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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.
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.
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