Remote Medicine: Whats in an Expiry date ?

[tniuqs]

This was forwarded to myself .. with a colleague in a very remote spot, when he noted some 'expiry dates" ... on OTCs

FAMILY OF DOCTORS IN ENGLAND HAVE BEEN HAMMERING THIS POINT THAT MEDICINES DON’T EXPIRE.

AN 80 YEARS OLD WELL KNOWN DOCTOR, IN MUMBAI, WITH VAST EXPERIENCE INSIST ON SAME POINT. DO MEDICATIONS REALLY EXPIRE ??????

By Richard Altschuler

Does the expiration date on a bottle of a medication mean anything? If a bottle of Tylenol, for example, says something like "Do not use after June 1998," and it is August 2002, should you take the Tylenol? Should you discard it? Can you get hurt if you take it? Will it simply have lost its potency and do you no good?

In other words, are drug manufacturers being honest with us when they put an expiration date on their medications, or is the practice of dating just another drug industry scam, to get us to buy new medications when the old ones that purportedly have "expired" are still perfectly good?

These are the pressing questions I investigated after my mother-in-law recently said to me, "It doesn't mean anything," when I pointed out that the Tylenol she was about to take had "expired" 4 years and a few months ago. I was a bit mocking in my pronouncement -- feeling superior that I had noticed the chemical corpse in her cabinet -- but she was equally adamant in her reply, and is generally very sage about medical issues.

So I gave her a glass of water with the purportedly "dead" drug, of which she took 2 capsules for a pain in the upper back. About a half hour later she reported the pain seemed to have eased up a bit. I said, "You could be having a placebo effect," not wanting to simply concede she was right about the drug, and also not actually knowing what I was talking about.

I was just happy to hear that her pain had eased, even before we had our evening cocktails and hot tub dip (we were in "Leisure World," near Laguna Beach, California, where the hot tub is bigger than most Manhattan apartments, and "Heaven," as generally portrayed, would be raucous by comparison).

Upon my return to NYC and high-speed connection, I immediately scoured the medical databases and general literature for the answer to my question about drug expiration labelling. And voila, no sooner than I could say "Screwed again by the pharmaceutical industry," I had my answer.

Here are the simple facts:

First, the expiration date, required by law in the United States, beginning in 1979, specifies only the date the manufacturer guarantees the full potency and safety of the drug - it does not

mean how long the drug is actually "good" or safe to use.

Second, medical authorities uniformly say it is safe to tak drugs past their expiration date -- no matter how "expired" the drugs purportedly are. Except for possibly the rarest of exceptions, you won't get hurt and you certainly won't get killed. Studies show that expired drugs may lose some of their potency over time, from as little as 5% or less to 50% or more (though usually much less than the latter). Even 10 years after the "expiration date," most drugs have a good deal of their original potency.

One of the largest studies ever conducted that supports the above points about "expired drug" labelling was done by the US military 15 years ago, according to a feature story in the Wall Street Journal (March 29, 2000), reported by Laurie P. Cohen.

The military was sitting on a $1 billion stockpile of drugs and facing the daunting process of destroying and replacing its supply every 2 to 3 years, so it began a testing program to see if it could extend the life of its inventory.

The testing, conducted by the US Food and Drug Administration (FDA), ultimately covered more than 100 drugs, prescription and over-the-counter.

The results showed, about 90% of them were safe and effective as far as 15 years past their expiration date.In light of these results, a former director of the testing program, Francis Flaherty, said he concluded that expiration dates put on by manufacturers typically have no bearing on whether a drug is usable for longer.

Mr. Flaherty noted that a drug maker is required to prove only that a drug is still good on whatever expiration date the company chooses to set. The expiration date doesn't mean, or even suggest, that the drug will stop being effective after that, nor that it will become harmful.

"Manufacturers put expiration dates on for marketing, rather than scientific, reasons, " said Mr. Flaherty, a pharmacist at the FDA until his retirement in 1999. "It's not profitable for them to have products on a shelf for 10 years. They want turnover." The FDA cautioned there isn't enough evidence from the program, which is weighted toward drugs used during combat, to conclude most drugs in consumers' medicine cabinets are potent beyond the expiration date.

Joel Davis, however, a former FDA expiration-date compliance chief, said that with a handful of exceptions -- notably nitroglycerin, insulin, and some liquid antibiotics -- most drugs are probably as durable as those the agency has tested for the military.

"Most drugs degrade very slowly," he said. "In all likelihood, you can take a product you have at home and keep it for many years." Consider aspirin. Bayer AG puts 2-year or 3-year dates on aspirin and says that it should be discarded after that.

