With Meds, How Expired is Expired?

If you take a big swig off the milk container that’s been sitting in your fridge too long, you’re likely to get an immediate — and nasty — surprise.  When dairy and meat products exceed their expiration dates, the change is anything but subtle. However, the same aesthetic and sensory clarity typically doesn’t exist for prescription and over-the-counter (OTC) medications. They may look, feel and smell the same…but are they effective and safe after the expiration date has come and gone, and if so, for how long?

The answer to that question can vary according to the kind of drug, how it’s been stored, if it’s been opened and its intended purpose. Medications are expensive, and we hate throwing them away if it isn’t necessary. On the other hand, we don’t want to take medications that are no longer potent or effective, especially if we rely on them for life-saving purposes such as epi-pens for allergic reactions, insulin for diabetes or antibiotics for fighting infections.

Where do you draw that line, though, on all those prescription bottles cluttering up your medicine cabinet, and common drugs such as pain relievers, topical ointments for itchy skin, and cough syrup?

What does an expiration date mean?

The expiration date is the final day that the manufacturer guarantees the full potency and safety of a medication. Drug expiration dates exist on most medication labels, including prescription, over-the-counter and dietary (herbal) supplements. U.S. pharmaceutical manufacturers are required by law to place expiration dates on prescription products prior to marketing. For legal and liability reasons, manufacturers will not make recommendations about the stability of drugs past the original expiration date.

The expiration date of a drug is estimated using stability testing determined by the Food and Drug Administration (FDA). Drug products marketed in the United States typically have an expiration that extends from 12 to 60 months from the time of manufacture. Once the original container is opened, either by the patient or the health care provider who will dispense the drug, that original expiration date on the container can no longer be relied upon.  However, the actual shelf life of the drug may be much longer.

At the pharmacy, “beyond-use” dates are often put on the prescription bottle label given to the patient. These dates often say “do not use after…” or “discard after…” and are required by the Board of Pharmacy in many states. These dates are typically one year from the date on the stock bottle. According to the manufacturer, the stability of a drug cannot be guaranteed once the original bottle is opened. Therefore, the United States Pharmacopeia (USP), the body that sets the standards for pharmaceutical quality in the U.S., recommends using “beyond use” dates. The “beyond use” date would never be later than the expiration date on the manufacturer’s bottle.

The American Medical Association (AMA) concluded more than a decade ago that the actual shelf life of some products is longer than the labeled expiration date. Over 3,000 lots, representing 122 different drug products, were assessed in a government test program. Based on stability data, expiration dates on almost 90 percent of the lots were extended beyond their original expiration date for an average of 66 months. Of these 2,652 lots, only 18 percent were terminated due to failure. Examples of common drug products that were tested with no failures included amoxicillin, ciprofloxacin, diphenhydramine, and morphine sulfate injection. Drug expiration extension dates on these products ranged from 12 to 184 months.

However, it is difficult for consumers or health care providers to know which specific products could have an extended shelf life. The ability for a drug to have an extended shelf life would be dependent upon the actual drug ingredients, presence of preservatives, temperature fluctuations, light, humidity, and other storage conditions. Additionally, the drug lots tested in the program were kept in their original packaging. Once a drug is repackaged into another container, as often happens in the pharmacy, the shelf-life might decline.

Is it safe to take expired medications?

There are no specific reports linking expired medication use to human toxicity. Solid dosage forms, such as tablets and capsules, appear to be most stable past their expiration date. Drugs that exist in solution or as a reconstituted suspension, and that require refrigeration (such as amoxicillin suspension), may not have the required potency if used when outdated. Loss of potency can be a major health concern, especially when treating an infection with an antibiotic. Additionally, antibiotic resistance may occur with sub-potent medications. Drugs that exist in solution, especially injectable drugs, should be discarded if the product forms a precipitant or looks cloudy or discolored.

EpiPen autoinjectors should not be used after the expiration date as the epinephrine has been shown to lose its potency. EpiPen’s are used in life-threatening situations like anaphylaxis, so there is a major health threat with an expired EpiPen. Expired medications that contain preservatives, such as ophthalmic (eye) drops, may be unsafe past their expiration date. Outdated preservatives may allow bacterial growth in the solution.

Insulin is used to control blood sugar in diabetes and may be susceptible to degradation after its expiration date. Oral nitroglycerin (NTG), a medication used for angina (chest pain), may lose its potency quickly once the medication bottle is opened. Vaccines, biologicals or blood products could also be subject to quick degradation once the expiration date is reached. If a patient finds a medication is powdery or crumbling, has a strong smell, or has dried up (as in the case of ointments or creams), these drugs should be discarded.

Proper storage of medications may help to extend their potency. The bathroom and medicine cabinet are not ideal places to store medications due to heat and humidity. Similarly, medications should not be left in a hot car. Medications remain most stable in dry, cool spaces away from light. Keep the prescription bottle caps tightly closed and always keep medications out of reach of children and pets.

If questions still remain about whether or not to use an old or expired medication, it is wise to speak with your pharmacist or physician, who can offer additional information and advice.

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