January 29, 2016
Press Release

A Matter of Life or Death: Pediatric Oncologists Issue Guidance for Allocating Scare Chemotherapy Drugs

Claiming that clinicians lack formal and concrete allocation guidance when faced with a critical drug shortage, experts in pediatric oncology and bioethics have issued a framework to avoid waste and guide difficult prioritization decisions among children in need of scarce life-saving chemotherapy treatment. The commentary is published today in the Journal of the National Cancer Institute.

Shortages of chemotherapy and supportive care agents related to cancer care, along with shortages of many other marketed drugs, have become increasingly common in the United States in the past decade.

“In the absence of a much-needed national advisory statement on how best to allocate scarce drugs, and until policymakers and stakeholders can prevent future shortages, the guidance articulated here supports reasoned decision-making in the face of an actual drug shortage and aims to minimize bias as might occur when individual clinicians or institutions are forced to make difficult, and at times tragic, rationing decisions for children with cancer,” the commentary states.

The commentary calls for a two-step allocation process: Step 1 includes strategies to mitigate an existing shortage, while Step 2 addresses actual prioritization, with very specific guidance. In the absence of evidence-based recommendations, the authors present a modified utilitarian model that maximizes total benefit from the available supply of drug, while respecting limited constraints on differential treatment of individuals.  They propose three critical factors in determining allocation of scare live-saving drugs for children with cancer: “Curability,” prognosis, and the incremental importance of a particular drug to a given patient’s outcome.

In an example of the commentary’s specificity, one recommendation on the impact on patient outcome states: “Due its crucial role in offering the chance for cure, doxorubicin should be prioritized to patients with sarcomas over patients with Hodgkin lymphoma.”

The framework’s strategies to maximize efficiency and minimize waste include not over-ordering, or hoarding, drugs.  Additionally, if the drug is available at another institution, rather than altering a treatment regimen, patients should be sent to that institution. At a policy level, the commentary calls for drug shortages to be treated similarly to natural disasters, thereby raising public awareness and providing a mechanism for potential policy change and remediation.

Given the challenging nature of bedside allocation decision-making, the authors emphasize that “a multidisciplinary institutional Drug Shortage Committee (DSC) or similarly appointed body make prioritization decisions.”

“Physicians and administrators faced with having to decide which of two children with cancer receives a scarce life-saving treatment need guidance and should not feel that they are on their own without a roadmap,” says lead author of the commentary Yoram Unguru, MD, MA, MS, a pediatric hematologist/oncologist at The Herman and Walter Samuelson Children’s Hospital at Sinai and a faculty member of the Johns Hopkins Berman Institute of Bioethics.

“The context of allocation is always complex, but it is unethical to leave these challenges unaddressed.  It is our hope that this framework will be helpful and spur further substantive action on this crucial issue,” Unguru says.

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