A new survey of US cancer centers shows that many continue to face drug shortages, impacting clinical trials and often requiring mitigation strategies to treat patients.
CNN —
While a shortage of the chemotherapy drugs cisplatin and carboplatin has improved in the United States, some of the nation’s largest cancer centers now report additional concerns related to drug shortages, a new report finds.
Among 28 large cancer centers across the country, 89% reported last month that at least one drug used to either treat cancer, its symptoms or the side effects of treatment was in short supply at their center, according to new survey results released Wednesday by the National Comprehensive Cancer Network.
That percentage has not changed much from last year, when about 86% of surveyed centers reported a shortage of at least one type of anti-cancer drug. But what has changed is specifically which cancer drugs are impacted.
The new NCCN survey, conducted from May 28 to June 11 of this year, found that among 28 of the network’s 33 cancer centers, more than half — 57% — reported a short supply of the chemotherapy drug vinblastine, which is often used in combination with other chemotherapy drugs to treat Hodgkin’s lymphoma, non-Hodgkin’s lymphoma, and cancer of the testicl*s.
The centers that participated in the survey also reported that several other key cancer medications are currently in short supply, with 46% reporting a shortage of the chemotherapy drug etoposide and 43% reporting a shortage of the chemotherapy drug topotecan.
Dr. Crystal Denlinger, chief executive officer of the NCCN, said in an email that she was not surprised by the new survey results.
“Sadly, as a practicing oncologist, I am well aware of and understand the challenges facing my patients and colleagues regarding oncology drug shortages, which have been going on for years. On the bright side, we have seen a new enthusiasm for both short- and long-term solutions since last year’s survey came out. Our new survey shows the short-term solutions were fairly effective at meeting immediate needs,” Denlinger said.
However, long-term solutions are still needed, she said.
“The current presidential administration and Congress have put forth various proposals. However, people with cancer don’t always have the luxury of time. Given the results of this most recent survey, it is imperative to keep this issue top of mind as this is an urgent issue that requires sustained attention and solutions.”
Last year, 21% of surveyed centers reported a shortage of vinblastine, and etoposide and topotecan were not mentioned by name in the previous survey.
But in that previous survey, 72% of centers reported ashortage of the chemotherapy medication carboplatin, and 59% reported ashortage of cisplatin. Carboplatin and cisplatin areused in combination to treat many types of cancer. Cisplatinand other similar platinum-based drugs are prescribed for an estimated 10% to 20% of all cancer patients,according to theNational Cancer Institute.
The new survey results suggest that the shortage of carboplatin and cisplatin has improved, as only 11% of surveyed centers reported a short supply of carboplatin and 7% reported a shortage of cisplatin.
“Thanks to policymakers, patient advocates, healthcare professionals and health systems who went to extraordinary efforts to collaborate and mitigate harm, the shortages for carboplatin and cisplatin are mostly resolved at this time,” Denlinger said.
‘A significant and ongoing problem’
The new survey also indicated that the current shortage of cancer drugs has not significantly disrupted patient care or clinical trials. But additional administrative work has been needed to ensure these things are not disrupted, according to NCCN.
Among the centers reporting drug shortages, more than half – 56% – indicated that their center still was able to treat patients who were receiving those medications by enacting “mitigation strategies,” such as limiting the use of medications that were in stock, adjusting doses, and implementing waste management strategies. Meanwhile, 37% of the centers with shortages reported still treating patients without mitigation strategies.
But among the surveyed centers that reported drug shortages, 43% indicated that the shortages have impacted clinical trials at their center, leading to greater administrative burdens, reductions in trial enrollments, reductions in open trials, and budget changes, among other disruptions.
It’s not just the large cancer centers that are part of the National Comprehensive Cancer Network that are experiencing these drug shortages.
Dr. Carolyn Hendricks, an American Society of Clinical Oncology (ASCO) board member, who was not involved in the NCCN report, said that smaller community cancer centers also are experiencing short supplies of critical cancer medications.
“I’m in a community oncology practice. We in the community are experiencing the same types of shortages that the NCCN cancer centers are experiencing, and this survey data, which is an update of some prior surveys, really speaks to the fact that this is really a significant and ongoing problem, both in the cancer center environment and also in the community,” Hendricks said.
