Expired-drug take vs. toss debate gets new vetting

Both the U.S. National Stockpile of drugs and an FDA testing program used to extend the shelf life of stockpiled meds are enjoying renewed visibility thanks to a Monday Washington Post report. Despite the Post's good intentions in airing the issue of whether patients should use drugs that have exceeded their expiration dates, the story does more to muddy the waters for consumers, as it contains informed arguments for both tossing and taking.

The story quotes authorities on the performance and safety of drugs which have expired, including an FDA spokesperson: "The [expired] drug could retain its potency," according to the story, or it "could degrade into nontoxic impurities, giving rise to an ineffective product, or the drug could degrade into toxic impurities."

So, should we take it or not? The FDA spokesperson "does not recommend swallowing medicine after its expiration date, even if it's just a couple of months too old," the report said.

But, alas, there is "a fudge factor." That's where the federal Shelf-Life Extension Program for stockpiled drugs comes in. The FDA analyzes specific lots of an expired stockpiled medication. If the drug passes potency and safety tests, the FDA extends the shelf life, as we've reported.

The program came in handy during the 2009 H1N1 flu epidemic, when children's liquid Tamiflu became scarce. Some expired solid dose Tamiflu batches in the national stockpile were tested by the FDA and then granted an extra two years. Pharmacists boosted supplies of the children's formulation by compounding the contents of expired tablets with cherry syrup.

Ironically, just one day after the Post story ran, the American Pharmacists Association (APhA) issued a definitive statement on the take-versus-toss question: Toss. "Expired medications can lose their potency, thus reducing or providing no value to the condition being treated," the statement said. "Check the date on everything in your medicine cabinet and dispose of anything that has passed the expiration date."

- here's the story
- see the APhA statement

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