A survey of 250 U.S. oncologists and hematologists finds that more than 80% of practicing oncologists and hematologists have encountered cancer drug shortages between March and September of 2012. Many of the doctors involved in the management and care of patients with cancer reported that these shortages affected the quality of patient care that doctors were able to provide. The study also found that the cost of care was driven upward because physicians were forced to substitute more expensive drugs for cheaper generics.The results of the study were presented at the 49th Annual Meeting of theAmerican Society of Clinical Oncology(ASCO), being held in Chicago, Il, May 31 – June 4, 2013
Shortages have also interfered with patient participation in clinical trials. According to thesurvey, whichwassupportedinpart by a Pfizer Medical and Academic Partnership Research Fellowship in Bioethics, thisresulted slowing down the pace of research and research progress. These findings were echoed by a second survey, conducted by the American Society of Clinical Oncology (ASCO). ?As physicians, it’s critical that we offer patients the best possible quality of life, in part by re-evaluating treatment regimens to reduce side effects without compromising survival,? said Andrew D. Seidman, MD, an oncologist at Memorial Sloan-Kettering Cancer Center in New York, NY and a spokesperson for ASCO. ?Quality cancer care also means providing patients with the right treatments at the right times, and we’re learning today that cancer drug shortages are still interfering with that mission. This ongoing crisis must not be forgotten ? it demands urgent solutions from regulators, policymakers and manufacturers today.?
Ongoing challenge
Drug shortages are a real and an ongoing challenge in all of healthcare, but the problem is particularly alarming in oncology, where scarcity of critical drugs can jeopardize a patient’s survival.The causes of these shortages are very complex and quite difficult to resolve.Based on the available data, it appears that cancer drug shortages in the United States will,for the foreseeable future, continue to be part of daily medical practice.
?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 co-author 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, Pa.
A survey of 250 U.S. oncologists and hematologists reveals that cancer drug shortages were common in mid-late 2012 and affected patient care.
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.??Unfortunately, cancer drug shortages will likely be a persistent issue.
Study design
Researchers distributed the survey to 454 board certified U.S. oncologists and hematologists randomly selected from the ASCO member directory. They received 250 responses and 214 of those were analyzed for the purpose of this study. 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 in university-based academic settings. The American Society of Clinical Oncology was not involved in conducting or analyzing Gogineni’s survey.
Common drugs
The drugs that were most commonly reported in shortage were leucovorin, liposomal doxorubicin, 5-fluorouracil, bleomycin, and cytarabine. These drugs are commonly used in the treatment of various forms of cancer, including gastrointestinal, breast, ovarian and testicular cancers. They are also used in the treatment of leukemia, lymphoma, myeloma.
Cytarabine is particularly critical for curing certain forms of acute leukemia. When asked about the impact of cancer drug shortages over the prior 6 months, 94% reported that their patient’s treatment was affected and 83% were unable to provide standard chemotherapy. About 13% of respondents reported that shortages prevented patient enrollment or suspended participation in clinical trials.
Adapting to shortages
Researchers also noted that doctors adapted to such shortages in different ways, including switching treatment regimens (78% of doctors), substituting alternate drugs part way through therapy (77% of doctors), delaying treatment (43% of doctors), choosing among patients to determine which one should receive the available supply of the chemotherapeutic agent (37% of doctors), omitting doses (29% of doctors), reducing doses (20% of doctors), and referring patients to another practice where drugs in shortage were available (17% of doctors). Most providers (70%) said they had no institutional guideline or committee to help make the difficult treatment modification decisions.
Most effected drugs
Generic drugs, particularly common chemotherapy drugs, have been most affected by shortages. While in some cases substitutions or ?workarounds? exist, in oncology there are often no replacements for the standard agents that have been shown to improve survival. Without them, oncologists are faced with the options of delivering suboptimal and/or more costly care.
For example, when shortages occur, doctors are often forced to substitute the brand-name equivalent drug or another similar drug, which can be several hundred-fold more expensive. This cost burden is shared by patients and institutions, as brand-name drugs typically have higher co-payments 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.
ASCO Member survey
Results of a separate ASCO?s Member Surveys on Drug Shortages? Impact in which ASCO surveyed its members in October 2012 and again in April 2013 to assess the impact of shortages over the previous six months to determine if recent legislative and regulatory efforts to address them are working resulted in surveys received from 390 and 462 respondents, respectively.
Although the results from the second survey suggested that chemotherapy drug shortages may have eased slightly, oncology and hematology practices are still faced with the need for drug substitutions. The respondents further expressed growing concern over the shortage of non-chemotherapy drugs and solutions, including those needed for supportive care, that are critical for cancer patient care such as anti-emetics, pain medications, and basic IV fluids and electrolytes.
Acute findings
Specific findings from the second survey included:
– 59% of physicians surveyed are aware of ongoing drug shortages in the community (e.g., experiencing shortages in their own practices, or have colleagues seeing shortages) versus 70% in October 2012.
– More than 40% of doctors surveyed said that drug shortages have not been resolved. Out of all physicians surveyed, 17% said they were worse than the fall of 2012, 16% said they were the same, and 9% said they were mixed, meaning that some shortages improved,
but others (such as supportive care drugs) were worsening.
These results were summarized by ASCO Chief Medical Officer Richard L. Schilsky, MD, who served as the discussant for Gogineni’s presentation. ?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,? Schilsky said ?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.?
For more information:
Abstract #CRA6510: Impact of oncology drug shortages.
Clinical Science Symposium: Bridging Evidence to Clinical Care: Cost and Availability of Treatment
Date: Tuesday, June 4, 2013, 12:00 ? 12:15 PM CDT
Study Author: Keerthi Gogineni, MD, MSHP
Institution: Abramson Cancer Center, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA
Photo:Keerthi Gogineni, MD, MSHP, a medical oncologist. Photo Courtesy of theAbramson Cancer Centerand thePerelman School of Medicineat the University of Pennsylvania in Philadelphia, Pa
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