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The Myth of Drug Expiration Dates

propublica.org

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Re: The Myth of Drug Expiration Dates

#181

Post by johnnyhillbilly »

StavrosK wrote: post #114
Greed wrote: post #34

Earlier quoted context omitted.

I work for a company that has some periphery exposure to FDA-regulation, and as a result we have to do a lot of very similar scientific calculations to satisfy their archival records. A big part of why most medicines still expire (at least for medicines available over the counter) much earlier than they should is that a majority of the testing is done to determine the expiration date at a controlled temperature, pres…

I don't understand your comment. You say they test at a controlled pressure, whereas conditions in the typical medicine cabinet vary wildly, and then say that that's why the drugs expire much earlier than they should. Do you mean that varying conditions make medicines last longer? You can't mean that medicines would last much longer if stored in perfect conditions, because that's not expiring "earlier than they shoul…

I'll chime in.

Most chemical processes happen faster with a higher temperature. Some drugs decay into harmful substances (e.g. Aspirin).

Other factors, such as humidity or UV, may play a part as well.

Rather than testing every permutation of storage conditions over time, manufacturers put a safety margin. Individual consumers aren't in a position to remember exactly how they treated any given container of pills. Even if the manufacturer knew how a given sequence of storage practices affected their drug, nobody would be the wiser.

Re: The Myth of Drug Expiration Dates

#182

Post by civilitty »

philipkglass wrote: post #121
civilitty wrote: post #64

Earlier quoted context omitted.

Wrong. LSD and fentanyl have polar opposite therapeutic indexes - the therapeutic index is specific to toxicity whereas I'm talking about clinical outcomes in general. There are drugs that have threshold doses below which there is essentially no effect on the patient but aren't toxic until 10-1000x that threshold dose. Fentanyl just happens to have an effective threshold dosage that is dangerously close to its LD50.

LSD has an exceptionally wide therapeutic index, but fentanyl's therapeutic index of 270 is pretty good as prescribed drugs go. That's a far wider TI than over the counter painkillers like ibuprofen. Warfarin, a common narrow-therapeutic-index drug, has a TI of ~2 .

Fentanyl's therapeutic index is NOT 270 except when used as an opioid supplement for surgical anesthesia cocktails, where the dosage is less a microgram per kilogram and it's balanced with several other drugs and opioid antagonists. The maximum recommended dose for fentanyl is 50 mcg/kg and that requires ventilation because it is well above the estimated LD50 of 30 mcg/kg. The recommended low dose for fentanyl on its own is 1 mcg/kg so at best we're talking about a therapeutic index of 30.

LSD's therapeutic index is unknown because its LD50 has never been established in humans or monkeys and you can't extrapolate from non-primate animals to humans (for example, rats can handle a dose of fentanyl that is a thousand times higher per kg than monkeys can, which is where many of our LD50 estimates come from).

Re: The Myth of Drug Expiration Dates

#183

Post by mandevil »

valuearb wrote: post #166
mandevil wrote: post #118

Earlier quoted context omitted.

Do you honestly think that baking soda is in shortage because of patent restrictions? The US drug system is messed up, but not that messed up. They are in shortage because it takes a long time (six-ish months) to certify a factory as producing something safe for consumption[1], and in the normal course of things, there is very little point in setting up a second line to produce medical grade sodium bicarb- no company…

This article isn't just about baking soda. If society freely allows you the massive competitive barrier of a patent to ensure your riches, you should also have some obligations to society as part of the contract.

The article isn't, but most of the really egregious price increases we've observed (e.g. epipens, all the drugs that Martin Shkreli bought, etc.) have likewise not been on drugs under patent protection.

In point of fact, most drug companies have faced what are called patent cliffs, where due to troubles in the R&D pipeline[1] drugs lose patent protections far faster than new drugs come online to replace them. While this is probably bad for society overall- we really want lots of new drugs getting discovered and making us healthier![2]- it means that patents protect smaller and smaller portions of the overall drug market. IOW, playing games with them has less and less overall value as the years have progressed.

Need to find new levers to have influence on this market.

[1]: A totally different subject with a lot of theories as to why, but not much in the way of solid evidence.

[2]: Yes, the 1k USD/pill Solvadi is amazingly expensive. By the same token, it actually works, and cures you after three months. This is the sort of medicine that improves humanity, even at that price. There are plenty of other drugs (especially cancer drugs that extend lifespan by averages of <4 months) that do not improve humanity, but Solvadi does. It just costs a ton.

Re: The Myth of Drug Expiration Dates

#184

Post by civilitty »

parshimers wrote: post #163
civilitty wrote: post #41

Earlier quoted context omitted.

In the United States, you can be prosecuted in some states for drug possession if your prescription has expired and you still have the drugs [1]. This has not been sufficiently tested with the Supreme Court so you could eventually win on appeal but not before spending lots of money and time behind bars. [1] https://edfolsomlaw.com/2013/01/illegal-possession-of-your-o...

> This assistant district attorney operates on the theory that if your prescription was expired on the date of the alleged conduct, you no longer “possessed a valid prescription” at that time and therefore cannot avail yourself of the affirmative defense. Christ. That is insane. What are people supposed to do for medicines that are used only in the case of an emergency? I really wonder what goes through some of these…

> I really wonder what goes through some of these prosecutor's heads sometimes.

(Re)elections.

Re: The Myth of Drug Expiration Dates

#185

Post by readams »

BurningFrog wrote: post #144
Greed wrote: post #34

Earlier quoted context omitted.

