The Myth of Drug Expiration Dates (propublica.org) 316
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.
This is the sort of testing the Feds should do. (Score:5, Insightful)
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)?
Re:This is the sort of testing the Feds should do. (Score:5, Informative)
From each lot that's manufactured, they put some of the tablets in a bottle and leave the bottle in a large closet with controlled humidity and temperature. Then every couple months someone goes in, gets the bottle, and performs an assay on a bunch of tablets. This keeps going on schedule until the expiration date, when they stop doing the testing and throw the bottle out. In general that's all that an expiration date is- nobody's doing stability tests on that lot of tablets anymore.
Re:This is the sort of testing the Feds should do. (Score:5, Insightful)
Sometimes I wish Slashdot had the ability to pin comments right to the top of the entire thread. This is probably the most useful piece of information I've read on any post at all today. Thanks for the info!
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Useful? perhaps not. Informative and interesting, definitely.
Re:This is the sort of testing the Feds should do. (Score:4, Informative)
Re:This is the sort of testing the Feds should do. (Score:5, Interesting)
I used to work at a drug manufacturer that did stability testing required by the FDA. From each lot that's manufactured, they put some of the tablets in a bottle and leave the bottle in a large closet with controlled humidity and temperature. Then every couple months someone goes in, gets the bottle, and performs an assay on a bunch of tablets. This keeps going on schedule until the expiration date, when they stop doing the testing and throw the bottle out. In general that's all that an expiration date is- nobody's doing stability tests on that lot of tablets anymore.
Thank you for the detail. There is an outstanding question.
Exactly how does the drug company initially determine an expiration date?
From your explanation, it is not based on testing or science at all. This merely suggests that Greed determines how long an expiration date is. Not that I'm surprised mind you. This is the Big Pharma we're talking about here. Part of the United States Medical Industrial Complex. Greed is part of their Creed.
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Re:This is the sort of testing the Feds should do. (Score:4, Interesting)
It also needs to be very conservative. Household stored medication is often stored in poor conditions of temperature, humidity, or even left out in bright light on a desk shelf. And many medications are sensitive to UV, to humidity, or to warmth. The result of an accidentally mis-stored medication is tragic, so caution is necessary for medication storage.
Re:This is the sort of testing the Feds should do. (Score:4, Informative)
In the USA, drugs are required to expire once their effectiveness falls below 95% of original manufacture - in the worst storage scenarios. I think it was Tylenol that was still 99% effective after 40 years but aspirin was less than 1% effective. Pills lasted the longest but liquids lasted the shortest, while there are a few medications that do turn toxic.
We do need far more testing because of the amount of wasted medications. Maybe something like an original (95% in worst conditions) date and extended (80% in good conditions) date.
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Depending on the drug, that extra 5% is relevant. For non-trivial prescription drugs even the brand matters. Different brands have different potencies that have very relevant effects on the patient. A good pharmacy will even be diligent about giving you the same brand of a generic you're already taking.
I see this being less useful for the more expensive drugs versus the cheap OTC stuff.
At a certain point, the cost from wasting an "expired product" becomes so trivial that there is no point in taking even the
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Re:This is the sort of testing the Feds should do. (Score:5, Interesting)
A simple answer would be to require the drug manufacturers to accept returned drugs for credit or exchange with fresh ones. Set a maximum legal exchange fee of $0.05 per dose and see what happens to the official expiration dates.
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You sound anti-profit. Sir, are you anti-profit, yes or no?
I didn't know Pharma Bro read Slashdot. Is that you Martin?
When it comes to capitalism and profits, there is a reasonable line that tends to be defined by morals and ethics. Big Pharma and the Medical Industrial Complex crossed that fucking line trillions of dollars ago, and much like Pharma Bro, earned their dubious monikers.
There is profit, and there is obscene profit that tends to drive humans to make money regardless of the impact, and continues to widen the chasm between the ultra-rich and the other
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Seriously, this is why we have such serious problems in this country today! You are laying a problem at the hands of capitalism, which is actually entirely created by government! Let me guess you solution is going to be more regulations too.
