Drug Shortages Adversely Affect Treatment Decisions

Beth Fand Incollingo @fandincollingo
Published: Monday, Jun 03, 2013

Dr. Andrew D. Seidman

Andrew D. Seidman, MD

Shortages of cancer drugs caused many oncologists and hematologists to choose suboptimal treatment plans for their patients last year, and government efforts have done little to boost the availability of the hard-to-find medications, according to results of three surveys presented June 3 during the 49th Annual Meeting of the American Society of Clinical Oncology (ASCO).

In a survey conducted by investigators at the University of Pennsylvania,1 94% of 214 oncologists and hematologists said their patients’ treatment had been affected by drug shortages between March and September of 2012. Of those doctors reporting shortages, 83% said they had been unable to provide standard chemotherapy at some point during that time period, and 13% reported that patient enrollment or continuing participation in clinical trials had been compromised due to drug unavailability.

Two-thirds of the respondents work in community oncology settings.

A separate pair of surveys conducted by ASCO reported that members of the organization noticed only a slight easing of drug shortages between October 2012 and April 2013 but during the same period became increasingly concerned about the limited availability of treatments critical to supportive cancer care, such as antiemetics, pain medications, and basic IV fluids and electrolytes.

“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,” said ASCO spokesperson Andrew D. Seidman, MD, an oncologist at Memorial Sloan-Kettering Cancer Center in New York City. “This ongoing crisis must not be forgotten—it demands urgent solutions from regulators, policymakers, and manufacturers today.”

According to ASCO, generic drugs, especially common chemotherapies, have been most affected by shortages. In oncology, there are often no replacements for the standard agents that have been shown to improve survival, the organization reported, and when there are substitutes available, they are sometimes brand-name drugs, which can be several hundred-fold more expensive. This cost burden is shared by patients and institutions, as brand-name drugs typically have higher copayments and out-of-pocket costs, ASCO stated.

In many cases, ASCO said, there is also a lack of clinical trial evidence to determine the appropriate dose for the substitute drug. In addition, according to a survey taken by the Institute for Safe Medication Practices,2 mistakes are sometimes made in the formulations or strengths of drugs given as alternatives for medications in short supply.

Drug shortages have also spawned borrowing and hoarding among medical institutions, the sale of counterfeit drugs, and a gray market for medications in limited supply, experts have said.

In the University of Pennsylvania survey, respondents said that the drugs most commonly 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, breast, ovarian, and testicular cancers. Cytarabine is particularly critical for curing certain forms of acute leukemia, ASCO stated.

Researchers noted that doctors adapted to such shortages in different ways, including switching treatment regimens (78% of doctors), 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.

Dr. Keerthi Gogineni

Keerthi Gogineni, MD, MSHP

“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.”

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