A national survey of health professionals showed that drug shortages are taking a heavy toll on cancer patients. The results characterize oncology drug shortages across the United States and the impact of shortages on clinical practice, patient safety, clinical trials, and health care costs. The researchers conclude that shortages may force treatment changes and delays that, for some patients, may meant worse outcomes, more therapy-related complications and higher costs. investigators played an important role in the study.

The survey, conducted, in part, by investigators from St. Jude Children’s Research Hospital, internationally recognized for its pioneeringresearchand treatment of children with cancer and other life-threatening diseases,queried oncology pharmacists and others involved in managing cancer drug shortages for academic medical centers, community hospitals and other cancer treatment facilities nationwide.

The 34-item online survey was distributed to 1,672 members of the Hematology/Oncology Pharmacy Association and other organizations to gather information on shortages of drugs essential in the care of cancer patients. This included agents for supportive care.

Of the 243 individuals who completed the survey, 98% reported having dealt with a shortage of at least one chemotherapy agent or other essential cancer-related drug in the previous 12 months. Among the participants, 93% reported that shortages forced delays in chemotherapy administration or other changes in cancer drug therapy.

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Disrupting clinical trials
Researchers found the shortages also disrupted cancer research and added to the cost and risks associated with cancer treatment. One institution linked a patient’s death to a shortage-related medication mistake. Overall, 16% of respondents tied shortages to adverse patient outcomes, including disease progression or more treatment-related complications.

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The survey is the first to focus specifically on the impact of cancer-related drug shortages. It was conducted by the Hematology/Oncology Pharmacy Association and focused on a 12-month period ending inOctober 2011. The results appear in theApril 1, 2013edition of theAmerican Journal of Health-System Pharmacy.

Risk to cancer patients
“This survey documents the risk that drug shortages pose to cancer patients of all ages,” said the study’s senior author,James Hoffman, Pharm.D., an associate member of the St. Jude Department of Pharmaceutical Sciences and the hospital’s medication outcomes and safety officer. “To cure cancer patients we must often use complex treatment regimens, and shortages add unnecessary complexity. Unlike medications for other diseases, there are few, if any, therapeutically equivalent alternatives available for many oncology drugs in short supply.

Highest number of drugs
“Drug supplies remain unpredictable and serious problems persist,” Hoffman said. In February, theUniversity of UtahDrug Information Service was tracking national and regional shortages of more than 320 drugs, which is the highest number since 2010.TheUniversity of UtahDrug Information Service tracks drug shortages and provides advice about managing shortages through the American Society of Health-System Pharmacists.

Previous study
The survey follows an earlier St. Jude-led study that linked a shortage of the chemotherapy drug mechlorethamine to a greater risk of relapse for some young Hodgkin lymphoma patients. Relapse meant those patients underwent additional intensive therapy that left them at greater risk for infertility and other treatment-related health problems later.

Multiple factors contribute to drug shortages, including manufacturing and quality problems, production delaysand discontinuations. Earlier studies have shown that most shortages occur in the supply chain of generic injectable drugs, particularly medications to combat cancer and infections. In 2012, new federal legislation gave the U.S. Food and Drug Administration (FDA) additional tools to prevent and ease drug shortages, including requiring manufacturers to report anticipated supply problems of key medications. “While the FDA and others have worked diligently to address the problem, additional action is needed to address continuing shortages,” Hoffman said.

Increasing costs
The survey found shortages increase health care costs as scarcity drives up the price and requires staff time to manage the problem. About one-third of institutions in this survey reported pharmacy staff spent at least 20 hours each week working on issues related to the drug shortage. That included time spent trying to find scarce medications to purchase or identify alternatives. Eighty-five percent of respondents reported shortages led to higher medical costs.

Drug shortages also disrupted the clinical trials that are essential for developing new cancer treatments. This survey found that shortages forced 44% of institutions to either halt or delay enrollment in clinical trials. The problem also led some providers to change or omit medications.

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In this survey, the drugs most frequently reported as being in short supply were fluorouracil, leucovorin, liposomal doxorubicin and paclitaxel. Such shortages hit patients battling ovarian, breast and colorectal cancers particularly hard. For some patients, the survey found shortages meant traveling to other institutions for treatment or receiving alternative medications. For other patients, it meant treatment was delayed or continued with either lower doses of the missing drugs or without the drugs at all.

Ali McBride, Pharm.D., TheOhio State University, is the first and corresponding author. Other authors areLisa Holle,University of Connecticut;Colleen Westendorf, formerly ofUniversity of Kentuckyand now of St. Jude;Margaret SidebottomandNiesha Griffith,Ohio State; andRaymond Muller, Memorial Sloan-Kettering Cancer Center,New York.

The study was funded in part by a grant (CA21765) from the National Institutes of Health and ALSAC.

For more information:
– McBride A, Holle LM, Westendorf C, Sidebottom M, Griffith N, Muller RJ, Hoffman JM. National survey on the effect of oncology drug shortages on cancer care. American Journal of Health-System Pharmacy April 1, 2013 vol. 70 no. 7 609-617
– Pam Brammann. Cancer Drug Shortage: There is HelpOnco’Zine, January 12, 2012
– Study Links Higher Rates of Hodgkin Lymphoma Relapse in Pediatric Patients to Cancer Drug Shortage. Onco’Zine, December 26, 2012

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