Tags: drug | shortage | dilemma | fda

Drug Rules Compound Shortages

Wednesday, 15 Feb 2012 03:08 PM


Hospitals faced with growing shortages of drugs for cancer and other diseases are confronting a dilemma about how to respond to rules requiring they be dumped after certain expiration dates – even if they continue to be safe and effective.
At one hospital in Florida, officials acknowledge they’ve discarded the scarce cancer drug doxorubicin, even as patients nationwide clamor for treatment, MSNBC.com reported this week.
“I’d never want to take a chance with not following the rules,” said Alan K. Knudsen, director of pharmacy legal services for Shands HealthCare at the University of Florida in Gainesville, in the report. “I wish I didn't have to throw it out."
Others told MSNBC that they are bucking federal regulations to provide patient care, as long as the drugs are still safe.
Federal regulators require most drugs be stored and handled in specific ways, and how soon they must be used after they're opened. Those requirements are approved by the Food and Drug Administration when a drug is cleared.
But a recent study at Cedars-Sinai Medical Center in Los Angeles found directions for many drugs are flawed. Of 50 drugs on FDA’s national shortage list, for instance, half lacked information about stability, storage and expiration dates after dilution, MSNBC reported.
The Institute for Safe Medication Practices and the American Society of Health-System Pharmacists have said the federal rules are exacerbating the problem of drug shortages. Last year, 267 drugs were in short supply, the most in U.S. history.




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Hospitals voice concerns about rules requiring drugs in short supply be handled and dumped in certain ways.
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Wednesday, 15 Feb 2012 03:08 PM
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