Record shortages of lifesaving chemotherapy drugs mean doctors across the US are still having to ration medication, delay treatment or even cancel chemotherapy appointments for people with cancer.
Several of these medications have been in and out of shortage for years, but this year has been particularly bad, according to experts who spoke Tuesday as part of a meeting hosted by the American Cancer Society and United States Pharmacopedia on how to fix the problem.
“There’s absolutely a crisis here for these specific essential backbone therapies in cancer, which are delaying treatment and which clearly are affecting lives,” said Michael Kleinrock, lead research director at the IQVIA Institute for Human Data Science. IQVIA uses data to help with health information technology and clinical research.
Children with cancer are especially vulnerable, according to Dr. Doug Hawkins. He was not part of Tuesday’s event, but it did feature data from his organization, the Children’s Oncology Group, the world’s largest devoted to exclusively to childhood and adolescent cancer research.
Hawkins, the group’s chair, said that of the 67 pediatric oncology centers that responded to a recent member survey, three-fourths said they have been negatively affected by a shortage of methotrexate.
Methotrexate, a chemotherapy drug that is used to treat a wide variety of childhood cancers, has been in shortage since February. Nearly half of the surveyed centers said they had to take active measures to conserve it, Hawkins said.
“That was pretty eye-opening,” he said.
Methotrexate hasn’t gotten as much attention as some other drugs that are also used to treat adults, he said, but it is used for one of the most common types of cancer in children: acute lymphocytic leukemia, a blood and bone marrow cancer. It’s also used to treat conditions like select brain tumors and non-Hodgkin lymphoma.
Pediatric cancers are also treated with carboplatin and cisplatin, two drugs that have been in serious shortage since the beginning of the year. In June, a survey of major cancer centers found that 93% couldn’t find enough carboplatin, and 70% had cisplatin shortages.
“You can imagine how big of a problem this is for children, when many of the drugs that we rely on to treat them are in shortage,” Hawkins said. “It’s just a huge problem.”
It’s a problem that’s unique to the US, he said. None of his organization’s pediatric oncology international members has been dealing with drug shortages.
In June, the Biden administration announced that it had worked with China and made a special allowance to import cisplatin to ease the shortage. But some health care systems are still struggling, according to Dr. Julie Gralow, executive vice president and chief medical Officer of the American Society of Clinical Oncology.
Some centers have been able to substitute the more expensive carboplatin for cisplatin, but not everyone has enough of either. One hospital-based system in Virginia, the Inova Schar Cancer Institute, told the society in August that it had enough carboplatin to substitute for cisplatin but was still using “conservation methods” such as lowering doses or taking longer intervals between treatments.
The shortage has affected providers both big and small, Gralow said. The US Oncology Network, which includes 500 cancer treatment centers across the country, told her group in August that they were able to use carboplatin to accommodate for the shortage of cisplatin, but they couldn’t quite get enough to keep up.
“So this very large network really felt the impact, but they did not feel it in a major way until mid- to late July, and it was ongoing in August, when they shared this data,” she said at Tuesday’s meeting.
Another, the Tennessee Oncology Network, had almost no doses of carboplatin or cisplatin for three weeks in the summer.
“They were totally out of those drugs, despite being a fairly large private network with 35 clinics and 200 providers,” she said.
Big academic centers were also struggling, she said. The University of Chicago, for example, saw a big drop in its ability to administer carboplatin and cisplatin early on “and has not recovered to date.”
About 82% of all drugs that are on the US Food and Drug Administration shortage list are generics, according to Kleinrock’s analysis of FDA data, and 52% are injectables. The volume of shortages has more than doubled since 2011, he said.
A large part of the problem, he said, is that generics are priced so low to be competitive, and when they can’t make a profit, companies don’t want to make them.
“Low price, when you have complexity, creates some challenges for the manufacturer,” Kleinrock said.
But it’s not just the manufacturers that are to blame.
Natural disasters can shut down plants, as can inspections that find something wrong. That often happens, he said, when margins are compressed and when businesses make tradeoffs to keep prices down.
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Pharmacists buy on price alone, he said. Some say that if manufacturers were to offer quality or reliability ratings, they could factor into purchasing decisions. But outside of an inspection, even the FDA doesn’t know when a manufacturer is having problems or plans to shut down. All such problems are self-reported.
Unless policies change or there is a way to incentivize companies to make more generic drugs, experts predict that there will be many more cancer medication shortages in the future.
Two other drugs used for children with cancer, vinblastine and dacarbazine, went into shortage just last week, according to the American Society of Health-System Pharmacists.
“These drugs are particularly used to treat patients with Hodgkin’s lymphoma. Hodgkin’s lymphoma is probably one of the most curable types of cancers out there,” Hawkins said. “The problem is neverending.
“It is horrible,” he added. “I mean, to say to a patient, ‘we know how to treat your child, but we can’t get the drugs,’ and this is America, and it’s 2023 – it’s crazy.”