Study Suggests Prescription Drugs Retain Potency Far Beyond Labeled Expiration Dates

Extending expiration dates on prescription drugs could yield enormous health care cost savings, according to a research letter published on Nov. 26 in the Archives of Internal Medicine. The letter’s authors point to study findings showing that many prescription drugs retain their full potency for decades beyond their labeled expiration dates.

A study of eight medications with 15 different active ingredients that had expired 28 to 40 years prior found that 12 of the 14 medications tested retained full potency for at least 336 months. Of those 12, eight retained full potency for at least 480 months. Only aspirin and amphetamine were present in amounts of less than 90 percent of labeled content.

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According to the study authors, the results of the study "support the effectiveness of broadly extending expiration dates for many drugs, the efficacy of which has been demonstrated by [Shelf-Life Extension Program (SLEP)] in a more controlled fashion." SLEP, which checks long-term stability of federal drug stockpiles, found that 88 percent of 122 different drugs stored under ideal environmental conditions had their expiration dates extended more than one year, with an average extension of 66 months and a maximum extension of 278 months.

While this research doesn't imply one can simply use all expired drugs, it does raise the issue for drug companies and regulators to evaluate further. "The most important implication of our study involves the potential cost savings resulting from lengthier product expiration dating," the authors note. "Each dollar spent on SLEP to demonstrate longer than labeled drug stability results in $13 to $94 saved on reacquisition costs. Given that Americans currently spend more than $300 billion annually on prescription medications, extending drug expiration dates could yield enormous health care expenditure savings."

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