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.
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)?
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.
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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.
I'm pretty sure that this experiment didn't set out to prove the FDA is corrupt and is maliciously slapping arbitrary expiry dates on drugs so you would waste your money. The FDA's primary goal isn't drug stability over 15 years, for example, it's what is safe in a reasonable amount of time for those drugs to be consumed. Do you really want to pay the FDA to do decades long studies on all prescription drugs with the intent of seeing how many generations you can pass your prescription drugs cache down?
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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?
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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.
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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.
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The FDA doesn't set these dates in the first place, the manufacturers do.
I think it's a matter of their testing process that sets the 2-3 year expiration on most drugs, they have ways to simulate that amount of aging (and/or they have stocks that old when they get to that point in the certification), but they don't have reliable ways to simulate aging beyond that point.
So they certify what they know at the time they initially manufacture the drugs.
There is no requirement for them to go back and do more testing, and no financial incentive (in fact, the incentive is to not do any testing, if they find the drugs loose potency faster, they open themselves up to liabilities, if they find they last longer they loose money on sales)
But the results of the tests by the military and the FDA on their stockpiles should be used to change the stated dates by the manufacturers on new production.
The Epipen example given by the article is a particularly troubling one. Pharmacies need to have enough stock on hand to handle a run of orders, and they will tend to sit around for a long time after being purchased. They say that they did studies of pens up to 4 years beyond their expiration and all were at least 80% effective (and these were ones returned by the public, so not stored under ideal conditions). This is a manufacturer who has shown very aggressive monopolistic exploitation of this drug (and worked very hard to block the drug from being produced by anyone else, even after the patent has expired), so there is no way they would do anything that would extend the legal shelf life of these drugs.
There are many scenarios where its got nothing to do with stock management - emergency care drugs, for example.
My wife is a GP - she is issued a drugs bag for home visits, which means she carries around morphine, adrenaline and a whole bunch of other stuff. Once that bag and its contents is issued to her, it cannot be issued to someone else for use - it she were to hand the bag back, it would have to be destroyed, another GP wouldn't get it because the chain of "custody" has been broken.
That means that my wife has to regularly do "stock" rotations on her drugs bag, which means old stock simply gets destroyed when its traded in for newer, longer life stuff.
Now think of that same scenario for millions of doctors around the world, for care homes, for home carers etc etc etc all issued drugs for use in an emergency, but that emergency never arising...
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.
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.
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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.
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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.
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.
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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.
I'm pretty sure that this experiment didn't set out to prove the FDA is corrupt and is maliciously slapping arbitrary expiry dates on drugs so you would waste your money. The FDA's primary goal isn't drug stability over 15 years, for example, it's what is safe in a reasonable amount of time for those drugs to be consumed. Do you really want to pay the FDA to do decades long studies on all prescription drugs with the intent of seeing how many generations you can pass your prescription drugs cache down?
No, I want the drug manufacturer to be responsible for that testing burden before FDA approval is given, and perhaps all expiration dates can be set to a reasonable time frame. (7 - 10 years)
To put it into perspective, look at your drivers license expiration date. It sure as hell isn't every 18 - 36 months, and for a valid reason.
Of course, even if this did happen, all that would occur is the cost of medications increasing to ensure Big Pharma doesn't "suffer" from the impact of making a few trillion less.
All (most?) doctors [like me] are well aware that the expiry date for most drugs is notional rather than real. If I or my family get sick I use expired drugs that I have, or have scrounged from the pharmacy.
Same thing goes for surgical disposables - though there the problem is the sterility inside the packaging - the packaging may deteriorate.over years.
But for most drugs there is a HUGE waste - and they can't even send them as charity to Oogaboogaland for fear of legal liability. And it's legal liability and hungry lawyers that drive this insane wastage. Certainly the Pharma Companies are not complaining . . .
No answers I'm afraid - apart from a mega research effort by the Surgeon-General - and that ain't gonna happen.
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Once that bag and its contents is issued to her, it cannot be issued to someone else for use - it she were to hand the bag back, it would have to be destroyed, another GP wouldn't get it because the chain of "custody" has been broken. That means that my wife has to regularly do "stock" rotations on her drugs bag, which means old stock simply gets destroyed when its traded in for newer, longer life stuff.
Aren't you talking about two completely different things? If she has to rotate the stock in her bag, it's presumably for a reason that would mean no other GP could use it either. If she quits her job the week after being issued a new bag and they have to just throw it away then it's the custody rules that are absurd. Maybe what you were trying to say - but in that case you left out several important bits - is that towards the end of the useful life of your wife's doctor bag it could be returned and re-purposed to hospitals and/or patients under treatment that have a high turnaround and would use the drugs before they expire to reduce waste, but that the regulations prevent that. If not the TL;DR version is just "Think of drugs kept for emergencies that never see any use".
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All (most?) doctors [like me] are well aware that the expiry date for most drugs is notional rather than real. If I or my family get sick I use expired drugs that I have, or have scrounged from the pharmacy.
Not just doctors, the government as well. Our military stockpiles drugs and medication for emergencies, and keeps stuff for a minimum of ten years, often longer. They run extensive tests on it and it's still at 95-100% effectiveness after that time.
Sorry, forgot to mention: This isn't the US and the FDA. Other countries governments know about it as well.
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.
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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...
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All (most?) doctors [like me] are well aware that the expiry date for most drugs is notional rather than real. If I or my family get sick I use expired drugs that I have, or have scrounged from the pharmacy.
