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.
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
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.
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 standard caps, pushing and rotating with a palm is much easier than pushing pills out of blister packs for people with arthritis.
I've taken to calling the dates on pill bottles the "warranty date", and I refer to the contents as being "out of warranty" instead of "expired". Ditto lots of food.
It is easy for me, but hard on the girlfriend. She can watch me eat a can of Chili that has been out of warranty for 5 years (making it 7 or 8 years old) and know that it is fine, but still be unable to take a bite herself.
Same problem with pills. A big bottle of ibuprofen costs just a little bit more than a small bottle, so if I need 2 pairs of pills, I'll almost always spend the extra $2 to get 200 instead of 50, or whatever. If I don't need them again for 4 years, it doesn't bother me at all that they've gone off warranty along the way.
Disgust is wired very deeply in the brain, even though the higher layers of the brain interact with it. And for most people, it is nearly impossible to overcome.
See that "Preview" button?
I used to 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.
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.
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.
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.
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 of the US pay the same for those Drugs and Procedures that everybody else does, win addition to whatever Government subsidies are needed.
A "strong individual insurance market" would disappear just like Phrenology has.
But you would rather have people die and/or go bankrupt to protect the fiction of your precious "Markets".
You prick.
Captcha: mankind
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