Drug Expiration Dating-A Marketing Ploy

I receive the following article from my e-mail just recently. I have posted a similar article in my blogs last February after our Medical Mission in Marinduque. But just in case you missed my article, here's a refresher. If you are from Marinduque, I will appreciate if you share this article with the medical, nursing, dental,and pharmaceutical professionals in our province and in the six towns of the island. Thank You!

Subject: DO MEDICATIONS REALLY EXPIRE? GOOD INFO!

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 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 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.

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" 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."

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 labeling."