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The Myth of Drug Expiration Dates (propublica.org)
schwit1 shares a report from ProPublica: Hospitals and pharmacies are required to toss expired drugs, no matter how expensive or vital. Meanwhile the FDA has long known that many remain safe and potent for years longer. The box of prescription drugs had been forgotten in a back closet of a retail pharmacy for so long that some of the pills predated the 1969 moon landing. Most were 30 to 40 years past their expiration dates -- possibly toxic, probably worthless. But to Lee Cantrell, who helps run the California Poison Control System, the cache was an opportunity to answer an enduring question about the actual shelf life of drugs: Could these drugs from the bell-bottom era still be potent?
Gerona and Cantrell, a pharmacist and toxicologist, knew that the term "expiration date" was a misnomer. The dates on drug labels are simply the point up to which the Food and Drug Administration and pharmaceutical companies guarantee their effectiveness, typically at two or three years. But the dates don't necessarily mean they're ineffective immediately after they "expire" -- just that there's no incentive for drugmakers to study whether they could still be usable.
Tests on the decades-old drugs including antihistamines, pain relievers and stimulants. All the drugs tested were in their original sealed containers. The findings surprised both researchers: A dozen of the 14 compounds were still as potent as they were when they were manufactured, some at almost 100 percent of their labeled concentrations. Experts say the United States might be squandering a quarter of the money spent on health care. That's an estimated $765 billion a year.
Gerona and Cantrell, a pharmacist and toxicologist, knew that the term "expiration date" was a misnomer. The dates on drug labels are simply the point up to which the Food and Drug Administration and pharmaceutical companies guarantee their effectiveness, typically at two or three years. But the dates don't necessarily mean they're ineffective immediately after they "expire" -- just that there's no incentive for drugmakers to study whether they could still be usable.
Tests on the decades-old drugs including antihistamines, pain relievers and stimulants. All the drugs tested were in their original sealed containers. The findings surprised both researchers: A dozen of the 14 compounds were still as potent as they were when they were manufactured, some at almost 100 percent of their labeled concentrations. Experts say the United States might be squandering a quarter of the money spent on health care. That's an estimated $765 billion a year.
If your drugs expired and you had to pay more money for more drugs. So frustrating would that be! Speaking of which, where's my money? Have my money by tomorrow and there, well you know, won't be any unfortunate problems, frustrating ones. Don't forget about my money!!!
The manufacturers have zero incentive to do these sorts of tests, and private individuals have no way to force the expiration dates to be changed, so this is exactly the sort of testing that the FDA should be funding.
But a more interesting question than the fact that several of the medications were at near 100% effectiveness, how many medications were actively harmful (as opposed to just less effective)?
we just find the drugs that DO expire and put an expiration date on that.
I'm sure our rock solid uncorrupted government will get right on this.
Typically the expiration date is set at the time period when the potency reaches 90% of labled. But it takes years to do the studies. Once long enough has shown reasonable stability, the manufacturer says "OK, 3 (or watever) years is good enough". And they never study the long term stability. Most drugs are very stable. That's why I never hesitate to take expired meds (aspirin, Tylenol, etc.). I'd worry if it were super critical medications, lifesaving, etc.
If the expiration dates are 2-3 years from the date of manufacture, presumably pharmacies could do a little better inventory management and not have to throw any out. 2 years warning is plenty. Just keep 1 year's supply on hand. If demand drops, don't buy any more until you need to.
I should use this sig to advertise my book ISBN-13 : 978-1501515132.
Most patients don't get their prescription pills in the original sealed container of hundreds of tablets or capsules that is shipped to the pharmacy, but in a non-sealed container that is subject to high humidity and large temperature variation when stored at home. So the at-home longevity is less, although still almost always at least a couple years longer than marked on the retail vial.
Inert materials dont go bad? Well I never thought that! Except maybe when I eat 15 year old hot dogs and I've come up with v2 of my hosts file security tool. I run a local DNS recursor that CNAMES everything to imabiggaybaby.com. It requires me to still run a hosts file to post on slashdot, but that's a small price to pay for getting the most out of my web browsing.
