
The Myth of Drug Expiration Dates - danso
https://www.propublica.org/article/the-myth-of-drug-expiration-dates
======
slr555
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the point where I would not want them if they were out of date.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 pharmaceuticals in a medically underserved community for a couple
of years. At that time when drug samples expired, sales representatives had to
return them to their companies for destruction. One doctor in the area made
sure that all the drug reps knew he would accept short dated (but not
outdated, which would have been against policy for reps) samples for a free
clinic he ran. Everyone I knew participated when they had short dated samples.
While reps could not distribute outdated samples, doctors had much more
latitude in how they dealt with them. It was one of those rare and wonderful
situations that was good for patients, created good will for reps and was all
completely within regulations.

I should say this was some years ago and regulations may have changed since
then.

~~~
t0mbstone
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"

~~~
kbenson
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.

~~~
mechnesium
I'm a test engineer. Highly accelerated life testing (HALT) can probably be
used to closely approximate the shelf life of medicine. You need to look at
the parameters that cause degradation (humidity, temperature, light exposure,
etc). HALT the samples at different temperature/humidity/lighting extremes and
use mass spectrometry to check purity. Use the data to create an algorithm
that approximates the product lifetime and then correlate the results with
actual shelf life for verification.

~~~
seehafer
Unfortunately, ALT is not a solution, because it's not accepted by FDA, except
as a temporary measure.

Any drug submission that supports shelf life via ALT data will be expected to
also say "and we're doing real time testing to support this", and FDA will
expect the follow up real-time data.

~~~
GordonS
Then perhaps the solution is for the FDA to allow HALT testing. Having said
that, I imagine there is little incentive for pharma companies to willingly
extend the shelf life of their products - perhaps the real solution is for the
FDA to actually _require_ HALT testing.

~~~
Broken_Hippo
I think the real thing here is, "Better safe than sorry". It's fine to use
things like HALT testing initially to say, "this drug should be effective for
8 years" so that folks can get it to market before 8 years have passed.

But if, in reality, that drug only lasts for a strong 5 years, after which
time it loses effectiveness, especially in high humidity or with high UV
exposure. We could catch this with real-time tests and adjust accordingly -
before it actually affects the general public's health.

------
harshreality
> 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 least a half-
> century, when the FDA began requiring manufacturers to add this information
> to the label. The time limits allow the agency to ensure medications work
> safely and effectively for patients. To determine a new drug’s shelf life,
> its maker zaps it with intense heat and soaks it with moisture to see how it
> degrades under stress. It also checks how it breaks down over time. The drug
> company then proposes an expiration date to the FDA, which reviews the data
> to ensure it supports the date and approves it. Despite the difference in
> drugs’ makeup, most “expire” after two or three years.

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.

~~~
civilitty
When working with biological systems, most of the time your acceptable error
margin is between 10-25%. 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. The ones where
it does matter are tightly controlled and clinically applied by a professional
with active monitoring.

The only drugs that weren't within 10% of their original concentrations,
according to the study, were amphetamines and aspirin. I can't think of any
uses off the top of my head for those two where even 25% would make much of a
difference to outcomes - amphetamines are mostly used as general purpose
stimulants or to treat ADD and aspirin is not the blood thinner of choice for
life and death situations. With amphetamines especially, what you eat and
small factors like blood pH can have a massive impact on their effectiveness
so we're already talking 10-20% differences day by day, let alone person to
person.

