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The Myth of Drug Expiration Dates

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Re: The Myth of Drug Expiration Dates

#131

Post by funkymike »

thaumasiotes wrote: post #88
harshreality wrote: post #4

> 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. What kind of reporting is this? Anything less than 100% is not "as potent as when manufactured", and the sentence implies some of those dozen weren't close to 100%. > The idea that drugs expire on specified dates goes back at…

> That seems to be the problem. There was a procedure in place to set expiration dates scientifically, and it was ignored for some reason, limiting the legal shelf life of even the most stable compounds to a few years. To investigate how a drug breaks down over a ten-year timespan, you'd need to do at least one ten-year study of the drug. That seems difficult to justify.

I was thinking about this today after hearing a report on the radio this morning on this topic. Hospitals end up throwing away large amounts of drugs each year due to expiration, potentially hundreds of millions of dollars - although there is no real data currently.

It seems like it would be a good long term investment for a group of hospitals to partner together and begin a systematic study of the actual lifetimes of drugs. Instead of destroying all expired drugs they could send off samples to a lab for testing. They could even intentionally keep expired drugs in an off-limits area for 1, 2, 3 years past their expiration dates to gather more information. With enough hospitals participating they could gather a significant amount of data without any one hospital shouldering all of the burden. Once there is enough evidence that a particular drug is still potent the FDA could extend the allowed shelf life. This would save the hospitals money over time since they could stop paying to dispose of and replace as many expired drugs. It would also provide a general benefit to the public since people would have solid scientific evidence for the actual effective lifetime for particular drugs. This would include poison control centers, the hospitals themselves, etc. that would be able to better handle cases where someone has already taken an expired drug.

Of course an alternate way would be to require the drug companies to accept returns from hospitals of small amounts of expired drugs that they would then be responsible for testing and providing the data to the FDA. Limiting the returns to large institutions would keep the costs down (reducing push-back from the pharma companies).

Re: The Myth of Drug Expiration Dates

#132

Post by Spooky23 »

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.

I don't think there's an economic pressure to have a longer shelf life either.

It's not any more efficient to stockpile drugs, and it doesn't make sense to do so, as your need for prescription drugs is likely not going to be multiple years.

Re: The Myth of Drug Expiration Dates

#133

Post by gph »

PixelB wrote: post #81
criley2 wrote: post #56

Earlier quoted context omitted.

This is completely wrong. Dosage studies happens between Phase 2 and Phase 3 trials (and Phase 4 "post marketing" too) and are the most expensive, longest and most scientific process that arguably any business engages in in the entire world. Phase 1 is a safety test in healthy ~men. These seek to find the maximum dose before adverse effects appear in the healthiest humans. Phase 2 is a safety/dosage test in a much la…

Sounds like you don't know what you are talking about. Your source is a book written with heavy influence by the Pharmaceutical industry to justify the obscene costs of their drugs, making billions in profits off of sick, poor people. You are the one who is completely wrong. The dosages most certainly do start out with a "best guess" in the pre-clinical phase. For any given drug we would guess at the doses based on o…

>It's all a guess until the end, and even then we're often not sure. Look at anti-depressants. We still don't know how a lot of those work but prescribe them to millions of people regardless. How do you think they determined the dose when they don't know how the drug works?

We know how antidepressants work, the chemical reaction is well known and can be quantified at different doses. We just don't know why they work because we don't understand why/how the brain works.

Pedantic but important difference.

Re: The Myth of Drug Expiration Dates

#134

Post by jkern »

jessriedel wrote: post #125
learn_more wrote: post #80

Earlier quoted context omitted.

The cost model is like a time limited software license. If there is some new trick to extend the license, the drug companies would likely just charge more up front.

Exactly. The price is set by the willingness to pay (the demand curve), which accounts for the fraction of purchased pills that will actually be consumed.

It seems like this would be true if everything were working perfectly and there was a gradient of purchasing options across price/expiration. As it is consumers really don't have any choice wrt expiration date since as far as I'm aware the option to pay more for longer lasting drugs doesn't really exist.

Re: The Myth of Drug Expiration Dates

#135

Post by [deleted] »

gist wrote: post #85
slr555 wrote: post #66

This issue is a conundrum. Most drugs don't fall off a cliff of efficacy when they reach their expiration date. There are drugs such as tetracyclines that should never be used past their expiration dates because they degrade into toxic compounds. Certain classes of drugs such as anti-arrhythmics or drugs like warfarin are dosing critical to the point where I would not want them if they were out of date. I worked in p…

The other issue (as mentioned in the article) is environment. For example I keep some drugs in a backpack that I regularly leave in a hot car. The drugs that were in the Pharmacy probably had near ideal conditions and didn't even move. Giving end users and consumers an algorithm to follow with regard to disposal simply would stand little chance of working in a practical sense. One size fits all is the way to go.

