How do you solve a problem like drug shortages?
- According to in-Pharmatechnologist, the all-time high for drug shortages was in 2011, when there were 251 new shortages.
- By comparison, in 2014, there were 44 new drug shortages, compared with 44 in 2013 and 117 new drug shortages in 2012.
- In 2012, the FDA enacted a law—the FDA Safety and Innovation Act (FDSIA)—designed to improve the agency's ability to help prevent drug shortages.
While there continue to be new drug shortages, it's not nearly as bad as it was only a few short years ago. Comapred to 2011, when there were 251 new drug shortages and President Barack Obama had to issue an executive order mandating that drug manufacturers communicate about possible drug shortages, things are considerably better now.
It's not that there aren't still shortages. Rather, it's that now there's more forewarning regarding shortages. The major reason things have improved is increased communication between drug manufacturers and the FDA—and the ability of the FDA to send out "Dear Healthcare Professionals" to alert the healthcare community about a drug shortage and discuss what is being done to address it.
But still, even with all of the communication in the world, shortages are shortages. Current drug shortages include saline, epinephrine emergency syringes, certain injectable diagnostic dyes, and injectable antibiotics ceftazidime, cefepime, and imipenem/cilastatin.
Drug shortages are more likely to occur when there is only one or a few manufacturers. By contrast, having a more competitive manufacturing environment decreases the risk of shortages. For that reason, David Gaugh, senior vice president, Science and Regulatory Affairs, Generic Pharmaceutical Association, suggests that one way to deal with shortages is to avert them by enhancing the generic approval pathway and allowing generics manufacturers to be part of the solution.
- in-Pharma Techologist Progress seen in addressing US drug shortages, but challenges remain