Drug Expiration Dates — Do They Mean Anything?

  

Category:  Health, Science & Technology

Via:  perrie-halpern  •  7 months ago  •  15 comments

Drug Expiration Dates — Do They Mean Anything?
FDA study gets to the heart of expired medicine and safety

S E E D E D   C O N T E N T



The big question is, do pills expire? With a splitting headache, you reach into your medicine cabinet for some aspirin only to find the stamped expiration date on the medicine bottle is more than a year out of date. So, does medicine expire? Do you take it or don't you? If you decide to take the aspirin, will it be a fatal mistake or will you simply continue to suffer from the headache?

The big question is, do pills expire? With a splitting headache, you reach into your medicine cabinet for some aspirin only to find the stamped expiration date on the medicine bottle is more than a year out of date. So, does medicine expire? Do you take it or don't you? If you decide to take the aspirin, will it be a fatal mistake or will you simply continue to suffer from the   headache ?

This is a dilemma many people face in some way or another. A column published in   Psychopharmacology Today   offers some advice.

It turns out that the expiration date on a drug does stand for something, but probably not what you think it does. Since a law was passed in 1979, drug manufacturers are required to stamp an expiration date on their products. This is the date at which the manufacturer can still guarantee the full potency and safety of the drug.

Most of what is known about drug expiration dates comes from a study conducted by the Food and Drug Administration at the request of the military. With a large and expensive stockpile of drugs, the military faced tossing out and replacing its drugs every few years. What they found from the study is 90% of more than 100 drugs, both prescription and over-the-counter, were perfectly good to use even 15 years after the expiration date.

So, the expiration date doesn't really indicate a point at which the medication is no longer effective or has become unsafe to use. Medical authorities state if expired medicine is safe to take, even those that expired years ago. A rare exception to this may be tetracycline, but the report on this is controversial among researchers. It's true the effectiveness of a drug may decrease over time, but much of the original potency still remains even a decade after the expiration date. Excluding nitroglycerin, insulin, and liquid antibiotics, most medications are as long-lasting as the ones tested by the military. Placing a medication in a cool place, such as a refrigerator, will help a drug remain potent for many years.

Is the expiration date a marketing ploy by drug manufacturers, to keep you restocking your medicine cabinet and their pockets regularly? You can look at it that way. Or you can also look at it this way: The expiration dates are very conservative to ensure you get everything you paid for. And, really, if a drug manufacturer had to do expiration-date testing for longer periods it would slow their ability to bring you new and improved formulations.

The next time you face the   drug expiration date dilemma , consider what you've learned here. If the expiration date passed a few years ago and it's important that your drug is absolutely 100% effective, you might want to consider buying a new bottle. And if you have any questions about the safety or effectiveness of any drug, ask your pharmacist. He or she is a great resource when it comes to getting more information about your medications.


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Gordy327
1  Gordy327    7 months ago

Medications can start to lose their efficacy after the expiration date. That doesn't mean they are completely ineffective or quickly "spoil" like milk can after their expiration date. As for the safety of a medication after expiration, that would largely depend on the medication and its storage conditions. Certain medications need to be temperature regulated or kept in a dark place as light can affect them. Moisture or air exposure over time can also cause meds to degrade and potentially become unsafe for use. But chances are, expired medications will not hurt you. They may not help you as well as they should. But they probably won't hurt.

 
 
 
Buzz of the Orient
1.1  Buzz of the Orient  replied to  Gordy327 @1    7 months ago

Does being "unsafe for use" past an expiration date mean they can become dangerous, such as poisonous, or simply become too ineffective to do what they are intended to do?

 
 
 
Perrie Halpern R.A.
1.1.1  seeder  Perrie Halpern R.A.  replied to  Buzz of the Orient @1.1    7 months ago

Buzz,

I have been trying to find it, but Cornell Veterinary School did a whole thing about the effectiveness of drugs past due, and they found that almost all pill drugs with the exception of the tetracycline group, are very effective even when they are 10 years old.