[deleted]

Re: The Myth of Drug Expiration Dates

#136

Post by bb611 »

burkaman wrote: post #11
harshreality wrote: post #4

> 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. What kind of reporting is this? Anything less than 100% is not "as potent as when manufactured", and the sentence implies some of those dozen weren't close to 100%. > The idea that drugs expire on specified dates goes back at…

From the study: > Twelve of the 14 drug compounds tested (86%) were present in concentrations at least 90% of the labeled amounts, the generally recognized minimum acceptable potency. Three of these compounds were present at greater than 110% of the labeled content. Two compounds (aspirin and amphetamine) were present in amounts of less than 90% of labeled content. One compound (phenacetin) was present at greater tha…

My brother-in-law works in pharma manufacturing, this stuff is really hard and it's basically impossible to create exactly identical pills, apparently in large part because the active ingredient is frequently Depending on necessity and value they can typically engineer more precision, but it gets very expensive very fast.

Re: The Myth of Drug Expiration Dates

#137

Post by breischl »

jessriedel wrote: post #123
breischl wrote: post #86

Earlier quoted context omitted.

>This article has some shoddy logic... all that potentially happens is a transfer between the consumer and the manufacturer. The point of the article is that this is an expensive mess for everyone except the manufacturer, which means approximately everyone. As a consumer, having the manufacturer "transfer" money from your pocket into their own sucks. Seems like the article's logic is actually pretty decent. Also, eve…

> As a consumer, having the manufacturer "transfer" money from your pocket into their own sucks. Seems like the article's logic is actually pretty decent. As I addressed in my second paragraph, it is not actually a transfer unless you introduce new assumptions into the standard model of a monopoly. Please describe them. > There are real costs in time, money, and resources for creating the packaging, transporting drug…

>Please, by all means, construct a more accurate model.

Gee, you get to just hand-wave an entire manufacturing process and supply chain into insignificance, but I need a model, huh?

Fine. Let's use a generic drug (ie, not paying patent/development costs) as a proxy for how much the entire supply side costs. How about loratidine. You can get that at Walmart (stocked on the shelf, since that's mostly what the article was discussing) for about 10 cents/pill.[1] Of course that's completely ignoring the disposal costs. I strongly doubt that disposing of hospital/pharmacy quantities of drugs is as easy as chucking them in the municipal landfill. Let's say it costs 10% of the purchase price. So 11 cents/pill just to run a pill through the supply chain and then dispose of it.

Intensifying the napkin math... CDC says there were ~3.4 billion visits that resulted in drugs "provided or ordered". [2] Let's say that those were an average of 7 days worth of drugs ordered, so ~30 billion doses. Let's say that 10% of that much is either wasted by the consumer, or wasted while sitting on a shelf before anybody bought it - 3 billion pills.

3 billion pills/year * 0.11 cents/pill = $330 million/year. I dunno, seems potentially significant, at least to an order of magnitude level. Especially since the costs of the FDA program to extend the shelf life was around 1% of that much.

Ref:

[1] - https://www.walmart.com/ip/Equate-Loratadine-10-mg-300-ct/20...

[2] - https://www.cdc.gov/nchs/fastats/drug-use-therapeutic.htm

Re: The Myth of Drug Expiration Dates

#138

Post by gnaritas »

zajd wrote: post #72
gnaritas wrote: post #44

Earlier quoted context omitted.

Laws are merely barriers to work around, incentives guide what's going to be attempted. Making something illegal adds some negative incentive, but isn't nearly as good a solution as simply having positive incentive to do the right thing.

What makes you think laws aren't incentives? "Merely barriers to work around" kind of misses why laws exist in the first place. Making something illegal is what society should do if we collectively agree that behavior is to the detriment of society without any positive gain. What do we gain by allowing drug manufacturers to put false expiration dates on their products?

As I just said laws are negative incentives, your response makes no sense, care to try again?

Re: The Myth of Drug Expiration Dates

#139

Post by 23443463453 »

Beyond just drug expiration dates, I really wish we could get legislation that requires printing the actual expiration date of foods.

Not to focus on any one particular group, but I have received suspicious looks when I suggested that dry goods or even canned goods are edible well beyond the nonsense "best by" dates.

Re: The Myth of Drug Expiration Dates

#140

Post by zentiggr »

dekhn wrote: post #106
agumonkey wrote: post #89

Earlier quoted context omitted.

Yeah unless we put something better in place, maybe a dedicated QR code website to quickly verify if that box is 1, 2, 10, toxic

But there are too many details in how the drug could fail depending on its individual storage.

A big chunk of this article's message is that those considerations seem to not have anywhere near as much of an effect as currently assumed. (EpiPens viable 50 months past their marked date)

I would push two prongs: reinforce that expiration dates are serious, and at the same time test and extend any/all dates to the actual behavior of each drug. turn a one year into 5, 10, 20? Hell yes.

Pretty obvious that big chunks of the health care system are rigged for profit, not efficiency or usefulness.

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