GAO: Drug shortages loom as health threat

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The Government Accountability Office (GAO) on Monday reported a public health threat from drug shortages that might force providers to “ration care or rely on less effective drugs.”

The three-fold spike in drug shortages since 2007 reportedly relates primarily to “generic-style injectable drugs.”

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“The immediate cause of drug shortages can generally be traced to a manufacturer halting or slowing production to address quality problems, triggering a supply disruption,” the report said. “Other manufacturers have a limited ability to respond to supply disruptions due to constrained manufacturing capacity.”
 
These quality control problems are unique to generic injectables industry, the GAO said, because the manufacturing companies often have low profit margins and limited infrastructure investments that frequently force them from the market.
 
In 2007, the GAO uncovered 154 drug shortages. That number went up to 456 in 2012, although the bulk of those began in prior years. The number of new shortages fell from 255 in 2011 to 195 in 2012.
 
The GAO said the Food and Drug Administration has prevented more shortages by improving its responsiveness and “developing procedures to enhance coordination between headquarters and field staff.”
 
“However, there are shortcomings in its management of drug shortage data that are inconsistent with internal control standards,” the report said. “For example, FDA has not created policies or procedures governing the management of the data and does not perform routine quality checks on its data.”
 
“Such shortcomings could ultimately hinder FDA's efforts to understand the causes of specific shortages as well as undermine its efforts to prevent them from occurring,” the report continued. “In addition, FDA has not conducted routine analyses of the data to proactively identify and evaluate the risks of drug shortages.”
 
The GAO recommended the FDA “strengthen its internal controls over its drug shortage data and conduct periodic analyses to routinely and systematically assess drug shortage information, using this information to proactively identify drug shortage risk factors.”
 
The GAO said the Health and Human Services Department agreed with its recommendations.