Does Medication Expire?

The expiration date on medication indicates the last day the drug manufacturer guarantees its safety and efficacy. Expiration dates on medications are more than just a formality—they ensure the effectiveness of your treatment.

Understanding what medicine expiration dates mean can help you make informed decisions about your loved one's health and avoid the risks associated with expired medications.

How drug expiration dates are determined  

Drug expiration dates are determined through stability testing under good manufacturing practices (GMP) and FDA guidelines.

During these tests, both prescription and over-the-counter drugs are exposed to various controlled conditions, such as temperature and humidity, to see how their properties change over time.

The results helps drug companies estimate a medication's safety and provides specific storage instructions to maintain its integrity throughout its shelf life.

Can expiration dates be extended?

The FDA allows a manufacturer to extend the original expiration of an approved drug if additional stability testing shows the drug remains safe and effective beyond its original date.

FDA also supports a public health program called the Shelf-Life Extension Program (SLEP). SLEP tests certain medications stored in federal emergency stockpiles to determine if their shelf life can be extended. While this program is designed for public health emergencies, it highlights that some drugs, when stored properly, may remain safe and effective past their expiration dates. For consumers, this highlights the importance of proper storage and consulting a pharmacist or healthcare provider about expired medications.

Potential loss of potency

Over time, the active ingredients in medications can break down, which reduces their ability to treat the condition for which they were prescribed. This can have serious consequences:

• Incomplete treatment: Medications like antibiotics that lose potency may fail to fully treat infections or contribute to antibiotic resistance.
• Ineffective emergency medications: For time-sensitive drugs like nitroglycerin (used for chest pain) or EpiPens (used for severe allergic reactions), reduced potency can delay or weaken their effect.
• Chronic condition risks: Insulin for diabetes or blood pressure drugs must uphold their precise potency to manage chronic conditions effectively.

Safety concerns about taking expired medications

Taking expired medications can pose serious risks to your health. While most expired medications are not toxic, they can lose their effectiveness over time.

Here's why this matters:

• Reduced effectiveness: Expired medications may not treat your condition correctly. For example, taking expired antibiotics can leave infections untreated and contribute to antibiotic resistance—a growing public health problem.
• Dangerous consequences: Medications requiring precise dosages, like insulin or blood thinners, can become unreliable. Using degraded insulin, for example, might cause high blood sugar levels, leading to emergencies like diabetic ketoacidosis (DKA).
• Changes in chemical composition: Over time, inactive ingredients in medications can break down, altering their texture, consistency, or ability to deliver the drug effectively.

The major concern with expired medications is not necessarily that they become harmful but that they might fail to work as intended.

Specific medications to be wary of

Some medications are especially critical to use before their expiration dates:

1. Insulin: Expired insulin loses its potency quickly, leading to inadequate blood sugar control for people with diabetes.
2. Nitroglycerin: This medication, often used for chest pain (angina), is sensitive to expiration and storage conditions. An expired dose might not provide the rapid relief needed during a heart episode.
3. EpiPens (Epinephrine): While using an expired EpiPen is better than doing nothing in a life-threatening allergic reaction, its effectiveness may be reduced. Let emergency responders know if you've used an expired dose.
4. Naloxone: Used to reverse opioid overdoses, expired naloxone may not work quickly or effectively enough in an emergency situation.
5. Antibiotics: Expired antibiotics, especially tetracyclines, lose potency quickly. They may fail to treat infections and increase the risk of resistance to bacteria.

How to store medications to preserve shelf life

When stored in proper conditions, medications can retain 90% of their potency for at least five years after the labeled expiration date. Some pharmaceutical companies keep their original potency even 10 years past the expiration date.

Here are some guidelines to follow:

• Location: Medications should be kept in a dark, cool, and dry place. Extreme heat, cold, or humidity can break down active ingredients. Avoid storing medicines in the bathroom, as frequent changes in humidity can compromise their quality.
• Medication labels: Always check the drug packaging for specific storage directions. For example, some medications must be kept below 25°C, while certain liquid medications like antibiotics or insulin require refrigeration at about 4°C.
• Security: Keep all medications, including tablets, liquids, and injectable drugs, securely stored to prevent accidents. A locked medicine cabinet or childproof containers are essential, especially if young children or visitors are in the home.
• Review: Check your medications every 6 to 12 months to remove expired or no-longer-needed items, especially if your loved one takes multiple medications or manages a complex health condition.

Disposal methods for expired medications

Proper disposal of expired medications can protect the public and the environment.

Here's how you can safely get rid of them:

• Take-back programs: The best way to dispose of expired medications is by using pharmacy take-back locations or participating in events like National Prescription Drug Take-Back Day.
• Household disposal: If take-back programs aren't available, you can dispose of expired medications in your household trash, but take extra precautions. Mix the medication with an unappealing substance like coffee grounds, dirt, or kitty litter, place it in a sealed, unmarked plastic bag, and throw it away.
• Avoid flushing: Flushing medications down the toilet or sink is discouraged unless the original packaging says to do so. Flushed medications can contaminate water supplies and harm aquatic life.
• Consult guidelines: Always follow FDA recommendations and local public health guidance for safe disposal. Some communities offer options like mail-back programs or hazardous waste collection events.

By disposing of expired medications responsibly, you can help protect others and minimize harm to the environment.