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Drug Expiration Dates: Do They Mean Anything?

POSTED BY: Florida Hospital

Your head’s pounding. You scramble through your medicine cabinet or your purse only to find that the painkillers you have has already expired. Should you take it? Will it work?

Any well-trained pharmacist will tell you it's risky and that you should probably discard the medication, even though the last thing you want to do is drive to the nearest drug store to replenish your supply.

Military Study
There’s a lot of conflicting information about whether it's safe to take expired medications. And it’s something the US military wondered about with its large stockpile of drugs in the 1980s. With the US Food and Drug Administration’s (FDA) help, a major study of their medication supplies were conducted in 1986 to determine their stability and whether the medications needed to replace every two to three years. The study was conducted again in 2006, and published in the Journal of Pharmaceutical Sciences. Both studies found between 80 to 90 percent of them were safe and effective past their expiration dates.

What Does It Mean?
So why adhere to the expiration date at all? According to Kevin Pacheco, clinical emergency medicine pharmacist at Florida Hospital, there are two dates you should be familiar with on medications: the expiration date and the beyond-use date.

Expiration Date
Since 1979, the FDA has required drug manufacturers to put expiration dates on prescriptions and over-the-counter (OTC) medications. After the expiration date, the manufacturer cannot guarantee that the medication is fully potent and safe to take based on product testing.

The expiration date is determined after extensive studies of the product’s stability (physical, chemical, therapeutic and microbial properties) and ranges from 12 to 60 months from the time the medication was manufactured.

“In most cases expired medications have not been tested for efficacy or toxicity past the labeled expiration date and should not be used by patients due to the uncertainty of desired therapeutic effects or risk of harm,” Pacheco says.

Beyond-Use Date
Once a pharmacist dispenses a drug to a consumer, he or she will put a “beyond-use” or “discard after” date on the label, which is required by Florida law. It’s determined by different factors, but the general practice is for the date to be one year after the container was opened or the manufacturer’s expiration date, whichever is earlier. Some factors used to determine that date include:

• The drug type and how fast it degrades
• Dosage
• Type of container
• Expected storage conditions
• How long the medication will be taken

The beyond-use practice is recommended by the US Pharmacopeia, the official standard-setting authority for prescriptions and OTC medicines sold in the US because of potential changes in conditions when a prescription is filled.

With some medications you run into sterility issues, not just potency issues, and they can become toxic and dangerous to use. Sterility issues are especially important with creams and any mixed medications, which include many antibiotics. 

Pacheco specifically stresses that any life-saving drugs not be used after the expiration or beyond-use date. Those include any heart medicines, insulin and epinephrine injections. “You want to take medications at the right potency or it could put you in the hospital or even worse,” he explains.

Storing Medications Safely
Properly storing your medications will help ensure they continue to work at maximum potency until their expiration date. Always store them according to the manufacturer directions, which can be found on the OTC product packaging or instructions from the pharmacy.

Generally, you want to store them in a cool, dry and dark place — not in your bathroom, where it can get hot and damp. Also, light can compromise the stability of some medications. A hallway closet or kitchen cabinet that’s not above the stove or sink, and out of children’s reach, are ideal places to store them.

Discarding Medications Safely
Though the medicine’s label may have specific instructions on disposal, which should be followed. Additionally, the FDA recommends mixing expired medications with dirt, kitty litter or coffee grounds and placing the mixture in a sealed plastic bag.

Throw the bag away in your household trash if permitted by disposal instructions and be sure to either remove the label from the empty pill bottle or packaging or scratch out all personal information before disposing of or recycling the container. There are also National Prescription Drug Take-Back Days coordinated by the US Drug Enforcement Agency.

Better Safe Than Sorry
Cleaning out your medicines cabinet to replace or dispose of any medicines more than a year past their expiration dates should become an important part of your spring-cleaning regime. If you have concerns about the safety of any medication, always talk with your pharmacist.

Aside from losing potency, medicines are continually being reformulated and improved, so keeping any that are past their expirations means you may not be using the most up-to-date product. There may be new instructions or warnings or new dosing devices since you last purchased the product. Regardless, it’s important that you don’t ignore the expiration or beyond-use date. The further past those dates you go, the less you know about the drug’s potency and effectiveness.