PHA-Exchange> Expired meds

[Aviva]

DO MEDICATIONS REALLY EXPIRE?
Try An Experiment With Your Mother-In-Law

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 labeling. And voila, no sooner th an 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 take 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. A contested example of a rare exception is a case of renal
tubular damage purportedly caused by expired tetracycline (reported by
G. W. Frimpter and colleagues in JAMA, 1963;184:111). This outcome
(disputed by other scientists) was supposedly caused by a chemical
transformation of the active ingredient. Third, 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. So wisdom dictates that if your life does
depend on an expired drug, and you must have 100% or so of its original
strength, you should probably toss it and get a refill, in accordance
with the cliché, "better safe than sorry." If your life does not depend
on an expired drug -- such as that for headache, hay fever, or menstrual
cramps -- take it and see what happens.

One of the largest studies ever conducted that supports the above points
about "expired drug" labeling 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 that about 90% of them were safe
and effective as far as 15 years past their original 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, especially if it's in the refrigerator."
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? Bec ause 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 labeling."
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