Drugs Expiration Date Dilemma!

A law passed in 1979 by the Food and Drug Administration (FDA) required all drug manufacturers to provide the expiration dates on their products (1). The Expiration date of a drug is given based on its stability in its original container and shows the time over which the potency and integrity of a drug in its sealed container are intact. Several factors, including types of the active and inactive ingredients as well as the storage conditions, can influence the expiration date of a drug. Drug companies would guarantee the safety as well as the full potency and stability of any of their products up to the expiration date noted on that product. It is important to note that the expiration date provided on the sealed container does not apply after the container is opened. Therefore, the expiration date of most drugs does not necessarily show their instability, ineffectiveness or lack of safety after that date.There have been questions and discussions on the accuracy and truthfulness of drug expiration dates that are given by drug manufacturers. It has been even speculated that the labelled expiry dates given by the industries are another way to sell more drugs despite the stability of drugs beyond their printed expiry dates. Even though it has been reported that the actual shelf lives of many drugs are longer than their printed expiration dates (2), some medications may harm patients if taken after this date. For example, consumption of tetracycline, an antibiotic with a broad spectrum, has been specifically mentioned to be dangerous if used after its expiration date.A joint program, called Shelf Life Extension Program (SLEP), has been administered by the U.S. Department of Defense (DoD) and U.S. Food and Drug Administration (FDA) to test medications in a controlled condition for their safety and stability for an extended period of time (3). This program has found that most of the tested medications would remain stable and effective beyond their expiration dates and some even for years past the printed date on the products.It is important to note that drugs differ in terms of their forms, dosage, and stability. Usually, drugs in liquid forms (e.g. solutions and suspensions) are not as stable as those in the solid forms (e.g. tablets and capsules). For example, it has been reported that bioavailability of EpiPen® (epinephrine auto-injectors) were reduced when administered between 1 to 90 months after the labelled expiration date compared with those that were not yet expired (4). Interestingly, the expired auto-injectors in that study were not discolored and did not contain precipitates.It should be kept in mind that improper storage of a medication (e.g. exposure of a medicine to oxygen, light, heat, and/or humidity) may result in losing its full potency and/or safety before the printed expiration time on that product. For example, nitroglycerin should not be exposed to light. Another familiar example is the storage of medications by many people in their medicine cabinet at their bathrooms. However, the high humidityof the bathrooms can result in a quicker breakdown ofdrugs.In summary, if a patient is in a situation when there isno other choice except for taking an outdated medicationthat has been kept under proper conditions, that drug maywork. However, despite the fact that expired drugs maynot be dangerous in most cases, they still can cause harm.It is wise to pay attention to the expiration dates seriouslyin patients who rely on medications for life threateningillnesses such as cardiovascular diseases. Besides, expirydates of drugs become very important in many cases whenpatients have to take medications that are fully stable andeffective. For example, certain drugs such as insulin,epinephrine auto-injectors, nitroglycerine, vaccines, aswell as blood and biological products may be susceptibleto degradation or loss of potency after their expirationdates. Additionally, tetracycline safety is questionableafter its expiration date. It should also be kept in mindthat medications that are disintegrated, have a strongsmell or are dried up (e.g. tubes of cream or ointment)should not be used.