Lets break this day.
FDA (government) say to drug makers you need to set expiration dates. They say okay well we know they will be good for three years our packaging technology and stabilizers are at least that good. Safe bet for us, because...
FDA (government) tells Ho
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Pre-existing conditions are a simple problem to.
There needs to be basically one rule, that if Mom is covered whoever is insuring mom has to allow a policy to originate for any infant born. Additionally policies need to be consider to be owned by the insured regardless of who is paying, that is if you insure little Timmy, the policy is Timmy's and if he does get sick while covered the insurer must allow Timmy to simply take over paying and continue the policy when Timmy becomes an adult.
Now we are compassio
Re:This is the sort of testing the Feds should do. (Score:5, Insightful)
The problem with pre-existing conditions is actually that they are expensive to cover. So, if you do find a way to cover them it involves other people paying for them somehow. If it is other people who are healthy directly paying for them, some of them will realize that the healthcare is not worth the cost--they're literally paying for a benefit they don't get--insurance for chronic conditions. Then folks will drop out, that will raise rates even more... that's death spiral.
The only way to deal with chronic conditions is to require only rich people to have them or for the government to pay for them.
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Pre-existing conditions were already a solved problem. It was called high risk pools and it worked very well in various states. It caught people who fell through the cracks and didn't completely break the private insurance market.
That was only the worst case. States with good regulators never let people who developed a chronic condition get dropped from insurance to begin with. People who contributed their entire lives weren't left out in the cold.
Now the entire private market is effectively just the high r
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You're American, aren't you. Now lift your head up, look around, and tell us just why your Stupid Libertarian Crackpot Ideas have never worked, ever, anyplace else.
Here's the STUPID simple fix:
Medicare for everybody. Universal Healthcare. And if that shrivels your balls right up your rectum, consider this:
Healthcare Research is International, and most new Drugs are being developed outside of the US these days. Just have the FDA adopt the Standards that pretty much everybody else uses, and have the Residents
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Re:This is the sort of testing the Feds should do. (Score:4, Funny)
This is either the best troll Slashdot has seen in a while, or we've got a low UID grumpy old git...
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Medical care is like cops or firemen. When your house is on fire you cant afford to shop around and let the market work. Similarly when you are sick you cant shop around and let the market work. Just like cops and firemen are paid through taxes, doctors need to be paid through taxes as well. There should be no medical insurance. A National Health Service should take care of health. People should also have to go through preventive care (just like you need to have fire inspections of buildings). Currently th
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Break it down a little further.
Why does the FDA say to put an expiration date on things?
Because greed can go to harmful extremes, people and companies will use things past a real expiration date, if they think they can get away with it, and it will make them additional money ( in not purchasing non-expired medicines ).
Why does the FDA say to toss expired drugs? See above.
Food was the same thing, people were getting killed eating tainted food because the seller would sell it, knowing it was bad or questiona
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That isn't true, it happened because of Tax policy. That is why it happened. Prior to that many union shops did have healthcare of a kind but it usually applied to injuries and illness that was clearly work related only.
Re:This is the sort of testing the Feds should do. (Score:5, Informative)
The government didn't start the employer sponsored healthcare system, the market did.
You're half-right. Employers started offering health insurance (among other benefits) "voluntarily" in response to Depression-era wage ceilings. They couldn't offer the higher pay they needed to retain their best employees so they came up with a workaround, paying some of their employees' living expenses directly and reserving the more tightly regulated wages for rewarding performance. Now we're stuck with it despite the obvious drawbacks (employer chooses the insurance plans; losing your job implies losing your health insurance). It's a good example of unintended negative side effects of price controls in the labor market.
