shortage on clinical practice at his facility. By spring of 2023, his practice had already begun taking measures to maximize their supply of shortage drugs.
“We were dose rounding as a practice to conserve as much as we could. Dose rounding is a medically accepted practice, up to a certain point,” Chadwick said. “We were doing everything we could to conserve the supply we had on hand. We were sourcing from as many places as we could, where we felt the product was valid and trusted. Still, there were absolutely days when we had no product.”
Chadwick said he worked collaboratively with the “great team of pharmacists” at Florida Cancer Specialists and Research Institute to determine which patients could be treated with the current supply.
“During those times we had all hands on deck, 7 days a week, trying to manage what supply we had, what supply we were certain was coming, what supply might be coming,” he said. “At the end of that, there were definitely days when we had to tell patients that we could not treat because we didn’t have the drugs needed to do that.”
ASCO’s response
ASCO chief regulatory affairs officer, Karen Hagerty, MD, discussed how the organization responded to the drug shortage. ASCO began hearing about the shortage around April of 2023, and by May, mounting concerns and requests for clinical guidance drove ASCO to establish its Drug Shortage Advisory group and create its dedicated drug shortages webpage. ASCO worked with the Society for Gynecologic Oncology to develop disease-specific guidance around the shortage.
“In June, we endorsed SGO’s disease site content, and by July, all additional ASCO disease site content was live on our website,” she said.
In addition to releasing general recommendations, ASCO also developed several other site-specific subgroups of experts, who then created site-specific guidance in breast, genitourinary, gastrointestinal, head and neck, and thoracic cancers.
“Our overall approach was to develop recommendations to conserve antineoplastic agents in limited supply and to minimize waste,” Hagerty said. “The clinical guidance was not intended to be comprehensive or cover all clinical scenarios.”
ASCO also recognized the need for institutions and practices to have clearly communicated, ethical and effective prioritization strategies, Hagerty added. For this reason, ASCO published a review of allocation principles on its website.
“Going forward, we are continuing to monitor all of the existing drug shortages very closely. We hear from our members when they’re having a particularly tough time, and that helps us guide our clinical guidance,” Hagerty said. “We have the process and the group set up now, and we’re in a good position to quickly pivot to additional clinical guidance as other drugs, unfortunately, will likely go into shortage.”
Looking toward the future
As the industry recovers from the recent oncology drug shortages, Abdelghany asked the panelists about indicators to look for in terms of potential future shortages.
Issues of quality drove the recent shortage, according to Jensen. She clarified that “quality” pertained not only to the drug working effectively, but also to the quality of the manufacturing facilities.
“When companies do have unforeseen quality issues that are suddenly discovered, we are working with them closely and getting the message out that we don’t want them to shut down,” Jensen said. “We want to work to get them back online. That’s really our role — to make sure that the products coming to the U.S. and being given to patients in the U.S. are safe and effective.”
The FDA has prioritized incentivizing quality among drug manufacturers to prevent shutdowns and subsequent shortages, Jensen said, adding that the FDA’s Office of Pharmaceutical Quality has been working on quality management maturity efforts.
“This is an incentive program where companies get rated for their quality management maturity at their facility,” she said. “What we’re hoping, in the end, is that purchasers will make decisions based on the ratings of those facilities.”
Jensen clarified that the products themselves would not be rated, since any FDA-approved drug marketed in the U.S. has been deemed safe and effective.
“This would be a facility rating system to prevent the kinds of shortage issues we’ve seen,” she said.
Hagerty discussed some of ASCO’s advocacy efforts toward preventing future shortages, including empowering the FDA to require notice from manufacturers regarding imminent supply issues.
“We advocated very strongly for those provisions, which gave the FDA additional authority to require reporting from manufacturers when they thought there was going to be an interruption or discontinuance in the supply chain,” Hagerty said. “Likewise, portions of the [Mitigating Emergency Drug Shortages (MEDS)] Act that made it into the recent legislation in 2023 contained requirements for manufacturers to start reporting the amounts they manufacture to the FDA. So, there is certainly a lot of legislation around this on the Hill right now.”
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