Supplies of four cancer drugs are currently limited, and it could be months before manufacturers are able fill back orders. Amid these shortages, hospitals are concerned about how patients will be impacted, particularly if they have to use less effective treatments or lower doses than recommended.
Currently, at least four cancer drugs are in short supply, and some manufacturers don't believe supplies will recover for months, Becker's Hospital Review reports.
According to the National Cancer Institute, methotrexate is used to treat acute lymphoblastic leukemia, breast cancer, lung cancer, and certain types of head and neck cancer. It comes in both oral and injectable forms.
So far, the American Society of Health-System Pharmacists (ASHP) has reported that 11 products are on back order, with some unavailable for months now, and one product is available. Although some manufacturers have said the drug is on back order due to manufacturing delays, others have not provided a reason.
Currently, manufacturers estimate that supplies will be restored between March and early June.
Cisplatin is labeled for the treatment of bladder cancer, but it can also be used off-label to treat "squamous cell head and neck cancer, cervical cancer, lung cancer, osteosarcoma, esophageal cancer, adrenal cortex carcinoma, breast cancer, endometrial cancer and liver cancer," ASHP said.
It has been in short supply since March 6 amid manufacturing delays and increased demand. However, manufacturers recently reported a restock of the drug.
5FU is an injectable drug that is typically used with newer chemotherapy drugs and is used to treat colon, breast, pancreas, and stomach cancers. There are currently no available products, and resupply dates range between March and June.
Pluvicto, which is manufactured by Novartis, is used to treat advanced prostate cancer. FDA initially reported the shortage on March 7 and said the drug will likely be unavailable for the next four months.
"There are challenges in meeting demand, and no therapeutic equivalents are available," FDA said.
Currently, Pluvicto is only manufactured in small batches in Italy. Although Novartis is working to increase production at two new U.S. plants, these sites need to be approved by FDA, which will take between four and six months.
With the supply shortage, the company said it will prioritize doses of the drug for patients who are currently undergoing treatment.
"We are operating our production site at full capacity to treat as many patients as possible, as quickly as possible," Novartis said. "However, with a nuclear medicine like Pluvicto, there is no back-up supply that we can draw from when we experience a delay."
So far, cancer centers and hospitals have been able to make do with their current supplies of methotrexate, cisplatin, and fluorouracil, but officials have expressed concerns about the lack of definite resupply dates.
"At the end of the day, the supply is what the manufacturer has," said Emily Pherson, assistant director of medication use policy and clinical informatics at Johns Hopkins Hospital. "And the fact that we're at the point where we're getting it directly means that there could be a risk the supply runs out and that we would have to look towards alternative strategies."
"Like so many hospitals, we face these types of considerations," said Yoram Unguru, a pediatric hematologist and oncologist at Children's Hospital at Sinai in Baltimore. And while he said he was hopeful the hospital would be able to continue buying the drugs it needs, the shortages have resulted in "time diverted from other important hospital tasks, which increases risk that care will be affected and, of course, sizable financial cost."
Patients are also expected to be negatively impacted by the supply shortages, with some unable to access the treatments they need.
"People will die from this [Pluvicto] shortage, for sure" since new patients won't be able to start the treatment right away, said Jonathan McConathy, director of the division of molecular imaging and therapeutics at the University of Alabama at Birmingham.
"Patients may have already exhausted other treatment options and have few remaining choices," said David Margraf, a pharmaceutical research scientist at the Resilient Drug Supply Project, which is part of the University of Minnesota's Center for Infectious Disease Research and Policy. "Oncology drug shortages reduce the expected survival times of patients, which leaves them less time to spend with their loved ones. It's truly a tragedy." (Van Beusekom, CIDRAP News, 3/16; Twenter, Becker's Hospital Review, 3/17; Howard, CBS News, 3/16)
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