On a truly private health insurance market chronic conditions would not be covered
Rightly so. It's more expensive to pay for treatment of chronic conditions indirectly through insurance vs. directly paying the health care provider. Why should an insurance company take a cut of the revenue? Chronic conditions are not unrealized risks; insurance has no place here.
nor would catastrophic health conditions because people underestimate the chances that they have them
Yet, surprisingly, people actually do buy insurance against "catastrophic" conditions—and not just employer-provided health insurance or the legally-mandated minimum level of automotive insurance. You're really not giving people enough credit here.
(I would personally expect most people to be more likely to overestimate the chances of truly catastrophic conditions, once they get past the sense of "immortality" which comes with adolescence. The general tendency I have observed is to underestimate things that happen often, and overestimate things which happen rarely.)
FDA Stability Requirements (Score:3)
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.
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Not entirely correct. The expiration date is a date where the product is guaranteed to have at least 90% potency. The date is a lower bound, not an upper bound.
Re:FDA Stability Requirements (Score:5, Interesting)
I would also guess that the expiration date is for more than the potency of the drug - its also for the accuracy of the box instructions, listed side effects etc, which the manufacturer also has to make reasonable effort to keep up to date.
Taking drugs from a 10 year old prescription in your medicine cabinet may mean the drugs themselves are still potent, but they may no longer list the severe side effect that was discovered 8 years ago, especially when taken with other medicine...
Yeah, no one looks at that stuff anyway, but the drugs companies have to cover themselves somehow for the inevitable legal fall out.
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So?
Put up a list of drugs and side effects on the FCC, or CDC, or whatever other won't-go-away-tomorrow place related to illness and medicine you can think of, post the address on the pamphlet and state that a fully up to date list of known side effects can be found there if you're worried.
Re:FDA Stability Requirements (Score:5, Informative)
Disclosure: I work in big pharma.
The problem is that what you suggest is not not enough for regulatory purposes. You can't say 'oh well then just do this or have people ask for that'. There are a ton of regulatory requirements on the manufacture and selling of drugs and medical devices. Companies are required by law to abide by them or risk getting shut down or lose control of your own plant. I know one place where that happened, resulting in a direct cost of a couple hundred million dollars + a hostile takeover as a result of the drop in stock value.
We follow all those 'stupid' rules because not doing so is not an option. If you want us to follow different rules, create the political momentum to change the laws that govern us.
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The problem is those rules were put into place because of companies that didn't follow rules or common sense and people died as a result.all cxx in a pharmacutical company should be held criminally libale for people I jured after taking the medication as presrcibed. Then we can do away with lots of regulations the pharmacutical companies don't like.
Regulations are rarely created in a vacuum a need or wrong is found and it is attempted to be fized
Re:FDA Stability Requirements (Score:5, Informative)
Regulations are created due to things like the thalidomide incident and the fact that the regulatory bodies create new rules to make sure that if the rules are followed, such incidents can never happen. And the reason that we follow those rules to the letter is that if we don't, the cost can easily run into hundreds of millions or even billions.
In the case of expiration dates, we have to prove that drug or device X, stored in Y conditions, still has effect Z all the way up to the expiration date. And we need to have the clinical trials and evidence to back this up. We cannot guarantee 10 years for example, because it would mean doing those trials and tests BEFORE releasing the product.
You are right, often it doesn't hurt. But there are enough cases where the potency or the health effects alter over time. So we CANNOT sell or distribute anything over date. If we do, we're back to the huge fines and lawsuits issue.
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Your points explain a lot where and why this madness exists.
It seems to me that, in an ideal world, big pharma should use those tests not to confirm a random expiration date, but to adjust the expiration date for every product periodically as the tests can give enough safety certainty over time.
I don't blame big pharma not beeing proactive in this, but this is something that should be regulated in some way.
Re:FDA Stability Requirements (Score:4, Informative)
That would be hard to do for 2 reasons.
