What Does the Expiration Date on Your Medication Really Mean?
- The U.S. Food and Drug Administration began requiring prescription medication be labeled with expiration dates in 1979. Expired drugs account for 25 percent of annual health care costs in the U.S.
- Analysis of 30-year-old medication demonstrates that up to 86 percent of the compounds remained potent, suggesting further testing may lead to longer expiration dates
- The best and most effective way of reducing your health care costs, and the cost to the environment of discarded medication, is to reduce your dependence on drugs through lifestyle changes
By Dr. Mercola
In 1979, the U.S. Food and Drug Administration (FDA) required drug companies to publish expiration dates on the drugs they produce. Prior to that, after drugs were sold, people used them until they felt it was time to dispose of them. As you’re likely well aware, I’m not a fan of using prescriptions drugs for just about any reason.
However, we are each on our own journey to health and it may be that you are transitioning from using prescription medication to manage health conditions, to providing your body with the nutrition, sleep, water and exercise needed to help you regain your health.
Prescription drugs typically have an expiration date between one and five years, depending on the drug. If you are like most people, you’d think twice before taking a medication past the expiration date, as it may have either lost potency (no longer work) or may be harmful to your health. This medication turnover is costly, to you, hospitals, pharmacies and the U.S. military — often costing millions of dollars each year.
In a study published in the Journal of the American Medical Association,1 researchers analyzed the potency of medications found in their original packages and unopened for nearly 30 years. It’s important to remember these drugs were found in a pharmacy, stored away from heat and light, and in a cool, dry environment.
Scientists Find 30-Year-Old Drugs Still Potent
The debate over whether your medication retains potency past the listed expiration date has been argued between physicians, pharmaceutical companies and the FDA.
In an effort to answer some of those questions, Lee Cantrell, professor of clinical pharmacy and director of the San Diego division of the California Poison Control system, and colleagues had access to prescription drugs with expiration dates earlier than 1970.2 Their focus was to evaluate the potency of prescription medications that may lead to lengthening expiration dates and reducing health care costs.
Other studies had already demonstrated that many medications retain their potency past their labeled expiration dates.3 This particular cache of prescription medications gave researchers a unique opportunity to scrutinize the potency of medications that expired decades earlier, but had been stored in a cool, dry environment away from heat and humidity. Eight different medications that contained 15 different active ingredients were included in the analysis. Three individual capsules or tablets of each medicine were tested.4
The scientists discovered 12 of the 14 drugs tested existed in 90 percent concentrations or more, or the generally accepted minimum standard for potency of a drug. As these drugs were manufactured before most standards for drug potency were regulated, three were actually present in greater amounts than the labeled content. Two medications were present at less than the 90 percent minimum, indicating the medications — aspirin and amphetamine — had lost potency over the years.
Cantrell and his colleagues believe these findings may suggest the expiration dates on some drugs may be safely extended.5 It is important to note, however, that the drugs tested had been unopened and stored in ideal conditions.
How Are Expiration Dates Determined?
Before doing this research, Cantrell knew the term “expiration date” was a misnomer. Instead, the dates were the point to which the FDA and pharmaceutical company would guarantee the effectiveness of the medication — but the date does not necessarily mean the drug “expires” immediately thereafter.6
Most drugs do not become dangerous after their expiration date.7 Neither Cantrell nor Dr. Cathleen Clancy, associate medical director of National Capital Poison Center, have heard of anyone being harmed by an expired prescription drug, and Cantrell has no knowledge of any recorded instance in the medical literature.8 The danger in taking an expired medication is that it won’t work — especially in medications used in life threatening situations, such as an epinephrine injection for anaphylactic shock.
Drug manufacturers are responsible for stability testing on their drugs that determines the shelf life of the medication. The testing is designed to ensure the potency of the drug when it’s used before the labeled expiration date. There are several factors that influence the ability of a drug to retain integrity and potency. These include the type of active ingredient, storage, the type of container the drug is stored in and preservatives in the medication.9
The underlying stress-testing of medication is guided by the FDA and three other U.S. governmental agencies10 and by the World Health Organization.11 The objective is to identify the likely rate of degradation of a product. The testing is usually carried out on a single batch of the product using humidity, temperature, photolysis and oxidation as stressors on the drug.
The FDA reviews the data provided to establish the expiration date. However, the drug companies do not have to continue to test the drugs past the labeled expiration date to determine if a longer date may be established for that medication.12 This may, in part, explain why medications are labeled with dates much earlier than they appear to lose their potency.
Federal Government Stockpiles ‘Expired’ Medication
The idea that expiration dates are not set in stone is not news to the U.S. Federal government. In 1986, the U.S. Air Force realized replacement costs for medications that were stockpiled to treat military personnel could drastically affect their budget. In order to alleviate some of the financial strain they asked the FDA to extend the expiration dates. In response to this request the FDA created the Shelf-Life Extension Program (SLEP):13
“Stockpiling drugs, vaccines, and medical products is critical to ensure public health emergency preparedness for both the U.S. military and civilian populations. To avoid the need to replace entire stockpiles every few years at significant expense, and because it was recognized through testing that certain products remained stable beyond their labeled expiration dates when properly stored, the Shelf-Life Extension Program (SLEP) was established in 1986.”
