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Warning! This article is meant to be a quick overview and not a detailed guide on medication expiration or use. To learn more about medication shelf life and long-term effectiveness, consult with your licensed physician or accredited healthcare agency.
Here’s the scenario: It’s 5:30 a.m. and you go to the fridge to grab some milk, only to notice it expired a day ago. You hear a disturbance from the other room and, soon, in rushes your wife in a panic, “Don’t drink that! It’s gone bad!” Without even stopping to breathe, she grabs the milk and pours it down the drain.
In the same household, if you go to the medicine cabinet, you’ll find medications that expired years ago. Why is it that food is immediately thrown out the minute it goes beyond the expiration date, but we keep expired medications “just in case?” Perhaps the easy answer is that we can always go to the store and get another gallon of milk before the sun comes up. The more challenging answer is that you kept your wife up all night hacking up a lung, and she told you three days ago to go to the doctor (and you didn’t). She will of course give the ultimatum that you go to the doctor today and get some medication, or else! Oh wait, she remembers that she has some cough medicine left over from when Johnny was sick … “Here, try this.” And all is better in the world. Thank goodness we kept that cough medicine for two years.
While this scenario could happen in any household in the world, it never happens in my household — because I have the best wife ever. However, I’ll discuss some of the issues to consider when taking medications that have been salvaged from their imminent demise beyond the expiration date.
When talking about medicine in general, we always consider the risk-to-benefit ratio. In other words, if we consider options of a particular scenario, are the risks associated with our decision greater than the benefits? If so, we might elect not to pursue that particular option. Sometimes, we may accept the risk and proceed anyway. It’s this scenario that comes to play when we take medication that has survived beyond its expiration date.
So what goes into determining the expiration date of a medication? According to the Food and Drug Administration, the expiration date of a medication is vetted by the manufacturer for the drug’s ability to maintain its strength, purity, stability, and quality during its shelf life. The manufacturer of the drug must provide research data in this regard. Included in this process is the proper storage information for the drug in question. As long as the medication is stored properly, it should perform as expected up to the expiration date.
Once the drug has gone beyond its expiration date, several things can occur. The most likely outcome is that the medication is no longer stable or potent to do what it was intended to do. In essence, it may not work as well. Due to lack of stability, it’s possible that the medication can break down into various components that may actually be harmful to the body. Although no pharmaceutical company that I have found has come forth with exactly what’ll happen due to the instability, every single document on the FDA’s website, and manufacturer’s website, says that it can occur.
To evaluate this conundrum, the FDA has created the Risk Evaluation and Mitigation Strategy as part of the FDA’s Amendments Act of 2007 to manage known or potential risks associated with a drug product. Part of that Strategy is to evaluate what happens beyond the expiration dates of medications. Back in 1986, the Department of Defense teamed with the FDA to enact the Shelf Life Extension Program. This was brought about to try to save the DoD money in replacing medications that had expired. It also increased the number of stockpile medications available in the event of necessity. Twenty years later, the Bioterrorism Act of 2002 created the Strategic National Stockpile, which built facilities to harbor medications targeting chemical, biological, radiation, or nuclear threats (CBRN). These medications also covered potential or emerging infectious disease threats. During President George W. Bush’s terms, the legislation centered on increasing the ease of availability of medications during CBRN threats.
So, thanks to the government, we have an understanding that medications, as related to the CBRN discussion, can be utilized beyond the expiration date. But how long? I’d always tell patients to discard any medications once they were a year old (some, like sublingual nitroglycerine, every three months). That really is nothing more than an arbitrary recommendation. It means that if you need that drug again and it has been a year since it has been prescribed, then I probably should see you anyway.
It also assumes that the medication has probably not been properly stored and will not be as effective as intended. As usual, it was probably stored in the bathroom, where humidity and temperature changes vary considerably. If it’s an antibiotic we’re talking about, it may be that the reduced efficacy may not entirely rid the body of the bacteria and may increase the chance that resistance will occur when the bacteria re-emerges. Then, the antibiotic likely won’t work at all. Perhaps you have infected other members in your household now with your crud and they too are resistant to the antibiotic.
If you’re trying to avoid going to the doctor by storing your medications, please don’t do it. Seek medical advice and expertise. However, if this is a true survival situation where chemical, biological, radiological, or nuclear threats have become a reality, then keep reading.
For chemical threats, we’re talking about sarin and tabun in modern-day warfare. Historically, it also included mustard gas and chlorine gas. To counteract the effects of these chemicals we use atropine, pralidoxime, or a combination of the two. Atropine can be extended by four years beyond the expiration date, while pralidoxime has been extended up to five years. Further testing by the manufacturers could extend those dates further.
For biologic threats, agents like anthrax and botulinum toxin are frequently discussed. Two common antibiotics to treat anthrax are ciprofloxacin and doxycycline. The latter can be used six to eight years after the expiration date, while I have found no concrete recommendations for ciprofloxacin. For botulism, penicillin and metronidazole are the recommended medications. Penicillin, like ciprofloxacin, may maintain its stability long after the expiration date if stored properly. The same could be the case for metronidazole. In a survival situation, this may be a case where the accepted risk is worth the potential benefit if no help is otherwise coming.
Radiological and nuclear threats have their treatments based on symptoms. Potassium iodide is typically part of the stockpiled medications to reduce the risk of thyroid cancer in an individual exposed to radiation. The body absorbs iodine and doesn’t care if it’s irradiated or not. The potassium iodide competes for binding sites in the thyroid with the irradiated iodine. With less of the irradiated iodine being taken up by the body, the adverse outcome may be lessened. Potassium iodide has been shown to be stable for several years after the expiration date.
How about emerging infectious disease threats? These would be diseases like influenza where oseltamivir could be utilized in stockpiles. This is reported to have a shelf life up to 10 years beyond its expiration date. Other diseases like Ebola, Zika, Chikungunya, and Dengue fever may not have specific treatments, but supportive care is important and could utilize a lot of resources in a major outbreak.
When those resources are scant in a catastrophe, there’ll be more risk taken when it comes to medications. The risk of taking an expired medication might be worth it, but should be considered with caution. Nitroglycerine is a medication used by heart patients and usually comes in a small brown bottle with tiny white pills. These pills degrade relatively quickly when exposed to light, air, and humidity. Of course, use it if you have to; however, these really only remain viable for three to six months.
Another common drug is insulin, which can be kept at room temperature for about 30 days before it starts to lose efficacy. When refrigerated, it can be kept longer, but beyond a year, the potency is weakened and doses will need to be adjusted upward. This, of course, creates more variables in an otherwise difficult disease to manage. (For more on surviving in austere conditions as a diabetic, see “The Diabetic Survivalist” in Issue 24.) Other drugs that are in suspension, such as antibiotics, eye drops, and cough medicines may lose their potency faster due to lack of stability once they’re placed in the suspension. It’s generally not recommended to take these types of medications beyond their expiration dates.
Understand the risks and benefits of every decision you make, especially when it comes to taking expired medications. Periodically go through the medicine cabinet or closet to catalog what you have available, then work to procure more updated medication. Planning for these types of situations in a controlled setting doesn’t take much time and can save a lot of angst when the stakes are high. Lastly, and most importantly, tell your wife how much you appreciate her looking out for you.
David L. Miller, DO FACOI, is an internist in private practice for 20 years. His experiences away from the office have included time as a fight doctor in regional MMA events and as a team physician for 10 years at a mid-major university in the Midwest. Currently, he serves as the lead medical instructor for the Civilian Crisis Response team based out of Indianapolis.