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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.
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)?
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.
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.
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?
Better known as 318230.
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.
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.