Carey Fitzmaurice has faced many challenges since she was diagnosed in March 2006 with stage IIIc ovarian cancer: First, her cancer returned a year after she completed six months of treatment. Then, in April 2008, she had a mastectomy after she was diagnosed with stage IIb breast cancer. But the last thing the Bethesda, Md., resident probably expected was that in 2011 a national drug shortage would make it impossible for her to get Doxil (doxorubicin liposome), the key part of a chemotherapy regimen that had been keeping her ovarian cancer under control for the previous four months.
The results of an American Society of Clinical Oncology (ASCO) members’ survey presented at the ASCO annual meeting earlier this year suggest that Fitzmaurice is far from alone. The study, conducted by a research team at the University of Pennsylvania in Philadelphia, found that 83 percent of 214 oncologists and hematologists who completed the questionnaire had experienced a drug shortage from March 2012 through March 2013 that prevented them from prescribing the best chemotherapy regimen for some patients.
Since 2006, it’s been difficult to obtain about 25 common cancer drugs, says Richard Schilsky, ASCO’s chief medical officer. The survey found that the worst shortages were among the generic versions of the chemotherapy drugs fluorouracil, bleomycin, cytarabine, doxorubicin liposome and leucovorin, which are used to treat a range of cancers.
You Don't Have My Medication?
Experts offer this advice to cancer patients who find out that a prescribed drug may be unavailable:
- Work with your doctor to explore other treatment options.
- Seek help from organizations such as the Patient Advocate Foundation.
- Avoid purchasing medications over the internet from companies outside the U.S., as these drugs might be counterfeit.
“Most of the shortages that we’ve had have been due to quality issues,” says Valerie Jensen, the associate director of the drug shortages program at the U.S. Food and Drug Administration (FDA). This has included glass or metal shards finding their way into drugs and unsterile manufacturing conditions. Limited raw materials and companies discontinuing older drugs have also affected supplies.
The survey found that doctors have coped with the shortages at times by having patients start treatment with different drugs or switch drugs mid-treatment, by delaying treatment, or by having the patient reduce or skip dosages. The shortages have also taken a toll on clinical research. Some doctors surveyed reported an inability to enroll or keep patients in a trial or get them their drugs on time.
In October 2011, an executive order required the FDA to rev up its efforts to get drug makers to warn the agency about potential shortages. As a result of this improved communication, Jensen says, “we’ve become more successful about preventing shortages before they start.” In July 2012, the Safety and Innovation Act became law, giving the FDA more resources to address drug shortages by allowing it to, among other things, increase industry fees to help speed up generic drug application reviews and expedite reviews and inspections as needed to avoid shortages.
Fitzmaurice, now 45, was able to go back on doxorubicin liposome in June 2012, four months after the FDA authorized a temporary importation of a generic version, called Lipodox, made in India by Sun Pharma Global. Lipodox received final approval earlier this year. Today, her cancer is still under control. But she continues to worry about drug shortages. “The last thing that a cancer patient needs to hear,” Fitzmaurice says, is a doctor saying, “ ‘There’s a cancer drug that works for you, but we can’t get it.’ ”
October 17, 2013