ASCO 2013: Adapting to Ongoing Shortages of Common Cancer Drugs
A survey of 214 U.S. oncologists and hematologists found that more than 80% encountered cancer drug shortages between March and September of 2012, and many reported that shortages affected the quality of patient care they were able to provide. As physicians were forced to substitute more expensive drugs for cheaper generics, the cost of care was driven upward. Shortages have also interfered with patient participation in clinical trials, slowing the pace of research progress. These findings were presented at the 2013 ASCO Annual Meeting (Abstract CRA6510) and echoed by two additional surveys conducted by ASCO.
“We were surprised by the large number of cancer doctors that had to make changes in the way they care for patients due to drug shortages,” said study coauthor Keerthi Gogineni, MD, MSHP, a medical oncologist in the Abramson Cancer Center and the Perelman School of Medicine at the University of Pennsylvania in Philadelphia. “Unfortunately, cancer drug shortages will likely be a persistent issue. Doctors are adapting to this new reality as best as they can, but more uniform guidance is needed to ensure that modifications are made in the most educated and ethical way.”
Impact on Patient Care
Researchers distributed the survey to 455 board-certified U.S. oncologists and hematologists randomly selected from the ASCO member directory, although ASCO was not involved in conducting or analyzing this survey. Of the 250 responses received (55% response rate), “214 medical oncologists and hematologists completed the survey and we limited our results to that sample,” Dr. Gogineni said. There was a statistically even distribution of respondents who practiced in the Northeast, South, Midwest, and West. About two-thirds of respondents practiced in community-based private settings and one-third practiced in university-based academic settings.
The drugs that were most commonly reported in shortage were leucovorin, liposomal doxorubicin, fluorouracil, bleomycin, and cytarabine. These drugs are commonly used in the treatment of gastrointestinal, breast, ovarian, and testicular cancers, as well as leukemia, lymphoma, and myeloma.
When asked about the impact of cancer drug shortages over the prior 6 months, 94% reported that their patients’ care was affected and 83% said they were unable to provide standard chemotherapy due to shortages.
Coping Strategies
Researchers noted that doctors adapted to such shortages in different ways, including switching treatment regimens (78%), substituting alternate drugs partway through therapy (77%), delaying treatment (43%), choosing among patients to determine which one should receive the available supply of the chemotherapeutic agent (37%), omitting doses (29%), reducing doses (20%), and referring patients to another practice where drugs in shortage were available (17%). Most providers (70%) said they had no institutional guideline or committee to help make the difficult treatment modification decisions.
Generic drugs, particularly common chemotherapy drugs, have been most affected by shortages. While in some cases substitutions or “workarounds” exist, there are often no replacements for the standard agents that have been shown to improve survival in patients with cancer. Substituting a brand-name equivalent drug or another similar agent can be several hundredfold more expensive. This cost burden is shared by patients and institutions, as brand-name drugs typically have higher copayments and out-of-pocket costs. In many cases there is also a lack of clinical trial evidence to determine the appropriate dose for the substitute drug.
Information was not available on how substitutions or delays affected patients’ survival or quality of life. Dr. Gogineni noted that was “difficult information to capture” and that data would “need to be measured over a period of years.”
Results of ASCO Surveys
ASCO surveyed its members in October 2012 and again in April 2013 to assess the impact of shortages over the previous 6 months and determine if recent legislative and regulatory efforts to address them are working. The first survey received 390 responses and the second received 462 respondents. These results were summarized by ASCO Chief Medical Officer Richard L. Schilsky, MD, who served as the discussant for Dr. Gogineni’s presentation.
Although the results from the second survey suggested that chemotherapy drug shortages may have eased very slightly, the changes were small, and practices are still faced with the need for drug substitutions. “The fact that we seem to be hearing less about the shortages probably reflects more adaptation on the part of doctors to be living with the shortages than it does to actual improvement of the shortages,” Dr. Schilsky said.
Respondents expressed growing concern over the shortage of nonchemotherapy drugs and solutions that are critical for cancer patient care, such as antiemetics, pain medications, and basic IV fluids and electrolytes.
Continued ASCO Advocacy
Comparing the results identified some changes. For example, 59% of physicians responding to 2013 survey reported they are aware of ongoing drug shortages in the community (experiencing shortages in their own practices, or have colleagues who are experiencing shortages) vs 70% in 2012. In 2013, more than 40% said that drug shortages have not been resolved; 17% said that the shortages were worse than the fall of 2012, 16% said they were the same, and 9% gave mixed assessments, saying some shortages improved, but others (such as supportive care drugs) were worsening.
“ASCO believes that there are likely numerous causes of drug shortages and will continue to call on Congress to convene a blue ribbon panel that includes providers, manufacturers, suppliers, FDA, and patients to develop comprehensive legislation to resolve these critical shortages,” said Dr. Schilsky. “The Government Accountability Office is also conducting a comprehensive investigation of the causes of the shortages and we will be eager to learn its assessment when the report is published early next year.”
The research presented Dr. Gogineni was supported in part by a Pfizer Medical and Academic Partnership Research Fellowship in Bioethics. Dr. Gogineni reported research funding from Pfizer.
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®.
