government

CMS rules contribute to drug shortages, hospital pharmacists say

An Institute for Safe Medication Practices survey concludes that strict expiration dates on drug labels, despite contrary evidence in national compendia, mean wasted medications.

By Charles Fiegl — Posted April 5, 2012

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Federal guidance requiring strict adherence to manufacturer labels for injectable drugs has forced hospitals to throw away perfectly good drugs that are in short supply, according to a survey of pharmacy directors and managers.

The Institute for Safe Medication Practices, based in Horsham, Pa., has called on the Centers for Medicare & Medicaid Services to review its policies involving stability and beyond-use dating of medicines. The institute surveyed 715 hospital pharmacists and managers who reported that following manufacturer directions has contributed to national drug shortages.

CMS requires pharmacists to be compliant with Food and Drug Administration-approved labels to avoid the use of expired drugs. But pharmacists who were surveyed said some labels are not current and that newer, evidence-based research supports a longer shelf life in certain circumstances.

Those studies have shown that diluted drugs remain stable beyond their stated expiration dates, said Allen J. Vaida, PharmD, the institute’s executive vice president. Nearly all of the respondents — 97% — said CMS rules requiring strict adherence to manufacturer’s directions when evidence-based compendia information recommends longer beyond-use dating increase waste of usable drugs.

In addition, 36% said following agency regulations often results in unnecessary waste, and 43% said it always results in waste. Six out of 10 respondents said they are compelled to discard injectable medications knowing that the labeling differs from information in national compendia.

“The survey results mean you’re not just wasting an expensive drug, it means you won’t be able to get more of” the drug to have on hand, Vaida said.

For instance, the drug label for succinylcholine, a neuromuscular blocker, says multidose vials are stable for up to 14 days at room temperature. But recent studies show it can remain stable for 30 days at room temperature, 45 days at 25 degrees Celsius and 90 days at 4 degrees Celsius.

Anesthesiologists and emergency medicine physicians have encountered shortages of that drug, Vaida added.

The institute has sent the survey results to CMS. Vaida said the institute hopes it can set up a meeting with the agency and the FDA to discuss its findings.

A CMS representative did not respond to a question about the survey by this article’s deadline.

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