Hundreds of common intravenous medications are in short supply, according to recent reports. 21 of these commonly used generic drugs in the reported shortage are used to treat cancer, which is obviously a concern for oncologists, cancer patients, and their families. Although the 21 generic drugs represent only a fraction of the chemotherapy drugs available, the shortage is still very much a concern at Winship Cancer Institute and other cancer treatment centers across the country. Some of the drugs, such as cytarabine, doxorubicin and etoposide, are very commonly used in a number of cancers we treat frequently at Emory. The medication shortage has caused delays in patients across the country starting their cancer treatment and has required that treatment teams substitute medications used in treatment. This is less than ideal.
The reasons behind this medication shortage are complex. In November, The American Society of Health-System Pharmacists (ASHP) held a meeting to discuss the drug shortages, and the American Society for Clinical Oncology was one of the sponsors. One of the cancer treatment medication shortage reasons cited is that some manufacturers have difficulty complying with Good Manufacturing Practices, principles relating to the safe manufacture of drugs and medical devices that is overseen by the FDA . This results in production stoppages or recalls. The group also noted that the FDA needs more authority to require generic drug makers to notify the agency six months in advance if it intends to stop making a drug.
Another reason for the shortage in cancer drug availability has to do with supply chain management. The efficient, cost-saving “just-in-time” method of delivering and acquiring goods in contemporary business – which means that a provider intentionally keeps inventory low to avoid costly warehousing and storage of products – may actually be contributing to the shortage. With all these factors (and more) at work, it’s surprising that these drug shortages don’t happen more often.
Winship has been fortunate to have very aggressive leadership from our pharmacy and treatment teams to help manage the shortage of generic cancer treatment medications. So far, through careful management and monitoring of patient needs, very few patients have been affected by treatment changes or delays. Each week, a team meets to assess each patient’s treatment plan, drug inventory to meet those plans, and how to make sure Winship has the drugs it needs, when it needs them. “One of the biggest things we’re doing is to really plan treatment in the context of the drug shortages,” said Donald Harvey, PharmD, director of the Phase 1 clinical trials unit at Winship. “And we’re doing everything possible to obtain inventory, including borrowing from other hospitals if we need to.”
Dr. Harvey, who also is president of the Hematology/Oncology Pharmacy Association, also recently met with representatives from Sen. (R-GA) Johnny Isakson’s staff to make sure that Sen. Isakson knows of the severity of the shortage. In years past, “It would be unheard of to have 21 anti-cancer drugs on short supply,” Dr. Harvey said as he discussed the shortage. Cancer drugs represent about 11 percent of the drugs in short supply, he told the Senator’s staff on April 27, asking for the Senator’s support for a bill introduced by Senators Amy Klobuchar (D-MN) and Bob Casey (D-PA) in February to help remedy the situation.
Our pharmacists and cancer treatment teams here at the Winship Cancer Institute are on top of this important issue, and I’ll keep you posted on updates that emerge. For more information on current drug shortages in general, visit: http://www.ashp.org/DrugShortages/Current/ For more on the recent announcement around shortages in cancer drugs, check out this release from Reuters.
Walter J. Curran Jr., MD
Executive Director, Winship Cancer Institute of Emory University
Associate Vice President, Cancer, Woodruff Health Sciences Center
Chair of Radiation Oncology