A survey found 93 percent and 70 percent of cancer centers are struggling with shortages of carboplatin and cisplatin, respectively, and while the FDA is trying to increase supply, hospitals are struggling to help patients.
There are eight oncology drugs in shortage: bacillus calmette-guerin, carboplatin, cisplatin, dacarbazine, docetaxel injections, fluorouracil, methotrexate and Pluvicto. The most concerning shortages are of carboplatin and cisplatin, commonly used together in chemotherapy treatment. Up to a half million cancer patients use those chemotherapies annually.
"It's unbelievable that we're in a place where cisplatin, which costs $15 a unit, and carboplatin, which costs $23 a unit, are in short supply and we can't deliver them to people even though, in some cases, they're front-line and lifesaving," Karen Knudsen, PhD, CEO of the American Cancer Society, told Axios on June 14.
Cancer centers struggle to provide treatment
A National Comprehensive Cancer Network survey found 93 percent of cancer centers report a shortage of carboplatin and 70 percent report shortages for cisplatin. A May survey by the Society of Gynecologic Oncology found physicians in at least 40 states had at least one chemotherapy drug in shortage.
"I don't know of a time that's worse than this," Julie Gralow, MD, chief medical officer and executive vice president of the American Society of Clinical Oncology, told NBC News.
Some hospitals are scraping vials together to fill therapy needs. Tallahassee (Fla.) Memorial Hospital workers are using emergency supplies to provide care for their 80 cancer patients, and a professor at Baltimore-based Johns Hopkins School of Medicine told ABC affiliate WJLA pharmacists are using "every drop of chemotherapy."
Physicians at Florida Cancer Specialists in Fort Myers have been rationing carboplatin for months by rounding down doses by 10 percent, but now they have no more of the drug. Like many others, they are waiting to get more prescriptions filled, often delaying treatment for patients until the drug comes in.
Medication shortages have been going on for decades, but Kenneth Komorny, PharmD, vice president and chief pharmacy officer at Tampa-based Moffitt Cancer Center, told ABC, "The past three to five years, it seems like oncology medications are impacted more than other medications."
He added that Moffitt has not yet had to ration drugs, but it has shifted some treatment plans due to the shortages.
Some worry about how the shortage will impact patients.
William Dahut, MD, chief medical officer of the American Cancer Society, told The New York Times that "if these drugs are not available, people are going to get inferior care. That's the bottom line. These aren't third- or fourth-line drugs where there are multiple other agents around. These are used up front for people you are trying to cure."
Potential solutions
The causes of the shortages have been attributed to supply delays. The American Society of Health-System Pharmacists said quality issues at drug manufacturing sites are triggering more drug shortages.
The cancer drug shortages are in part due to a manufacturer in India that halted production due to quality concerns. In a statement to NBC News, Intas Pharmaceuticals said it is working with the FDA to release existing carboplatin and other medically necessary products. It is working with the agency to resume manufacturing but does not know when that may happen.
To combat the delays and low manufacturing rates, the FDA recently allowed China-based drugmaker Qilu Pharmaceutical to import four lots of cisplatin 50 milligram/50 milliliter injections, and the agency's commissioner noted there might be a similar allowance for imported carboplatin.
"The agency is fully engaged in cross-government discussions to identify potential policies and provide input on proposals informed by our current authorities, resources and industry knowledge to ensure meaningful solutions," an FDA spokesman told Axios in an email. "While the FDA cannot directly affect many of the business decisions related to the drug supply chain, the agency has, among other things, encouraged the adoption of advanced manufacturing technologies and mature quality management practices to further these important efforts."
Naomi Ko, MD, a medical oncologist at Boston Medical Center, said the system and government can do more to prevent shortages.
"Rethinking the reimbursement of medications and patients," she said in a June 14 Boston University article. "Reconsidering how profit influences manufacturing of lifesaving cancer medications. Coming up with policy and strategies on how to ensure the profitability and availability of essential medications. A pharmacist on our team suggested that 'state and federal government officials need to be more stringent with pharma/generic manufacturers about how long these shortages last.'"