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The Myth of Drug Expiration Dates

propublica.org

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Re: The Myth of Drug Expiration Dates

#211

Post by civilitty »

philipkglass wrote: post #191
civilitty wrote: post #182

Earlier quoted context omitted.

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…

I didn't know that extra context about the numbers for fentanyl. Thanks for correcting me. I was going to post something long about LSD but it turns out I am just wrong. So thanks twice, and have my upvote.

Glad I could enlighten. The therapeutic index is a very subjective measurement that makes some drugs sound safer (or more dangerous) than they really are. Both the numerator and denominator in the ratio are very situation dependent. For example, trazadone is a hypnotic at doses in the tens of milligram but an anti-depressant at doses in the hundreds of milligrams so depending on what you're using it for, its therapeutic index could be different by up to 100x.

Likewise, in a clinical setting (i.e, with a trained anesthesiologist in fentanyl's case), the dose at which 50% of patients die from a given drug is usually much higher because trained professionals can quickly receive feedback by monitoring the patient's symptoms and apply drugs or medical devices to keep them alive well beyond what could kill someone on the street.

Re: The Myth of Drug Expiration Dates

#212

Post by Steeeve »

A silicon valley startup by the name of SIRUM (http://www.sirum.org/) has done some pretty incredible work in this space. They re-distribute medicine nearing it's expiration from hospitals/pharmacies/etc. with surplus to areas that need it and can use it before it expires.

I'm sure they do more - I only have a slim memory from hearing one of their founder's speak.

They do have a pretty incredible impact and deserve mention in this conversation - they've been attacking this problem from a "what can we do now" perspective for the last 5 or 6 years while others have been spending time debating what to do or if anything really needs to be done. They are good people.

Re: The Myth of Drug Expiration Dates

#213

Post by kiahjw »

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.

Most medications at the patient-level are in amber vials in the US (all pills loose). BUT there are still plenty of meds still further up the supply chain that are in tamper-evident packaging and could be donated if short-dated.

Re: The Myth of Drug Expiration Dates

#214

Post by cbr »

jessriedel wrote: post #199
breischl wrote: post #137

Earlier quoted context omitted.

>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 w…

> Gee, you get to just hand-wave an entire manufacturing process and supply chain into insignificance, but I need a model, huh? Nope, for this you just need a number! (In my comment, the "model" part referred to how monopoly pricing was done.) > So 11 cents/pill just to run a pill through the supply chain and then dispose of it. Good, your estimate process is a reasonable one, and I accept this number. > $330 million…

$765B is their estimate for all waste, not just wasted pills:

    ProPublica has been researching why the U.S. health care
    system is the most expensive in the world. One answer,
    broadly, is waste — some of it buried in practices that
    the medical establishment and the rest of us take for
    granted.  We’ve documented how hospitals often discard
    pricey new supplies, how nursing homes trash valuable
    medications after patients pass away or move out, and how
    drug companies create expensive combinations of cheap
    drugs. Experts estimate such squandering eats up about
    $765 billion a year — as much as a quarter of all the
    country’s health care spending.
Later on they say:

    Tossing such drugs when they expire is doubly hard. One
    pharmacist at Newton-Wellesley Hospital outside Boston
    says the 240-bed facility is able to return some expired
    drugs for credit, but had to destroy about $200,000 worth
    last year. A commentary in the journal Mayo Clinic
    Proceedings cited similar losses at the nearby Tufts
    Medical Center. Play that out at hospitals across the
    country and the tab is significant: about $800 million
    per year. And that doesn’t include the costs of expired
    drugs at long-term care pharmacies, retail pharmacies
    and in consumer medicine cabinets.
This isn't estimating the same thing as the GP's $330M (hospital waste instead of consumer waste) but $800M is on the same scale, suggesting to me that the marginal cost of drugs might matter some.

(I do agree with your point that most of the cost, and especially the most egregious examples like the wasted epi-pens, don't represent real costs because of monopolies.)

Re: The Myth of Drug Expiration Dates

#215

Post by kiahjw »

Steeeve wrote: post #212

A silicon valley startup by the name of SIRUM ( http://www.sirum.org/ ) has done some pretty incredible work in this space. They re-distribute medicine nearing it's expiration from hospitals/pharmacies/etc. with surplus to areas that need it and can use it before it expires. I'm sure they do more - I only have a slim memory from hearing one of their founder's speak. They do have a pretty incredible impact and deserve…

SIRUM Co-founder here! Super pumped and happy to chat with anyone!

