Oncology drug shortage raises safety concerns

August 15, 2011

Continuing shortages of generic oncology chemotherapeutic agents dangerously limit patient-care choices, affect clinical outcomes, and stretch already tight pharmacy resources.

Key Points

Continuing shortages of generic oncology chemotherapeutic agents have become a danger. It is limiting patient-care choices, affecting clinical outcomes, and stretching already tight pharmacy resources.

"The shortage has changed how we handle these products and these patients," said Sylvia Bartel, RPh, MHP, vice president, pharmacy services, Dana-Farber Cancer Institute, Boston. "We are doing more advance planning for individual patients to ensure that product is available when needed. We are sequestering product for specific patients. We are making multiple calls daily to FDA, to manufacturers, wholesalers to move in parallel with shortages instead of being surprised by them. It is a matter of putting additional resources and staff behind the effort. And every time we have to substitute a drug or a formulation, safety becomes a huge issue."

Safety concerns are greatest for common generic agents that are part of multiple regimens for multiple tumor types. The Institute for Safe Medication Practices has linked shortages of cisplatin, doxorubicin, cytarabine, methotrexate, vinblastine, IV etoposide, fluorouracil, asparaginase, and mitomycin with adverse chemotherapy outcomes, errors, and near misses.

Oncology isn't the only area affected by shortages. Antimicrobials, neuromuscular blockers, cardiovascular agents, CNS drugs, and hormones have all been in short supply over the past 1 to 2 years. Drug-supply expert Erin Fox, PharmD, manager, drug information services, University of Utah Hospitals and Clinics, Salt Lake City, noted that the number of drug shortages has been rising since 2006. If current trends continue, 356 drugs will be in short supply this year, up from 211 in 2010.