Posted on 07/19/2019 1:52:58 PM PDT by Sheapdog
I wonder how ‘expiration’ dates or ‘use by’ dates are determined.
For quick shelf-life projects, such as fresh fruits and veggies, milk, fresh meats, etc., and even frozen products those dates can be determined by testing. But, for a can of corn, for example, it may be good years after the recommended date.
In the article it goes on about how the military and government have extensions for their stockpiles.
After Cantrell and Gerona published their findings in Archives of Internal Medicine in 2012, some readers accused them of being irresponsible and advising patients that it was OK to take expired drugs. Cantrell says they weren’t recommending the use of expired medication, just reviewing the arbitrary way the dates are set.
“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.
In fact, the federal government has saved a fortune by doing this.
At a goverment stockpile, drugs don’t expire as fast
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 they support the date and then approves it. Despite the difference in drugs’ makeup, most “expire” after two or three years.
Once a drug is launched, the makers run tests to ensure it continues to be effective up to its labeled expiration date. Since they are not required to check beyond it, most don’t, largely because regulations make it expensive and time-consuming for manufacturers to extend expiration dates, says Yan Wu, an analytical chemist who is part of a focus group at the American Association of Pharmaceutical Scientists that looks at the long-term stability of drugs. Most companies, she said, would rather sell new drugs and develop additional products.
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.
Industry officials say patient safety is their highest priority. Olivia Shopshear, director of science and regulatory advocacy for the drug industry trade group Pharmaceutical Research and Manufacturers of America, says expiration dates are chosen “based on the period of time when any given lot will maintain its identity, potency and purity, which translates into safety for the patient.”
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. One pharmacist says he sometimes takes home expired over-the-counter medicine from his pharmacy so he and his family can use it.
The federal agencies that stockpile drugs — including the military, the Centers for Disease Control and Prevention and the U.S. Department of Veterans Affairs — have long realized the savings in revisiting expiration dates.
In 1986, the Air Force, hoping to save on replacement costs, asked the FDA if certain drugs’ expiration dates could be extended. In response, the FDA and Defense Department created the Shelf Life Extension Program.
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.
Some that failed to hold their potency include the common asthma inhalant albuterol, the topical rash spray diphenhydramine, and a local anesthetic made from lidocaine and epinephrine, the study said. But neither Cantrell nor Dr. Cathleen Clancy, associate medical director of National Capital Poison Center, a nonprofit organization affiliated with the George Washington University Medical Center, had heard of anyone being harmed by any expired drugs. Cantrell says there has been no recorded instance of such harm in medical literature.
Marc Young, a pharmacist who helped run the extension program from 2006 to 2009, says it has had a “ridiculous” return on investment. Each year the federal government saved $600 million to $800 million because it did not have to replace expired medication, he says.
An official with the Department of Defense, which maintains about $13.6 billion worth of drugs in its stockpile, says that in 2016 it cost $3.1 million to run the extension program — which saved the department from replacing $2.1 billion in expired drugs. To put the magnitude of that return on investment into everyday terms: It’s like spending a dollar to save $677.
“We didn’t have any idea that some of the products would be so damn stable — so robustly stable beyond the shelf life,” says Ajaz Hussain, one of the scientists who formerly helped oversee the extension program.
Hussain is now president of the National Institute for Pharmaceutical Technology and Education, an organization of 17 universities working to reduce the cost of pharmaceutical development. He says the high price of drugs and shortages make it time to re-examine drug expiration dates in the commercial market.
“It’s a shame to throw away good drugs,” Hussain says.
The AMA tries to extend shelf life — and fails
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.”
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.
No one remembers the details — just that the effort fell flat.
“Nothing happened, but we tried,” says rheumatologist Roy Altman, now 80, who helped write the AMA report. “I’m glad the subject is being brought up again. I think there’s considerable waste.”
At Newton-Wellesley Hospital, outside Boston, pharmacist David Berkowitz yearns for something to change.