Firstly, everything related to the expiration of drugs, potency etc is required to be printed on the packaging, the blisters (if any) and the included printed piece of paper that I don't know the English name for. You know the piece of paper in 2 pt font, the size of a piece of wallpaper. That particular prodcution lot will always be covered by the set dates that were included. You can't print X on the blister but say Y on some website. Everything on that giant sheet of paper in small print is included because it has to be by law, not because we enjoy the cost of including millions of sheets of paper that noone will read in detail.
Second, while it would be possible, theoretically, to increase the limit per production lot, this would require extra clinical trials and effectiveness studies, which are extremely time consuming and expensive.
Re:FDA Stability Requirements (Score:5, Interesting)
I'm not sure that madness is the right way to describe this. When you don't understand a complicated system, it looks crazy from the outside. When you understand it, it makes far more sense. Too much of the world is now twitterfied to jump to react at anything they've spent 15 seconds thinking about, regardless of how little they understand of it.
As Richard posted above [slashdot.org], and Interfacer posted here, it's not just that the drug manufacturers need to ensure that it's effective over many years. It has to have the effectiveness, side effects, and interactions with other medicines potentially not yet released tested over that span of years. That means clinical trials, and it means hoarding and storing all your products in the way they'd be stored in warehouses, stores, and homes for years and years before running the trials. It's just not feasible to do.
From a user-safety standpoint, a three year expiration date means that three years from now, people will replace that bottle with a new one, and that new one will have updated information regarding new known side-effects and interactions with other medicines. It's not like you can functionally recall medicine with a decade life-span if new findings and regulations means you need to update the product warnings. I see encouraging people to routinely clear out old medicine as a logical and reasonable step. Is it wasteful? Sure. But it's also very safe. And how do you balance those two, when the entire point of medicine is to make people better, not worse?
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Some drugs really do expire with potentially disastrous results. [nih.gov]
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You didn't even read your own citation. FAIL.
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I think you skipped down to the part where it said go ahead and use them anyways because the benefits outweigh the risks but missed this part: "Epinephrine bioavailability from the outdated EpiPen autoinjectors was significantly reduced (P
So less effective dosage then?
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Summary: EpiPen dosages can be used past expiration until visible discoloration or separation of the components occurs.
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You missed the point entirely.
It says:
For prehospital treatment of anaphylaxis, we recommend the use of EpiPen and EpiPen Jr autoinjectors that are not outdated. If, however, the only autoinjector available is an outdated one, it could be used as long as no discoloration or precipitates are apparent because the potential benefit of using it is greater than the potential risk of a suboptimal epinephrine dose or of no epinephrine treatment at all.
Translation: EpiPen dosages can be used past expiration because even a less effective/non effective EpiPen is less of a risk than no Epipen.
Re:FDA Stability Requirements (Score:4, Insightful)
OK, I think I'm not being clear. I agree completely and that's why my original post stated "potentially disastrous results"
The study I posted said that expired Epipens are more likely to provide a reduced dose but should be used anyway if there is no other option since a reduced dose is better than no dose and the Epipen won't poison you. IE the best of the worst options.
For that, I got 2 replies (not going to count the AC) and a downmod from people who fail at reading comprehension who took the study to mean that expired Epipens are just fine, when the study said no such thing.
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I think there may also be some risk these things might decay into something bad for you. Probably not with asprin, tylenol etc as that would have come to light by now.
I agree though there is no reason not use expired household pain killers of those types. The risk is your headache does not go away and you have wait 3 hours before you can try some other pills. Not exactly life threatening.
Inventory Management Much? (Score:5, Insightful)
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.
Re:Inventory Management Much? (Score:5, Insightful)
There are many drugs kept only for emergencies, in settings that have few emergencies, that must be thrown out and replaced when they expire. A good example is a general practitioner's office. They will keep a defibrillator, epinephrine, atropine, D50W, etc for medical emergencies, and may never use them over the course of a decade or two.
Another example is the now infamous EpiPen. People that have severe allergic reactions must keep them on hand to ward off anaphylaxis, but they are usually so diligent about avoiding their allergens that they never need them. Thus they expire before they are used.