We help orgs donate surplus meds that are often short-dated. We're tackling the $5B of unused, UNEXPIRED meds that go to waste every year in the U.S.

Re: The Myth of Drug Expiration Dates

#216

Post by slr555 »

t0mbstone wrote: post #152
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…

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"

I'm sure there is some degree of companies wanting expiry to be like the dates on grocery items that are really "taste best by" dates but in speaking to manufacturing and development people their are some layers of complexity. Compounds do degrade over time in many cases and things like light, temperature and humidity play a role. In pharmacy warehouses they aren't just required to control climate they have to log temperature 24 hours a day in an auditable format. Because of these factors the target is a moving one and while many things would likely be fine, for prescription medicine the tolerance for risk is so low that it pushes things in a very conservative direction.

There is a great comment farther down about how complex label changes can be. Getting a revised label, or packaging through FDA is an enormous undertaking. This why sometimes dosing seems very weird. If research says we need a 2mg and a 4mg but later in the process patients need a .5mg it's a big mess.

Suffice to say it's a deep rabbit hole.

Re: The Myth of Drug Expiration Dates

#217

Post by mandevil »

sliverstorm wrote: post #195
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…

At least in government, that sort of thing is usually handled with second-source agreements as a contingency of a supply contract. Can have the side benefit of introducing some competition. See AMD, once-second-source-supplier for Intel, Fairchild, and National Semiconductor.

Sure, and for some stuff this is done now. But there are something like 9,000 different pharmacy items (leaving aside medical supplies like sterile bandages, which are procured through a totally different system) in my wife's very small hospital (that ships out all the difficult cases, requiring specialized medicines, to larger nearby hospitals). Should there be second-source agreements- and extra productions lines- ready to go for all of them?

Most of these medicines are like sodium bicarb- the national population doesn't need that much, but if you need it, it's hard to get a good substitute. Snake antivenom or daraprim are good examples of these niche products that are even more crucial than bicarb, but still probably not used enough for any one organization to be able to justify a second-source contract.

Re: The Myth of Drug Expiration Dates

#218

Post by jessriedel »

cbr wrote: post #214
jessriedel wrote: post #199

Earlier quoted context omitted.

> Gee, you get to just hand-wave an entire manufacturing process and supply chain into insignificance, but I need a model, huh? Nope, for this you just need a number! (In my comment, the "model" part referred to how monopoly pricing was done.) > So 11 cents/pill just to run a pill through the supply chain and then dispose of it. Good, your estimate process is a reasonable one, and I accept this number. > $330 million…

$765B is their estimate for all waste, not just wasted pills: ProPublica has been researching why the U.S. health care system is the most expensive in the world. One answer, broadly, is waste — some of it buried in practices that the medical establishment and the rest of us take for granted. We’ve documented how hospitals often discard pricey new supplies, how nursing homes trash valuable medications after patients p…

Hey thanks! This is a good clarification. I'm happy to modify my criticism from "the author is strictly off by a factor of 1000" to "the author strongly leads the reader to believe the size of the effect is 1000 times stronger than it really is, but he deftly avoids saying anything that's technically false, and in any case the reader shouldn't care about this since it represents an dead-weight loss of about $2 per person per year, which is less than the value of the reader's time spent reading this article".

Re: The Myth of Drug Expiration Dates

#219

Post by kbenson »

t0mbstone wrote: post #152
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…

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"

The point is we don't necessarily know, or know to the degree of certainty the FDA requires, how many of these things degrade. Perhaps in certain conditions, they degrade at one rate, but in other conditions (such as a temperature difference), they degrade at a different rate. Testing how drugs perform years after production in multiple different scenarios is necessarily time consuming, because it takes at least that much time to be sure.

Re: The Myth of Drug Expiration Dates

#220

Post by perseusprime11 »

kbenson wrote: post #219
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"

The point is we don't necessarily know, or know to the degree of certainty the FDA requires, how many of these things degrade. Perhaps in certain conditions, they degrade at one rate, but in other conditions (such as a temperature difference), they degrade at a different rate. Testing how drugs perform years after production in multiple different scenarios is necessarily time consuming, because it takes at least that…

I see medicines in foreign countries wrapped in some kind of aluminum foil. Will that prolong the life of the medicine given there is no oxygen to react?

Given the amount of money spent on medicines, I really think there is a good moral business case to identify the correct expiration dates and save money for people.

We just went through the Health care ordeal. Money saved anywhere is money saved for people who desperately need healthcare to work for them.

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