On a recent weekday, Berkowitz sorted through bins and boxes of medication in a back hallway of the hospital’s pharmacy, peering at expiration dates. As the pharmacy’s assistant director, he carefully manages how the facility orders and dispenses drugs to patients. Running a pharmacy is like working in a restaurant because everything is perishable, he says, “but without the free food.”
Penicillin can be dangerous past its expiration date. Not sure how long past, but I’ve heard that’s true for that medicine at least.
It's conclusion was "many prescription pharmaceuticals retain their full potency for decades beyond their manufacturer-ascribed expiration dates."
Stability of Active Ingredients in Long-Expired Prescription Medications
Yes, toss it in a salad.....................
I have repeatedly read that almost all expiration dates are BS.
After having some personal experience with doxycycline that had gone past its expiration date, I think this topic needs a little more research and a lot more specificity. Be careful. Putting expired drugs into your body may be hazardous to your health.
The key word is “almost.” I would not ignore the expiration date unless I saw the test results for that specific drug or all it’s active ingredients.
If it has scent of vinegar it is from acetic acid....a breakdown product of aspirin(acetylsalicylic acid). But it loses much of its antiplatelet clotting activity if it degrades..it can still be analgesic as salicylic can do that.
If one were to look at history, medics during WWII collected urine from patients that had been treated with penicillin and used the urine on subsequent patients. Some drugs are stable even when excreted. Every drug should have a realistic shelf life and it isn’t too hard to study that shelf life. The USAF already has an effective plan for stored food and the template for the drugs is already in place.
Hell I’m only one year past 50 and I’ve lost 30 percent of mine :)
Meaning they are still 90% effective.
Some Medical Research Drs I know and I were discussing the Epi-pen price hike that was in the news a year or so ago. We talked about how expensive they were and that they had a shelf life of 2 years. They told me not really. The 2-year life is what the manufacturer has been able to statistically demonstrate to the FDA based on testing.
As they explained, drug manufacturers have really no incentive to be able to sell extremely long shelf life drugs. Even if a drug could last for 10, 15 or 20 years, why should a manufacturer go to the required testing and documentation to seek an FDA approval for a long shelf life? The Drug manufacturers go for a reasonable length shelf life based on seasonal usage patterns, and the time it takes from manufacturing to warehousing and distribution to the final retail outlet.
Specifically, they said if they had a 4 year old Epi-pen and I suddenly saw someone attacked by a swarm of bees and go into shock, they would use the Epi-pen past its pull date. Likely if might at worst be only 95% as effective as a similar drug within its pull date. Still if would probably save a life anyway.
“Meaning they are still 90% effective.”
Exactly. 90% is good enough for me.
Expiration dates are arbitrary and usually have more lawyer input into the process than science. Not uncommon to see foreign countries buying these up in large numbers.
This article is most correct. However, a bit of caution is advised. Their are some drugs that truly do have a very short shelf life, and this in particular are biologicals.
Most drugs if put in a freezer will last many years beyond their expiration date. Do not do this with biologicals. In our pharmacy we keep the biologicals in the refrigerator and some in an extremely cold freezer dependent on what biological it is. If it is a biological drug the expiration date is to be respected.
charlie the pharmacist.
My late ex-FIL was a drug rep who started a program in his company to collect expired meds from hospitals and sent them to medical missionaries in 3rd world countries.
He said the degradation of quality was so minimal it was insignificant. The Pharma companies ended it when their lawyers found out.
I have a 14 year old bottle of Amoxicillin Capsules my parents picked up for me from Mexico that still work. Recently found and took one and it cleared up my abscessed tooth till I could get a prescription from Dentist.
I've always understood that tetracycline and some of it's derivitives can be liver harmful once they deterioate. I suppose the timeframe of deterioration after “expiration” is relative to storage conditions. Having never seen any specific guidelines on how that toxicity timeline works, I've ALWAYS abided by the “expiration” date on the cyclinic drugs.
What this article fails to mention is that some of the degradation products are toxic. One of the antibiotics (doxycycline?) produces a toxin that targets the liver, IIRC.
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