Are Expired Medications Still Good?
Are Expired Medications Still Good? As a consultant pharmacist, I get asked this question almost daily. Whether it’s from a patient at home, someone at a nursing facility or an ambulatory surgery center, we all encounter expired medications. Can you still use them? Should you replace them? How should you handle expired medications?
Can you still use expired medications?
Unfortunately, the answer is “it depends”. There are many variables that impact the decision and below I will address the main ones. Ultimately, it comes down to how important is it to you that the medication you are about to take is at full potency. In some cases, such as taking a pain reliever for a mild headache, it may not make much difference. Taking nitroglycerin for chest pain, on the other hand, is a completely different story.
According to the Food and Drug Administration (FDA), as long as a medication is stored according to the labeled instructions, it should retain its strength and quality until the expiration date. Manufacturers are required to conduct stability testing and provide it to the FDA along with a proposed expiration date. The dates are usually two to three years out. The FDA then determines if the proposed date is supported by the testing data.
What happens after the expiration date?
We know that drug potency doesn’t just fall off a cliff the day after the labeled expiration date. We also know that the FDA tests medications in federal stockpiles and most (roughly 90 percent) retain their potency for years beyond the labeled expiration date. It’s a bit more difficult to make this claim when medications aren’t kept in ideal conditions. How were they stored prior to delivery, during delivery and once at the final destination? All these could reduce the potency of the medication. We currently don’t have any examples of medications that become toxic upon expiration. The most commonly cited example of this is tetracycline, but this medication was reformulated many years ago and the concern is no longer relevant. Finally, it’s important to realize that for some medications it’s important to ensure full potency. Some examples include antiepileptics, insulin, contraceptives, nitroglycerin, antibiotics and emergency medications such as epinephrine and naloxone.
Can medication expiration dates be extended?
Manufacturers can extend the expiration date for a medication based on their own testing provided they follow the FDA’s protocol. With drug shortages occurring with increasing frequency and facilities struggling to obtain replacements, the FDA has also approved extensions of expiration dates when there is enough data to support the extension. In fact, the FDA provides a Search List of Extended Use Dates to Assist with Drug Shortages where you can find a product in question and determine if it can be retained for a longer period of time. I always recommend that facilities keep this information on hand as it can a quick way to ensure patient safety, as well as an opportunity for cost savings.
Should you use an expired medication?
This determination will always require assessment of the variables at play, as mentioned above. Paramount in the determination is what is in the best interest of the patient and patient safety. For facilities, who are licensed and accredited by organizations such as Centers for Medicare and Medicaid Services (CMS), Accreditation Association for Ambulatory Health Care (AAAHC), The American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF) and The Joint Commission (TJC), consideration must also be given to meeting regulatory standards which require the removal of all expired medications. That being said, all these organizations are working hard to enhance patient safety and what is in the best interest of patient safety when it comes to life saving medications. I submit that a patient in need of emergent epinephrine, is much safer receiving a recently expired dose, for example, than they would be if that same epinephrine were not available. Importantly, I recommend facilities label expired medications appropriately and document all attempts to obtain replacements. We provide a Drug Shortage Monitoring Tool to our clients, but you can also create your own.
My ultimate recommendation is that you consider the data you have and look at it from a patient safety perspective. It may be tempting to analyze the situation from a formulary and cost perspective, but I believe that if you do the best thing for the patient, the regulatory and cost concerns take care of themselves. Work with your consultant pharmacist to devise a plan on handling expired and beyond use medications. Not to be a broken record from my other posts but. . . you need a policy and then you need to follow that policy. Review your current policy and procedures and if they have changed due to the current drug shortage environment, update your documents.
If you don’t have a consultant pharmacist or have questions about your policy, feel free to reach out and we’re always happy to help.
