Friday, February 14, 2014

Report: Drug shortages continue to be a serious problem despite efforts to keep supplies available

In the wake of continued drug shortages, the U.S Government Accountability Office has released a report calling on the Food and Drug Administration to monitor the drug shortage data it collects more closely.

"Drug shortages may result in higher drug costs as well as greater risks to patients," wrote the authors in the 94-page report, which was issued on Monday.

"To obtain drugs in short supply, providers may turn to suppliers they do not typically use, including authorized alternative suppliers, compounding pharmacies, or gray market suppliers - those not authorized by the manufacturer to sell the drug - who typically obtain small quantities of a drug that is in short supply and offer it for purchase at an inflated price," they wrote.

The report includes the recommendation that the FDA "strengthen internal controls over its drug shortage data and conduct periodic analyses" that will allow the agency to be proactive in dealing with shortages.

The report is one of the requirements of the FDA's Safety and Innovation Act, signed into law in 2012, that mandated that the GAO study drug shortages.

The authors analyzed data from the University of Utah Drug Information Service on drugs that were in short supply from Jan. 1, 2007, through June 30, 2013. They paid close attention to more than 200 drugs that were in short supply between June 1, 2011, and June 30, 2013.

The authors also conducted interviews with officials from the FDA and other federal agencies, groups representing patients and providers, and drug manufacturers. Bedford-based Ben Venue Laboratories was one of five manufacturers interviewed.

Among the report's findings:

*The number of reports of new drug shortages fell in 2012, but the total number of shortages - new and ongoing - have increased since 2007. In 2011 a record 255 new drug shortages were reported. That number dropped to 195 in 2012.

* Generic sterile injectable drugs are the most affected by drug shortages, making up nearly half of the shortages. Others affected include orally administered drugs available in generic form (18 percent); sterile injectable drugs available in brand-name form (17 percent); orally administered drugs available in brand-name form (8 percent); and drugs with other delivery methods, such as nasal, topical and eye drops.

* From June 2011 through June 2013, 219 drug shortages were labeled as "critical."
*Since Jan. 1, 2007, the average shortage has lasted 340 days.

* The biggest cause of the shortages are generally due to a manufacturer stopping or slowing production while they put quality control issues in place.

On the heels of its announcement in October that it would shut down operations permanently, Ben Venue officials said they would work with city officials to find a buyer for the company to save some of its 1,100 jobs.

The company's woes began in 2011 when it voluntarily shut down manufacturing after an FDA inspection turned up a variety of infractions. That temporary shutdown led to the shortage of several key drugs to treat cancer and other conditions.

Ben Venue's shutdown continues to cause a shortage of the cancer drug Doxil, but a generic version of the drug has been available for about a year.

In a statement released Monday by the American Society of Clinical Oncology, the group said it "remains alarmed about the high number of drug shortages, particularly of sterile injectable chemotherapy and supportive care products, and supports strengthening the FDA's current capacity to monitor the adequacy of the nation's drug supply for the benefit of people with cancer and other conditions."

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