Study Questions Drug Expiration Policy

 

From the 8 October 2012 article at MedPage Today

By Charles Bankhead, Staff Writer, MedPage Today

Published: October 08, 2012

Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, BSN, RN, Nurse Planner

Prescription drugs retained their potency for as long as 40 years after expiration date, an analysis of 14 different compounds showed.

Overall 12 (86%) of the compounds tested at concentrations at least 90% of the labeled amount. Three compounds had concentrations that exceeded labeled amounts, and in two cases laboratory tests showed the compounds had less than 90% of the labeled concentration.

The findings add to existing evidence that prescription drugs retain their potency long after the expiration date, according to a research letter published online in Archives of Internal Medicine.

“The most important implication of our study involves the potential cost savings resulting from lengthier product expiration dating,” Lee Cantrell, PharmD, of the California Poison Control System in San Diego, and co-authors wrote. “Each dollar spent on SLEP [the Shelf-Life Extension Program] to demonstrate longer-than-labeled drug stability results in $13 to $94 saved on reacquisition costs…

…

The study involved eight medications comprising 15 different active ingredients, all in original, unopened containers. The medications were methaqualone, codeine, meprobamate, amphetamine, pentobarbital, secobarbital, and hydrocodone.

In addition to the primary ingredient, one or more of the eight medications included butalbital, aspirin, phenacetin, caffeine, phenobarbital, homatropine, chlorpheniramine, acetaminophen, and caffeine.

Ultimately, the authors evaluated medications representing 14 drug compounds. For each of the eight medications, the authors dissolved the contents of tablets/capsules, sonicated in methanol, reconstituted in analysis buffer, and analyzed with liquid chromatography time-of-flight mass spectrometry. Homatropine was the only drug not included in testing.

Of the 14 compounds analyzed, 12 retained the generally recognized minimum acceptable potency of 90% of labeled amount. The only two that did not meet the 90% minimum standard were aspirin (200 mg labeled, 2.28 mg by analysis; 226.8 mg labeled, 1.53 by analysis) and amphetamine (5.0 mg labeled, 2.2 mg by analysis; 15.0 mg labeled, 8.1 mg by analysis).

 

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