~~~
JohnJamesRambo
And to add into that, dosage studies are rarely adequately done for most
drugs. The dose we take is often a best guess and may be twice or more than we
need, so 10% is even more inconsequential.

~~~
criley2
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 larger and varied sample. We know
dose ranges and begin testing them for efficacy in a varied population.

Phase 3 is the big one. It's a randomized, controlled, double blind test of
SPECIFIC dosages in SPECIFIC target populations to scientifically prove
efficacy over placebo.

The dose we take is not a "BEST GUESS"

It is the result of a billion dollars of scientific study and that PRECISE NME
(new molecular entity) has been studied, at that PRECISE dose, in a target
population, for it's effectiveness, and it must be better than existing-
treatments and better than placebo.

It should be highlighted that this process takes on average 10 years, costs $1
billion dollars, and has a success rate (success meaning FDA approval) of
about 1 in 10,000 attempts (hence the price tag).

Source: Drugs: From Discovery to Approval, Second Edition
[http://onlinelibrary.wiley.com/book/10.1002/9780470403587](http://onlinelibrary.wiley.com/book/10.1002/9780470403587)

~~~
PixelB
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 our
calculations, and give a range on either end. If we thought the effective dose
would be 1 mg/kg, we would run an LD50 of doses much higher than that,
10mg/kg, 100mg/kg. Sometimes our guesses would be wrong, and the low dose
animals would die as a result. After figuring out a safe dose, we would then
split it further into different dosing groups to test the effectiveness of the
compound. Most people in the field are underpaid, overworked, and do sloppy
work

Please talk to someone who has actually worked in the Pharma research field,
they will tell you most of what they do is just guessing.. why do you think
only 1 in 10,000 make it through?

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?

~~~
civilitty
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.

~~~
chillwaves
> 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.

How does one accomplish this absent trial and error?

This fact undermines the entirety of your argument.

"Best guess" is exactly what they do.

~~~
civilitty
You do know what "unique" means in this context, right? Hint: it means that
antidepressants are the _exception_ to my argument because psychopharmacology
is so much more dependent on genetic/environmental factors than the rest of
the pharmacological field that we cannot draw conclusions on the effectiveness
of dosages pre-treatment without spending 100-1000x more time and money on the
clinical trials than we do now.

Please take your clearly ignorant bias and anti-pharma prejudice somewhere
else - you have no idea what you're talking about.

------
jessriedel
This article has some shoddy logic. For the vast majority of drugs, the actual
marginal manufacturing price per pill is essentially zero. That means that
when the expired pills are thrown away and new pills are manufactured, there
is no true economic loss. Rather, all that potentially happens is a transfer
between the consumer and the manufacturer.

If pill prices were set by some external force, this could at least be an
important society-wide transfer. But in fact, in equilibrium pill prices will
be affected by the expected rate at which pills expire without being consumed.
Even when manufactures have a monopoly, the manufacturer-surplus maximizing
price is determined by the demand curve of the consumer which takes into
account the expiry rate of pills. (If 10% of pills expire before I consume
them, they are worth 10% less to me in expectation.)

Yes, I'm sure there are market model where expiry dates create net economic
drag, or a net value transfer between manufacturer and consumer, but it's not
even clear which direction the transfer goes. Such an analysis depends on the
details of the world and how they are reflected in your model, which are
completely absent in this article. Most importantly, the intuition that
"letting $100 pills expire for no good reason must cause $100 of damage" is
completely false when the marginal cost of manufacturing is low.

(There are exceptions where the marginal manufacturing process is expensive,
but the article doesn't focus on these.)

~~~
valuearb
Your logic would be fine if manufacturers were required to replace expired
pills with new ones. But they aren't, so early expiry dates impose enormous
economic costs on consumers of drugs, while manufacturers get the massive
benefits of selling drugs twice to same consumer.

~~~
refurb
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.

