The box of prescription drugs had been forgotten in a back closet of a retail pharmacy for so long that some of the pills predated the 1969 moon landing. Most were 30 to 40 years past their expiration dates
the cache was an opportunity to answer an enduring question about the actual shelf life of drugs: Could these drugs from the bell-bottom era still be potent?
The age of the drugs might have been bizarre, but the question the researchers wanted to answer wasn’t.
Pharmacies across the country — in major medical centers and in neighborhood strip malls — routinely toss out tons of scarce and potentially valuable prescription drugs when they hit their expiration dates.
Gerona and Cantrell, a pharmacist and toxicologist, knew that the term “expiration date” was 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.
ProPublica has been researching why the U.S. health care system is the most expensive in the world. One answer, broadly, is waste — some of it buried in practices that the medical establishment and the rest of us take for granted.
We’ve documented how hospitals often discard pricey new supplies, how nursing homes trash valuable medications after patients pass away or move out, and how drug companies create expensive combinations of cheap drugs. Experts estimate such squandering eats up about $765 billion a year — as much as a quarter of all the country’s health care spending.
In his lab, Gerona ran tests on the 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. Overall, the bottles contained 14 different compounds, including antihistamines, pain relievers and stimulants. All the drugs tested were in their original sealed containers.
The findings surprised both researchers:
A dozen of the 14 compounds were still as potent as they were when they were manufactured, some at almost 100 percent of their labeled concentrations.
“Lo and behold,” Cantrell says, “The active ingredients are pretty darn stable.”
“Refining our prescription drug dating process could save billions,” he says.
But after a brief burst of attention, the response to their study faded. That raises an even bigger question: If some drugs remain effective well beyond the date on their labels, why hasn’t there been a push to extend their expiration dates?
It turns out that the FDA, the agency that helps set the dates, has long known the shelf life of some drugs can be extended, sometimes by years.
For decades, the federal government has stockpiled massive stashes of medication, antidotes and vaccines in secure locations throughout the country. The drugs are worth tens of billions of dollars and would provide a first line of defense in case of a large-scale emergency.
Maintaining these stockpiles is expensive. The drugs have to be kept secure and at the proper humidity and temperature so they don’t degrade. Luckily, the country has rarely needed to tap into many of the drugs, but this means they often reach their expiration dates.
Though the government requires pharmacies to throw away expired drugs, it doesn’t always follow these instructions itself.
Instead, for more than 30 years, it has pulled some medicines and tested their quality.
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 reviews the data to ensure it supports the date and approves it.
Despite the difference in drugs’ makeup, most “expire” after two or three years.
Each year, drugs from the stockpiles are selected based on their value and pending expiration and analyzed in batches to determine whether their end dates could be safely extended. For several decades, the program has found that the actual shelf life of many drugs is well beyond the original expiration dates.
A 2006 study of 122 drugs tested by the program showed that two-thirds of the expired medications were stable every time a lot was tested.
Each of them had their expiration dates extended, on average, by more than four years, according to research published in the Journal of Pharmaceutical Sciences.
Each year the federal government saved $600 million to $800 million because it did not have to replace expired medication
Some medical providers have pushed for a changed approach to drug expiration dates — with no success.
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.”
ProPublica asked the FDA whether it could expand its extension program, or something like it, to hospital pharmacies, where drugs are stored in stable conditions similar to the national stockpile.
“The Agency does not have a position on the concept you have proposed,” an official wrote back in an email.
Whatever the solution, the drug industry will need to be spurred in order to change, says Hussain, the former FDA scientist.
Considering how beneficial these supposed expiration dates are for pharmaceutical companies, I expect it will be darn near impossible to have them officially extended.
I’m happy to hear how well the effectiveness is maintained because I keep stockpiles of unused meds. Most prescriptions were so expensive that I can’t bear to throw any of them out.
“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.”
By coincidence I had just recently posted about this myself:
8 Facts about Expired Medications