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Klobuchar touts legislation as experts warn of drug shortages

By Julian Pecquet - 03/28/11 12:09 PM ET

The U.S. faced an unprecedented shortage of 240 pharmaceuticals in 2010, healthcare experts warned in a conference call with reporters Monday.

The call coincides with the release of a new report from the Premier healthcare alliance that found that drug shortages have risen to "critical levels," endangering the public's health. Disruptions in the supply chain, including recalls, industry consolidation, and offshore production are largely to blame, according to the report.

"In 2010, over 240 drugs were either in short supply or completely unavailable and more than 400 generic equivalents were backordered for greater than five days," the report states. "In most instances, these did not progress to critical shortages, but point to instabilities in the supply chain that cause national concern. Many of the drugs identified in 2010 remain unavailable or in short supply in 2011."

The shortages, especially acute for cancer drugs, put patients at risk for several reasons: In some cases no substitute exists, and when they do, they may be less effective or have greater risks of adverse side effects.

"The chance of medical error also rises," Sen. Amy Klobuchar (D-Minn.) said during the call, "as providers are forced to use second- or third-tier drugs that they're less familiar with."

Klobuchar has introduced legislation that would require drugmakers to give the Food and Drug Administration early notification of any incident that could result in a drug shortage. The bill would also require the FDA to give "up-to-date, public notification of any shortage situation." 

"Right now, pharmacists and physicians are about the last to know that a shortage is coming," Klobuchar said. "Sometimes they find out just before a patient's treatment. That's just not right."

The industry trade group Pharmaceutical Research and Manufacturers of America has not taken position on the legislation.

PhRMA said in a statement that drugmakers already work with the FDA to coordinate access to medicines in case of a disaster.


Source:
http://thehill.com/blogs/healthwatch/medical-devices-and-prescription-drug-policy-/152163-klobuchar-touts-legislation-as-experts-warn-of-drug-shortages

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