FDA acknowledges ongoing drug shortage, warns pharmacists of fraud

September 1, 2011

Drugs such as Taxol, Cytarabine, Daunorubicin, Doxil, and Leucovorin are in short supply, delaying patients with various forms of cancer from getting the treatments they need or forcing them to seek alternative, possibly less-effective treatments, FDA announced recently.

Drugs such as Taxol, Cytarabine, Daunorubicin, Doxil, and Leucovorin are in short supply, delaying needed treatments for some cancer patients or forcing them to seek alternative, possibly less-effective treatments, FDA announced recently.

During the past few years, the number of drug shortages has continued to increase. In 2010, there were 178 drug shortages reported to FDA, a record high, according to the announcement.

“There has been an immense amount of concern in the healthcare community about drug shortages, especially given the rising number of shortages in critical areas of medicine,” said Valerie Jensen, associate director, Drug Shortage Program, FDA Center for Drug Evaluation and Research, in the agency’s announcement. “In 2011, FDA has continued to see an increasing number of shortages, especially those involving older, sterile injectable drugs.”

FDA continues to work with manufacturers to resolve shortages; however, the agency suggests that healthcare professionals help patients understand that a delay in treatment is better than suboptimal or potentially harmful treatments. Healthcare professionals may also need to identify other treatments for their patients.

“In hospitals and health systems, the pharmacy department can play an important role in developing and implementing appropriate strategies and processes for informing practitioners of shortages and ensuring the safe and effective use of therapeutic alternatives,” FDA noted.

FDA also is warning pharmacists to be wary of sellers who may try to take advantage of the shortage by either price-gouging or selling drugs that have expired, were diverted, or may be counterfeit. Pharmacists should report any faxed and e-mailed advertisements from unknown distributors offering these drugs to FDA’s Office of Criminal Investigations, the announcement said.