Think of all the times patients are prescribed a medication but they cannot finish taking them (there are side affects, or the medicine isn't effective so another med is prescribed, etc, etc) and there are full pill bottles sitting around that could be used to treat other family members when they become ill. That would be.... efficient, would it not?
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Think of all the times patients are prescribed a medication but they cannot finish taking them (there are side affects, or the medicine isn't effective so another med is prescribed, etc, etc) and there are full pill bottles sitting around that could be used to treat other family members when they become ill. That would be.... efficient, would it not?
I think you intentionally wrote "other family members" rather than "others" because even you realize how much of a cluster fuck it would be to try re-issuing medicine in general and even then I'd be skeptical of anyone but my closest family. Apart from a few very generic prescription-free drugs that are probably kept/shared today, you expect people to keep stock of old medications for years on the off chance that someone else in close family will suffer from the same condition and need the exact same medica
Re:Inventory Management Much? (Score:5, Insightful)
There are many drugs kept only for emergencies, in settings that have few emergencies, that must be thrown out and replaced when they expire. A good example is a general practitioner's office. They will keep a defibrillator, epinephrine, atropine, D50W, etc for medical emergencies, and may never use them over the course of a decade or two.
This category calls for more active management (which would never work in our real world because it would require cooperation and security). Each doctor's office small supply of these drugs could sit on the shelf for, say, half of their useful life, and then be transferred to the ambulance squad which will go through them before they expire. Instead the ambulance squad buys its own, and the office supply is wasted, for a net waste of money and supplies, because the transfer would count as an unlicensed re-sale or is prohibited (rather than treating it as an inter-pharmacy transfer or whatever the law calls it).
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I was thinking less of a problem for hospitals but for families, especially those that are poor or live in remote areas.
Imagine a growing family. So little Timmy has a cold, or an infection, or whatever. The parents get pediatric medications but not all of it is used, so it sits on a shelf. Little Timmy isn't so little any more, but his little sister Jenny gets something similar to what Timmy had five years ago. Will the medicine left on the shelf be safe for little Jenny?
For a lot of people this is of
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> 1. have sufficient stock on hand for a run of requests
Except they don't.
I have problems with pharmacies being out of stock or under stock all the time.
NOBODY wants to waste real estate on product that doesn't move. Pharmacies are no exception.
Original sealed container (Score:5, Insightful)
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.
Re:Original sealed container (Score:5, Informative)
In the UK, it is *incredibly* uncommon for you to get a pill bottle any more - you get prescribed a specific dosage for a set period, which almost always corresponds to a specific container, so a 2.5mg tablet twice a day for 14 days means you get a 28 dose box with two 14 pill blister strips in it.
I wouldn't know why you would get handed a generic pill bottle with individual pills in it these days, I haven't seen it happen in a couple decades.
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I wouldn't know why you would get handed a generic pill bottle with individual pills in it these days, I haven't seen it happen in a couple decades.
Bulk drugs are less expensive, easier on people with arthritis, and pill bottles (not caps, usually) are recyclable.
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They also get accidentally reused for things that arent on the label, often aren't cleaned properly when refilled... you see where I am going?
And as pill bottles are required to be child proof, how are they easier on people with arthritis?
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They also get accidentally reused for things that arent on the label, often aren't cleaned properly when refilled... you see where I am going?
Understandable after not seeing them in over 20 years, those are false assumptions. Pill bottles are only used for what is on the label. The label is not replaced. The bottles are only reused a limited number of times if and only if they are prescribed that way. Many are not.
And as pill bottles are required to be child proof, how are they easier on people with arthritis?
Understandable ignorance from someone that has nothing to compare to. Pill bottles are not required to be child proof, but you must ask for an alternative. There are alternative cap options for those with physical ailments. Even with st
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They also get accidentally reused for things that arent on the label, often aren't cleaned properly when refilled... you see where I am going?
