Drug Expiration Dates: How They Benefit the Pharmaceutical Companies

Anyone in the medical profession, who is trained to administer medications, can tell you one important step they were taught was to always check the “expiration date” before administering medication to a patient. When you go to the pharmacy to pick up a prescription, the pharmacist may include a “how to use medication” fact sheet, which will also include a note, stressing the importance of not using medication after the stamped expiration date. However, despite a common knowledge that medications should not be used passed the expiration date, few know why. What exactly does that, sometimes hard to read, expiration date signify? And what are the ramifications if taken after that date?

According to the Food and Drug Administration, drug manufactures are required to indicate an expiration date or shelf life date, basically because there is little assurance that a medication given after this regulatory date will continue to be effective or safe. So, it is more of a safety net for both the manufacturer and the consumer, and the expiration date is just a requirement to prove only that the drug is still good on that given date. The date does not suggest that the drug will be ineffective, or even harmful.

The FDA began requiring expiration dates on prescription and over the counter medications in 1979, as a way to set up testing and reporting guidelines. Today, stability testing analyzes how a drug maintains its identity, strength, quality, and purity for the specified period chosen by the manufacturing company. So, if a company chooses a two year expire date, it does not have to test beyond that for prolonged effectiveness.

One might also assume that the expiration dates, worn upon prescription and over the counter medication, are more of a marketing tool, which in the long run benefit drug manufacturers. If certain drugs were found to have a longer shelf life, then it would decrease the turnover rates and profits for many drug-manufacturing companies. As it stands now, the average expiration date is three years, and then the drug is discarded, and must be bought and re-stocked. Of course, there are some valid exceptions, such as medications like nitroglycerine used to treat heart conditions, insulin used by diabetics, and some antibiotics, which do not degrade slowly, and should be utilized with expiration guidelines. However, most drugs degrade slowly, and with the proper research, could extend the shelf life. So, why are drug manufacturing companies not testing products to see if they can extend out the expiration? It becomes impractical for them to impose the extensive studies, when they are in a constant mode of product improvement, and change.

There is a not so widely publicized research and study which has been in play since 1985, and implemented out of an United States Air Force initiative. At that time, the Air Force was facing the process of destroying, and replenishing their drug stockpiles, and decided to request permission from the FDA, to begin a testing program aimed at extending the shelf life of many of their stockpiled supply, and deeming them potent and safe. The Air Force, in conjunction with the FDA, found that the expiration dates set by the drug manufacturers were modest and could be extended out longer than what the manufacturers stipulated. The military’s shelf-life extension program is still implemented today, with the FDA conducting the testing to see how long the drugs can be used past their manufacturer labeled expiration dates. This program has saved millions of dollars for the military and the American taxpayer.

As for whether or not there is any harm from using drugs after the given expiration date, the facts are evident in the military’s shelf-life extension program. Military personnel and their family members use medications that have been extended past the manufacturers specified date.

Some recommendations, when you obtain a new prescription or purchase an over the counter medication, ask the pharmacist or prescribing physician what, if any, are the harmful side effects from taking the medication past the expired date. Know that the worst place to store any medication is in the bathroom medicine cabinet; since, it is a hot and moist environment, and this can have interfere with the effectiveness of certain medications. Medications are better kept in a cool and dry space. Also, never treat a present ailment that has not been diagnosed, by a physician, with medications you may have from a previous diagnosis. This can be a harmful practice, and has little to do with the expiration date of the medication.

All in all, there is little proof in the notion that a drug taken past its expire date has lost its potency or is harmful. There is more evidence to assume that drug-manufacturing companies conservatively date the drugs, as a means to increase turnover and profit, protect against liability, and overall benefit to the company-not the consumer. The expiration date does not indicate that a drug will be ineffective or harmful after that date, but rather that said drug is still good on the manufacturers chosen date; and has little to do with scientific testing. The FDA has little control over the chosen dates, and it falls more on congress to enforce and better regulate the drug-manufacturing companies, with the encouragement of carrying out shelf life extension testing.