Drug shortages, deficits persist despite efforts

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Drug shortages have increased annually since 2007 and -- despite new authority given to the U.S. Food and Drug Administration to better manage shortfalls -- deficits persist, forcing doctors to delay or ration care in the most serious cases, according to a new report from a government watchdog.

An analysis compiled by the U.S. Government Accountability Office, issued Monday, said that new shortages actually declined from 2011 to 2012 -- but that when the 195 new shortages are added to 261 carried over from prior years, there were 456 total drug shortages in 2012, nearly triple the number reported in 2007.

Full figures weren't available for 2013, but based on shortage reports issued through June 30, last year's total number seems likely to eclipse the 2012 number.

From potassium phosphate (found in IV drips) to diuretics to epinephrine allergy injections to anti-anxiety drugs, the shortages include oral and injectable therapies.

The good news, according to the GAO, is that the FDA helped prevent 154 potential shortages in 2012. By way of new data and authority conveyed by the 2012 FDA Safety and Innovation Act, the agency can now better predict, and communicate, oncoming shortages to pharmacies, hospitals and patients.

The GAO said most drug shortages can be traced to supply disruptions created when a major manufacturer halts or slows production, creating shortfalls that cascade throughout the distribution chain.

Some disruptions can be traced to recently issued manufacturing guidelines. "Many of the older plants did not meet the new standards," said Mary Beth Lang of HC Pharmacy Central Inc., a for-profit group purchaser that supplies UPMC and non-UPMC facilities. "We had shortages because they had to retool."

Other shortages, particularly in cancer therapies, were exacerbated when Ohio-based Ben Venue Laboratories Inc. shut down last year, she said.

Another factor is the plain old profit motive -- as products age, prices erode, and "generics can't make money," Ms. Lang said. So manufacturers stop producing certain drugs.

And sometimes, shortage symptoms are worsened by the FDA's own early-warning system: Once news of an impending shortage is issued, providers may try to hoard supplies.

At present, shortages in about 85 broad drug categories are ongoing, according to the FDA's own accounting. Within those categories, there are more than 1,600 products -- different brand names, different dosages -- on the shortage list.

Despite the size of the list, Ms. Lang said the situation has improved from a year ago, when a number of cardiac response drugs were in short supply.

For a current listing of drugs and therapies, visit www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm.

Bill Toland: btoland@post-gazette.com or 412-263-2625.

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