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We have our expensive lifestyle, part of which is extreme safety. We have rules on how steep a ramp can be, no matter how expensive that makes construction. Every cafe must have a public toilet, no matter how expensive that makes the cafe, No one is going to make hand pulled taffy without wearing gloves.
The first time a pharmacists gives expired drugs to a parent for their child, and the child does not improve, of in the worst case dies, even if the death has nothing to do with the drug, we are going to see a multimillion lawsuit. Hell, we live in country where a child watch something on TV, then does it, and we see a multimillion dollar lawsuit.
So you know, maybe we can sell the drug at half price to medicare patients, but who is going to volunteer their parent as the one to take the expired drug over the non-expired drug?
"She's a scientist and a lesbian. She's not going to let it slide." Orphan Black
I already knew it's safe to take old medicines except tetracycline and similar antibiotics. But the surprise in this article is the fact that in a bigger study, 1/3 of medicine DOES lose its potency after expiration. The most important one is albuterol, the main "rescue" inhaler drug for asthma. This one is important because it's so tempting to stockpile--it's incredibly expensive in a lot of countries, so if you get a cheap source, you might want to buy enough for a decade or so. Too bad it doesn't last forever. I assumed all medicines were good forever if they're kept dry, but that's apparently not the case. If it differs per medicine, do the research when in doubt.
However, I can say from anecdotes (mine and others I found online) that albuterol is good for a few years after expiration.
A cat can't teach a dog to bark.
The militry stockpiles a lot of drugs and has been looking at how long drugs are good in an effort to save costs while ensuring the drugs were still good.
I'm a consultant - I convert gibberish into cash-flow.
If they are so expensive and so vital why the hell are they sitting on a shelf unused for 3+ years. Either they have shithouse stock management processes or they are ordering way to much, either way this isn't really a problem from the expiry dates not being long enough.
Place them in cool dry conditions.
There is no incentive to figure out meaningful shelf lives of drugs because the manufactures can, and would prefer to, make more. Why bother to bless a blister pack of pills for 10 years instead of two? The drug maker can profit 5 times instead of once. And, presumably, like many government agencies, the FDA is a revolving door agency so, if anyone were to rock the boat and suggest that many drugs retain potency for vastly longer than 2-3 years, it would severely limit their future job prospects.
Who would have thought a government agency would screw up in a way that would benefit large corporations in the billions, enabling large campaign contributions from said companies... astounding!
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" The findings surprised both researchers"
These researchers sound stupid.
How can something be "almost 100 percent of labeled concentration" and "as potent as when they were manufactured"? Seems like an article trying to sensationalize non-news. Milk doesn't necessarily expire on it's expiration date either, in fact, different states have different requirements for when that date is suppose to be set.
And of course drug manufactures must have *some* incentive to prolong the expiration dates, else they'd all be 3 months (or at least the same time frame). Longer expropriations mean you can manufacture more drugs in one run (and use the same workers to manufacture something else before the next run).
Those 122 compounds were over-representing publicly available products (over-the-counter), as opposed to medically regulated compounds. You would need more rigor for a study where the compound efficacy actually mattered. This doesn't make a general finding, across all classes of drugs so it feels a lot like misinformation. 25% difference in a beta blocker, glycerine, or blood thinner is a fatal change. These drugs are monitored with physical symptoms (metroprolol) and/or regular blood testing (sodium warfarin/heparin/lovenox). I know from experience that after a couple months the inert warfarin is unaffected, but the metroprolol is noticeably less effective.
Often wrong but never in doubt.
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Everyone knows me.
I've taken to calling the dates on pill bottles the "warranty date", and I refer to the contents as being "out of warranty" instead of "expired". Ditto lots of food.
It is easy for me, but hard on the girlfriend. She can watch me eat a can of Chili that has been out of warranty for 5 years (making it 7 or 8 years old) and know that it is fine, but still be unable to take a bite herself.
Same problem with pills. A big bottle of ibuprofen costs just a little bit more than a small bottle, so if I need 2 pairs of pills, I'll almost always spend the extra $2 to get 200 instead of 50, or whatever. If I don't need them again for 4 years, it doesn't bother me at all that they've gone off warranty along the way.
