Most of us have reached for a painkiller, at one time or another, only to discover the date on the label shouts out that it has expired. But what does an “expiration” date on medicine really mean? Is it dangerous if you take it anyway? Or just less effective?
This issue is a conundrum. Most drugs don’t fall off a cliff of efficacy when they reach their expiration date.
Pharmacies across the country — in major medical centres and in neighbourhood strip malls — routinely toss out tons of scarce and potentially valuable prescription drugs when they hit their expiration dates.
The term “expiration date” is a misnomer. The dates on drug labels are simply the point up to which the Food and Drug Administration and pharmaceutical companies guarantee their effectiveness, typically at two or three years. But the dates don’t necessarily mean they’re ineffective immediately after they “expire” — just that there’s no incentive for drugmakers to study whether they could still be usable.
But then when you inadvertently “underdose” yourself by taking antibiotics that aren’t full strength, you run the risk that the bacteria you’re battling will figure out not only how to defeat this weakened drug, but
other antibiotics, too.At least 23,000 people each year in the U.S. alone die from infections that have become resistant to antibiotics, according to the Centers for Disease Control and Prevention.
Therefore, Roy Gerona, a researcher at the University of California, ran tests on some decades-old drugs, including some now defunct brands such as the diet pills Obocell (once pitched to doctors with a portly figurine called “Mr. Obocell”) and Bamadex, in his lab.
Overall, the bottles contained 14 different compounds, including antihistamines, pain relievers and stimulants.
The findings were surprising: A dozen of the 14 compounds were still as potent as they were when they were manufactured, some at almost 100 percent of their labelled concentrations.
Lo and behold, the active ingredients are pretty stable.
The idea that drugs expire on specified dates goes back at least a half-century, when the FDA began requiring manufacturers to add this information to the label. The time limits allow the agency to ensure medications work safely and effectively for patients.
To determine a new drug’s shelf life, its maker zaps it with intense heat and soaks it with moisture to see how it degrades under stress. It also checks how it breaks down over time. The drug company then proposes an expiration date to the FDA, which it reviews to ensure it supports the date and approves it.
Despite the difference in drugs’ makeup, most “expire” after two or three years. Pharmacists and researchers say there is no economic “win” for drug companies to investigate further. They ring up more sales when medications are tossed as “expired” by hospitals, retail pharmacies and consumers despite retaining their safety and effectiveness.
That being said, it’s an open secret among medical professionals that many drugs maintain their ability to combat ailments well after their labels say they don’t.
The federal agencies that stockpile drugs , including the military, the Centers for Disease Control and Prevention and the Department of Veterans Affairs, have long realized the savings in revisiting expiration dates.
In 2000, the American Medical Association, foretelling the current prescription drug crisis, adopted a resolution urging action. The shelf life of many drugs, it wrote, seems to be “considerably longer” than their expiration dates, leading to “unnecessary waste, higher pharmaceutical costs, and possibly reduced access to necessary drugs for some patients.”
Citing the federal government’s extension program, the AMA sent letters to the FDA, the U.S. Pharmacopeial Convention, which sets standards for drugs, and PhRMA asking for a re-examination of expiration dates. But the effort just fell flat.
The 2006 FDA study of the extension program said it pushed back the expiration date on lots of mannitol, a diuretic, for an average of five years.
On rare occasions, a pharmaceutical company will extend the expiration dates of its own products because of shortages. That’s what happened in June, when the FDA posted extended expiration dates from Pfizer for batches of its injectable atropine, dextrose, epinephrine and sodium bicarbonate. The agency notice included the lot numbers of the batches being extended and added six months to a year to their expiration dates.
The 2015 commentary in Mayo Clinic Proceedings, called “Extending Shelf Life Just Makes Sense,” also suggested that drugmakers could be required to set a preliminary expiration date and then update it after long-term testing. An independent organization could also do testing similar to that done by the FDA extension program, or data from the extension program could be applied to properly stored medications.
Whatever the solution, the drug industry will need to be spurred in order to change, says Hussain, the former FDA scientist. “The FDA will have to take the lead for a solution to emerge,” he says. “We are throwing away products that are certainly stable, and we need to do something about it.”
