Chemo Drug Shortages Put Patients at Risk of Death
A new survey finds medical facilities are increasingly experiencing shortages of oncology drugs, posing health risks to patients, slowing down critical treatments and medical research, and impacting the cost of care.
By Jessica Firger
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FRIDAY, March 29, 2013 —For most cancer patients, undergoing chemotherapy treatments comes with tremendous anxiety, but a new report finds that hospitals providing the treatments are increasingly facing an anxiety all their own: a potential shortage of the drugs they need to save lives.
The report, released by the Hematology/Oncology Pharmacy Association (HOPA), found hospitals and treatment centers are experiencing shortages of standard and critical oncology drugs because pharmaceutical companies and suppliers are running low on inventory and failing to keep up with production. A chemo drug shortage can dramatically alter the course of a patient's treatment.
"We're fearful that by delaying therapy or changing to a different regimen of drugs, we may not be able to produce the same benefit for long-term effect," said Lisa Holle, PharmD, assistant clinical professor at the University of Connecticut's School of Pharmacy, immediate past president of HOPA, and a co-author on the paper, just published in the American Journal of Health-System Pharmacy.
According to the Food and Drug Administration, the number of drug shortages has tripled over the last six years. In 2005, there were only 61 reported shortages, but that number jumped to 178 in 2010, and 251 in 2011.
Among the HOPA report's 243 respondents — mostly pharmacists from academic medical centers and community hospitals — 98 percent said they ran low on an oncology drug in 2011, and that limited supplies significantly slowed necessary treatments for their patients. Around 34 percent of respondents said at least 1,000 hours of staff time were spent troubleshooting the problem. The researchers found the most difficult drugs to obtain were ones used to treat the most common types of cancer, including breast, lung, ovarian, and colorectal cancers. Liposomal doxorubicin, fluorouracil, leucovorin, paclitaxel were the cancer drugs that topped the respondents' lists.
Additionally, 85 percent of respondents saw an overall increase in drug costs, which they attributed to shortages and scrambling to find a particular drug from another supplier that charged more, or buying brand name drugs, which according to the report can cost three to four times more for a patient, as a substitute for unavailable generics,
This growing problem also directly impacts progress in cancer research since a drug shortage can slow the development of new treatments. "Maybe the study needs to be halted because there isn't an alternative," Holle said. "That can result in causing a clinical trial to close early or take a longer time to complete."
Risk of Death for Cancer Patients
A chemotherapy drug shortage can also potentially put cancer patients in danger of relapse and possibly death. Holle pointed to a recent analysis from doctors at St. Jude's National Children's Research Hospital, published in the New England Journal of Medicine last year. The study found pediatric and teenage non-Hodgkin's lymphoma patients were more likely to experience relapse when they were given the chemotherapy drug cyclophosphamide instead of mechlorethamine, which is the standard treatment for the disease. The two-year survival rate among patients given cyclophosphamide was 75 percent, versus 88 percent among patients who received mechlorethamine.
Holle said the shortage has forced some patients to make difficult decisions, such as whether to use an alternate drug, delay treatment, or seek treatment at a different medical facility. "It's important to advocate for yourself," she said. "The patient should really have a good conversation with their health care team to figure out the best alternative for the situation."
In recent years, FDA has looked for ways to manage this growing problem. In 2012, Congress passed Title X of the Food and Drug Administration Safety and Innovations Act, which outlines reporting guidelines for manufacturers. Before the bill was signed, a manufacturer's responsibility to report drug shortages to the FDA was voluntary, but now reporting is mandatory. However, the law has not completely solved the problem, because FDA does not have control over a pharmaceutical company's production volume or whether they continue to make a specific drug when supplies run low.
Holle believes the FDA must take more action to solve the problem. Her organization has advocated for collaborative efforts among FDA, health care providers, patient advocacy groups, and the drug manufacturers themselves. HOPA has recommended the FDA consider giving financial incentives to manufacturers to generate larger quantities of these drugs, provide sufficient reimbursement for use of brand name drugs when generics are unavailable, and find alternate treatments that are proven to be clinically effective.
But until sufficient action is taken, hospitals frequently have to fend for themselves. Stan Gerson, MD, director of University Hospitals Seidman Cancer Center in Westlake, Ohio, said in the past his hospital has turned to outside facilities for help. "We have had to finagle and scrounge to find drugs that happen to be on the shelves of other hospitals and pharmacies," he said. "Some of these drugs are single-sourced or have unique properties, or are not commonly used."
Dale Adams, PharmD, senior vice president of hospital operations and chief pharmacy officer at City of Hope, a cancer treatment facility in Duarte, Calif., said he's noticed the problem has worsened over the last five to eight years. He said sometimes his hospital's pharmacy is forced to dilute a drug dose or add a drug to another IV bag. This can lead to under- or overdosing and drug errors. "Every day we're made aware of something that might not be available for a definite period of time," he said. "You have to retool, reeducate, and also make sure your medical staff is aware of these changes.
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