A 55-year-old patient requests new prescriptions at a routine appointment. She will be traveling internationally next month and wants to replace her emergency medication kit, as the medications in it (ciprofloxacin, loperamide, and oxycodone) have all expired.
What do you do?
A) Replace the prescription for ciprofloxacin.
B) Replace all three medications.
C) Tell the patient that all the meds should still be fine.
This is a common concern brought up by patients. Many patients discard medications when they pass the expiration date on the package. Is this necessary? Is there a health risk to taking expired medications, and is it okay from a therapeutic standpoint to use medications past their expiration date?
The expiration date is not a date that the drug stops being effective or potentially becomes toxic. It is a date, required by law, that the manufacturer can guarantee greater than 90% original potency of the medication. There really isn’t incentive for pharmaceutical companies to extend the expiration dates, as it is profitable for patients to throw away expired medications and replace them with new prescriptions.
The U.S. military purchases a large stockpile of drugs and has the potential for having a great deal of expired medications. To help reduce this problem, the Food and Drug Administration administers the shelf-life extension program (SLEP) for the U.S. military as a testing and evaluation program designed to justify an extension of the shelf life of stockpiled drug products.1
Robbe Lyon, MD, and colleagues reported data from the SLEP.2 A total of 122 drugs were studied representing 3,005 lots, with 88% of these extended at least 1 year past the expiration date, with an average extension of more than 5 years. Several antibiotics were studied, including ciprofloxacin (mean extension, 55 months), amoxicillin (mean extension, 23 months), and doxycycline (mean extension, 50 months).
Lee Cantrell, PharmD, and coinvestigators looked at sealed drugs from a retail pharmacy that were 28-40 years past their expiration date.3 Amazingly, 12 of the 14 compounds tested were in concentrations that were at least 90% of the labeled amount. Among the drugs that were tested that maintained greater than 90% of the labeled amount were acetaminophen, codeine, hydrocodone, and barbiturates. Aspirin and amphetamine were the two drugs that did not have greater than 90% of the labeled amount. The aspirin amounts were very low, about 1% of the listed amount on the package.
The major myth surrounding expired medications is that taking an expired medication could be toxic.
There is one case report of toxicity from the use of expired tetracycline.4 This was a case series of three patients who developed reversible Fanconi syndrome linked to using an expired tetracycline preparation. That preparation of tetracycline is no longer available.
There are no other reports of toxicity due to use of expired medications.5,6 There appears to be no direct risk of toxicity to the patient by using medication past the expiration date.
The risk that isn’t answered is the risk of using medications that may not be effective if potency isn’t guaranteed beyond the expiration date. It appears that most drugs are effective for years past the expiration date.
This isn’t an issue for medications for treatment of chronic conditions, as patients take the medications every day, and the medications will be used up long before they expire. For medications that are used infrequently – analgesics, antihistamines, and medications for traveler’s diarrhea – they appear to be stable for years past expiration, and there is little risk to the patient if the medications are not fully effective.
I think aspirin should not be used past expiration, given the data showing that it breaks down more so than other medications. For the case at the start of this article, I think having the patient use the expired medications should be fine.
References
1. J Pharm Sci. 2014 May;103(5):1331-6 .
2. J Pharm Sci. 2006 Jul;95(7):1549-60 .
3. Arch Intern Med. 2012 Nov 26;172(21):1685-7 .
4. JAMA. 1963 Apr 13;184(2):111-3 .
5. Med Lett Drugs Ther. 2015 Dec 7;57(1483):164-5 .
6. J Am Acad Dermatol. 2014 July;71(1):193-4 .
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at dpaauw@uw.edu .
