The chemotherapy drugs cisplatin and carboplatin have become difficult for hospital systems across the country to access in recent months, disrupting cancer treatments and leading health care providers and patients to worry about the future.
According to the Society of Gynecologic Oncology, platinum drug shortages, including cisplatin and carboplatin, were first reported to the Food and Drug Administration on Feb. 10. In December 2022, the FDA temporarily shut down platinum drug shipments for safety reasons from a factory in India, the primary supplier.
The FDA announced in June that it was collaborating with Qilu Pharmaceutical Co. in China and pharmaceutical company Apotex in Canada to increase the availability of the drugs.
For cancer treatment centers across the U.S., including those in Pittsburgh, the move to work with Qilu couldn’t have come at a better time.
“A few weeks ago, we were really very concerned,” said Dr. Stanley Marks, chairman of UPMC Hillman Cancer Center. “We really had almost no drugs left for our patients, where our supply was almost depleted.”
The Chinese product, along with a renewed availability from manufacturer Ingenus in New Jersey, has put the health system in a “much better position,” he said.
“Fortunately for us, there’s been very little impact on our patients,” Marks said. “There may have been a few patients who had their therapy delayed a week or two, but that’s been the extent of it.”
Managing shortage
Not all types of cancer require cisplatin and carboplatin treatment, but for some types of cancer, it’s an essential part of chemotherapy, Marks said. Lung cancer, testicular cancer, gynecological cancers, and head and neck cancers are among the conditions that use cisplatin and carboplatin.
Jodi Lech, director of pharmacy for Allegheny Health Network’s Cancer Institute, said the health system is being impacted by the shortage but is “working very closely with the Cancer Institute physicians, as well as our pharmacy team, to keep everybody informed about the impact of the shortage of certain drugs on the health system.”
Cisplatin was the first of the drugs to become limited at AHN, she said, with the health system first becoming aware of a potential problem in February. Shortages like these sometimes move in a cyclical manner, she explained.
“We’ve been dealing with this for quite some time,” she said. “With the laws of supply and demand, one drug goes down, and typically an alternative regimen is carboplatin. Then, you’ll see a run on carboplatin, which creates a shortage.”
AHN is managing its existing supply of the drugs, seeking alternative sources for medicines that are in short supply, and adjusting chemotherapy regimens for impacted patients, she said. The health system is following guidance from the American Society of Health-System Pharmacists, American Society of Clinical Oncology and the Society of Gynecologic Oncology.
“We’ve actually been pretty consistent for the last few months,” she said, noting that AHN did receive a limited amount of new cisplatin from the newly approved facility in China. “We have implemented some restrictions based on our current supply, where cisplatin would be reserved for more of certain cancers.”
Drug shortages on the rise
The increased supply from China and from other U.S. locations is expected to improve the immediate shortage situation in the next few months, and the FDA will soon allow the Intas facility in India to begin exporting the drugs again, Marks said.
But chemotherapy drugs are just one out of a plethora of other medications that have undergone shortages in the past few years.
Laura Mark, vice president of pharmacy at AHN, said there are generally around 100 medications at any given time that are on a watchlist the health system is monitoring for shortages.
“They change periodically, and we have a weekly meeting with all hospitals that we look at our usage,” she said. “We look at some of the telltale signs that (a medication) is coming back, or what is the latest update. We consult national resources that monitor drug shortages, and we look for alternatives, alternative routes of administration that we might utilize if we can, and alternative sourcing mechanisms. … It’s unfortunately become a standard of practice in managing drug shortages over the years.”
Part of the problem is that cisplatin and carboplatin are both “generic” drugs that have moved out of their patents, said UPMC’s Marks.
“Once drugs become generic, there’s not a lot of margin in those drugs, so pharmaceutical companies, unfortunately, aren’t that interested in focusing on generics,” he said. “There are only a handful of generic manufacturers in this country or around the world.”
Incentivizing U.S. manufacturers to produce generic drugs could help alleviate these situations, which have been an issue even since before the pandemic, he noted.
“It definitely got worse during covid. There are the usual supply chain issues as you would expect. But again, it goes back to the basic issue about generics not being attractive to pharmaceutical companies,” he said. “This is going to be a chronic problem, I think, until the FDA acts.”
Predicting when drugs will become available or experience shortages is a difficult task, Lech said.
“We’ve experienced things over the years where you think you have a plan going and then an unexpected event — a hurricane or things like that — occurs. That is tough,” she said. “My best recommendation for patients is if you have concerns about a drug shortage, contact your oncologist, and make an appointment and talk to them. They are the experts in treating your cancer, and they have the most information.”
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