Reading beyond labels

Like the proverbial bogus coin, this issue keeps turning up: Do expiration dates on medicines mean anything?

“Medicines are still effective even after expiration,” Dr. Diana Sarmiento wrote Wednesday in “Yahoo She.” “Very often, we review the contents of our medicine cabinet and find a few of the drugs we stored have gone beyond their expiration date. Out they go, into the trash bin.”

The Poison Control System of the California School of Pharmacy’s latest study zeroed in on 14 medications still packed in original, sealed packages from 28-40 years ago. Conclusion: 12 of the 14 drugs retained more than 90 percent of their potency.

This new data supports the advocacy of the Shelf-Life Extension Program in the United States. “So, the next time you do a general cleaning of the medicine cabinet, don’t be too rash in chucking those out-of-date tablets,” Sarmiento added.

Here, this question often erupts in COA (Commission on Audit) reports. Auditors routinely strafe officials for having, in stock, medicine beyond expiry dates.

Critics earlier raked the fund-strapped V. Luna Hospital for accepting donations of drugs nearing expiry dates. Our soldiers deserve better than lapsing—and “ineffective”—medicine, the argument went.

The stamping of expiration dates on drugs started in 1979. They “stand for something,” Harvard Medical School says in its 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 the COA, local governments and families follow:

Much of what’s known today about drug expiration stems from a question the US military lobbed over to the Food and Drug Administration (FDA): Should it junk its $1-billion stockpile of medicine every two or three years?

The FDA studied more than 100 drugs. It found that 90 percent of prescription and over-the-counter medicines were perfectly good for 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 the full potency and safety of the drug.”

“Many drugs stored under reasonable conditions retain 90 percent of their potency for at least five years after the expiration date on the label, and sometimes much longer,” notes Brigham Young University Health Center. A simple way, such as “placing a medication in a cool place, such as a refrigerator, helps a drug remain potent for many years.”

Some medicines that the FDA tests found effective after their expiration dates include Bayer’s antibiotic Cipro and aspirin and SmithKline Beecham PLC’s Thorazine, a tranquilizer. Wyeth-Ayert’s antidote to chemical poisoning was still effective 15 years beyond the expiration date.

The 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 short of drugs—from simple aspirins to anti-tuberculosis drugs.

“TB or not TB is the congestion,” Woody Allen wisecracked. But TB is no joking matter here. TB incidence in the Philippines is triple that of Thailand’s.

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, author of “Total Health Program.” “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 Mercola.

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 would 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 comfortable point of commercial convenience,” Cohen quotes Mark van Arandonk of 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.”

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-percent effective (as for stroke, cancer, etc.) “You might want to consider buying a new bottle.” Or ask your doctor.

The COA and other agencies unquestioningly abide by what’s stamped on medicine label. But it may be time to hone that mechanical response with current medical knowledge.

Far too many Filipinos are poor and cannot afford medicine. It would be a crime to deny them perfectly good drugs due to the inability to read beyond a label. “If you don’t have a cold,” the Chinese say, “you need not fear to eat watermelons.”