Disgust is wired very deeply in the brain, even though the higher layers of the brain interact with it. And for most people, it is nearly impossible to overcome.
See that "Preview" button?
I used to take a drug where in the small print the expiration date was explained that at that date they guaranteed 99% of the active substance to be still present. With me being on a "high dosage" I took 3000mg/day. Lower dosage options were 1000mg/day and 2000mg/day. i.e. when the doctor wants you to take 2100mg (it's not that accurate), he'll have to prescribe 3000.
In short, it wouldn't even be all that bad if say 10% of the stuff was inactivated by a timed decay.
There is no incentive to figure out meaningful shelf lives of drugs because the manufactures can, and would prefer to, make more.
There can be incentive: competition. If an EpiPen alternative lasts 3 years instead of 18 months, lots of people will switch away from the EpiPen.
It won't be the case for all meds, but most common ailments have attracted more than one manufacturer, since the market is big enough. Where you will hit a problem is with smaller markets, where there is one manufacturer. In those cases, extending expiration dates could even be detrimental... if it's a small-time drug maker that depends on a certain volume of sales to keep the production line running.
The summary puts this number out of context.
"ProPublica has been researching why the U.S. health care system is the most expensive in the world. One answer, broadly, is waste — some of it buried in practices that the medical establishment and the rest of us take for granted. We’ve documented how hospitals often discard pricey new supplies, how nursing homes trash valuable medications after patients pass away or move out, and how drug companies create expensive combinations of cheap drugs. Experts estimate such squandering eats up about $765 billion a year — as much as a quarter of all the country’s health care spending."
So that total includes many things, including "expensive combinations of cheap drugs", not just, as the summary implies, expired drugs that are still usable.
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Talk about ambiguous, what is $765 a year, the money spent or the money squandered? And this also seem highly unlikely a figure because one would like have to assume that a very large percentage of healthcare is both spent on drugs and a large percentage of that is then thrown away because of the lack of any kind of stock control.
If you have to check the dates in order to be able to throw away drugs then surely when you do that check you'd be organising the drugs a bit, putting the oldest to be used 1st, not rocket science is it.
If I ran a hospital and millions was being wasted because of there not being stock control, somebody would be getting fired for being extremely negligent.
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The reason that they set say 2 years or 1 year expiration date is that these are reasonable lengths of time for the drug to be manufactured, distributed, stored, purchased and ultimately used, and they are time-scales that are reasonable to test over and therefore set during the clinical trials phase of the drugs approval process. So at launch the drugs gets a set 1 year or 2 year expiration date, that is reasonable from the manufacturers point of view (so they can have an efficient distribution system) and FDA's point of view (they care that the drug is known safe and effective over a reasonable length of time that allows safe use). The FDA would flag if an expiration date was excessively short because of real stability issues with the drug, as there is real potential for the drug to be taken accidentally after the drug had reached the expiration date, but drugs that fit within industry norms for expiration dates would not have any issues.
Once approved there is no reason for the manufacturer to want to extend the product expiration date time-scale. It actually helps drives sales by forcing customers to purchase new batches of drugs when old batches expire. The FDA only care about the safety and efficacy, cost and waste are not a consideration. There simply isn't a regulatory or commercial lever to drive testing to extend the expiration dates of drugs.
There are other ways to try and reduce waste and maximise expensive drug use. In the UK at least there are specialist dispensary pharmacies that can take expensive drugs as they are packaged by the manufacturer, and split them into smaller doses or in smaller packets dependent on the specific requirements of the patient. A good example is many biologic drugs are pre-packaged with single dose shots with more drug than is actually required for a standard dose. For example a prepackaged syringes where you may only use 1/2 or 3/4 of the material in the syringe and throw the rest away. These dispensaries are able to split those pre-packaged large doses and distribute them as smaller doses to get more doses out of them.
Pharma manufs claim that the real cost of drugs is not the pills but the R&D behind them. That is, their thing about the first pill costs $50 million, the second costs 5 cents.
So then the law should be that a manuf has to exchange any expired meds for free or some nominal processing fee.
