Health

Drug Expiration Date Myth Makes Drug Companies Rich

| by Michael Allen
Prescription MedicationPrescription Medication

Many Americans see an expiration date on a bottle of medication, think the drugs inside have gone bad after the date, and toss the medicine in the garbage. Hospitals and pharmacies are required by law to trash their expired medications. However, many of those expired drugs remain good for years, even decades.

According to ProPublica, expiration dates on drugs are only the final date that the FDA and the drug companies will guarantee the medications will still be effective.

But those expiration dates do not mean that the drugs are not effective after the dates. In other words, drugs don't suddenly go bad after the expiration date like milk.

Prescription drugs are usually trashed after two or three years, which means people will simply buy more from the pharmaceutical companies, which have no financial incentive to actually test to see how effective their expired drugs will be.

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ProPublica notes that the U.S. health care system wastes about $765 billion a year because hospitals trash drug supplies, nursing homes toss out valuable drugs after people die or move out, and the pharmaceutical industry makes expensive combinations of cheap drugs.

A study published in the Archives of Internal Medicine in 2012 found that 12 of 14 prescription drugs tested 30 to 40 years past their expiration dates remained potent -- with some almost at 100 percent potency.

One of the researchers, Lee Cantrell of the California Poison Control System, said there has not been any recorded instance in medical literature of expired drugs harming people.

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Dr. Cathleen Clancy, associate medical director of National Capital Poison Center, also says she has not heard of any such case.

"Refining our prescription drug dating process could save billions," Cantrell added.

ProPublica reports that the FDA has known for a long time that some drugs can be used far past their expiration dates -- and the federal government's stockpiles prove it.

While the federal government requires pharmacies and hospitals to toss out expired drugs, federal government agencies such as the Centers for Disease Control and Prevention, the military and the Department of Veterans Affairs all stockpile expired drugs.

The federal government has reportedly saved stashes of medications, vaccines and antidotes at secure locations at the proper humidity and temperature around the U.S. These expired drugs are valued in the tens of billions, and would be used during a large-scale emergency.

Expiration dates came into use in the middle of the 20th century. Drug companies put their products through heat and moisture tests to observe how the drugs break down. The drug makers then propose an expiration date for their drugs to the FDA, which studies the data.

Yan Wu, an analytical chemist who is part of a focus group at the American Association of Pharmaceutical Scientists, told ProPublica that most drug manufacturers would rather market new drugs and products instead of researching how expiration dates on old drugs could be lengthened.

Olivia Shopshear, director of science and regulatory advocacy for the drug industry trade group Pharmaceutical Research and Manufacturers of America, said that expiration dates are selected "based on the period of time when any given lot will maintain its identity, potency and purity, which translates into safety for the patient."

One pharmacist told ProPublica that he has taken home expired over-the-counter medications for his family to use.

The FDA and the Defense Department created the Shelf Life Extension Program after the Air Force asked the FDA in 1986 if some drugs would still work past their expiration date.

ProPublica asked the FDA if the same drug extension program could also be used at hospital pharmacies, to which the FDA responded: "The Agency does not have a position on the concept you have proposed."

Ajaz Hussain, a former FDA scientist and present president of the National Institute for Pharmaceutical Technology and Education, told the news site: "The FDA will have to take the lead for a solution to emerge. We are throwing away products that are certainly stable, and we need to do something about it."

Marshall Allen, who wrote the ProPublica article, told NPR that no one formally recommends that people take expired drugs. Some expired drugs may not be strong enough to help people taking them, which could cause a serious risk, such as in the case of people seeking relief from asthma.

"Just because some drugs are having their expiration dates extended, does not mean that every drug can safely have its expiration date extended," Allen added.

Sources: ProPublica, NPR / Photo Credit: Chris Potter/Flickr, Quinn Dombrowski/Flickr, J. Troha (Photographer)/Wikimedia Commons

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