Headlines from the June meeting of the American Society of Clinical Oncology (ASCO) in Chicago announced to the general public what oncologists and hematologists have known for more than two years: sporadic shortages of cancer drugs are forcing suboptimal treatment plans for patients, and government efforts have not filled the void.
Two months after three surveys were presented at ASCO’s 49th Annual Meeting, our editors asked both the FDA and Keerthi Gogineni, MD, MSHP, who presented one of the studies in Chicago, to offer updates on cancer drug shortages
Gogineni, a medical oncologist in the Abramson Cancer Center and the Perelman School of Medicine in Philadelphia, was a co-author of the study conducted at the University of Pennsylvania.
While the FDA’s Lisa Kubaska, PharmD, reports that the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) is helping the agency identify shortages and find temporary solutions, such as importations of drugs, Gogineni states that some shortages remain, even though the FDA is “doing what it can.”
“There are factors that contribute to drug shortages that the agency has limited control over,” Gogineni said.
Kubaska and Gogineni agree that the majority of shortages are due to quality control problems at several large drug manufacturing plants. Kubaska said preventing shortages is a “top priority,” and that passage of FDASIA has enhanced the agency’s ability to anticipate pending problems through an early notification system. However, the FDA and physicians like Gogineni on the front lines view things differently.
Said Kubaska, “There has been one new shortage in 2013, lomustine tablets, which was resolved through import of a drug with unapproved packaging until the approved package could be made available.”
Gogineni said that her own hospital “has had considerable difficulty acquiring this drug to treat patients with brain tumors. There is an ongoing attempt to obtain this drug by enabling NextSource Biotech to import the product but under a different trade name…Theoretically this should have made emergency supplies of the drug easier to obtain by July 2013, but practically speaking, this has not been the case.”
What the Surveys Found
In the Penn study,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.
In the University of Pennsylvania survey, respondents said that the drugs most commonly in shortage were leucovorin, liposomal doxorubicin, 5-fluorouracil, bleomycin, and cytarabine. (According to Kubaska, the FDA arranged to have the first two temporarily imported to address the shortage.) 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 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.
“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,” Gogineni said in Chicago. “Unfortunately, cancer drug shortages will likely be a persistent issue. Doctors are adapting to this new reality as best they can, but more uniform guidance is needed to ensure that modifications are made in the most educated and ethical way.”
The research was supported, in part, by a Pfizer Medical and Academic Partnership Research Fellowship in Bioethics.
ASCO’s 2012 and 2013 surveys of its members asked whether, in the previous six months, legislative and regulatory efforts to address drug shortages had been effective. A total of 390 and 462 doctors, respectively, responded.