Out of Drugs: Planning for the Unthinkable

• September 22, 2014
• Dave Ghose

Pediatric cancer specialists have faced an enormous challenge in recent years. With critical chemotherapy drugs often in short supply, they’ve been forced to improvise alternative treatments or purchase medicine from questionable secondary sources.

These practices raise safety and ethical concerns. Emerging evidence indicates that shortages are harming patients in some instances, exposing them to more toxic substitute therapies and delaying clinical trials. “There is no question that care has been impacted,” says Yoram Unguru, MD, a pediatric hematologist and oncologist at The Herman & Walter Samuelson Children’s Hospital at Sinai in Baltimore.

Drug shortages aren’t a new phenomenon; penicillin was in short supply in the 1940s, Dr. Unguru notes. But the issue has gotten worse in recent years, with the number of drug shortages quadrupling from 2005 to 2011, according to an article co-authored by Dr. Unguru in the March issue of Pediatrics.

Particularly affected have been commonly used pediatric cancer drugs, such methotrexate, cytarabine, asparaginase and daunorubicin. Childhood cancer therapies tend to rely on sterile, injectable agents—the drugs frequently in short supply. Over the past decade, eight of the 10 drugs used in treating acute lymphoblastic leukemia, the most common childhood cancer, were temporarily unavailable, according thePediatrics article.

Dr. Unguru, also a faculty member at the Berman Institute of Bioethics at Johns Hopkins University, is a member of a working group created under the auspices of the Children’s Oncology Group, the National Cancer Institute-supported clinical trials organization, to explore the issue. The Pediatrics article — “Chemotherapy Drug Shortages in Pediatric Oncology: A Consensus Statement” — outlines the working group’s recommendations for tackling the problem.

The article suggests six overarching recommendations, but Dr. Unguru says perhaps the most practical suggestion for hospitals is to create cooperative arrangements with other hospitals to share scarce drugs in times of need. “We feel that coordination and sharing have to happen until the problem can be prevented,” he says.

To tackle the issue on a broader scale, however, pediatricians should push for policy changes that address the myriad economic and regulatory causes of shortages, Dr. Unguru says. Among other things, they could advocate for banning the so-called “gray market” — the ticket scalpers of pharmaceutical industry, if you will — and for creating a hoard of critical drugs modeled after the Centers for Disease Control and Prevention’s Strategic National Stockpile. They also could support policies that increase Medicare reimbursements for generic sterile injectables — a change that could give manufacturers an economic incentive to increase supply.

Reference:

DeCamp M, Joffe S, Fernandez CV, Faden RR, Unguru Y. Chemotherapy drug shortages in pediatric oncology: a consensus statement. Pediatrics. March 2014, 133(3):716-724.