August 14, 2008

Out of Time

Bryan A. Liang, MD, PhD, JD


Last week, the Food and Drug Administration (FDA) issued a consumer alert warning patients that two Baltimore pharmacies may have received either expired or possibly counterfeit drugs.  Earlier this year, New York Attorney General Andrew M. Cuomo initiated legal action against CVS and Rite Aid pharmacies after a statewide investigation found it had sold expired products, including over-the-counter medications.

From a medical point of view, expiration dates are important. Over time, prescription and over-the-counter drugs lose potency and degrade as their chemical ingredients break down. This loss can be anywhere from five to 50 percent of the drug's original strength. Any reduction in can lead to clinically important complications if the drug is used to treat serious conditions.

The expiration date specifies the date that the manufacturer guarantees the full potency and safety of a drug. As my colleague, Professor Marv Shepherd, shared with MarketWatch, "To be safe, the pharmaceutical companies will put maybe a 12-months or 24-months expiration date on [a drug] when they know it's probably good for 36 months, but they don't want to take any chances because they don't know where the person's going to store it. If you put it in a glove compartment in the southern United States, it won't last very long at all."

This raises another important medical issue: drug storage. Because along with time, another important factor that affects a drug's potency is how it's stored. Sunlight, heat and humidity accelerate a drug's breakdown. Unfortunately, common places such as bathrooms, kitchens, and cars are some of the worst sites to store medicines since they are exposed to extreme changes in temperature and humidity. The best places to store medications are in dry, dark places at either reasonable room temperature or, if required, in a refrigerator.

Although there are sometimes signs that signal significant deterioration, many drugs do not display any visual signs of degradation.

As a patient safety matter, patients should go through their prescription and over-the-counter medicines at least once a year and remove expired drugs and move all drugs into appropriate storage areas. To learn more about how to safely dispose of expired medications, download the FDA's guide to "How to Dispose of Unused Medicines.”