Cancer centers are battling shortages of key chemotherapy drugs, with potentially disastrous consequences once shortages begin to affect patients.
new investigation A report released this week by the National Comprehensive Cancer Network (NCCN) found that 93% of cancer centers report carboplatin deficiencies and 70% report cisplatin deficiencies. These two drugs are commonly used together to treat various cancers, including breast, lung, prostate, and many types of leukemia, often with curative intent.
A survey conducted in May found that while cancer centers are still able to treat patients with cisplatin without delay or denial of claims, only 64% of centers are able to keep patients on carboplatin. It turns out there is. One-fifth of cancer centers said they were able to continue prescribing carboplatin for some but not all patients.
According to Mike Ganio, director of pharmacy practices and quality at the American Society of Health System Pharmacists (ASHP), the United States “is experiencing a serious ongoing shortage that is at its highest level in nearly a decade.”
Much of the current shortage is due to the fact that an Indian facility run by Intus Pharmaceuticals restarted production in March after the Food and Drug Administration (FDA) discovered a “series of failures” in the factory’s quality control. This is attributed to the large-scale production disruption that occurred during the shutdown. .
FDA import alert It told the facility that all future shipments from the facility would be denied entry into the United States, except for 24 drugs that are in short supply, including carboplatin and cisplatin.
“These are important oncology drugs,” said Alyssa Schatz, NCCN’s senior director of policy and advocacy.
“I think the good news is that there are often safer alternatives, but the NCCN is asking payers how those medications will be covered, with or without prior authorization. We are concerned that the lack of guidance and clarification of this could cause detrimental delays in treatment,” she said. she said.
Schatz said when cancer treatments were interrupted by the pandemic, insurers responded by offering flexibility with telemedicine and publishing guidance on coverage for the mailable equivalent of oral chemotherapy. pointed out.
To help with the current chemotherapy shortage, insurance companies need to do the same and provide clear guidance on waiving pre-approval for chemotherapy alternatives, he said.
Shortages of these critical medicines have recently resulted in Democratic Senators Dick Durbin (Illinois), Senators Debbie Stavenau (Michigan), Rep. Gary Peters (Michigan), and Rep. Elissa Slotkin (Michigan). States) have attracted the attention of Congress. to call He called on the FDA to take immediate action, including importing chemotherapy and alternative therapies from other countries.
FDA Commissioner Robert Calif seemed to heed these calls. announced Last week, his agency announced it would allow “temporary importation of certain foreign-approved versions of cisplatin products from FDA-registered facilities.”
The FDA is working with China’s Qilu Pharmaceuticals and Canadian pharmaceutical company Apotex to distribute it to increase the availability of cisplatin.
While these short-term solutions may improve the situation for the time being, officials warn that drug shortages are an ever-growing problem that needs to be addressed at a systemic level.
In a roundabout way, Schatz pointed to low-cost generic drugs as one factor contributing to drug shortages.
“Paradoxically, low drug prices are a major driver of this shortage. We hear a lot about how the US overpays for medicines, but the story is mostly about branded medicines. ‘, said Schatz. “Generic drug manufacturers operate on very thin margins, which can lead to quality and supply issues.”
These margins put pressure on manufacturers to operate near capacity, reducing the number of manufacturers in the market and making the market vulnerable in the event of a crisis.
“We’re talking about low-margin stuff. So there’s little incentive to invest in equipment, and little incentive for manufacturers to get into making those products,” ASHP’s Ganio said. Stated.
Healthcare organizations continue to push Congress to move forward policy This will encourage manufacturers to invest in the production of critical medicines for cancer and other diseases, improve the functioning of the National Strategic Stockpile and facilitate enhanced manufacturing quality.
To that end, Rep. Buddy Carter (R-Georgia) and Rep. Lisa Blount Rochester (D-Delaware) reintroduced the Essential Drugs Strategic Stockpile Act earlier this year. The bill would direct federal agencies to develop a stockpile of 50 generic drugs at risk of shortage to supply American patients for six months.
While the bill won’t address the root causes of shortages, it will bring drugs to market while addressing supply chain disruptions, experts told The Hill.
and letter A bipartisan group of 70 members of the House of Representatives on Thursday told the Caliph and Health and Human Services Secretary Xavier Becerra about how the federal government can improve oversight and enforcement of the drug supply chain in light of chemotherapy shortages. asked someone.
“Patients, physicians and pharmacists are most affected by these shortages, even though they are often the last to know when essential medicines will become unavailable,” the researchers wrote.
“We strive to ensure that our patients, physicians and pharmacists never experience shortages of essential medicines, but when shortages do occur, we need to let these people know as soon as possible so they can be better prepared. It is important.”
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