Two of your pediatric patients with cancer require an injectable oncology drug, but due to a drug shortage, you can only treat one.

Which child do you treat?

This ethical question increasingly is no longer theoretical, as “shortages of essential drugs, including critical chemotherapy drugs, have become commonplace,” points out a consensus statement published in Pediatrics.1

“Drug shortages cost significant time and financial resources, lead to adverse patient outcomes, delay clinical trials, and pose significant ethical challenges,” wrote the Working Group on Chemotherapy Drug Shortages in Pediatric Oncology, which authored the statement.

RELATED: Chemotherapy Drug Shortages: The Impact on Oncology Practice

What is the principal cause of these shortages? “Economics,” Yoram Unguru, MD, MS, MA, a pediatric hematologist/oncologist at the Herman and Walter Samuelson Children’s Hospital at Sinai and a faculty member at the Johns Hopkins Berman Institute of Bioethics, Baltimore, MD, told ChemotherapyAdvisor.com.

Dr. Unguru, principal organizer of the Working Group—which included representatives from the US Food and Drug Administration (FDA) in an unofficial capacity—said declining profit margins, market consolidation, and the free market economy all contribute to drug shortages, creating what he calls largely an American problem. “It is untenable for this situation to continue any longer,” he said. “We have a clear moral obligation to act to address this critical issue.”

Unfortunately, oncologists typically receive little or no training about what to do. “When a drug shortage occurs, oncologists face an acute moral dilemma: how to fairly manage or ration care in a situation of scarcity,” Reshma Jagsi, MD, PhD, of the Department of Radiation Oncology at the University of Michigan in Ann Arbor, and colleagues, wrote in an article published in The Oncologist that addresses ethical considerations for the clinical oncologist.2

In such cases, physicians face several options: change the regimen, lower the dose, wait until supply returns, withhold chemotherapy from a different patient, or, as Dr. Unguru noted, decide whether to buy drugs on the “grey market,” where prices may run 4,000% higher for ara-C and dexamethasone or nearly 3,000% higher for leucovorin. The grey market comprises “unauthorized secondary drug distributors who oftentimes profit from the shortages,” he said.

Such shortages are likely to get worse now that Boehringer Ingelheim Ben Venue Laboratories, Inc., which supplies multiple sterile injectable products for Bedford Laboratories, including generic liposomal doxorubicin, thiotepa, and methotrexate, has ceased production at its plant in Bedford, OH.3

The consensus statement is one effort to move away from the current strategy of reaction to shortages and to focus instead on prevention. In an editorial in the same issue of Pediatrics, FDA representatives wrote that it “accomplishes two important tasks: it highlights a serious public health threat and proposes steps to address the problem.”4

RELATED: FDA Announces Plan to Prevent Drug Shortages

Although the focus is on pediatric oncology drugs, the statement’s “comprehensive blueprint for action” seeks to prevent all drug shortages. The Working Group endorsed two core ethical values and, from these, developed the following six recommendations: “1) supporting national policies to prevent shortages, 2) optimizing use of drug supplies, 3) giving equal priority to evidence-based uses of drugs whether they occur within or outside clinical trials, 4) developing an improved clearinghouse for sharing drug shortage information, 5) exploring the sharing of drug supplies among institutions, and 6) developing proactive stakeholder engagement strategies to facilitate prevention and management of shortages.”

In October 2013, the FDA published a strategic plan for preventing and mitigating drug shortages in response to the FDA Safety and Innovation Act, signed into law on July 9, 2012.5 Information about drug shortages is available on the FDA and American Society of Health-Systems Pharmacists (ASHP) websites. The ASHP Drugs Shortages website lists more than 200 agents, of which approximately 15% are oncology products.

References

  1. DeCamp M, Joffe S, Fernandez CV, et al. Chemotherapy drug shortages in pediatric oncology: a consensus statement. Pediatrics. 2014 Feb 2. [Epub ahead of print]
  2. Jagsi R, Spence R, Rathmell WK, et al. Ethical considerations for the clinical oncologist in an era of oncology drug shortages. The Oncologist. 2014;19(2):186-192.
  3. Ben Venue Laboratories, Inc to cease production [press release]. Bedford, OH: Boehringer Ingelheim Ben Venue Laboratories; October 3, 2013. http://www.benvenue.com/news_/october_3_2013.html. Accessed February 9, 2014.
  4. Murphy D, Reaman G, Jensen V. Pediatric oncology drug shortages: a multifaceted problem. Pediatrics. 2014 Feb 2. [Epub ahead of print]
  5. US Food and Drug Administration. Strategic plan for preventing and mitigating drug shortages. October 2013. http://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM372566.pdf. Accessed February 9, 2014.