By Yoram Unguru, MD, MS, MA

Drug shortages have existed in one form or another for decades, but over the past ten years, they have become increasingly commonplace and this includes shortages of life-saving chemotherapeutics.  Since 2004, the number of new drug shortages has increased each year with 58 shortages in 2004, peaking at 267 by 2011.  Moreover, the inability to resolve existing drug shortages means that the number of scarce drugs has continued to climb; currently in the United States there are close to 300 drugs in short supply.

According to Dr. Michael Link, a pediatric oncologist at Stanford University and recent Past President of the American Society of Clinical Oncology, “We have had shortages before, but they have been intermittent, and never anything as extensive both in terms of the breadth of drugs affected and the depths of shortages and how long they lasted.”

Although not unique to the US, the shortages are largely an American problem. The reasons for the shortage are complex, including economic drivers, manufacturing and quality issues, and regulatory considerations.

The majority of drugs in short supply are sterile injectables and are made by generic manufacturers.  According to the University of Utah Drug Information Service, which collects data on drug shortages, the top 5 drug classes impacted by the shortages are antimicrobials, chemotherapeutics, cardiovascular and CNS drugs, and electrolytes and nutritional preparations meaning that the shortages affect nearly every discipline within medicine.

Oncology practices in general, and pediatric oncology in particular, is susceptible to shortages of sterile injectable drugs.  Many sterile injectables comprise the backbone of proven and standard life-saving regimens for countless adults and children with cancer.  As most chemotherapy is administered via sterile injectable, oncology practices are disproportionately affected by the shortage.  Over the past decade, 8 of the 10 commonly used drugs in the treatment of acute lymphoblastic leukemia, the most common childhood cancer, have been temporarily unavailable.  Emerging evidence suggests that shortages have resulted in adverse patient outcomes, some related to use of alternative therapies, and delayed clinical trials.

Drug shortages raise a host of critical ethical concerns for children with cancer, their parents, clinicians, institutions, and the health system.  Confronted with a shortage of chemotherapeutics, how should decisions be made about allocating these life-saving drugs and who should decide?  To further supply, should treatments be delayed, administered at a lower dose, or skipped altogether?  Should scarce drugs be given on a first-come-first-serve basis, “sickest first,” or based on a child’s prognosis?  Should patients who require smaller doses of a scarce drug receive access ahead of those who require higher doses allowing for a greater number of patients to be treated?  Importantly, how can future drug shortages be avoided?  Should health systems coordinate their responses to the shortage?  What role should professional associations, government, and industry assume?

To address these issues, the Working Group (WG) on Chemotherapy Drug Shortages in Pediatric Oncology, a multidisciplinary and multiinstitutional group was convened.  Members were selected based on their expertise in childhood cancer and pediatrics, ethics, drug shortages, and health policy.  The WG defined the unique ethical challenges associated with managing pediatric oncology drug shortages with a special focus on how a coordinated effort by stakeholders can prevent and mitigate the shortages.  The WG Consensus Statement appears in the journal Pediatrics. In an effort to determine the specific impact that the chemotherapy shortages have had on pediatric clinical care and pediatric oncology research, both at the individual and the institutional level, we are now embarking on a national survey of pediatric oncologists.  Along with the WG recommendations, this critical information will contribute to preventing and managing future drug shortages.

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DeCamp M, Joffe S, Fernandez CV, Faden RR, Unguru U. Chemotherapy Drug Shortages in Pediatric Oncology: A Consensus Statement. Pediatrics, available online 2 Feb, 2014.

Yoram Unguru, MD, MS, MA, Division of Pediatric Hematology/Oncology, The Herman and Walter Samuelson Children’s Hospital at Sinai and Johns Hopkins Berman Institute of Bioethics

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