Like
the proverbial bad penny, this issue keeps turning up: Do expiration dates on
medicines mean anything?
This
question often arises in Commission on Audit reports. In Cebu and Camarines, for
example, COA annual reports strafed officials for having, in stock, medicine beyond
their expiry dates.
Critics
earlier raked the fund-strapped V. Luna Military Hospital for accepting donations
of drugs nearing expiry dates. Our soldiers deserve better than lapsing - and
"ineffective" - medicine, the argument went.
So,
should you junk "expired" medicine? Or do you use them?
Stamping
expiration dates on drugs started in 1979. They "stand for something,"
Harvard Medical School says in it's Family Health Guide. "But (it's) probably
not what you think it does."
The
Harvard article forms part of "updating literature" for all US doctors.
Excerpts that may be useful for COA, local governments and families follow:
Much
of what's known today about drug expiration comes a question that the US military
tossed the Food and Drug Administration: Should it junk it's $1-billion stockpile
of medicine every two or three years?
FDA,
therefore, studied more than 100 drugs. It found that 90 percent of both prescription
and over-the-counter medicines, were perfectly good to use even 15 years after
the expiration date.
"Expiration
dates don't indicate a point at which the medication is no longer effective or
has become unsafe," the Harvard note states. "This is the date at which
the manufacturer can guarantee full potency and safety of the drug."
"Many
drugs stored under reasonable conditions retain 90% of their potency for at least
5 years after the expiration date on the label, and sometimes much longer",
notes Birgham Young University Health Center.
A
simple device, such as "placing a medication in a cool place, such as a refrigerator,
will help a drug remain potent for many years", it adds.
Some
medicines that FDA tests found effective after their expiration dates include,
among others: Bayer's anti-biotic Cipro and aspirin; SmithKline Beecham PLC's
Thorazine, a tranquilizer. Wyeth-Ayert's antidote to chemical poisoning was still
effective 15 years beyond the expiration date.
FDA's
findings saved the US military $263.4 million on it's initial grant of $78,000
for the study. We extended shelf lives instead of "destroying large quantities
of still-useful medical products," says Francis Flaherty who oversaw the
FDA testing program
This has implications for the Philippines and other poor
nations. Here, government clinics are perennially drug-short, from simple aspirins
to anti-tuberculosis drugs.
"TB
or not TB is the congestion," Woody Allen once wisecracked. But TB is no
joking matter here. TB incidence in the Philippines is triple that of Thailand.
But
many turn down drug-company donations, if they're within a year of expiration
dates. Is misinformation depriving sick people of medicine? "Is there no
balm in Gilead?" cried the ancient writers.
"Unless
you have nitroglycerin, insulin and liquid antibiotics, you can pretty much be
assured that your medication expires years beyond the date it says it does,"
notes Dr Joseph Mercola.
"The
major tragedy is many Third World countries needlessly discard the drugs that.
could actually be saving lives due to lack of appreciation of this concept,"
adds this author of "Total Health Program".
So,
are expiration dates just a marketing ploy?
"Look
at it another way," the Harvard note suggests. "Expiration dates are
very conservative to ensure you get everything you paid for. If a manufacturer
had to do expiration-date testing for longer periods, it'd slow their ability
to bring you new and improved formulations".
Drug-industry
officials don't dispute the results of the FDA's testing, within what is called
the "Shelf Life Extension Program", reports Wall Street Journal's Laurie
Cohen. "They
agree expiration dates have a commercial dimension. But they say relatively short
shelf lives make sense from a public-safety standpoint, as well".
"Two
to three years is a very comfortable point of commercial convenience," Cohen
quotes Mark van Arandonk, senior director for pharmaceutical development at Pharmacia
& Upjohn Inc. "It gives us enough time to put the inventory in warehouses,
ship it and ensure it will stay on shelves long enough to get used."
But
companies uniformly deny any effort to spur sales through planned obsolescence.
U.S.
Pharmacopeia, a non-profit scientific group, urges pharmacists to peg expiration
dates at no more than one year, if drugs are dispensed in containers other than
the original packaging.
"New
containers may let in more moisture and heat into the container the manufacturer
used for the stability study," says the USP General Counsel Joseph Valentino.
The one-year rule is "motivated by product integrity, not by profit."
When
faced by the drug expiration date dilemma, the Harvard note suggests a rule-of-thumb:
If the expiration date passed a few years ago and it's important that your drug
is absolutely 100% effective (as for stroke, cancer, etc.) "you might want
to consider buying a new bottle". Or ask your doctor.
COA
and other agencies unquestioningly abide by what's stamped on medicine label.
But it may be time to hone that mechnical response to current medical knowledge.
Far
too many Filipinos are poor and can not afford medicine. It'd be a crime to deny
them perfectly good drugs due to inability to read beyond a label. Health is precious.
"If you don't have a cold," the Chinese say, "you need not fear
to eat watermelons."
(E-mail: juan_mercado@boholchronicle.com) | 