~~~
valuearb
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 and
gets stuck with expired drugs due to excessively shortened expiry dates,
that's on the maker. The maker knows the real expiry dates, usage can never be
anything but an estimate.

~~~
refurb
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.

------
hyperrail
> But neither Cantrell nor Dr. Cathleen Clancy, associate medical director of
> National Capital Poison Center, a nonprofit organization affiliated with the
> George Washington University Medical Center, had heard of anyone being
> harmed by any expired drugs. Cantrell says there has been no recorded
> instance of such harm in medical literature.

I am more than a little surprised by this. Fanconi syndrome, a kidney disease
that can cause bone damage [1], has been repeatedly found in the medical
literature to be caused by taking expired pills of the antibiotic
tetracycline. [2]

That these people completely failed to remember these cases is distressing at
best.

(I heard an interview with the author of this story on NPR Morning Edition
today, and also scanned this story webpage. The only mention of tetracycline
was by a web commenter on the story.)

[1]
[https://medlineplus.gov/ency/article/000333.htm](https://medlineplus.gov/ency/article/000333.htm)

[2]
[https://scholar.google.com/scholar?hl=en&q=tetracycline+fanc...](https://scholar.google.com/scholar?hl=en&q=tetracycline+fanconi+syndrome)

~~~
Herodotus38
I was going to post a similar reply. However, outside of tetracycline, there
have never been reported adverse effects from expired drugs. Furthermore,
there were only three cases of expired tetracycline related Fanconi Syndrome
and that preparation responsible is no longer made. Of course, if it's old...

Otherwise I agree I'm surprised by the reporting ignoring this because this is
a classic board question in internal medicine.

Source:
[http://www.mdedge.com/internalmedicinenews/article/113748/sh...](http://www.mdedge.com/internalmedicinenews/article/113748/should-
i-throw-out-my-expired-medications)

Edit: Apologies that the above link has a paywall. When I accessed it via
google it worked once, then shot up a paywall. If it doesn't work at all I'll
remove it.

------
mherdeg
I have a lot of respect for this kind of reporting from ProPublica. It's a
really good public service to report news that isn't actually new.

In this case, part of the news is that the FDA's 1986 Shelf-Life Extension
Program (
[https://www.fda.gov/EmergencyPreparedness/Counterterrorism/M...](https://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/MCMLegalRegulatoryandPolicyFramework/ucm411446.htm)
) has been working fine for decades. This is important for people to know and
it's worth re-publishing from time to time as a reminder.

They had another great article like this last month,
[https://www.propublica.org/article/hundreds-of-judges-new-
yo...](https://www.propublica.org/article/hundreds-of-judges-new-york-preside-
without-law-degrees) , which basically reported "local courts in New York
state had terrible problems according to an in-depth 2006 New York Times
report and are still terrible in 2017". Great stuff.

Likewise a lot of the reporting on "civil forfeiture continues to happen and
continues to be unfair, here are more examples" provides a valuable civic
service.

I know it can be tough in a news organization to re-report something that
everyone already knows is true. It can certainly be tempting to pass over
truly important stuff in favor of seeking out brand-new news -- a fair amount
of science reporting is driven by "what's in the journals this week" \-- but
this kind of long-term focus on "what's still true that needs your attention"
is equally valuable and great work.

------
Reason077
_" Berkowitz picks up a box of sodium bicarbonate, which is crucial for heart
surgery and to treat certain overdoses. It’s being rationed because there’s so
little available."_

Huh? US hospitals have a shortage of _Baking Soda_?

~~~
doctoring
Oh yes... it's a pain in the ass. Recently in the news, too [1].

There weren't many days where the hospitals I've worked at weren't short on
_something_. (And these are like, big name academic medical centers in big
U.S. cities.) I've run into a shortage of normal saline before. Yes... salt
water.

Sometimes hospitals will even stockpile basic supplies to keep from running
into shortages... which only makes the whole situation worse.

It causes a lot of patient harm, even if it's usually not catastrophic because
we usually have redundant meds. Recently my hospital was out of a common,
generic, cheap antibiotic. For many infections in many patients, this meant we
had to switch to the second-line drug -- which was more expensive, had more
side effects, and was less effective against the bug. This type of thing
happens to chemo drugs, to drugs you give after a heart attack, to drugs you
need for planned surgeries or procedures.

I don't know how to solve this. Less regulation? More regulation? Subsidies
for manufacturers of essential medications / supplies? I mean, normal saline
is already ridiculously expensive enough [2].

For more reading: [http://news.medill.northwestern.edu/chicago/hospital-drug-
sh...](http://news.medill.northwestern.edu/chicago/hospital-drug-shortages-
what-is-really-causing-them/)

[1]: [https://www.nytimes.com/2017/05/21/health/sodium-
bicarbonate...](https://www.nytimes.com/2017/05/21/health/sodium-bicarbonate-
solution-critical-shortage-hospitals.html)

[2]: [http://www.nytimes.com/2013/08/27/health/exploring-
salines-s...](http://www.nytimes.com/2013/08/27/health/exploring-salines-
secret-costs.html)