I remember from my pharmacology course my teacher told us that the ONLY compound you should never take once it has expired is acetaminophen/paracetamol since it breaks down to NAPQI all by itself over time. Everything else, however, is not toxic. It just simply loses potency over time.
Of course as a physician prescribing medication you would never recommend taking expired medication since, as mentioned in TFA, the manufacturer does not guarantee potency. Therefore you cannot know if the therapeutic dose can be reached in your patient. Since there's a risk of patients not being treated with expired meds, you always recommend they take non expired medication.
Seven puppies were harmed during the making of this post.
To this day the recommendation is to dispose drugs by flushing them down the toilet. That is the dumbest idea ever! A lot of that stuff is difficult to get out of the water.
It seems like the best solution would be to change the laws to force drug companies sell drugs to pharmacies on consignment, so any unsold drugs get returned before or at their expiration date for the drug companies to dispose or re-certify, as their business model dictates. This is letting the business and free market determine the best way to handle the drugs. Some are so cheap to manufacture it is not worth saving the expired ones. Others are worth recovering.
The only flaw I see in this is the drug companies losing 768 billion in sales, but I think most Americans will sleep ok with that on their conscience.
Expect FUD, calling the study "flawed" soon. There are a few in Pharma whose job it is to watch for such studies being done and squelch it before it hits the news. They are going to get severely castigated for this news story to develop this far ahead.
sed -e 's/Chuck Norris/Rajnikant/g' joke > fact
Is it me or is is an awfully funny coincidence that this revelation occurs just as the drugs the US prisons needs to kill people are expiring?
We used to have a Bill of Rights. Now, with the rights gone, all we have left is the bill.
...many elected officials have no expiration date. Hmmm. Curious...
Care killed the cat, but satisfaction brought it back.
I have to question your assertion that common drugs don't decompose into dangerous compounds.
Several years ago I was prescribed the exact same prescription that I had sitting in the back of my medicine cabinet, but what I had was past the expiration date. I was thinking I could save a couple of bucks and use what I had on hand (there was enough left for the recommended course of treatment) but I decided to do a bit of research to see if that was safe. When I looked into it I found that It did indeed breakdown into something fairly toxic and I was somewhat surprised, because I am certain there are many people who would use old pills that they had on hand - I thought there should have been a warning label or something more than just an expiration date.
I wish I could remember the name, it was a fairly common antibiotic (ending in -cycline or -fil, I just can't remember)
Drug companies have no more incentive to extend / eliminate expiration dates than DeBeers has for telling women a used diamond's as good as a new one.
Mother: "Silly, child! You bought Himalaya Salt, with expiration date next month!" :("
Child: "Wow, that must have been very unlucky. The salt lying in the Himalaya mountains for millions of years and just after they got it into the shop its expiration date is over
Honestly, if stuff is on a more or less constant temperature and safe from light, most things last nearly indefinitely. E.g. sugar, flour, oils, etc. especially if they are in air tight containers. Even a egg in the fridge lasts half a year, it only dries out slowly.
Food in tin cans easy lasts for decades, despite of the expiration date being in 6 month or what ever.
Cost free eBook I read (by iBook/Kobo/Amazon/ObookO/Gutenberg etc.): "The Green Odyssey" by Philip Jose Farmer.
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For all the thought(lessness) that went into your post, three words prove you completely and irrevocably wrong.
My.
Religion.
Disagrees.
The pharmaceutical companies have no incentive to validate the shelf life of their drugs, since expired drugs lead to additional sales.
In light of this, why don't we fund the FDA to test the shelf life of modern drugs? Or let them contract out the testing to independent labs, then make policy based on the results.
We don't have to test everything either. I am sure doctors, pharmacies, and hospitals would be happy to provide a list of drugs that should be vetted first.
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According to the latest ruleset, this post should be modded as Vorpal Flamebait +5.
The cost of non-generic drugs primarily comes from profit taking, lobbying, marketing, and research. It is of limited value to extend the expiry date of drugs since this would just mean a higher per unit cost if fewer were sold. The cost of generic drugs is probably weighted more towards manufacture but the value of being able to still use things like 5 year old bottles of generic acetaminophen isn't going to make much difference to overall drug costs.
