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The Myth of Drug Expiration Dates

propublica.org

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Re: The Myth of Drug Expiration Dates

#141

Post by jinglebells »

tzs wrote: post #110
coding123 wrote: post #31

Almost all of the drugs I have in my cabinet are expired, and all have been 100% potent as the day I got it when I needed to take it years later. I have known this for a long time. There is also a reason the expiration date on your prescriptions is exactly one year after you get it from the pharmacy, when those bottles are actually sitting in a different bottle for months and months at the pharmacy. The entire reason…

For prescription drugs in the hands of consumers, as opposed to hospitals and pharmacies, I would be concerned about consumers misusing drugs. For example, suppose someone goes to their doctor with certain symptoms and are diagnosed with a specific condition. They are prescribed a drug to treat it. They use up half the prescription, and the condition goes away. A couple years later they develop similar symptoms. Inst…

> and cost of a doctor visit.

And we've nailed the problem. I don't pay to see the doctor so I have no reason to stockpile the drugs.

Re: The Myth of Drug Expiration Dates

#142

Post by civilitty »

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…

You and the GP talking about entirely different things. You're talking about how investigators choose the initial dose for the clinical trials, he's talking about the dosage that is actually prescribed by doctors.

Hence the 'The dose we take is not a "BEST GUESS"' (emphasis mine). Unless you're a lab animal or a person in a clinical trial, the does you take is the end result of lots of money spent on first figuring out maximum safe dosages (Phase 1) to prescribing guidelines that doctors are taught (Phase 3).

Antidepressants are a unique group of drugs because the dosage is highly dependent on each person's unique brain chemistry and a huge part of a good psychiatrist's job is working with their patients to find the right dosage and combination. The problem is that many psychiatrists don't have the time (due to insurance billing practices) or the patience to do the work but any decent psychiatrist will tell you that recommended doses for antidepressants are just a safe starting point for most patients, not the dosage that they will eventually find most effective.

For the record, I have worked in the pharmaceutical industry on pre-clinical drug development and Phase 1-3 marketing applications and the GP's description is largely accurate whereas you seem to have a chip on your shoulder. I wouldn't trust a single book about the drug development process that wasn't heavily influenced by the pharmaceutical industry in one way or another just like I wouldn't trust anyone without semiconductor industry experience when talking about Intel's cutting edge fabrication processes.

Re: The Myth of Drug Expiration Dates

#143

Post by vkou »

gumby wrote: post #77

(former pharmaceutical developer here). This article makes it sound like there's a big conspiracy, which there isn't. A very few drugs (like erythromycin) become toxic so should be discarded. Some drugs become less efficacious over time, but nobody really knows the shape of the curve as they are simply tested to see if they have the same efficacy on day E as they did on day 0. Well of course all drugs will become wor…

> And of course US egg producers take steps that reduce the storage time of eggs, which can be months old when you get them -- and then "expire" a week after getting home.

I've yet to have a US carton of eggs go bad, and they often spend a few weeks in my fridge.

Re: The Myth of Drug Expiration Dates

#144

Post by BurningFrog »

Greed wrote: post #34
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…

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.

Re: The Myth of Drug Expiration Dates

#145

Post by YawningAngel »

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…

SSRIs, SSRIs, MAOIs and TCAs all have reasonably well understood pharmacology. As an extreme example, there are very detailed guidelines on how to prescribe venlafaxine, to whom, and who should supervise. You're free to dispute these claims but I think you need to produce more than a blanket dismissal, especially as the OP offers a seemingly reasonable source.

Re: The Myth of Drug Expiration Dates

#146

Post by dp-tyvek »

euyyn wrote: post #82
unics wrote: post #21

In Denver there is a program that supplies hospitals internationally with expired drugs and equipment that would otherwise be without. It's been going on for decades and saved many lives.

I'd think there's a business opportunity in recycling the still-active chemicals in those pills.

A lot of cost of drugs comes from R&D, quality control etc. The chemical synthesis itself generally isn't that expensive. And expired pills would be a quite unpredictable precursor, which isn't very desirable in the pharma industry (or anywhere else for that matter). In other words, I doubt you could make much of a profit (if any) from purifying non-decomposed chemicals from pills.

Re: The Myth of Drug Expiration Dates

#147

Post by BrandoElFollito »

dragonwriter wrote: post #116
collyw wrote: post #100

Earlier quoted context omitted.

Most medicines are sold in blister packs these days. Won't that prevent a fair bit of the environmental stress from affecting them?

> Most medicines are sold in blister packs these days. Won't that prevent a fair bit of the environmental stress from affecting them? Well, it keeps out humidity, and might prevent air-exposure effects. It won't prevent heat effects and some other environmental effects. Also, quite a lot are sold in bottles of pills or other non-blister-pack forms.

I live in France and cannot remember the last time I saw pills not in a blister pack.

I remember vaguely having seen pills in bottles maybe 20 or 30 years ago. Again this is for France, I know that e.g. in the US one gets refills.

Which by the way I find great because the waste of pills is tremendous. It would have been much better to get the specific number prescribed.

Re: The Myth of Drug Expiration Dates

#148

Post by sevenfive »

civilitty wrote: post #64
sevenfive wrote: post #50

Earlier quoted context omitted.

> There are a few compounds (like fentanyl or LSD) where the dosages are so small and the compound so potent that 10-25% makes a difference but for the majority, precision isn't that critical. Wrong. Therapeutic ratio, not dosage.

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.

Excuse me, index. A dimensionless quantity. Nothing to do with potency. And you could hardly pick worse drugs to spread misinformation about.

Re: The Myth of Drug Expiration Dates

#149

Post by epistasis »

ballenf wrote: post #94
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 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…

See this comment for some contrary opinions on harm with citations in the literature:

https://news.ycombinator.com/item?id=14797616

Personally, I take all quotations like the ones in the article with a huge grain of salt. There's often enough of a communication barrier that even good reporters can misunderstand an answer, or for the researcher to be answering a different question than the reporter asks. And there's also the possibility that the researcher just had a failure of memory.

Re: The Myth of Drug Expiration Dates

#150

Post by tpm »

gph wrote: post #133
PixelB wrote: post #81

Earlier quoted context omitted.

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…

No, we don't know the antidepressive mechanism of antidepressants, therefore we don't know how they work. Understanding some neurochemical reactions and biological adaptations they cause is not enough. (We also don't have a complete understanding of depressive disorders, we don't really have very effective medication/therapy for many depressive people, etc.)
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