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, 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 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 motherin-law
was right, once again. And
I was wrong, once again, and with
a wiseacre attitude to boot. Sorry
mom.
www.smartgovernance.in | February 2020 41