Each year since 1986, drugs from this stockpile are selected and analyzed to decide if the expiration date could be extended. For nearly 30 years the program has found the shelf-life of drugs goes well beyond the labeled expiration dates.14 In fact, the FDA found that nearly 90 percent of 100 different prescription and over-the-counter drugs retained their potency even 15 years after the labeled expiration date.15
Another study evaluated 122 different drugs for potency past the expiration date and found 88 percent of the lots could be extended up to 66 months.16 When medications are stored properly, it appears the integrity and potency of the drugs extends well past the labeled expiration date.
Expensive Medications Thrown Out While Health Care Costs Soar
The SLEP program has helped government agencies preparing for emergencies to save millions of dollars on replacing medication when the drugs reach their expiration dates. However, this same savings is not enjoyed by pharmacies, hospitals, physicians or you. In recent years the contribution of medication cost to the overall cost of health care has been front page news.17
In 2004, a poll conducted by The Associated Press18 found 1 of every 3 people who responded to the poll said that paying for prescription medication was a financial challenge, and 3 of every 4 said they put off filling a prescription because of the price. One in 10 respondents also admitted to purchasing prescription medications illegally from Canada or Mexico to reduce the cost. Since 2004, the cost of medications has only risen.
Cantrell’s original research was published in 2012, triggering a burst of attention during which the researchers were accused of irresponsibly advocating the use of expired medications. However, Cantrell is adamant their intention was to shed light on an issue that may help reduce health care costs. He commented that,19 “Refining our prescription drug dating process could save billions.”
Acknowledging the SLEP program consistently saves the government each year, the American Medical Association (AMA) requested a re-evaluation of expiration dates of medications.20 Letters were sent to Pharmaceutical Research and Manufacturers of America, FDA and the U.S. Pharmacopeial Convention, which sets standards for medications. Rheumatologist Dr. Roy Altman helped write the AMA report said: “Nothing happened, but we tried. I’m glad the subject is being brought up again. I think there’s considerable waste.”
Once in a while a pharmaceutical company will have the documentation to extend their expiration dates. When Pfizer extended the dates for injectable atropine, epinephrine, dextrose and sodium bicarbonate, Newton-Wellesley Hospital in Boston saved a quick $7,500.21 Experts estimate each health care agency that discards expired medications may incur costs up to $765 billion each year, nearly 25 percent of annual health care spending.
The Best Defense Is a Great Offense
The best defense against rising health care and medication costs is to live a healthy lifestyle that reduces your risk you’ll need pharmaceutical intervention. Unfortunately, conventional medicine focuses on the treatment of disease and not on prevention. What you put into your mouth is your choice and your responsibility. What you choose also helps to determine the health you enjoy.
It is important to replace processed foods with real food made at home from scratch to ensure optimal nutrition. This will automatically help you cut out the vast majority of refined sugars, processed fructose, dyes and other chemicals that impact your health and increase potential for illness and disease. As you increase the amount of healthy fat in your diet, you reduce your body’s dependence on glucose and increase the ability to burn healthy fats for fuel.
Ditching processed food may be a challenge. You’ll have the most success by planning your meals in advance and make changes in a step-by-step fashion as described in my nutrition plan. It is not only possible, but also painless, to remove processed foods from your daily diet.
Plan your meals around organic produce from your local farmers market, which is often priced to sell. Make enough for two meals, so one can be used for lunch the next day at work or frozen for a second meal on a night when time doesn’t allow for cooking. You may plan for a week of meals at a time that allows you to have all the ingredients on hand and takes out the question of what to make for dinner as you’re driving home from work.
If you struggle with emotional eating, I highly recommend using the Emotional Freedom Techniques (EFT). EFT is simple and effective, and can rapidly help you eliminate your food cravings naturally.
Dispose of Your Old Medications Responsibly
In response to the problem of disposing of medications without polluting our water supply, some states instituted a “take-back program.” The FDA has also released guidelines22 for individuals who don’t live in areas that have take-back programs and the precautions that should be taken to protect the environment. These guidelines include:23
• Follow any specific disposal instructions on the drug label or patient information that accompanies the medication. Do not flush prescription drugs down the toilet unless this information specifically instructs you to do so. I recommend never flushing ANY drug down the toilet, to protect your community's water quality
• Take advantage of community drug take-back programs that allow the public to bring unused drugs to a central location for proper disposal. Call your city or county government's household trash and recycling service to see if a take-back program is available in your community. The Drug Enforcement Administration (DEA), working with state and local law enforcement agencies, sponsors National Prescription Drug Take-Back Days throughout the United States.
• If no instructions are given on the drug label and no take-back program is available in your area, throw the drugs in the household trash, but first:
- Take them out of their original containers and mix them with an undesirable substance, such as used coffee grounds or kitty litter. The medication will be less appealing to children and pets, and unrecognizable to people who may intentionally go through your trash
- Put them in a sealable bag, empty can, or other container to prevent the medication from leaking or breaking out of a garbage bag
- Remove and destroy any prescription labels before throwing away the containers
- In some states, pharmacies can take back medications. When in doubt, ask your pharmacist for advice. Most are very well trained and educated professionals who will be glad to assist you in this area
Of course, these suggestions merely move the problem from one area of the environment to another. The DEA has a national take-back program that continues to gather more drugs every year it is available. In 2017, the program had over 4,000 law enforcement offices engaged, nearly 5,500 collection sites and a record 450 tons of drugs collected.24,25 The primary goal of the program is to dispose of opioid prescriptions that may be misused, but the DEA also collects any other prescription medication in pill form.26
However, the best and most effective way to reduce environmental drug pollution is to take control of your health and cut down on the number of pharmaceutical drugs you use in the first place.