However, Chris Allen, a vice president at the Bayer unit that makes aspirin, said the dating is "pretty conservative"; when Bayer has tested 4-year-old aspirin, it remained 100% effective,he said. So why doesn't Bayer set a 4-year expiration date? Because the company often changes packaging, and it undertakes "continuous improvement programs,"

Mr. Allen said. Each change triggers a need for more expiration-date testing, and testing each time for a 4-year life would be impractical. Bayer has never tested aspirin beyond 4 years, Mr. Allen said. But Jens Carstensen has.

Dr. Carstensen, professor emeritus at the University of Wisconsin's pharmacy school, who wrote what is considered the main text on drug stability, said, "I did a study of different aspirins, and after 5 years, Bayer was still excellent”. Aspirin, if made correctly, is very stable. Okay, I concede. My mother-in-law was right, once again. And I was wrong, once again, and with a wiseacre attitude to boot. Sorry mom. Now I think I'll take a swig of the 10-year dead package of Alka Seltzer in my medicine chest to ease the nausea I'm feeling from calculating how many billions of dollars the pharmaceutical industry bilks out of unknowing consumers every year who discard perfectly good drugs and buy new ones because they trust the industry's "expiration date labelling ."

[CPhT]

For the most part, the article is correct. The basis of most expiration dates is the actual potency of the drug. For example, we have an algorithm we follow when establishing the "beyond use" dating on our compounded medications. The algorithm takes into account the base of the medication (water based or otherwise), the form of the active ingredients (compounded from manufactured tablet vs compounded from a base powder), the storage temperature (fridge, freezer, room temp), and the sterility of the product. We can range from as small as 24 hours (high risk non-sterile chemo med compounded from a powder and into sterile IV form), through 180 days for most of our low risk meds (capsules and other "dry" medicines). All of our medications are tested by a third party laboratory to determine if we can actually use a different (longer) expiration date. They test the product for potency at the date it was made and every 30 days thereafter until the product loses 10% of it's labeled potency. Once the product drops below 10% of it's labeled potency, we can establish that as it's expiration date.

Now that having been said, would I use a medication at home that was expired? Short answer; yes. In a pinch, expired medicine is better than not having it at all.

Long answer; it depends on the product. If it was ever a refrigerated product, no. If it was a sterile product (eye drops, IV or other injection), no. If it was a narrow therapeutic index product, no. If the problem was severe enough that I really needed to trust the efficacy of the medication I was taking, no.

[tniuqs]

Nice from a pharmo tech .. interesting intel.

The biggest question is if and when anectine really was ineffective .. point being that it comes in 400 mg jugs and if your using correct dosage one has double the '100% " dosage with a certain degradation rate when would 400 be ineffective stored @ temps of 40 C.

Over seas, in lands far away have used Pen G (dried) in bottle and after 8 years stale date .. bottom line patient survived nicely, I never throw bug juice out unless its a suspension .

cheers

[CPhT]

Nice from a pharmo tech .. interesting intel.

The biggest question is if and when anectine really was ineffective .. point being that it comes in 400 mg jugs and if your using correct dosage one has double the '100% " dosage with a certain degradation rate when would 400 be ineffective stored @ temps of 40 C.

Over seas, in lands far away have used Pen G (dried) in bottle and after 8 years stale date .. bottom line patient survived nicely, I never throw bug juice out unless its a suspension .

cheers

I'm actually not familiar with either of those products yet (we don't use too many common/ commercially available products in my pharmacy, most of our work is either low-production or one-off). However, just looking at the anectine, it looks like it's an IV product, most commonly sold in 20mg/ml, 10ml multi-dose vials. MDVs, in our side of things, all contain preservatives, and will actually last longer than a SDV (single dose vial). The downside, is that per FDA regulations, once a multi-dose vial is punctured, the expiration date automatically changes to 28 days later.

The rationale behind the 28 days thing is that no matter how clean you're getting the septum of the vial and the needle itself, you'll still introduce a small amount of bacteria into the vial. After 28 days, the bacteria may have grown to the point where injecting the mixture has a high likelyhood of causing infection.

Have we had patients inject after the 28 days? Oh yeah we have. On several occasions. We've also had people take their vials and keep them on the shelf for almost a year (6 month non-punctured expiration on these products typically), use it once, then let it sit for a month and use it again. The expiration dates for most of our products are just what you'd expect; they are a way for us, as a pharmacy, to cover our butts when either A) a product has lost it's efficacy, or they experience an adverse affect from the product.

[DFIB]

In my remote experience with medicine, for years we would use expired ophthalmology drops, local anesthesia, analgesics, antibiotics and corticosteroids. All with very positive results. The surgeon said that he had talked directly to the rep. from xxxxx pharmaceutical company and had been told off he record that if the eye drops were still clear they were still good.

Edited November 20, 2011 by DFIB