Chemotherapy Drug Shortages Threaten Quality of Treatment
Over the past several years, there have been recurring shortages of widely used generic chemotherapy agents in the United States. In a letter to The New England Journal of Medicine, Gogineni et al described a survey of U.S. oncologists regarding types and frequency of chemotherapy shortages and consequences for patient care. The survey showed that more than three-quarters of oncologists could not prescribe preferred treatment due to shortages within the previous 6 months and that more than one-third had to delay treatment due to shortages.
Study Details
Between September 2012 and March 2013, 454 randomly selected U.S. oncologists were surveyed about chemotherapy shortages and effects on treatment practices. A total of 250 (55.1%) responded to the survey. Analysis of responses was limited to 214 oncologists who were routine prescribers of chemotherapy.
Drug Shortages
Of the 214 oncologists, 177 (82.7%) were unable to prescribe preferred chemotherapy agents due to shortages at least once during the previous 6 months. The most commonly reported shortages were for leucovorin (66.4% of respondents), liposomal doxorubicin (61.7%), fluorouracil (5-FU; 18.7%), bleomycin (17.3%), and cytarabine (16.4%). As noted by the authors, all of these agents “are integral to curing malignant conditions such as colon cancer, breast cancer, and leukemia as well as providing palliation for patients with metastatic cancer.”
Consequences
A total of 176 oncologists (82.2%) reported modifications in their treatment of patients due to shortages. Modifications included switching chemotherapy regimens for 78.4% of these physicians, substituting a different drug partway through the treatment regimen for 76.7%, delaying treatment for 43.2%, excluding patients from treatment for 36.9%, omitting doses for 29.0%, reducing doses for 19.9%, and referring patients to another practice for 16.5%.
In total, 149 oncologists (69.6%) reported that their centers or practices lacked formal guidance for decisions about allocation of drugs in the setting of shortages. Of the oncologists reporting shortages, 59.2% substituted a more expensive brand name drug for a less expensive generic drug (eg, Xeloda [capecitabine] for 5-FU). As stated by the authors, “This substitution makes one cycle of treatment for colon cancer 140 times more expensive and further adds to the increasing cost of care for patients with cancer.”
The authors concluded, “The majority of oncologists face chemotherapy shortages that compromise the delivery of standard cancer care and lead to higher costs. Since the crisis related to shortages of generic drugs is unlikely to be resolved in the foreseeable future without economic and regulatory intervention, oncologists would benefit from formal guidance on how to address these shortages to mitigate the impact on patients with cancer.”
The authors of the letter to The New England Journal of Medicine are Keerthi Gogineni, MD, Katherine L. Shuman, BS, and Ezekiel J. Emanuel, MD, PhD, of the University of Pennsylvania.
Dr. Gogineni reported grants from the Pfizer Medical and Academic Partnership Program during the conduct of this study.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
