Drug Shortage Shocker

by Don Jewler, Director of Communications, ACCC

This week the national press highlighted a growing problem facing the oncology community: the ability of cancer patients to access many cancer drugs, including cytarabine, cisplatin, leucovorin, and etoposide. The Washington Post, the Los Angeles Times, and even the Reading Eagle in Reading, Pa., and “NewsNet5″ in Akron, Ohio, raised the alarm that manufacturing stoppages are limiting the availability of certain cancer therapies that are critical to providing quality care.

Last year, more than 240 drugs were either in short supply or completely unavailable anywhere in the U.S., and shortages continue for many of the products, according to a report issued at the end of March by the Premier Health Care Improvement Alliance based in Charlotte. And nationwide, reports of new shortages this year are arriving at more than one a day.

“We’re not talking about obscure medications or orphan drugs, which are those used to treat rare conditions. These are drugs used every day in operating rooms, by emergency crews and in cancer centers,” wrote Michael Hiltzik, of the Los Angeles Times on April 19. “They include such widely used medications as leucovorin, a component of the gold standard for the treatment of colorectal cancer.”

“Never in my 30 years of treating patients with leukemia has such a drug shortage occurred, resulting in inadequate therapeutic options for patients,” wrote Hagop M. Kantarjian, MD, in The Washington Post, April 18. Kantarjian is chairman of the department of leukemia at the University of Texas’s MD Anderson Cancer Center. “With cytarabine combination chemotherapy, the cure rate in AML is 40 percent to 50 percent. Without cytarabine, there is no cure.”

“At Akron Children’s Hospital, there is concern a drug shortage will prevent doctors from treating children suffering from cancer,” wrote Lee Bowman, Scripps Howard News Service. “Shari Meglich’s 2-year-old daughter, Payton, has acute myeloid leukemia. The Akron toddler has been through five rounds of chemotheraphy. She has one more treatment scheduled for late April. The chemo drug, Cytarabine, is critical to her treatment, but it’s in desperate, short supply.”

What’s going on?

Valerie Jensen, associate director of the Food and Drug Administration’s drug shortages program, says it’s not clear why the shortages are getting worse. “We really don’t know the reason, but it is a concerning trend,” she said in Kantarjian’s article. Asked whether financial considerations play a role in the shortages, Jensen said, “The older drugs are often not cost-effective for companies to make. Often we see products like [cytarabine] get discontinued. . . . We cannot require a company to manufacture a product.”

The good news is that FDA is working with the companies to make cytarabine widely available again and also examining the possibility of allowing temporary importation of the drug from foreign sources. It’s interesting to note that no shortages of cytarabine have been reported in other countries.

What else can be done?

In order to prevent unnecessary drug shortages, the Association of Community Cancer Centers (ACCC) believes manufacturers should play an increased role in preventing and reporting discontinuances in production.

ACCC supports efforts to pass the “Preserving Access to Life-Saving Medications Act,” S. 296 recently introduced by Senator Amy Klobuchar (D-MN) and Robert Casey (D-PA). This bill shifts shortage reporting responsibility from providers to manufacturers; requires all manufacturers to report upcoming drug shortages to the FDA; increases manufacturer accountability by requiring them to anticipate and notify of future manufacturing stoppages, but does not impose fines or other sanctions for reporting; and allows providers to better anticipate impending shortages so both providers and patients can prepare for alterations in treatment regimens.

It’s a good first step.

(To voice your support for bill S.296, click here. Visit ACCC’s Legislative Action Center, Issues and Legislation. We’ll help you craft a letter to Congress.)