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Antibiotics are a different class all to their own. Remember they are often made from mold.
when was she ever hot? i cannot for the life of me understand why.
It has an expiration date, too... Expiration dates really don't mean much...
Browsing at +1 - no ACs, I ignore their posts. So refreshing!
my teacher told us
Not really my assertion, is it? He told us. That doesn't mean I believe everything he said 100%. But the principle was there. I certainly don't hesitate when I'm taking antihistamines at home that have been expired for 6 months thinking I will die from it, for example.
Seven puppies were harmed during the making of this post.
I know !! That's cool !! In civilised countries we get tons of cheap and excellent healthcare and the stupid Americans subsidise it all for us ! Win !!!
So, you guts keep on doing exactly what you've been doing, ok ? I'd rather have dead Americans due to their shitty healthcare system than dead everone-else if the costs rose due to Americans not being reamed anymore and paying for my drugs and MRI machines !
Carry on :)
Don't forget, pharma companies would need to spend a lot of time and money to validate longer lifespans for drugs. Also, they have to assume that some storage will NOT be as called for regards temperature and humidity and need to allow for that by being cautious about drug lifespans. Not every drug bottle kept since the 1960s will have been in good storage for all of that time.
You're a fuck8ng retard.
This is the whole problem with the US. Millions of brainwashed morons babbling about Jebus and gerns and jerbs and Commies.
Hey genuis, how come US healthcare is shit then ? Why does it have the worst outcomes of ANY Western nation ? Why do tiny countries like Sweden, Australia and Norway run rings around you ?
Because the US is the only Western nation where healthcare is rationed.
It's rationed by price and ability to pay through the nose.
It's great if you're rich, but for the 99% of shit poor plebs that live there (and you're one of them) if you get sick, you're fucked.
The rest of the West uses US healthcare as the bogeyman of precisely what NOT to do. At the highest levels of society people scare their kids with "if you're not careful you'll end up like America"....
The buyback and reseller programs that pharmacists could leverage to make even more money! That's at least $500 billion per year on the table.
Most drugs just deteriorate into something useless but not necessarily dangerous, usually in a decaying exponentiial. A few drugs deteriorate into something toxic, or otherwise having different drug-like effects. Another few may react with their breakdown products to decay at a harder to predict non-linear rate.
IMHO it would be useful to identify, publicly, which are which - especially the ones that get toxic after a while. It would also be useful to have an estimate of how rapidly they degrade under various storage conditions.
That way people could avoid things that get dangerous with age, but use (at their own risk) longer-lived drugs, perhaps slightly raiding the dose, for long after the 95% effectiveness "expiration date".
Bantam Dominique roosters crow a four-note song. Once you've heard it as "Happy BIRTHday" you can't NOT hear it that way
I just found a tab of white pyramid from the 90's... do you think I'll still trip balls as hard as I did back then if I eat it now?
That is literally the worst shitpost I've ever seen on the internets.
In many European countries pills come in blister packs of 10, not bottles like in the US. I suspect that the pills in those blister packs can be stored much longer. Don't know why the US keeps dispensing pills in bottles...
The Feds have tested medicines for longevity beyond "expiration date". Specifically, the military, which (a) has warehouses of various drugs, and (b) is used to overcoming a lot of realworld issues. I forgot what the report said, but they examined several drugs. Some were fine, model had decreased potency that they could model (100mg -> 97mg or whatever), but there were a couple that turned toxic. I think you can find their report if you look for it. I did when first heard of that study... on slashdot a couple of years ago.
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It's not just waste of money. Let's assume that pharmacies and hospitals dispose of their out-of-date drugs in a responsible fashion. (Really?? Yeah, ok, just for the sake of argument. Bear with me here.)
What are Ma and Pa Kettle going to do when their antidepressants and heart medication and statins and pain medication pass their sell-by date? There's supposed to be some way to responsibly dispose of these medications, and I'm sure that lots of people in the well-educated crowd here know what it is, or at least know why it's important and would be responsible enough to do some googling.
