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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.
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.
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.
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...
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.
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.
Quattuor res in hoc mundo sanctae sunt: libri, liberi, libertas et liberalitas.
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.
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.
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
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.
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.
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.
-- Note to Mods: There is a good reason there's no "-1 Disagree" option. --
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.
That's also how food expiration is often set. FDA testing or otherwise won't be useful without change to tort law... if the manufacturer is required to guarantee the product until expiration date and required to set one, they'll set one that is within their ability to run a stability test on and long enough that their manufacturing can keep up with demand. Setting it longer requires longer, more expensive testing and might not keep the production line operating at a nominal clip. So it isn't in their interest to make it longer anyway, and having it arbitrarily set by the government might 'fail' otherwise useful drugs that just happen to be less stable than the 10 year target.
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.
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.)
"The state is that great fiction by which everyone tries to live at the expense of everyone else." - Bastiat