I work for a company that has some periphery exposure to FDA-regulation, and as a result we have to do a lot of very similar scientific calculations to satisfy their archival records. A big part of why most medicines still expire (at least for medicines available over the counter) much earlier than they should is that a majority of the testing is done to determine the expiration date at a controlled temperature, pres…

Here's a startup idea: Develop an "indicator pill" that changes color at the same rate as an individual medication. It would be in (or part of) the bottle with the other pills, and be customizable to react to humidity, temperature and time in the same way as the particular medication.

The main problem is that there just isn't data on how much these drugs degrade. The expiration date is based on some preliminary measurements and conservative guesstimates. Neither the FDA nor the drug companies really cares or wants to see these dates extended.

Re: The Myth of Drug Expiration Dates

#186

Post by refurb »

valuearb wrote: post #168
refurb wrote: post #109

Earlier quoted context omitted.

A lot of manufacturers accept expired drug. And even if they don't, distributors often do as well. And expired drugs comes down to inventory management. Don't buy more product than you can sell.

If lots of manufacturers were all manufacturers, this article wouldn't have been written. In truth, the vast majority of expensive drugs aren't being replaced by distributors or manufacturers, or the Shelf Life Extension program for the government would not be saving $2B a year. And don't blame the victims, which is what your sentence on inventory management does. If a hospital over-estimates patients usage of a drug…

I would suggest you read up on the Shelf Life Extension Program. It's a specific program around either limited use products or products where the gov't hold such large stockpiles that companies won't take returns, it just wouldn't make sense. The most likely scenario is one where the products are never used.

I had a friend who worked on the federal Tamiflu stockpiles. The gov't and the manufacturer have a deal where the gov't gets a significant rebate on unused product that is either put back into circulation or the manufacturer buys it back and destroys it.

Remember, the gov't has companies competitively bid on manufacturing these products (particularly for generics which were most of the examples in the article). Is the company going to give a 100% money back guarantee if it's not used? Would you? I wouldn't.

So yes, there are certain scenarios (stockpiling) where manufacturers don't take back product. That's not most scenarios.

Most scenarios are hospitals holding 30-45 days on hand of product. If they screw up their inventory they should pay a penalty not the manufacturer.

Re: The Myth of Drug Expiration Dates

#187

Post by EpicEng »

yomly wrote: post #179
Kalium wrote: post #161

Earlier quoted context omitted.

There's also the not-irrelevant issue that testing is slow and potentially other than free. How do you find out when a drug expires? You have a bunch of it sit around and test it periodically, right? I assume that would be done after bringing a drug to market, otherwise drugs could easily be delayed 10+ years if they're shelf-stable.

I would expect the chemistry to be characterised well enough to the point where you shouldn't need clinical tests to know it's degredation profile...

I don't know about that. There are variables beyond theoretical chemistry, like the packaging, the manufacturing process, etc.

I'm not anywhere near knowledgeable on pharma, but I worked on an FDA regulated medical device. If we made a claim, we had to test it. Knowing that e.g. every component in the machine was rated safe between temperatures X and Y did not mean that we didn't have to perform real environmental testing.

Re: The Myth of Drug Expiration Dates

#188

Post by sliverstorm »

deelowe wrote: post #177
ballenf wrote: post #94

Earlier quoted context omitted.

The article states with absolute certainty that no patient has ever been harmed by an expired drug. Not doubting your point about tetracycline, but how much would a patient need to ingest to be harmed? Then there's the argument that the reason no one's been harmed is because the policy is working. Harm due to unavailability of drugs or higher costs are much harder to track, of course. Yet another case of a balance be…

I thought antibiotics lose their efficacy part there due date

I have to think they must, considering they need to be refrigerated. (Or at least the ones I've used did)

Re: The Myth of Drug Expiration Dates

#189

Post by Jessica- »

_rpd wrote: post #174
t0mbstone wrote: post #152

Earlier quoted context omitted.

Wouldn't the real solution here be to put real expiration dates on things that can harm you, and real expiration dates on things that haven't actually expired? Like a "dangerous to use after 01/01/2019" label on things that actually are dangerous. Other items could have labels like, "Safe for use until 01/01/2025 - Effectiveness may be degraded after 09/05/2019"

Any such labeling change would likely result in decades of litigation over the precise meaning of each term when someone inevitably comes to harm while taking the drug. From the manufacturer's point of view it's cheaper and possibly safer to use a single clear good/bad date.

Aunty Violet just got a new blue MINI Cooper Clubvan Wagon only from working part- time off a pc at home... http://bit.do/dnRs5

Re: The Myth of Drug Expiration Dates

#190

Post by sliverstorm »

lostcolony wrote: post #79
Greed wrote: post #34

Earlier quoted context omitted.

I work for a company that has some periphery exposure to FDA-regulation, and as a result we have to do a lot of very similar scientific calculations to satisfy their archival records. A big part of why most medicines still expire (at least for medicines available over the counter) much earlier than they should is that a majority of the testing is done to determine the expiration date at a controlled temperature, pres…

Beyond that, what is the incentive on the part of the company? No one is evaluating medications based on shelf life. Longer expiration dates -at best- do nothing favorable for the company, and at worst both reduce the purchase of more of the drug, -and- open the company up to litigation in the even it's dangerous. Why take that risk? There is simply no economic pressure to.

Well, although supposedly the Army specifically liked Cipro because of the shelf life, so that's one case counter.
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