Understandable after not seeing them in over 20 years, those are false assumptions. Pill bottles are only used for what is on the label. The label is not replaced. The bottles are only reused a limited number of times if and only if they are prescribed that way. Many are not.
Yup, a pharmacist may be regimented enough to not reuse a pill bottle, but what about standard Joe Blogs and his wife? Putting half their medication into a random pill bottle for safe keeping, travelling etc, and then sticking it in the medicine cabinet and forgetting... wait a minute, is this really oxycodone or is it paracetamol...?
And as pill bottles are required to be child proof, how are they easier on people with arthritis?
Understandable ignorance from someone that has nothing to compare to. Pill bottles are not required to be child proof, but you must ask for an alternative. There are alternative cap options for those with physical ailments. Even with standard caps, pushing and rotating with a palm is much easier than pushing pills out of blister packs for people with arthritis.
So its not a blanket statement as was originally used then, eh?
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Yup, a pharmacist may be regimented enough to not reuse a pill bottle, but what about standard Joe Blogs and his wife? Putting half their medication into a random pill bottle for safe keeping, travelling etc, and then sticking it in the medicine cabinet and forgetting... wait a minute, is this really oxycodone or is it paracetamol...?
That's no worse than the remnant of a blister pack that was snipped down to the last unused pills & no longer can be distinguished between oxy/ibu as is so common. Yeah, Joe's wife may remember that _that_ one, was the Oxy, and that one is the ibu given that they were her prescriptions, but maybe not & Joe won't know.
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The bottles I get from my pharmacy have double sided caps. turned one way, it is child proof. Turned the other it is easy opening.
Prior to that, you could just ask the pharmacist for the easy opening bottles when you picked up your prescription..
Pharmacies don't reuse bottles typically. Often people will peel the label off of a bottle and use it for something else. But to avoid confusion, the bottles I get describe the pills on the label so you can make sure you're getting the right thing.
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Pill bottles are often used for treatment with no set duration - mainly anti-anxiety meds, the "Take when necessary" kind of stuff.
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In the UK, it is *incredibly* uncommon for you to get a pill bottle any more (...) I wouldn't know why you would get handed a generic pill bottle with individual pills in it these days, I haven't seen it happen in a couple decades.
Here in Norway I'd say pill bottles are still common for many medications, but it's never a generic bottle that anyone at the pharmacy creates or is reused. Typically they're bulk medicines that gets prescribed at different or on-demand rates to different people like pain killers and not "cures" that follow a particular schedule like antibiotics or to kill a fungal infection or anything like that, those have blister packs. Many people have their own pill box which has a grid of days and times that they load
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It's the same in Australia with getting blister packs. I rarely require medication, but when I have been on prescriptions I have always received blister packs.
Your Australian experience is different than mine. One of my nephews had a kidney replaced at the age of two and for the rest of his life has to take between 30-40 different tablets and capsules over the course of a day as well as cop a daily injection in his leg. The majority of his tablets/capsules (Caltrates, Sodibics, Tacrolimus, etc.) come in bottles with twist tops. The only blister packed ones I can think of at the moment are Mycophenolates.
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This is the thing - there is a difference between manufacturers' inventory where drugs can be stored safely and patients holding onto drugs. For the latter - there are issues with some drugs hanging around. There is a risk that they might be misused by others in the same home. But probably more importantly, in many cases if the symptoms for which they were prescribed have not been successfully treated, or changed then it is probably a good idea that a clinician re-evaluates. We do not really want people sto
The US is wealthy (Score:5, Interesting)
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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Countries more wealthy than the US and those of a similar level of wealth also tend to generate a lot less waste. There is a certain cultural element to the US being very wasteful compared to other countries.
That being said, erring on the side of caution with medicine (and thus being wasteful) is common throughout the developed world. Drug expiry dates will always remain based on pessimistic expectations and the manufacturer has no incentive to invest in studies that could show whether those expectations ma
Surprise: some medicines DO expire. (Score:5, Informative)
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.