~~~
maxerickson
Your second link says _including $546 for six liters of saline that cost the
hospital $5.16._

That doesn't sound like the cost of the saline is much of a problem. It sounds
like hospital billing is the problem.

~~~
dragonwriter
It sounds like the labor and other costs of tracking, delivering, etc. the
saline, rather than the material costs of the solution itself, are the issue.

~~~
maxerickson
Sure, if you think $100 a bag is reasonable for that, then that would be a
reasonable explanation.

------
gumby
(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
worthless as t approaches ∞ but you can guess that since tablets have a very
low moisture content, if they are kept in a cool dark place it's likely
they'll last a very long time. I also happily keep expired drugs in a
controlled environment and use them; all drugs in my car's and backpack's
first aid kits get replaced annually because they are exposed to harsh
environments.

(Stockpiling drugs doesn't prove anything BTW: if you are stockpiling them
against an emergency the presumption is that _some_ efficacy is better than
none).

Nobody is going to do accelerated life testing beyond what they have of
course. I think extending the required lifetime is a good idea, though I
question the size of the economic return claimed in the article.

The expiration dates on food are slightly more scandalous: the FDA doesn't
require the same level of testing as they do on the medical side so they are
mainly set stupidly short. Last week purchased some vacuum-packed lamb that
had a manufacturer label with an expiration date a month away, but was
prominently labeled to expire this week. 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.

~~~
vkou
> 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.

~~~
ars
I've stored eggs for 2 months _out_ of the fridge and they did not go bad.

As far as I know eggs will not go bad at all - they will just slowly dry out.

~~~
code_duck
One time I accidentally opened an egg that an absentee roommate-landlord had
left at a girlfriend's house. They had expired 14 months before, and inside
the one I cracked was a very foul smelling blue moldy glump.

------
Steeeve
A silicon valley startup by the name of SIRUM
([http://www.sirum.org/](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.

~~~
kiahjw
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.

------
Overtonwindow
Another facet to this is "Medication Adherence" which is defined generally as
taking medication properly, but which the drug industry defines as taking all
of your medication, and getting a refill for more. Speaking only as a lobbyist
who has (regrettably) worked for a Pharmacy Benefit Manager in the past, there
is tremendous amount of money and thought being put into how to get patients
to take all of their medication. The belief is that this will lead to patients
refiling that prescriptions, oh and probably help them overall, but refills
are the number one priority for the drug industry.

~~~
L_Rahman
Along with some other people in the healthcare industry (process person at a
large provider, product person at a large EHR), I'm trying to make a map of
the "systems truth" of healthcare in America.

We'd love to talk to you (in confidence!) about how the PBM part of the world
works. Please reach out to me if you'd be interested - contact information is
in my HN bio.

------
pipio21
Most of the time the drug handles time well but the excipient degrades. This
makes it very hard to control how those drugs will work. It opens so many
variables.

It is like not using the seat belt could save your life if you are thrown away
of the car at some specific circumstances, like happened to a person I know.
But they are there because it works better most of the time as engineers could
design safety with less variables.

My father had an emergency immune problem(that we have already identified as
it is recursive) and the only required drugs in house were expired for some
years. He took those before we bought the new ones and the old ones were like
1/3 potency of the new ones.

Given that most of the price of drugs come from intellectual property and
patents and each pill cost dollar cents to make, I don't see the urgency of
taking expired drugs.

If Hospitals trow away expired drugs then it is a good reason to take into
account in the global negotiation process, and I bet they already do in
countries that buy drugs in bulk.

------
korethr
I'm glad people are contacting the FDA to try to get them to extend drug
expiration dates, but this article gives me the impression that after the FDA
fails to reply, or replies non-committally one way or another, people give up.
Have any of the efforts involved tried to move up the chain of command to
Congress? The FDA might not seem to be willing to move on the issue, but if
one could get one's senator or representative to care, that congressman
probably has more means to get the FDA to act than the average person.

------
noonespecial
The cynic in me suspects that if this gains too much traction, drug
manufacturers will simply start adding self destruct compounds to all of their
formulations "for our safety".

In fact, some of them have track records of such "ethical" behavior, it
wouldn't even surprise me if they turned them poisonous vs simply inactivating
them.

