Mounting shortages of crucial drugs are creating a new dilemma for the nation’s hospital pharmacists, who say they find themselves caught between breaking government rules for storage and safety -- or throwing away vital and lifesaving medications.
At one hospital in Florida, officials acknowledge they’ve discarded the scarce cancer drug doxorubicin, even as patients nationwide clamor for treatment.
“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. “I wish I didn't have to throw it out."Surprise, surprise, FDA rules require following the inserts that come with the drugs, even when those inserts are now out of date, and the regulatory cost of updating those inserts is excessive:
Those requirements should be listed in the official prescribing information package inserts that are approved by the federal Food and Drug Administration when a drug is cleared. But the directions may be incomplete or outdated. It can be costly and time-consuming to seek new FDA label approval, so updated science often doesn't make it into the inserts.The problem here is that at a certain point, common sense and the needs of the patients have to take precedence over slavish following of rules. But slavish following of rules is what the federal government is creating.