Drug shortages may compel providers to "ration care or rely on less effective drugs," according to a new report from the Government Accountability Office (GAO).
Drug shortages are up nearly 300 percent from 2007, from 154 to 456, due mainly to generic versions of sterile injectable drugs, according to the report.
The GAO attributed the problem to manufacturers halting or slowing production to address quality problems, which triggers a supply disruption.
Although the report acknowledged that the Food and Drug Administration has made strides to avoid drug shortages in recent years, the GAO said the FDA still lacks a standardized data management policy, and does not run regular quality checks on that data. These limitations hurt efforts to prevent drug shortages and also hinder identification of their root causes, the report said.
"[The] FDA should 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 report states. These precautions will help the agency "recognize trends, clarify causes, and resolve problems before drugs go into short supply."
The GAO added that the Department of Health & Human Services agrees with the recommendations.
Although the looming drug shortage is a concern, the report noted that new shortages, declined in recent years, falling from 255 in 2011 to 195 in 2012. The FDA believes this decline is due to rules that require a manufacturer to report any issues (or potential issues) that will affect availability, FiercePharmaManufacturing previously reported.
To learn more:
- here's the report (.pdf)