~~~
verroq
The only solution is to fix the economic incentives so that drug manufacturers
want to make less wasteful medicines. Same with preventing planned
obsolescence. The only solution is to encourage more competition.

~~~
zajd
Or we could just make it illegal. Then again, with today's political climate
it wouldn't surprise me if someone was unironically opposed to regulating drug
manufacturers.

~~~
gnaritas
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.

~~~
zajd
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?

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

------
unics
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.

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

~~~
dp-tyvek
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.

~~~
cwkoss
I wonder if you could get around drug patent laws with the first-sale
doctrine.

------
bcook
I always assumed that the expiration date was partly legal, in the way that
you only have 1 year within which you can legally have the drug in your
system.

I mean, if I am prescribed oxycontin, can I legally have the drug in my system
for the rest of my life?

~~~
schrodinger
I'm pretty sure it's never illegal to have a drug in your system (besides
something secondary like a DUI). It's only possession that's illegal.

~~~
rhblake
Depends on the country. In Sweden it's illegal to have certain drugs in your
system. E.g. if THC is found in your blood you can be convicted for a minor
drug offense. We're sadly pretty extreme with regards to drugs though.

~~~
dragonwriter
Is it illegal to have THC in your system or is having THC in your system
admissible as rebuttable evidence of possession/use of illegal drugs? Either
would support the outcome you describe, but they are meaningfully different.

E.g., with alcohol, the “in the blood is illegal” rule would criminalize auto-
brewery syndrome occuring in those legally denied alcohol (e.g., due to age),
while the “in the blood is admissible as evidence of use” would not, though
those with the syndrome might need to present evidence of it to avoid charges.

~~~
rhblake
It's the latter: ( _intentional_ ) use of (illegal) drugs is illegal, and
having THC in your blood is proof enough to convict you (even if you've
consumed it in a different country where it's actually legal; there's
precedent). Typically you'd just get a fine though, if you admit guilt and
don't go to court. See § 1 here for the exact law:
[http://www.notisum.se/rnp/sls/lag/19680064.htm](http://www.notisum.se/rnp/sls/lag/19680064.htm)

------
barking
At one time we were required to keep an extensive list of emergency drugs at
work.

Off the record, it was generally accepted that we should never, under any
circumstances, use any of those drugs, bar adrenalin, for fear of doing more
harm than good.

The cost was substantial and one company seemed to have the monopoly on
supplying them. They also kept a record of the expiry dates and supplied
replacements as stocks went out of date.

The most annoying thing was that they seemed to deliberately supply drugs with
most of their lifespan expired.

They of course denied that this was a policy.

------
pitaa
I was once sedated for a procedure, and heard the Doctor ask for a certain
type of needle. The Nurse replied that they were out; she had just thrown them
all away since they were expired. The Dr asked "how expired", and she said "2
weeks". He replied that that was fine, he wanted them anyway. And then I heard
the lid on the trash can opening...

I found it quite humorous; I couldn't care less that their supplies were a bit
'expired,' nor that the sealed packages had sat in the trash can for a bit!

------
valuearb
Allowing drug makers to set expiry dates is a huge conflict of interest, they
have massive incentives to expire their drugs as soon as possible. I'm
surprised the FDA doesn't do the testing and set the dates itself.

The best solution is to require drug makers to replace expired drugs with new,
for free. Given that manufacturing costs are typically a tiny fraction of
sales price, this is not an expensive warranty. This will also give them
incentive to make expiry dates as reasonable as possible.

------
lovemenot
Due to complexity it doesn't seem realistic to try to save money by using
legacy drugs.

On the other hand, the economics of pharma industry are such that
manufacturing cost is usually a very small proportion of price.

Therefore a better solution would be to introduce a mandatory new-for-old
trade-in policy. So they wouldn't lose money on the deal, pharma companies
would be rewarded at mfg cost. I.e. sans profit, marketing or research cost.