In Hendricks’ practice in Maryland, she said that the center is currently experiencing a significant shortage of the chemotherapy drug etoposide, which was named in the new NCCN report. She added that the center received an alert Tuesday about the shortage.
“It’s more used for thoracic oncology, lung cancer – and the drugs that are incorporated in the lung cancer regimens are very important – and some testicular cancers and some other types of solid tumors,” Hendricks said about etoposide.
“Cancer care is complicated, but the vast majority of all cancer patients are treated with combination regimens, and so therefore it’s critical that if one drug is in shortage, it becomes a challenge to administer the entire regimen to the patient and to afford either the highest chance of cure or the best quality of life in patients who have advanced disease,” she said.
In February, the chief medical officer and executive vice president of ASCO, Dr. Julie Gralow, testified before the US House Committee on Ways & Means about chronic drug shortages in the United States, calling the shortage a crisis.
“Every day we hear from oncologists around the country about the challenges cancer patients and their providers are facing amid some of the worst oncology drug shortages to date,” Gralow said at the time. “This crisis is forcing providers to make impossible choices, including having to decide which patients receive lifesaving and life-prolonging oncology drugs on schedule and in the established doses — and which ones won’t.”
What needs to change
The issue of cancer drug shortages continues to be driven by a combination of supply chain and economics, Dr. William Dahut, chief scientific officer for the American Cancer Society, who was not involved in the new NCCN report, said in an email. He added that he was not surprised by the report’s findings.
“Most older chemotherapy agents, particularly sterile injectable ones are produced in just a few settings, often times overseas. There is very little incentive financially for production. Therefore there is little redundancy and significant vulnerability if there is a manufacturing or supply chain issue,” Dahut said. “The regulatory bodies can help signal the potential for shortages as well as help oversee the manufacturing, but without a change in the economic model shortages are likely to continue.”
Hendricks said that she thinks the way drugs are developed and then maintained in the supply chain are among the factors driving the ongoing drug shortage crisis.
“The problem is the medications that are transitioned from a blockbuster drug into generic status,” Hendricks said.
“In the United States, when new drugs come in development, they’re under patent. They’re usually blockbuster drugs — big in the news, high chance of cure — but mixed in amongst them are drugs that have come off the patent system and are classified as generics. The price goes down, which is good for the patients, but that means the supply chain of these generic medications is so vulnerable. They’re not profitable,” she said. “If we don’t create a way to get pharmaceutical companies to want to make both the phenomenal blockbuster drugs we have and the generics then this problem will be chronic, and we won’t be able to dig our way out or see a clear solution.”
Several generic cancer drug manufacturers have discontinued products over time for economic reasons, according to a White House statement last year. A Senate Finance Committee white paper from this year notes generics make up anywhere between 66-84% of drug shortages.
In the new NCCN report, the surveyed centers called for solutions and noted concerns about how the marketplace currently operates. For instance, when asked what policy solutions they would like to see enacted to address oncology drug shortages, 75% of centers reported “economic incentives to encourage high quality manufacturing of generics” and 64% reported “better information systems” to accredit or rate generics suppliers so hospitals can contract with those using high-quality practices.
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“What we are seeing is a marketplace that was designed in an unsustainable way. Generic medication manufacturers currently operate on very narrow margins, which are continually being squeezed. This may result in de-prioritization of generic drug manufacturing in favor of newer, and more expensive agents that remain on patent. This results in a fragile supply chain for older, but still critical, generic medications that can and does break frequently and recovers slowly,” Denlinger said about the ongoing shortage.
“It has also led to fewer companies in the generic market and demands extreme efficiency from those companies still in the market. When a supply issue occurs, it is difficult to ramp up additional capacity in the system. We need to invest in economic incentives for the generic drug market — which is distinctly different from the brand name drug market — to encourage the stable manufacturing of quality generic drugs,” she said. “We also need better systems to communicate information about impending shortages and other supply concerns with health care systems and providers so that health care providers can prepare in advance for anticipated shortages before it becomes a crisis.”
