Chemotherapy Drug Shortages Affect Patient Care, Impact Clinical Trials

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CHICAGO—A survey of practicing U.S. oncologists/hematologists found 83% reported a shortage of chemotherapy drugs in the prior 6 months, with 94% stating their patients' care was affected, a study presented at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting concluded.

Shortages of both curative and palliative agents forced the oncologists to modify preferred treatment regimens, results of the self-administered survey revealed, with the majority having “no guidance to aid decision-making” in the face of these shortages, said Keerthi Gogineni, MD, MSHP, of the Abramson Cancer Center, Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, and colleagues.

The number of drugs critical for the treatment of common and curable cancers for which shortages have been reported has grown from 58 in 2004 to 211 in 2010, Dr. Gogineni said. However, reports of the prevalence and consequence of these shortages have largely been anecdotal.

The investigators developed a survey instrument in collaboration with the Center for Survey Research at the University of Massachusetts in Boston, MA. Using ASCO's 2012 membership list, they contacted 500 randomly selected oncologists in the United States. Nonrespondents were contacted by phone and email. A total of 214 surveys were analyzed, for a response rate of 55%.

Survey respondents were 72% male and 65% white; 61% were in community-based private practice and of the 91% in clinical practice, they treated a mean of 72 patients each week. Geographically, 23% were from the West and 25% each from the Northeast, Midwest, and South.

The top 12 drugs and reported shortage for each were leucovorin (66%), liposomal doxorubicin (62%), 5-fluorouracil (19%), bleomycin (17%), cytarabine (16%), doxorubicin (13%), etoposide (13%), mechlorethamine (12%), paclitaxel (12%), methotrexate (11%), daunorubicin (11%), and mitomycin (10%). Dr. Gogineni said only three manufacturers provide 70% of sterile injectable agents.

Of the 176 respondents who adapted to a drug shortage, 78% switched regimens, 77% substituted a drug, 43% delayed treatment, 37% chose among patients, 29% omitted doses, 20% reduced doses, and 17% referred patients out.

Nearly 60% substituted more expensive agents when cheaper generic drugs were in shortage; for example, levoleucovorin for leucovorin (approximately 30-times costlier), capecitabine for 5-fluorouracil (140-times costlier for one cycle of colon cancer treatment), and nab-paclitaxel for paclitaxel. Critical shortages included agents needed for the FOLFOX regimen for colon cancer, for the acute myeloid leukemia 3+7 regimen, and doxorubicin for breast cancer. Hidden costs include staff hours trying to manage the shortage.

The drug shortages also had an impact on clinical trials: more than 11% of the time, clinical trial enrollment was prevented or delayed; study drug administration was delayed; or involvement in a clinical trial was suspended.

On bivariate analysis, “oncologists who saw more patients per week were more likely to encounter drug shortage (P=0.002),” she said. No difference was observed in the frequency of shortage at community-based private versus university-based academic practices, nor was there a difference in the likelihood of encountering a shortage based on geographic region.

Dr. Gogineni said despite shortages being a recurrent problem, more than two-third of oncologists “had no guidelines to follow when a shortage occurred,” which is even more of an issue in the community, where most patients are treated. She added, “ASCO has an opportunity to play an important role in developing guidelines to help physicians manage shortages.”

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