Implications of the Shortage of Chemotherapy Drugs on Patient Care

Over 90% of top cancer centers in the US are facing a shortage of chemotherapy drugs, according to a recent survey by the National Comprehensive Cancer Network (NCCN). The majority (93%) of cancer centers reported a shortage of the chemotherapy medication carboplatin, while 70% experienced a shortage of cisplatin. Both drugs are central to the treatment of many types of cancer and cisplatin is one of the most powerful chemotherapeutic drugs used in the treatment of ovarian and testicular cancer. The shortages can lead to delays in treatment, “worse patient outcomes, and force patients to switch to suboptimal treatments,” explained Dr Julie R. Gralow, chief medical officer for the American Society of Clinical Oncology.

Cisplatin and Carboplatin are FDA-approved, generic medications commonly used to treat bladder, testicular, ovarian, cervical, endometrial, lung, head and neck, esophageal, gastric, and breast cancers. They are safe, effective, and affordable, Dr. Gralow added. Approximately 500,000 patients could be affected by the current shortages annually. Drug shortages are an ongoing issue with generic medications. There is an alarming number of cancer drugs on the Food and Drug Administration’s shortage list, with the last decade being “significantly worse” for drug shortages.

Several reasons could contribute to drug shortages, such as manufacturing and quality problems, delays, and discontinuation. One manufacturer had to stop production of cisplatin and carboplatin because of safety and quality issues, and there simply wasn’t enough capacity to ramp up production at other plants, said Jeffrey Pilz, assistant director of pharmacy and medication safety and drug policy for The Ohio State University Comprehensive Cancer Center. Even the fact that carboplatin and cisplatin are sterile injections could contribute to the issue because of the many steps involved in manufacturing the drugs.

Healthcare providers are working to make sure patient outcomes are not impacted. One way providers are navigating the shortage is by using alternative medications or different dosing schedules. However, the shortages result in extreme moral distress for both clinicians and patients who understand how patient care would progress with the proper medications. The inability to administer cisplatin and carboplatin could lead to inferior outcomes, including lower survival rates and a greater risk for disease recurrence, according to Dr Yoram Unguru, an oncologist at the Herman & Walter Samuelson Children’s Hospital.

While Dr Robert W. Carlson, chief executive officer for NCCN, is hopeful that the shortage will be back to near-normal by the fall, if not sooner, he cautioned that the shortages could potentially worsen before they get better. “We must find ways to eliminate the problem of drug shortages before the care of more people with cancer is negatively impacted.”

Meanwhile, the longer-term consequences of the shortages remain to be seen. “Some patients may experience a relapse of their disease that could have been avoided were they to receive chemotherapy as originally intended,” Dr. Unguru said.

Another potential issue is that small cell lung cancer, as well as some gynecologic cancers, are very platinum-sensitive, meaning these drugs have a dramatic curative effect on the cancer, said Sanjay Juneja, MD, a triple board-certified hematologist and medical oncologist with Mary Bird Cancer Center, Baton Rouge, Louisiana.

Dr. Juneja explained that other treatment options do not have the same effect on these types of cancer.

Alternatives do not necessarily eliminate the chance of a patient becoming cancer-free, but depending on when they are given, the risk of recurrence with an alternative is likely higher.

“As if having a cancer diagnosis is not hard enough on a patient as well as their loved ones, having this lingering question of ‘what if,’ even if the outcome would have been the same, is particularly tragic,” Dr. Juneja said.

There is one spot of brightness in all of this, though. According to Dr. Gralow, the FDA announced it would begin importing cisplatin, and domestic manufacturers have increased production, which is welcome news, Dr. Gralow said.

But oncologists are still concerned about meeting demand, even with this announcement. In fact, Dr. Unguru said it’s hard to see how the nation’s supply will catch up to the demand anytime soon.

“What is sad is, the person who is the closest point of contact for a patient to overcome this nebulous disease, does not have the slightest knowledge on the inner workings of drug development and delivery,” said Dr. Juneja.

“It makes it particularly hard when being asked this question by understandably desperate family members and patients,” he said. “It makes an already emotionally difficult thing, even more difficult.”

The goal of organizations like the NCCN and ASCO is to not only resolve this problem but make sure it doesn’t happen again in the future.

“We are calling on the federal government to use their influence to spur safe manufacturing of these highly effective generic drugs and to consider strategic stockpiling of key generic drugs in the future,” Dr. Carlson said.

Repairing broken markets and supply chains is crucial, he said, especially since there is limited incentive to manufacture generic drugs. Meanwhile, public and private payers could improve treatment by working with healthcare providers to authorize guideline-concordant alternative therapies in an efficient and streamlined manner.

“[In the meantime], people with cancer can be assured that NCCN and other cancer providers are working for them day and night to eliminate this shortage,” Dr. Carlson said. He recommended patients visit the NCCN website for free resources to help them understand their care plans, including alternate options where applicable.

“Working together, we can find long-term solutions and prevent drug shortages like this in the future,” Dr. Carlson said. “People with cancer should know that their well-being and concerns are of the utmost importance, and they should bring any questions they have to their providers.”