It has been estimated that in excess of $765 billion in healthcare dollars is wasted each year, with discarded medications (due to their listed expiration dates) making up a large chunk of that figure. For example, hospitals throw away an estimated $800 million of unused medication each year. Pharmacies, physician offices and nursing homes add significantly to that number. Given that the U.S. spends between $3.5 and $4 trillion dollars for health care annually, it is estimated that up to 20 percent of this cost could be reduced if things such as expiration dates on medications were extended.
Concerns over expired medications include safety and efficacy, as well as loss of potency or the risk of potential toxic effects if utilized after their expiration date. However, several studies suggest that many medications may be stable and useful for years after the reported expiration date.
The dates limiting a medication’s shelf life are set by the Food and Drug Administration and the pharmaceutical companies and require pharmacies, hospitals and physician offices to throw out all medications after their listed expiration dates. Last week, as required by law, my nurse was forced to throw out thousands of dollars of “sample” medications and all of the medication in our emergency “crash cart” due to their date of expiration notwithstanding that much of these medications were probably still useful and potent. This waste directly affects consumers, as individuals are instructed to discard both prescription and over-the-counter medications due to an expiration date.
In 2012, a toxicologist and pharmacologist published an article in the Annuals of Internal Medicine after tests on sealed medications from the 1960s showed many ingredients were still active and remained as potent as the day they were packaged. This outraged the FDA and pharmaceutical companies, who suggested the study would encourage patients to use expired medication. Nonetheless, this important study revealed the longevity of prescription and OTC medications may be significantly underestimated. If correct, the study suggests pharmaceutical companies may be benefiting from these expiration dates by forcing consumers to re-purchase medications which may still be useful; thus increasing costs to consumers as well as the health care industry unnecessarily.
According to FDA guidelines, in general, after a dosage form has lost more than 10 percent of its labeled potency, it becomes unsuitable for administration. If this is a reasonable assertion, it is important to consider exactly how many medications are affected and how long does this process take to occur? According to Bhagwan D. Rohera, professor of pharmaceutics and industrial pharmacy at St. John's University in Queens, N.Y., “While the fact that the drug product may still retain its labeled potency of the drug (within acceptable limits), it may not be safe and/or therapeutically efficacious because of the changes that do take place in the drug or drug product over time.”Read Full Article
Rohera explains there are several ways a drug product may become ineffective/unsuitable for administration. “This may result because of not only loss of potency owing to chemical degradation of the drug, but also potential toxicity arising from degradation product(s) in some cases. In addition, physical degradation of the dosage form leading to loss of therapeutic efficacy and microbial contamination of sterile products are other reasons that may render the product unsuitable for administration.”
As such, Rohera says extreme caution must be exercised when taking expired medications. “A consumer must understand the fact that while some pharmaceutical products do retain therapeutic potency of the drug many years beyond their stamped expiration date, it might have undergone time-bound changes that would have compromised with the safety and/or therapeutic efficacy of the product. Hence, it is in the best interest of the consumer to follow the expiration date stamped on the product.”
There are several medications which do lose their potency after a short period of time. Examples include nitroglycerin, Insulin and certain antibiotics. Liquid based medications also have a shorter shelf life, as well. Moreover, heat, humidity and light may also have an effect on potency. Nonetheless, certain life-saving medications may last much longer than the listed expiration date. One example is the EpiPen. A recent report suggested that an EpiPen may retain potency for four years (not the 12 to 18 months as listed). Thus, should this be one of the medications looked at in an effort to save lives and reduce costs?
There are obvious monetary incentives when considering whether expiration dates should be extended. Indeed, if the shelf life of medications were extended by even a single year, the savings to consumers could exceed hundreds of millions of dollars. As everything in medical care should be based on pros/cons, risks and benefits, it may be time for the FDA and Pharma to re-examine their policies, guidelines and protocols when determining expiration dates. Perhaps using a more pragmatic approach on extending expiration dates, taking into consideration efficacy while not compromising safety, is overdue. A subtle change could significantly impact cost savings and enable patients to enjoy some savings of their health care dollar.
Until such changes are made, it is recommended that expiration dates always be followed to avoid the risk of an unanticipated or detrimental effect.
Dr. Michael Schwartz is board certified in internal medicine and is affiliated with Soundview Medical Associates with a private practice in Darien. For comments or questions, visit his web site at drmichaelbschwartz.com.