Re: (Score:2)
Yes. Antibiotics often should be kept in the refrigerator to prolong their effectiveness. Same for any medication in liquid form.
The article is slim on details and admits many are "almost as effective" as when first made. Well... almost isn't necessarily good enough since medications depend on concentration. What exactly is "almost?" 85%? 90%? Taking the wrong dose thinking it's the full dose can make things worse -- especially for antibiotics or when figuring out drug interactions.
Lots of docto
Re: (Score:3)
Yes. Antibiotics often should be kept in the refrigerator to prolong their effectiveness. Same for any medication in liquid form.
The article is slim on details and admits many are "almost as effective" as when first made. Well... almost isn't necessarily good enough since medications depend on concentration. What exactly is "almost?" 85%? 90%? Taking the wrong dose thinking it's the full dose can make things worse -- especially for antibiotics or when figuring out drug interactions.
I doubt 10% or 20% really makes a difference for most drugs, the dosing guidelines are not that accurate. My wife and I each received identical antibiotic prescriptions (for unrelated reasons), and we both had the exact same dose despite me being over one foot taller and weighing nearly twice her weight.
https://science.slashdot.org/s... [slashdot.org]
Re: (Score:2)
Old news (Score:5, Interesting)
Disposable Society (Score:2)
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.
Click bait sensationalism... (Score:2)
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 manu
How were the drugs selected? (Score:3)
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.
Warranty (Score:5, Interesting)
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.
Re: (Score:2)
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.
I get that we all gotta die someday, but that obituary will be a bitch to swallow when your life is expired by a $2 can of old food..
Risk vs. Reward. Mitigate wisely. Your girlfriend would probably appreciate you being around a bit longer.
Re:Warranty (Score:5, Informative)
I get that we all gotta die someday, but that obituary will be a bitch to swallow when your life is expired by a $2 can of old food.
The thing is, an undamaged can effectively has no expiry date. People have recovered cans from the holds of ships that wrecked a hundred years ago and, upon opening them, discovered the contents to be safe. Unappetizing, perhaps (they do tend to dissolve into mush), but safe. The whole point of canning is that it makes microbial growth impossible, so if you're gonna be poisoned by a can of food, it makes no difference whether that can has been sitting on the shelf for a day or a decade. If it wasn't toxic on the day it was canned, it won't become so in the can. "Expiry dates" on cans are more to do with producers not wanting to create a bad impression by having customers try to eat soggy goop.
But do check to make sure the can is undamaged! A tiny pinprick of a breach, and all bets are off.
Small print. (Score:2)
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.
$765 billion a year is misleading (Score:5, Informative)
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.
$765, All or a quarter? (Score:2)
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 b
Pharmacology (Score:5, Informative)
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 [wikipedia.org] 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.
Re: (Score:2)
That seems unlikely to be true. We're constantly making new compounds. I find it hard to believe that all of them, including things we've not invented yet, with the single exception of paracetamol degrade safely.
Re: (Score:2)
Worse: Disposal of drugs (Score:2)
Real solution (Score:2)
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.
Expect FUD coming out soon (Score:3)
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.
Curious coincidence (Score:2)
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?
Re: (Score:2)
And yet... (Score:2, Offtopic)
Incentive (Score:4, Funny)
Reminds me about this joke (Score:5, Funny)
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.
avoiding the wasting of drugs (Score:3)
Re:So to solve the health care crisis... (Score:5, Insightful)
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?
Re: (Score:2)
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.
Re: (Score:2)
Re:asking wrong question (Score:5, Informative)
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...
Re: (Score:2)
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-purpo
Re:so frustrating would it be (Score:5, Informative)
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.
The Cutter
Re:so frustrating would it be (Score:5, Interesting)
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.
Re: (Score:2)
Re:so frustrating would it be (Score:4, Informative)
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.