Drug shortages continue, despite preventive legislation

Drug shortages continue to plague hospitals across the nation despite legislation last year that attempted to make it easier for the Food and Drug Administration to prevent the shortages, reports MedPage Today.

Hospitals still face 300 ongoing drug shortages, essentially the same number of shortages it experienced at this time last year, according to the University of Utah Drug Information Services, which MedPage cites in the article.

The good news is new drug shortages are slightly down, which researchers attribute to the FDA's ability to prevent more of these shortages. This year the Drug Information Service recorded 54 new shortages, compared to 204 new ones last year and 267 in 2011.

Last year Congress passed The FDA Safety and Innovation Act, which requires manufacturers to notify the FDA as soon as possible when a production interruption occurs in a "life-supporting" or "life-sustaining" drug and at least six months in advance if it plans to discontinue such a product.

"For what Congress can legislate, yes, it did help," Sarah Fox, PharmD, director of the school's Drug Information Service, told MedPage Today. "At least the FDA is doing more to prevent these shortages from happening in the first place. That's the silver lining in all of this."

Meanwhile, hospital pharmacies are looking into a cost-effective option for ensuring the adequate flow of crucial compound drugs: Mixing them in-house.

According to Pharmacy Practice News, hospital pharmacies have run up against compound drug shortages because many vendors are closing their doors after failing FDA inspections following the fallout over the recent meningitis outbreak caused by tainted compounding.

Although bringing the sterile compounding workload back into the hospital has its own challenges, such as adjusting staffing and workflow and compliance with regulation involving beyond-use dating (BUD), the long-term savings and adequate stock of drugs may outweigh the risks. The more prepared solutions that a pharmacy has on hand with BUD, the more stable its supply and the better it can schedule to maximize workflow.

For hospitals that decide to start mixing the compound drugs in-house, there are affordable technologies available, such as semi-automated compounding devices that can be used safely within an ISO Class 5 hood, Bernadette Ellegard, R.Ph., principal at Ellegard Pharmacy Consulting, LLC, in Kent, Conn., told Pharmacy Practice.

These types of technologies are worth the price because they create less medication waste. Products don't expire as fast because they're sterile, she said, and technicians don't have to manually test the samples and then discard them.

To learn more:

- read about the drug shortages
- read the article about compound drugs

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