~~~
PixelB
Great idea, never going to happen.

Why would they sign up for that when they can just as easily charge full price
for those replacement drugs (as they do now)? The only people out there who
can change this are making huge profits from the system currently in place, so
why would they?

~~~
lovemenot
There might be some up-side in terms of reputation gain, but it would have to
be imposed by a regulator.

------
rectangletangle
Degraded tetracycline has been documented to be dangerous in those who are
suffering from renal failure.

There's also the possibility that a person may be suffering from a new
undiagnosed condition, which hadn't yet onset when they were initially
prescribed the drug. In this case you could think of it less as an expiration
for the drug, and more of a suggestion to seek additional medical guidance on
continuing after a certain date.

There's also the remote possibility that a new drug is developed which could
potentially become dangerous when expired. The general population would have
to unlearn little morsels of knowledge such as this, in the meantime people
could be harmed.

Edge cases like this are enough in my opinion to warrant _not_ spreading
blanket advice like this, even if it's nearly always true. Erring on the side
of caution is the best approach with medical affairs, even if it costs a bit
extra monetarily. Giving patients potentially dangerous advice so they can
save money is ethically questionable at best.

~~~
valuearb
3 cases in 50 years? That's all you've got?

~~~
rectangletangle
I would be more concerned about the second point. A patient developing
additional complications isn't unheard of.

------
devy
Read similar article on HN before. U.S. Army was able to save millions after
FDA okays them to use expired drugs.[1]

[1]: [https://www.thepharmaletter.com/article/fda-tests-let-
milita...](https://www.thepharmaletter.com/article/fda-tests-let-military-use-
expired-drugs)

~~~
srtjstjsj
yes. For the scientists in OP to say they were surprised, they completely
failed sat lit review.

------
djrogers
It seems that a law simply allowing private testing of drugs for efficacy, the
same way the federal government is allowed to, would go a long way to saving
money here.

Hospital systems and HMOs are large enough to save millions for a bit of
testing, and once enough data is gathered they can easily and safely adjust
their retention policies.

~~~
jws
Hospital systems and HMOs turn their inventory fast enough that inventory
control can probably handle their problem.

Small hospitals and pharmacies probably suffer more from expirations.

~~~
lobster_johnson
Aren't there many drugs that hospitals need to have at hand, but are rarely
used? Things like antivenins, anti-rabies serums, or other agents that are
only reached for in extreme cases. It may not be a high proportion compared to
what hospitals are using on a daily basis, of course (but they might be
proportionally more expensive, too).

~~~
pitaa
As far as antivenins, it is my understanding that most hospitals don't keep
them on hand for the most part, and instead rely on an "antivenin bank" to fly
it in when needed. Interestingly, the main bank in the US is run by the Miami-
Dade Fire Rescue [1]. They have a 24 hour hotline and will arrange to have
antivenin immediately flown to anywhere in the world.

[1] [http://www.miamidade.gov/fire/about-special-
venom.asp](http://www.miamidade.gov/fire/about-special-venom.asp)

~~~
lobster_johnson
That's very interesting, thanks!

