July 14, 2022
It has been said that American urine is the most expensive in the world due to the many expensive vitamins and supplements that we consume, but which our bodies do not absorb. The same may be said about American garbage, into which we dump millions of dollars’ worth of unused medications simply because they are past their marked expiration dates. At a time when health care spending has reached crisis proportions, we are literally throwing expensive pharmaceuticals into landfills in the form of “expired” medications that are often perfectly safe and effective.
In 1979, Congress passed a law mandating that an expiration date be stamped on every medication sold in the United States. When a drug manufacturer applies to the FDA for a new pharmaceutical, it must propose an expiration date and attest to the stability, efficacy and safety of the medication in the time period between the sale date and the expiration date. Note that the proposed expiration date is entirely arbitrary, at the discretion of the manufacturer. Needless to say, a shorter shelf life for sold medicines benefits the manufacturer because it results in more sales, since expired medications must be thrown away.
Medicines are effective and safe after the expiration date
Since 1986, the Department of Defense has collaborated with the FDA on the Shelf Life Extension Program (SLEP), which monitors the efficacy and safety of over 100 medications, after their stamped expiration dates. In 2006, the FDA published the results of this program, showing that 88% of the 122 medications tested maintained their stability and efficacy for at least a year past their expiration date. On average, the shelf life of each drug could be safely extended by over four years.
Using this data, the Department of Defense estimates that extending the shelf life of these drugs would save the government about $2.1 billion –every year. Even better, in a more extreme study of 30 to 40 year old expired medications, published in 2012, researchers Lee Cantrell and Roy Gerona found that 12 of the 14 medications studied had maintained nearly 100% of their original concentration of active compounds.
Expiration dates not based on science
Although the scientific community has known for years the truth about (self-serving) arbitrary expiration dates, American hospitals annually throw away $800 million worth in expired medications. Worse yet, American households also feel compelled to dump expensive medications paid for with hard-earned money. Consumers are not given any context for the meaning of drug expiration dates. Because of this, many consumers will not take a medication even a single day past the expiration date, fearing that it might have become toxic, or ineffective. This wastefulness is harmful not only to our wallets, but also to the landfills and water supplies constantly inundated with active chemical compounds.
As an example of this unnecessary waste, consider epinephrine, the life-saving treatment for severe allergic reactions. The drug is notoriously very expensive, It has a labeled shelf life of only 18 months. This stamped expiration date clearly drives consumer behavior. My own patients have told me they have avoided using epinephrine injectors—even in true emergencies—because the drug was a few weeks past its expiration date. Yet a recent study of epinephrine injectors four years past their expiration dates found that 80% to 90% of the drug was still effective, with no safety issues. The financial burden of buying new injectors every 18 months cannot be overstated, especially for families with multiple children suffering from allergies.
Create authoritative guidelines for consumers
As more studies are published demonstrating the efficacy of expired medications, there is a growing risk of individuals turning to unreliable internet sources for medical advice. A simple internet search reveals countless websites counseling patients that expired medications are safe to use. These websites are the natural response to people seeking counsel in their efforts aimed at maximizing the use of their costly medications. But oftentimes internet “advice” may be unreliable and may create threats to public health. Case in point, certain medications — eye drops, for example — may indeed become contaminated past a certain date. The use of expired drops may lead to eye infections. This clearly indicates that there is a need for authoritative and accurate guidance on expiration dates.
Role of the FDA
Clearly pharmaceutical companies have no economic incentive to fund the testing needed to determine the longest safe and effective shelf life of the medications they sell. Expiration dates mean more frequent replacement and therefore more sales. However, ensuring accurate labeling and use of medications falls squarely under the purview of the FDA. A simple approach to establish meaningful expiration dates would be for the FDA to provisionally approve new drugs using the shelf life proposed by the manufacturer; but then require the manufacturer to perform a post-product launch analysis to determine the optimal expiration date. This would be part of being responsible about giving fact based information to consumers about valuable and expensive medications, while minimizing wasteful spending to replace medications that are safe and effective.
Change the regulations
The mandatory use of the word “expiration” on labels for medications, as dictated by the 1979 law, should have been tossed away years ago. The word “expiration” means that there is a discrete point in time after which a medication is ineffective at best, or dangerous at worst. This is not the case for most medications. A “best if used by” label would be more appropriate. And regardless of the precise wording, such labels should be based on fact-based studies, not arbitrary timeframes that maximize the convenience and profits of pharmaceutical firms, as opposed to the interest of consumers who want to minimize unnecessary health care expenditures. Given the amount of money that Americans spend on pharmaceuticals every year, consumers deserve to have meaningful labeling that reflects objective data, this way maximizing the benefit of medications for the patients who need them, while also keeping our environment cleaner and safer.
Dr. Ziv Harish graduated from Ben Gurion university school of Medicine in Israel. He completed his residency in pediatrics and a fellowship in Allergy Asthma and Immunology at the Albert Einstein College of Medicine in Bronx New York where later on he was an assistant professor. He recently retired after 27 years of private practice in Englewood New Jersey.