Erickson Tribune

Health Secrets

UPDATED: Friday, June 01, 2007

The truth about medication expiration dates

Posted on Wednesday, May 30, 2007
 

By Lisa M. Davila
THE ERICKSON TRIBUNE

Your doctor has just prescribed Lipitor to help lower your cholesterol. Because you have taken Lipitor before, you have an older bottle in the back of your kitchen cabinet. You check the expiration date on your bottle, which reads, “drug expires 5/01/2005.” The prescription has been expired for two years. Is it safe for you to take the medicine now?

The expiration date does not mean that your medication is necessarily ineffective or harmful after the date passes. “Drugs are not likely to become dangerous or poisonous when they’re expired but they are going to lose their effectiveness over time. Your biggest risk is not getting the full effect of your medication’s dose,” says William Russell, M.D., Erickson Health vice president and regional medical director.

There has only been one report of a serious illness (and no reported deaths) associated with someone taking an expired drug. The case involved a person who had kidney damage after taking expired tetracycline— an antibiotic. Since that incident, which occurred in the early 1960s, tetracycline has been improved to prolong its chemical stability.

What the expiration date means
The expiration date is the last date the manufacturer guarantees the effectiveness and safety of a drug in its original, unopened package. That date may change, however, once your pharmacist opens the original package and counts out the pills to fill your prescription.

“The expiration date on your prescription medication is either the date on the manufacturer’s bottle or one year from the date it’s filled- -whichever comes first,” says Barry Bress, a registered pharmacist and vice president of pharmacy operations for NeighborCare.

“After the pharmacy fills your prescription and it goes home with you, they no longer control how or where the drug is stored. That’s why the pharmacy stock bottle may have an expiration date beyond what is printed on your bottle,” adds Russell.


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Different drugs, different expirations
Expiration dates can be from one to five years for prescription drug products in the U.S., according to the Pharmaceutical Research and Manufacturers of America. The average expiration date for both prescription and over-the-counter (OTC) drugs is two to three years from the date they are manufactured.

“Medications can vary regarding their long-term stability. Solid forms such as pills tend to be the most stable. Other forms, like liquids and injectables, can break down easier and can get contaminated with bacteria--especially eye drops,” says Bress.

Testing a drug’s shelf life
The Food and Drug Administration (FDA) began requiring drug expiration dates on both prescription and OTC drugs in 1979 as a way to set up testing and reporting guidelines. If a pharmaceutical company chooses a two-year expiration date, then the company does not have to test the drug beyond two years for safety or effectiveness.

Additional testing has been done on many drugs, however, by the FDA, in an ongoing U.S. military program called the Shelf Life Extension Program (SLEP). The SLEP, established in the mid-1980s, tests various drugs under tightly-controlled conditions to evaluate their shelf life. The shelf life is the period of time the drug is expected to remain potent or effective when stored according to the manufacturer’s directions.

SLEP research has shown that 90% of more than 100 tested drugs, both prescription and OTC, were found to be safe and effective even 15 years after the original expiration date. The drugs were laboratory tested by the FDA after being stored for various lengths of time in SLEP facilities.

Storing Medicine at Home
The environment where the tested drugs were stored was carefully controlled by researchers. The conditions at home where you keep your medications may not be the same. Factors such as air temperature, light, and humidity can change your medication’s effectiveness.

“People often keep medications in their bathroom medicine cabinets where ventilation and light can change. Bathrooms tend to be damp places. Humidity is especially bad for medication storage,” says Russell.

“Practically all medications should be stored in a cool, dry place—especially creams, ointments, and liquids. Some may need to be kept in the refrigerator. NeighborCare prescriptions come with storage information printed on the Patient Advisory Leaflet, which is included with your medication,” says Bress.

Protect yourself and your medicine
If you have many medications to keep track of, you might feel slightly bewildered. “Older adults can end up with several medications at home because of hospitalizations, moves to rehabilitation facilities, Medicare or insurance companies changing preferred drug brands, or brand-name drugs converting to generics. It’s very important to gather and organize your medications to keep them up-to-date,” Russell says.

Your continued good health may depend on your medications’ full effectiveness. Here are some things you can do to help prolong their shelf life:

• Keep all medication in its original packaging along with the storage instructions.

• Store your medications in a cool, dry place--away from light, heat, or appliances that give off air, heat, or moisture.

• If there’s a cotton plug in the bottle, take it out. Cotton acts as a wick, attracting moisture.

• Inspect all medications before taking them for changes in color or texture. Pills, for example, may start to dissolve in high humidity and become soft.

• Discard expired injectable medications; multi-dose vials like insulin are subject to bacterial contamination.

• Check all medication expiration dates. If they have expired or are unreadable, ask your doctor or pharmacist for advice.

Your doctor and pharmacist can evaluate your medications according to your situation. “We are patient focused and want to support our patients based on their economic situations and values,” says Russell.

“But if a drug is out of its original packaging, and you’re not sure what it is or how old it is, you have to throw it out. You just can’t take a chance.”



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