CHICAGO—Two independent surveys reported here at the American Society of Clinical Oncology Annual Meeting show that the ongoing cancer drug shortage has not lessened and that oncologists are adapting in different ways. Both studies were presented during a Clinical Science Symposium titled “Bridging Evidence to Clinical Care: Cost and Availability of Treatment.”
The first report, from the University of Pennsylvania's Abramson Cancer Center and Perelman School of Medicine (Abstract #CRA6510), surveyed 250 oncologists and hematologists from throughout the United States and found that:
* 83 percent experienced shortages of sterile injectable drugs between March and September 2012;
* 94 percent reported that patient care was affected;
* About 13 percent indicated that the shortages either prevented enrollment in or caused suspension of clinical trials;
* About 60 percent had to substitute more expensive drugs when cheaper generic drugs weren't available; and
* About 70 percent lacked any formal guidance in helping them manage the allocation of drugs that were in short supply.
Senior author Keerthi Gogineni, MD, MSHP, a Penn medical oncologist who received support from a Pfizer Medical and Academic Partnership Research Fellowship in Bioethics, and colleagues Ezekiel J. Emmanuel, Katie Shuman, Derek Chinn, and Katherine L Shuman reported that oncologists were often forced to use more expensive brand name drugs, and had to delay or modify treatment.
The brand names were rarely in short supply, while the off-patent standard generics were often difficult to obtain—perhaps more than just suggesting that financial incentives may have played a role in availability.
The drugs that were most often in shortage were leucovorin, liposomal doxorubicin, fluorouracil, bleomycin, and cytarabine, commonly used to treat gastrointestinal, hematologic, breast, ovarian, and testicular cancers.
Respondents reported adapting to the shortages in several ways:
* 78 percent switched treatment regimens;
* 77 percent substituted alternative drugs during treatment;
* 43 percent delayed treatment;
* 37 percent made decisions about choosing which patients should receive the available drugs;
* 29 percent omitted doses;
* 20 percent reduced doses;
* 17 percent referred patients to practices where the drugs were available.
Gogineni responded to a query during the presentation that the survey did not include any questions related to whether physicians even discussed the drug shortage with patients or how it would affect their treatment.
The survey—which the authors referred to as “the largest study of oncologists to quantify the toll of the cancer drug shortage to date”—was distributed to 454 board-certified oncologists and hematologists randomly selected from ASCO's membership directory. There was a response rate of 55 percent (250), but only 214 were analyzed in the study because 36 respondents were not medical oncologists. About two-thirds were in community-based private practices and the rest were in university-based cancer centers.
‘Improvising When Standard Therapy is Not Available’
The second drug-shortages presentation, “Improvising When Standard Therapy is Not Available” by ASCO Chief Medical Officer Richard L. Schilsky, MD, consisted of two identical sequential surveys sent to ASCO members from Oct. 5 through Nov. 2, 2012 with 390 respondents, and from March 15 through April 8, 2013 with 462 respondents. Although the number of respondents was higher than in the Penn study, Schilsky noted that the response rate was much lower since the surveys were sent to a much larger pool of oncologists. The time interval was used to show any changes as a result of legislative and regulatory efforts to ameliorate the shortages.
The second ASCO survey suggested that though chemotherapy drug shortages may have eased slightly, the changes were small and drug substitutions were still necessary.
“It's not so much that the shortage is getting better but less is being heard about it because oncologists are adapting,” Schilsky said, noting that those adaptations may be compromising care and were increasing costs.
Respondents were also concerned about the shortage of supportive care drugs critical to patient care such as anti-emetics, pain medications, and basic IV fluids and electrolytes.
* 59 percent of respondents were aware of ongoing drug shortages in the 2013 study with some 70 percent aware in 2012;
* More than 40 percent said the drug shortages had not been resolved, with 17 percent reporting they were worse in 2013 than in 2012; 16 percent, that they were the same; and nine percent noting that while some shortages improved, others—including supportive care drugs—were getting worse.
Schilsky said that the drug shortage was not new and has been a problem for the last decade, tripling since about 2006. “It's been a pervasive problem, and the drug supply has been unpredictable. It is never clear if there will be a shortage, which drugs will be affected, and when it will happen.”
Regarding pharmaceutical companies, he said that 18 percent of the time companies decided to stop making drugs for financial reasons, that oncology drugs were often only a small part of their business, and that because there aren't strong incentives to fix problems, it is sometimes just easier to drop the drug from their portfolios.
Although Schilsky, who also served as Discussant for Gogineni's presentation, said that both the Penn and ASCO survey results were largely similar, he noted that the one major difference was that that more than two-thirds of the Penn respondents said they had no formal institutional guidelines to help them cope with shortages, while nearly two-thirds of the ASCO survey respondents indicated that they did have guidance from their institutions. This may have reflected the fact that more of the ASCO respondents came from academic centers.
Schilsky said that ASCO's ethics committee has prepared a white paper now under review for publication in the Journal of Clinical Oncology, which would provide guidance for physicians making decisions in handling drug shortages.