 
 
 
Gordy327
1.1.2  Gordy327  replied to  Buzz of the Orient @1.1    7 months ago

Possibly both. But again, it can vary depending on the med, its handling and storage.

 
 
 
Buzz of the Orient
1.1.3  Buzz of the Orient  replied to  Perrie Halpern R.A. @1.1.1    7 months ago

I still have Tylenol and Tylenol 3 (codeine) that I brought with me more than 13 years ago.  I used it so rarely because I have a high tolerance for pain, so I'm glad it could still be somewhat effective if I need it.  I can't remember the last time I used them.  

 
 
 
bccrane
2  bccrane    7 months ago

And here I have been trying to use them up as fast as I can before the expiration date. 

 
 
 
Perrie Halpern R.A.
2.1  seeder  Perrie Halpern R.A.  replied to  bccrane @2    7 months ago

See, now you don't have to rush jrSmiley_7_smiley_image.png

 
 
 
Split Personality
3  Split Personality    7 months ago

Nonsense for every dry thing stored in its original containers.  They will last for decades.

Liquids in an opened container will degrade.  Quicker if exposed to sunlight.

Anything left out on the bathroom or kitchen counter in a tray, exposed to the sun and varying levels of humidity will suffer from

the same decay that eventually makes your sofa cushions fail.

 
 
 
Perrie Halpern R.A.
3.1  seeder  Perrie Halpern R.A.  replied to  Split Personality @3    7 months ago

Well said SP!

 
 
 
MUVA
3.2  MUVA  replied to  Split Personality @3    7 months ago

Every thing?

 
 
 
Split Personality
3.2.1  Split Personality  replied to  MUVA @3.2    7 months ago

Did I state every thing? No.

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 — possibly toxic, probably worthless.

But to Lee Cantrell, who helps run the California Poison Control System, 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?

...

“This was very cool,” Gerona says. “Who gets the chance of analyzing drugs that have been in storage for more than 30 years?”

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.

...

What if the system is destroying drugs that are technically “expired” but could still be safely used?

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.”

...

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.


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.

...

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, but it 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.

https://www.propublica.org/article/the-myth-of-drug-expiration-dates
 
 
 
sandy-2021492
3.2.2  sandy-2021492  replied to  Split Personality @3.2.1    7 months ago
a local anesthetic made from lidocaine and epinephrine

Yup.  Actually, it's the epinephrine that loses its potency, so epinephrine autoinjectors should be checked regularly..

 
 
 
Split Personality
3.2.3  Split Personality  replied to  sandy-2021492 @3.2.2    7 months ago

and inhalers, like almost any aerosol, lose their "charge" over time...

 
 
 
Kathleen
3.2.4  Kathleen  replied to  Split Personality @3.2.3    7 months ago

I use mine up before it expires.

 
 
 
MrFrost
4  MrFrost    7 months ago

The only thing I take with regularity is insulin. After 28 days, I am supposed to pitch it and start a new vial. I get it through the VA so it's not a big deal, 29 bucks for 3 months. I usually use a vial for ~2 months, (I don't require a lot of insulin). Kit Kat, (my cat), is diabetic as well, (yea, it's a thing, I had no idea). So the vet tells me that he needs insulin, 1 unit, twice a day. One unit is almost literally a drop. She also tells me that he needs feline insulin. So, I load him into the Jeep and head for the pharmacy. She phoned it in so it would be ready when I get there. His insulin was $300.00 a vial, (that's supposed to be pitched after 28 days), because Kit Kat doesn't get insurance through his job. So I bought supplies for him, needles, sharps container, blood glucose monitor, etc.. I get home and I pull out his insulin to put it in the fridge and I noticed something.. It looked familiar. I grabbed a vial of my insulin and compared the two. Identical. No difference at all. 

If I followed the guidelines and threw it out after 28 days, for my insulin and Kit Kat's, $7,776.00 a year. Kit Kat now gets my insulin, since I never come close to running out. 

 
 
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