A survey of 250 U.S. oncologists and hematologists finds that more than 80 percent of cancer doctors encountered cancer drug shortages between March and September of 2012, and many reported that 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 as, as physicians were forced to substitute more expensive drugs for cheaper generics. Shortages have also interfered with patient participation in clinical trials, slowing the pace of research progress.

These findings were echoed by a second survey, conducted by the American Society of Clinical Oncology (ASCO).

Drug shortages are an ongoing challenge in all of healthcare, but the problem is particularly alarming in oncology, where scarcity of critical drugs can jeopardise a patient’s survival. The causes of these shortages are complex and difficult to resolve.

At this point, it appears that cancer drug shortages in the United States will continue for the foreseeable future.

“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. “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.”

Researchers distributed the survey to 454 board certified U.S. oncologists and hematologists randomly selected from the ASCO member directory; 250 responses were received and 214 of those were analysed 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 (Note: ASCO was not involved in conducting or analyzing Dr. Gogineni’s survey).

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, blood (leukaemia, lymphoma, myeloma), breast, ovarian and testicular cancers. Cytarabine is particularly critical for curing certain forms of acute leukaemia. When asked about the impact of cancer drug shortages over the prior 6 months, 94 percent reported that their patients’ treatment was affected and 83 percent were unable to provide standard chemotherapy. About 13 percent of respondents reported that shortages prevented patient enrollment or suspended participation in clinical trials.

Researchers noted that doctors adapted to such shortages in different ways, including switching treatment regimens (78 percent of doctors), substituting alternate drugs part way through therapy (77 percent of doctors), delaying treatment (43 percent of doctors), choosing among patients to determine which one should receive the available supply of the chemotherapeutic agent (37 percent of doctors), omitting doses (29 percent of doctors), reducing doses (20 percent of doctors), and referring patients to another practice where drugs in shortage were available (17 percent of doctors). Most providers (70 percent) 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, 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.

This research was supported in part by a Pfizer Medical and Academic Partnership Research Fellowship in Bioethics.

Source: ASCO