When I asked him about his expired reserve, he laughed and said he had worse squirreled away. The expiration dates don’t concern him, since none of the medications treat chronic, life-threatening ailments. He’s happy to pop old pills if he has a sore shoulder (the naproxen), and he will take a chance with the malaria meds (the chloroquine) on his next work trip to Africa.
Is this a good idea?
Probably not, said Shelly Burgess, a spokeswoman for the Food and Drug Administration. She said neither the FDA nor drug companies can guarantee what happens to an outdated medication. “The drug could retain its potency,” Burgess said, or “the drug could degrade into nontoxic impurities, giving rise to an ineffective product, or the drug could degrade into toxic impurities.”
In any event, she does not recommend swallowing medicine after its expiration date, even if it’s just a couple of months too old.
Exceptions to the rule
There are studies, however, that suggest a certain fudge factor can temper this rule.
A 2006 study in the Journal of Pharmaceutical Sciences done by the FDA found that 88 percent of drugs held in the Strategic National Stockpile, a repository of medical supplies maintained around the country for emergency situations, had their shelf life extended “at least one year beyond their original expiration date” because an FDA testing program found they were still safe to use. Among the types of drugs that were extended were pain medications, antibiotics, antivirals and malaria drugs. The testing information “supports the assertion that many drug products, if properly stored, can be extended past the expiration date,” the study reported.
Desmond Hunt, a senior scientific liaison for the United States Pharmacopeia, the nonprofit group that sets standards for drugs used in this country, said it’s probably not fair to extrapolate that advice to your own medicine cabinet, however.
Medication that the average person buys, he said, “can go through many hands from the time it is shipped from the manufacturer until it reaches the end-user. During each handoff and during the transportation process, there is a potential for a drug product to be stored outside its labeled temperature requirements. It could sit on the tarmac in humidity, for example, or sit out in the rain.” In maintaining its stockpile, on the other hand, he said, the government “has a tight control over its products, who they buy from, how they are shipped and how they are stored. This is the best-case scenario.”
He added that “if you have a choice, I wouldn’t take an out-of-date medication.”
To get FDA approval, drug manufacturers must prove that their medications retain their potency throughout their promised shelf life. To do this, scientists expose the drugs to various temperatures and humidity levels and then check to see how well the packaging has held up and whether there has been a change in the look or smell of the medication. In the case of tablets, they then dissolve the drugs in a chemical solution to separate out the drug component and test whether its strength has diminished or remained stable. Drugs in liquid form receive comparable tests.
Maryland and the District are especially cautious about shelf life: Both stipulate that the expiration date for prescription drugs is the one stamped on the package by the manufacturer or one year after a drug is dispensed, whichever comes first.
Virginia does not have a similar law, but “it is common practice among pharmacies to indicate an expiration or ‘use before’ date on the prescription label,” said the executive director of Virginia’s Board of Pharmacy, Caroline Juran. “This date is generally one year [from when drugs are dispensed] or the manufacturer’s expiration date, whichever is shorter.”
Not in the bathroom
Tamiflu is one of the drugs in the Strategic National Stockpile whose expiration dates have been extended. During the H1N1 flu epidemic in 2009, the shelf life was lengthened for some batches of the antiviral medication.
“The products are usually extended for two years,” said Mansoor A. Khan, director of the Division of Product Quality Research for the FDA. “But we test them every year” to ensure that the second year’s extension is warranted.
Experts agree that in a home environment, medications should be kept anywhere but in the bathroom, where humidity is most likely to cause them to degrade or lose their effectiveness. Frank Palumbo, the director of the Center on Drugs and Public Policy in the School of Pharmacy at the University of Maryland, said, “They should be kept in a relatively cool, dry place, outside of direct light. It could be a dresser drawer.”
Linda Thompson, a family physician in Bethesda, suggested storing drugs in well-marked plastic containers in the kitchen, though well away from food and beyond the reach of children. Also, make sure they are not exposed to changes in temperature.
She said she is especially cautious about the longevity of gel capsules and liquid syrups. “Capsules deteriorate faster,” Thompson said. “They absorb water and humidity and become wet. You wonder: Is there bacteria in there? I had a container of gel vitamins that got all stuck together because of the humidity. I couldn’t take them.”
That is why the integrity of the packaging is so important, Khan said. Coated pills, typically used for some nonprescription analgesics, are different, Thompson said. Even if they were bought two or three years ago, “they should be still good, depending on how you stored them,” she said. “But I wouldn’t give them to a child.”
Thompson has been practicing for more than 20 years. She has taken antibiotics that were three years old. “I got better,” she said, “but I don’t tell my patients to do that.”
Hambleton is a Washington-based freelance writer and documentary filmmaker.