------
JshWright
The "extended use dates" that Pfizer published mean that we now have 'older'
drugs with expiration dates that are past the expiration dates of newer
batches. They didn't just say "add 1 year to all expiration dates" they said
"for these specific lot #'s, the new expiration date is: XYZ".

They only published extended dates for some lots, since they expect more
recent lots to still be in date by the time the shortage is addressed.

I may have spent the better part of a day a couple weekends ago relabeling a
bunch of vials with a sharpie...

------
dfinlen
Drug Expiration Date Excuses

FDA requires testing. testing expensive... really ... how hard would it be to
grab 50 tablets per drug for each environment (high UV, extreme humidity
etc..) let them sit and once a year grab a pill and run chem analysis. Sounds
like it could pretty much be automated, except for maybe the maintenance of
the environments. Maybe 500k to 1m per year with the work out sourced with
various statistical validations. (Yes I realize this is hard part, damn
humans) Take all the generic tablets and voila..

Drugs are cheap to produce

Really though, medicine doesn't cost much. It costs because society deemed it
so. As it's been explained above/below, but, paying for research, marketing
and regulations is probably 90% of the cost.

The hard question is

A more interesting question is how much can we afford to help others when they
are sick? If the difference between health is as trivial as getting the right
medicine I know I'd feel guilty if I didn't do something. This is especially
true for chronic disease, as the cost benefit is tilted.

------
cwkoss
Seems like an easy fix would be to require the manufacturers of patented drugs
to replace, free of charge, any unused expired drugs.

Incentivizes the manufacturers to accurately measure expiration times and the
marginal cost to them of replacement is much less than to the consumer.

------
hemanthtt
Can't there a company which buys up all the "expired" drungs and get the
appropriate approval from FDA and resell it for a cheaper price?

------
maxerickson
What's going on with our healthcare system that pharmaceutical grade baking
soda is being rationed?

W T F.

~~~
wolfgang42
More discussion here:
[https://news.ycombinator.com/item?id=14798615](https://news.ycombinator.com/item?id=14798615)

It seems the problem is that the suppliers' supplier had a problem supplying a
component (not the bicarbonate itself, but the vial it comes in, I think) and
this caused production to come to a halt while the issue was being sorted out.
Presumably this particular component has been certified in some way and
replacing it with an alternative requires recertification, though the news
articles merely say that the companies could not divulge additional details.

~~~
maxerickson
That's the proximate explanation.

I wonder more about whether such a fragile supply chain is inevitable in a
mostly capitalistic society or whether we could do more to ensure stability.

------
samstave
I wonder if there are any that become more potent/dangerous after a period of
time.

------
dmschulman
The myth is that those dates on the side of most drugs are expiraration dates.

~~~
azhenley
But mine explicitly say "EXP" beside the date.

~~~
DamnYuppie
I believe the OP's point is that really isn't when it not be effective but
when you are supposed to throw it away as per the FDA. It could very well be
effective well past that expiration date.

------
coding123
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 a 1 year expiration date is money.

~~~
tzs
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. Instead of going to the
doctor and getting diagnosed they just assume that it is the same thing the
had before, and so start taking the drug again.

If they are right, great. They have saved the time and cost of a doctor visit.
But what if they are not right? What if this time they have something
different that just shares some major symptoms with the prior illness, but
that needs a different treatment? Worse, it could even turn out that the side
effects of the drug make what they have this time worse.

~~~
jinglebells
> 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.

~~~
AstralStorm
Oh but you do. Even in socialized care there are taxes and opportunity cost of
time to visit.

It sometimes gets hilariously bad as a patient is supposed to get out of bed
very ill to go get a sick leave paper...

