Shortages of cancer drugs are putting patients at risk

Several cancer treatments have been in short supply since March, and these shortages have only worsened over the last few months, leading more patients to face delays in care.

According to a recent survey of 27 major cancer centers from the National Comprehensive Cancer Network (NCCN), 93% reported a shortage of carboplatin, and over a third of these organizations said they were unable to treat all patients with the intended dose and schedule due to the shortage.

Similarly, 70% of the cancer centers surveyed reported shortages of cisplatin, but so far, the organizations have been able to maintain cisplatin treatments for existing patients.

"This is an unacceptable situation," said NCCN CEO Dr. Robert Carlson. "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."

Dr. Kari Wisinski, a breast cancer specialist at the UW Health Carbone Cancer Center, said she's had to either switch some of her patients to other treatments or switch the order in which they receive certain treatments due to the shortages.

"It's really difficult as a physician to have these conversations with a family or a patient about not having a medication you'd like to prescribe to them," Wisinski said.

According to Amanda Fader, a professor at the Johns Hopkins School of Medicine and president-elect of the Society of Gynecologic Oncology, these shortages constitute "a public health emergency because of the breadth of the individuals it affects and the number of chemotherapy agents that are in shortage right now."

Efforts to address these shortages are ongoing

To address the ongoing shortage of cisplatin, FDA is working with Qilu Pharmaceuticals and Apotex to temporarily import some foreign-approved versions of the drugs from factories that are registered with the agency.

FDA is also allowing Intas Pharmaceuticals to resume shipping cisplatin, carboplatin, and 14 other injectable drugs after it halted production in March due to a "cascade of failures" in quality control at one of its facilities. To ensure the safety and quality of the imported products, the company will have to complete a review and test from a third party.

Aside from these adjustments, the federal government and lawmakers are also looking for long-term solutions. In May, the Biden administration assembled a team to evaluate the impact of "developing tools that could foresee potential drug shortages before they start, creating quality scores for manufacturing facilities, increasing the FDA's unannounced inspections, robust testing of imported products, and requiring foreign manufacturers to keep electronic records instead of paper ones, since those can be destroyed."

In addition, a bipartisan group of 70 House lawmakers also sent a letter to FDA Commissioner Robert Califf and HHS Secretary Xavier Becerra asking how to improve oversight and enforcement of the country's pharmaceutical supply chains to avoid future drug shortages.

"Patients, physicians, and pharmacists are often the last to know when an essential drug will no longer be available, yet, are affected by these shortages the most," the lawmakers wrote. "We strive to ensure patients, physicians, and pharmacists never have to experience shortages of essential medications, but when shortages do occur it is vital that these individuals are made aware as quickly as possible so that they can better prepare." (Murphy, Associated Press, 6/7; Choi, The Hill, 6/10; Becker, Fierce Pharma, 6/8; Howard, CNN, 6/7)

The COVID-19 pandemic revealed the vulnerability and inflexibility of the health care supply chain. Now, leaders face the challenge of rebuilding the supply chain in such a sustainable way that it will not “break” during the next crisis – but without adding unnecessary cost into the system. Explore our toolkit with insight on the future healthcare supply chain, including case studies from high-performing providers and suppliers.