Slashdot Mirror
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)?
If the expiration dates are 2-3 years from the date of manufacture, presumably pharmacies could do a little better inventory management and not have to throw any out. 2 years warning is plenty. Just keep 1 year's supply on hand. If demand drops, don't buy any more until you need to.
I should use this sig to advertise my book ISBN-13 : 978-1501515132.
Most patients don't get their prescription pills in the original sealed container of hundreds of tablets or capsules that is shipped to the pharmacy, but in a non-sealed container that is subject to high humidity and large temperature variation when stored at home. So the at-home longevity is less, although still almost always at least a couple years longer than marked on the retail vial.
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?
There are two types of people in the world; those who believe there are two types of people, and those who don't.
We have our expensive lifestyle, part of which is extreme safety. We have rules on how steep a ramp can be, no matter how expensive that makes construction. Every cafe must have a public toilet, no matter how expensive that makes the cafe, No one is going to make hand pulled taffy without wearing gloves.
The first time a pharmacists gives expired drugs to a parent for their child, and the child does not improve, of in the worst case dies, even if the death has nothing to do with the drug, we are going to see a multimillion lawsuit. Hell, we live in country where a child watch something on TV, then does it, and we see a multimillion dollar lawsuit.
So you know, maybe we can sell the drug at half price to medicare patients, but who is going to volunteer their parent as the one to take the expired drug over the non-expired drug?
"She's a scientist and a lesbian. She's not going to let it slide." Orphan Black
I already knew it's safe to take old medicines except tetracycline and similar antibiotics. But the surprise in this article is the fact that in a bigger study, 1/3 of medicine DOES lose its potency after expiration. The most important one is albuterol, the main "rescue" inhaler drug for asthma. This one is important because it's so tempting to stockpile--it's incredibly expensive in a lot of countries, so if you get a cheap source, you might want to buy enough for a decade or so. Too bad it doesn't last forever. I assumed all medicines were good forever if they're kept dry, but that's apparently not the case. If it differs per medicine, do the research when in doubt.
However, I can say from anecdotes (mine and others I found online) that albuterol is good for a few years after expiration.
A cat can't teach a dog to bark.
The militry stockpiles a lot of drugs and has been looking at how long drugs are good in an effort to save costs while ensuring the drugs were still good.
I'm a consultant - I convert gibberish into cash-flow.
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.
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've taken to calling the dates on pill bottles the "warranty date", and I refer to the contents as being "out of warranty" instead of "expired". Ditto lots of food.
It is easy for me, but hard on the girlfriend. She can watch me eat a can of Chili that has been out of warranty for 5 years (making it 7 or 8 years old) and know that it is fine, but still be unable to take a bite herself.
Same problem with pills. A big bottle of ibuprofen costs just a little bit more than a small bottle, so if I need 2 pairs of pills, I'll almost always spend the extra $2 to get 200 instead of 50, or whatever. If I don't need them again for 4 years, it doesn't bother me at all that they've gone off warranty along the way.
Disgust is wired very deeply in the brain, even though the higher layers of the brain interact with it. And for most people, it is nearly impossible to overcome.
See that "Preview" button?
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
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.
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.
Mother: "Silly, child! You bought Himalaya Salt, with expiration date next month!" :("
Child: "Wow, that must have been very unlucky. The salt lying in the Himalaya mountains for millions of years and just after they got it into the shop its expiration date is over
Honestly, if stuff is on a more or less constant temperature and safe from light, most things last nearly indefinitely. E.g. sugar, flour, oils, etc. especially if they are in air tight containers. Even a egg in the fridge lasts half a year, it only dries out slowly.
Food in tin cans easy lasts for decades, despite of the expiration date being in 6 month or what ever.
Cost free eBook I read (by iBook/Kobo/Amazon/ObookO/Gutenberg etc.): "The Green Odyssey" by Philip Jose Farmer.
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, 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?
Velociraptor = Distiraptor / Timeraptor