Generic Chemotherapy Drug Shortages

I’m no longer surprised when I read listserves or hear from colleagues that a generic chemotherapy drug is not available from the manufacturer. Over the past year commonly administered drugs, including doxorubicin, vincristine, and others have been in short supply—or unavailable—for varying periods of time. In most cases, drug shortages have lasted weeks to months.

Some facilities that either happen to have a supply or have stockpiled commonly administered generic chemotherapy drugs often share their supply so that patients can continue optimal cancer treatment. However, in other cases, clinicians have been grappling with delaying treatment, reducing doses, or switching to another (and possibly inferior) chemotherapy drug that is available. Nurses at a conference recently talked about the ethical dilemma that this presents and how difficult it is to explain what is happening to patients. Patients just don’t understand how life-saving treatment chemotherapy drugs could be in short supply.

The American Society of Anesthesiologists, the American Society of Clinical Oncology, the American Hospital Association, and the American Society of Health-System Pharmacists (ASHP), and other groups are urging Congress to pass federal legislation to ease drug shortages. The group suggested several options that could be included in federal legislation, including a requirement for advance notification of supply or production problems by both single-source and multi-source manufacturers; changes to FDA regulations for reporting interruptions in medically-necessary product supplies prior to planned action at least 12 months in advance; and revision of FDA’s definition of “medically necessary” to allow for inclusion of the impact of medication-use factors. These options were discussed by the groups at the Drug Shortages Summit in November 2010. Recommendations from the summit are available at www.ashp.org/drugshortages/summitreport.