The Chemotherapy Drug Shortage: An Unprecedented Crisis

The ongoing chemotherapy drug shortage is a critical situation impacting cancer care in the US.

According to a recent survey from the National Comprehensive Cancer Network (NCCN), over 90 percent of the country’s largest cancer centers reported being directly affected by the shortage, with 93 percent experiencing a scarcity of carboplatin and 70 percent reporting a shortage of cisplatin.

The two drugs are often used in combination to treat many types of cancer, including lung, breast and prostate cancers, as well as many leukemias and lymphomas​​.

The shortage began about four months ago but hit a critical stage in the last four weeks, according to the NCCN.

The crisis is particularly concerning given that cisplatin and similar platinum-based drugs are prescribed for an estimated ten to 20 percent of all cancer patients, according to the National Cancer Institute (NCI)​​.

This shortage has created a significant burden on medical facilities, resulting in doctors scrambling to find suitable alternatives for treating their patients. This means patients are being given alternate drugs that could have more severe side effects, or instead of a combination, they may be only given one drug that is available.

Concerningly, the survey also revealed that only 40 percent of the surveyed NCCN cancer centers received any indication from manufacturers or suppliers about when carboplatin or cisplatin would be readily available again.

The good news though is that 100 percent of the centers are still able to treat patients who need cisplatin without any delays or claim denials, according to the survey. Unfortunately, the same isn’t the case for carboplatin, as only 64 percent of centers have been able to keep all current carboplatin patients on the regimen.

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In a press release from the NCCN addressing the chemo shortage, NCCN’s chief executive officer Robert W. Carlson said, “This is an unacceptable situation. We are hearing from oncologists and pharmacists across the country who have to scramble to find appropriate alternatives for treating their patients with cancer right now.”

“We were relieved by survey results that show patients are still able to get life-saving care, but it comes at a burden to our overtaxed medical facilities. We need to work together to improve the current situation and prevent it from happening again in the future.”

Alyssa Schatz, senior director of policy and advocacy for the NCCN, said the results of the survey “demonstrate the widespread impact of the chemotherapy shortage.” She added that, “We hope that by sharing this survey and calling for united action across the oncology community, we can come together to prevent future drug shortages and ensure quality, effective, equitable and accessible cancer care for all.”

Meanwhile in Canada, there are currently shortages of two cancer drugs — thyrotropin alfa, which is used to treat thyroid cancer, and asparaginase, which is used to treat acute lymphoblastic leukemia (ALL). Supplies of carboplatin and cisplatin remain available in Canada because the country has multiple suppliers.

There are currently no shortages of cancer drugs in Europe or other countries; however, last year, Germany was experiencing a critical shortage of the breast cancer drug tamoxifen. Medicines for Europe said the supply issues were evidence of the damaging effects of European cost-containment measures. They argued for an urgent revision of unsustainable pricing and tendering policies, which they suggested contributed to the shortage.

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What is Causing the Chemotherapy Drug Shortage?

The chemotherapy drug shortage highlights vulnerabilities in the US drug supply chain, which often relies on only a handful of manufacturers to produce the most in-demand products.

The production of cisplatin and carboplatin, which are used for breast, ovarian and colorectal cancers, is particularly affected by this fragility. These drugs are often generics and hence have a low unit price, making them less appealing to manufacturers. About 90 percent of all prescription drugs in the US are in fact generics.

The situation becomes problematic when a single plant shutdown or quality problem causes a substantial ripple effect​​.

The carboplatin and cisplatin shortage partly stems from a quality issue that occurred earlier this year at a factory in India that produces both cisplatin and carboplatin. Production of the drugs was halted after an inspection flagged quality concerns​​.

The Role of Policymakers

In a statement addressing the ongoing chemotherapy drug shortage, the NCCN has called on the federal government, pharmaceutical industry, providers and payers to “each do their part in preventing and mitigating the impacts of anti-cancer drug shortages.”

It said, the “causes and solutions to the recurrent anti-cancer drug shortages that deprive oncology patients of optimal therapy are multiple and fixable.”

The ongoing shortage is also a topic of debate in Congress about the possible expansion of the US Food and Drug Administration’s (FDA) authority. Lawmakers are discussing whether the FDA should have the power to order manufacturers to report significant increases in demand that could trigger a shortage and even require the stockpiling of critical drugs. Lawmakers are divided on the issue, debating whether the FDA should have this kind of increased authority to regulate the drug supply chain​​.

The FDA recently announced it is working with foreign companies to increase the US supply of cisplatin. This includes China-based Qilu Pharmaceutical to import cisplatin, and Canadian pharmaceutical company Apotex to distribute the drug.

Looking Ahead

The current shortage underscores the need for a resilient and safe drug supply chain. While the FDA cannot directly influence many of the business decisions related to the drug supply chain, it has encouraged the adoption of advanced manufacturing technologies and improve quality management practices to address these challenges​​.

As the population ages and more go-to treatments lose patent protection, there’s a risk that the problem could escalate if fundamental changes to the system aren’t made.

The current shortage demonstrates how profits in the generic drug market can send shocks through the supply chain, creating a ripple effect that impacts the healthcare system and patients relying on these lifesaving treatments​​.