LIKE A BUM CHECK, this old story keeps on bouncing. Only the names, places and time change. And it pivots around an old issue:Do expiration dates on medicines really mean anything?
The latest version happened in Talisay City. “Some medicines distributed to indigents during a medical-dental mission were already expired”, the papers reported.
The 34-year old polio victim said medicine she received, in February 2007, had expiry dates for March 2006 The chair of the Talisay health committee was “disgusted”. And the Bureau of Food and Drugs threatened legal action.
Isn't this old hat? Critics earlier raked 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, do you trash expired medicine? Or don’t you? Expiration dates, which started in 1979, “stand for something,” Harvard University’s Medical School says in its Family Health Guide. “But (it’s) probably not what you think it does.” The article is part of updating literature” for all US doctors, I wrote earlier.
Excerpts: Most of what is known today about drug expiration comes from a question that the Pentagon tossed to the US Food and Drug Administration: Should the armed forces junk it’s over $1-blllion stockpile of medicine every two or three years?
In response, FDA studied more than 100 drugs in military pharmacies, 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”.
Some medicines that FDA tests found effective after their expiration dates include, among others: Bayer’s anti-biotic Cipro and aspirin; Smith Kline 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 its 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. Pharmacopoeia is a non-profit scientific group.
It 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 than 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 and 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 ask your pharmacist. Indeed, health is better than hard cash. “If you don’t have a cold,” the Chinese say, “you will not be afraid to eat watermelons.
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