- Miriam E Tucker, freelance journalist
- 1Bethesda, Maryland, US
The drug shortage in the United States seems to be improving, but it’s unlikely to disappear any time soon. For the past few years, critical shortages of drugs—primarily generic sterile injectables used in anesthesiology and for the treatment of infections and cancer—have forced US physicians to use alternatives that are less effective, more costly, or associated with more adverse events. And in some cases, no alternatives have been available.
In 2010, 178 drug shortages were reported to the Food and Drug Administration. In 2011 that number grew to 251, of which 183 were sterile injectables. Currently, the website of the American Society of Health-System Pharmacists lists 226 ongoing shortages (www.ashp.org/drugshortages/current).
In a survey of members conducted by the American Society of Anesthesiologists in March 2012, 98% of 3063 respondents reported current shortages of at least one anesthetic. Of those, 96% reported having to use an alternative drug, 50% had to change an anesthetic procedure in some way because of a shortage, 7% had to postpone cases, and 4% had to cancel cases.1
Efforts by the FDA, specialty societies, patient advocacy groups, and other stakeholders have raised awareness of the situation, and steps have been initiated to mitigate the problem. The passage of the Food and Drug Administration Safety and Innovation Act (FDASIA) in July is viewed as a possible turning point. Among other measures, it requires all manufacturers—not just sole manufacturers, as in the previous law—to inform the FDA of impending shortages so that action can be taken to prevent them, such as identifying additional sources of the product or allowing for temporary foreign import.
But, the recent fungal meningitis outbreak crisis involving contaminated products …