But regular people, who don't know or care about the consequences, -- they're going to throw them in the trash, or flush them.
So pragmatically, we're not just wasting money, we're also increasing the amount of drugs that could reach the water table.
Yes yes, I know, it's probable that "drugs in our drinking water" is being over reported (fear porn). But still, as a society, are we being responsible here?
Oliver's law of assumed responsibility: If you're seen fixing it, you will be blamed for breaking it.
Unable to communicate effectively... Yep. That sums up the post.
Although I guess I should start looking for Thor and Zeus in the universe. I have to rule them out after all.
my teacher told us
Not really my assertion, is it? He told us. That doesn't mean I believe everything he said 100%. But the principle was there. I certainly don't hesitate when I'm taking antihistamines at home that have been expired for 6 months thinking I will die from it, for example.
..well he did capitalize ONLY, maybe that was a typo but perhaps it was meant to convey a confident and forceful statement of fact or belief.
What about existing conditions?
The benefit of work based health insurance in America is you get accepted without screening. The benefit to the insurance company is they get a large pool of people so the healthy ones offset the sick ones-which is how insurance works.
Under your system if a healthy person got sick, could they switch to good insurance? If you let them switch, the insurance companies get shafted. If you don't, they get shafted (by themselves). But unfortunately that becomes responsible people's problems as they bare the free emergency care given to others.
The only solution I see is to somehow require everyone have some sort of minimum coverage that avoids these issues. But who decides what get covered and how do you force people to pay?
In the US courts, it is not 'beyond all doubt.' It is 'beyond reasonable doubt.' The distinction in question is important. I believe the same level of assurance can be used. Yes, it means some die without much more than making them as comfortable as possible. This may need a shift in public perspective... We can do that.
"So long and thanks for all the fish."
From a doctor's report known to me, A Western UK doctor who travelled in Soviet Russia, in a remote location a Russian medical doctor caring for a vast area was shipped out of date or old 'Foreign Medicine' in English labelled packaging by Soviet central planning. The UK doctor spent time translating the labels etc. for the local doctor's use. The local doctor used these and on subsequent visits the Uk doctor learned they were mostly OK, some were not so effective, so local doctor had increased the dose rate. Likewise food stored in Scot's hut in Antartica was edible during a 1960's test at my university on recovery 50 years later. The poor cannnot be litigous and must use what is available, perhaps a concerted USA effort to ship out of date but expensive medicine to poorer countries or poorer places inside the USA to give a level of medicare availability , perhaps with a 'no lawsuit proviso', would help the indigenous poor in USA or elsewhere.
Regards Eion MacDonald
Taking advantage of using past expiration is not going to lower drug costs, if it's done on a mass scale. Drug costs are determined by the cost of running the whole pharma enterprise. If fewer sales occur in a seller's market -- and that's what drugs enjoy -- prices will rise to keep revenues constant. So, the only effect will be older drugs that cost more.
On an individual level, I use noncritical "expired" drugs all the time, keeping in mind which ones can actually cause harm. In fact, it's more likely that drugs imported from unregulated places like India have less potency and more dose variability than domestic drugs past expiration.
those drugs that actually do break-down into toxic substances? Expiration may be based on outdated assumptions, but there are other very serious factors involved.
I'm applying Hanlon's law here: Never attribute to malice what can be adequately explained by stupidity. It far more likely that bad knowledge and over careful scientists made expiration very short. Some drugs really do break down faster than others, some are incredibly stable and will last for decades, and some become deadly over time.
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Seems like a solution would be to have samples of "expired" drug stockpiles randomly sampled and tested every year. This would allow their expiration dates to be extended or reissued by lot numbers. Perhaps a secondary market could be established in the case of drugs that become less potent, so the "reissued" drugs would be prescribed at a different dosage level.
PlaynBass
I had a pharma supply company as a client back in the 1980s. They used to make and package single doses. The owner said it's well known the expiration date is way short. In some cases well over a decade short as long as it doesn't get too hot and as long as it's in the original packaging (doesn't get wet). It's just a way to force rotation of the stock and keep the company in business. To do anything requires so much paperwork and money, they have to do this.