As part of its continued effort to monitor and assess the impact of oncology drug shortages, ASCO will be conducting the third round of its biannual survey of members. The results of the first two surveys indicated that serious problems persist in the accessibility of life-extending oncology drugs, despite legislation that passed in July 2012 in an attempt to address the shortages.
Background on Shortages
In 2010 and 2011, the number of chemotherapy drug shortages rose significantly, with more than 20 chemotherapeutic drugs reported to be in short supply, compared to only four in 2009. The majority of these agents included decades-old, off-patent drugs—such as methotrexate, cytarabine, and fluorouracil—that are used in standard, evidence-based care of adult and pediatric patients with many types of cancer.
Reasons cited for the shortages include manufacturing and quality problems, economic factors, and a lack of U.S. Food and Drug Administration (FDA) authority and resources—factors that are under consideration in multiple federal investigations of the issue.
In a step to alleviate the crisis, the reauthorization of the Prescription Drug User Fee Act (PDUFA) in July 2012 included provisions that ASCO had recommended to address drug shortages. The measure mandates an early-warning system, requiring drug manufacturers to notify the FDA of a discontinuance or interruption in the production of a life-saving drug at least 6 months in advance. In addition, PDUFA expands the FDA’s authority to collect user fees from generic drug manufacturers as part of the regulatory approval process, which will provide the FDA resources to speed generic drug application reviews, making the drugs available to patients sooner.
ASCO Survey Results
Despite this legislation, which the FDA has stated has helped the agency mitigate some shortages since its passage, ASCO survey data indicate that, although shortages appear to be improving very slightly, unavoidable drug substitution decisions persist. This is a troubling trend that has both patient care and cost implications.
The first two surveys were conducted in October 2012 and April 2013, with 390 and 462 respondents, respectively. Among respondents to the first survey, 55% noticed an improvement between July 2012 and October 2012 in the availability of drugs included in the shortages, and 58% of respondents to the second survey had a similar assessment of the drugs’ availability between October 2012 and April 2013.
However, 70% of respondents to the first survey and 59% of respondents to the second survey indicated that they were aware of ongoing drug substitutions resulting from the unavailability of standardly used drugs. In addition, some respondents to both surveys indicated that they were aware of dose alteration and the use of different treatment regimens. And they noted that a limited number of patients were using atypical drug procurement methods. Of note, those responding to the second survey indicated that although the shortage of chemotherapeutic agents seemed to be easing very slightly, significant concern was expressed over the growing shortages of supportive drugs such as opioids, IV fluids, and steroids.
Commenting on the findings, ASCO spokesperson Andrew D. Seidman, MD, an oncologist at Memorial Sloan-Kettering Cancer Center in New York, said that cancer drug shortages are still interfering with oncologists’ mission to provide patients with “the right treatments at the right times.”
Results of the third survey, which will be sent to ASCO members soon, will likely be released in mid to late November. ■
© 2013. American Society of Clinical Oncology. All rights reserved.
