Feb. 10—Although the number of drug shortages remains high, medical shortfalls have been declining since 2011, the Government Accountability Office (GAO) reported Monday.

The total number of active drug shortages increased from each year since 2007 before peaking at 255 shortages in 2011. The 195 pharmaceutical shortfalls in 2012, a 24 percent decrease, was the first drop in reported shortages since 2006.

The decrease appears likely to continue. Although GAO reported data for only the first half of 2013, only 73 shortages were reported in the first half of the year.

However, the number of active, ongoing shortages continues to increase. Ongoing shortages each year grew rapidly from 40 in 2007 to 261 in 2012. Through June 2013, 288 ongoing shortages were reported.

Most of the recent shortages, 40 percent, resulted from “quality concerns”—manufacturing shutdowns due to problems related to the purity of drugs or sterility of pharmaceutical makers’ facilities—according to a GAO analysis of data from the Food and Drug Administration (FDA).

The GAO found 30 percent of drug shortages in a recent 18-month period were due to “manufacturing delays or capacity issues.” Typically, these involved temporary shutdowns to perform remediation of problems identified in the production process.

Additionally, 12 percent of the recent shortages resulted from product discontinuations and 9 percent were from the unavailability of raw materials, GAO found.

Helping to reduce the incidence of new shortages, according to the GAO report, were several FDA initiatives, including expedited review of abbreviated new drug applications and working with manufacturers to increase production.

The GAO concluded FDA’s actions prevented 89 potential shortages in 2011, 154 potential shortages in 2012, and 50 potential shortages through June 2013. Those were an increase from the 50 prevented through June 2011.

Likely to further help is ongoing implementation of the 2012 Food and Drug Administration Safety and Innovation Act. Among the provisions in that law that will continue to help reduce shortages are new requirements for manufacturers to increase their notifications of impending shortages.

Provider advocates reported that advanced notifications have helped, but many drug shortage problems first addressed by GAO in 2011 continue. For instance, drug shortages are still causing delays in or rationing of care, scrambles to find alternative drugs, and increasing risk medication errors associated with switching to replacement medications with which clinicians are less familiar.

The GAO urged increased FDA oversight of drug shortages, particularly in relation to a new drug shortages information system.

Publication Date: Monday, February 10, 2014