Not just doctors, the government as well. Our military stockpiles drugs and medication for emergencies, and keeps stuff for a minimum of ten years, often longer. They run extensive tests on it and it's still at 95-100% effectiveness after that time.
Yes, these results are public somewhere. (I forgot where I read them.)
There are a _few_ cases where something went wrong with some of them. And there were studies of public "drug went bad" stories in media. One woman did have kidney damage from Tetracycline (I think), exposed and stored in a damp environment. So even the cases where something happened, the situation was an outlier.
Older drugs are quite safe for the most part and it's hard to pin down reasons why they are not. There COULD be a small risk, but probably isn't. I still wouldn't store medications in a hot car, a pocket, purse, or backpack, or in a garage. But any house or office would be fine and low risk to use after the expiration date.
So they certify what they know at the time they initially manufacture the drugs.
There is no requirement for them to go back and do more testing, and no financial incentive (in fact, the incentive is to not do any testing, if they find the drugs loose potency faster, they open themselves up to liabilities, if they find they last longer they loose money on sales)
Those damn pesky Ethics getting in the way again.
It might not make them cheaper to slap the longer expiration on there, though. If they aren't keeping the manufacturing line active then there are startup and shutdown costs. If they don't forecast demand well then there'll be more shortages, etc. For nominal manufacturing costs it should be produced at some constant sustainable rate.
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.
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Why do you need mother government to do it for you? Never mind the Feds.
Drug safety is a far more useful and fundemental government function. It's that whole life and death thing.
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> The 2014 FDA budget was US$4.7B,
That covers everything. This includes making sure your chicken and flour don't kill you. This budget is for a continent spanning nation of 300M people. It's comparable to budgets of all of the EU for the same thing.
Also, there are a LOT of drugs. That's a lot of testing. Nobody really cares if your Tylenol expires. Fixating on that cheap crap is a waste of time. You might also want to figure out what it is that causes shelf life to suffer. Doing that for a wide range of drugs will be expensive just in terms of raw labor. Forget about the pills themselves.
It's really a much bigger problem than you seem to realize. That's a pretty common problem here really.
A Pirate and a Puritan look the same on a balance sheet.
Tetracycline is one of the drugs you absolutely do not want to take after it expires, as it does become toxic. However it's one of a small subset of common medications that actually can cause a problem. The vast majority of drugs are stable over a long period of time. The problem is that most drug companies don't want to spend money doing testing out past what they are required to do for the FDA.
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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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I'm pretty sure that this experiment didn't set out to prove the FDA is corrupt and is maliciously slapping arbitrary expiry dates on drugs so you would waste your money.
Have you ever read ProPublica? Of course it did. I'm conflicted over this because this looks like an actual, valid concern; ProPublica is really good at taking facts and using them to construct an inaccurate narrative to get people angry at someone they trust. It's surprising how readily you can line up a bunch of things that are themselves true and create a complete lie, although ProPublica often simply misinterprets, mischaracterizes, and makes overgeneralized statements about the facts.
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Either you are guessing or you know of studies done on the stability of medication.
I don't know shit about how long standard medications can be relied upon for _normal_ (=reliable) dosage for normal problems. And that is the main problem: if a medication that is guaranteed to contain x mg of an active substance and y mg of filler for period of time t what happens at 2t, 3t etc.?
Some chemicals are almost infinitely stable under stable weather condition in a hermetically sealed package, some are not. How long can it be relied upon containing the active chemical within an acceptable deviation of the original formulation _and_ an acceptable amount of potentially active breakdown products? If one don't know then the medication that was carefully formulated is suddenly an unknown factor. That's the problem.
It would be a good thing if the most common medications could be studied and a separate extended expiration date created for them. But that is only generally possible if they will be stored in known, stable condition (like in a hospital). Maybe such research could lead to extensions of the normal expiration date too.
It has an expiration date, too... Expiration dates really don't mean much...
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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.
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Certainly the Pharma Companies are not complaining . . .
Only when it's their product being artificially turned over. When it's the raw materials the FDA requires THEM to turn over, there's complaining. In quality control testing, the sterile, deionized water needed to have an expiration date added of something like a year from when it was received. We then needed to throw it out three months before the expiration date we had just made up for water. I'm sure they complain about the more expensive stuff.
I'd assume that complaining is all done through lobbyists though.
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.
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".
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See, the problem is; in virtually every country the pharmaceuticals have manufacturing and management operations, the drug company gets to decide what to donate and what value to claim on their donations for tax credit/deduction purposes. Shipping off expired or non-approved drugs at their (former) American retail value is a double win for them.
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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.
Oogaboogaland? WTF dude?
That's the main problem. Those drugs might have been stored in a freezer or air conditioned room for twenty years. But there's no guarantee that there wasn't a hot or cold day. One solution would be to have environment sensitive cards that would have segments that changed colour based on the maximum and minimum temperature and humidity.
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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.
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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
There have been several studies, including a pretty large one done by the US military, on the stability of common drugs (include the rather old study that propublica referenced in the article from the summary) that show that most drugs are stable and potent past their expiration date. The problem is that there are drugs like tetracycline that decompose and not only lose potency but become toxic to humans, and other that just lose potency. And like I said, there is no real reason that a drug company would want to go through the cost of certifying a drug out to 5 or 10 years, especially for a generic. This is something that would be best suited for the government to fund since they (and, by the transitive property of taxes, the citizens) would be the primary financial benefactor .
I browse on +1 so AC's need not respond, I won't see it.
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.