Yes. You need enough samples to do each test and assay needed for release testing, as well as duplicates in the event of out-of-specification results and recalls. For one lot of one type of tablet, you’re looking at 3-4 days of lab work minimum to get the work completed and audited. Some products get made in hundreds of lots of different dosages per year.
You need to store them in rooms with monitored storage conditions - even if you are only doing 25 +/- 2 C and Ambient relative humidity (many companies also do 5C/Amb. RH for long-term stability; you need even more for accelerated work), you need to maintain that temperature during the entirety of the stability study. You need to track and monitor using calibrated thermometers and humidity meters. You need to have staff on call 24/7 in case the power and backups go out, in order to move the samples to another location or find some way to ensure the storage conditions (I was not involved in this, but I know people who got called in on Christmas day because of a blackout).
That’s just off the top of my head - I’m sure there’s a LOT more I haven’t thought about. You really have no idea what goes into this sort of stuff, do you?
Big Pharma doesn’t generally use undergrad technicians for this sort of work, at least not in Canada. Interns are used for physical appearance, pH & volume, mass, friability, hardness…physical chemistry. Dissolution testing, HPLC or GC analysis - the sort of stuff you have to do for impurity and degradation product testing - gets done by people with BScs or higher.
Nevermind the cost of instrumentation - tens or even hundreds of thousands of dollars for a single instrument. Technicians to maintain them. Parts to repair them. Validation and certification protocols to write and maintain. Columns, filters, mobile phase solutions - various disposable materials that are used in a single assay.
Then you don’t know a damn thing about medicine. Many drugs are novel, or are derivatives of other drugs - we don’t always know what the derivatives will do that will be different than the original. Drug design and chemistry just isn’t as simple as you seem to think it is.
We can hypothesize and predict chemical behaviour… but we need to test it to prove it.
Had the original manufacturers of those tested lots continued stability studies for more than 15 years, the cost might have exceeded $1 billion dollars. I don’t know that for sure, but then again, you don’t know that it wouldn’t have.
There may be cost savings. There may not be. I would, in fact, be interested in knowing where that line is, and if it means longer expiration dates, then fine, so be it. But you can’t look at only one side of the equation - there is a cost in drug research and stability study that needs to be considered as well.
You don’t know that.
The FDA saying that lot ABC1234 of Tylenol manufactured in 1985 is safe 15 years later says nothing whatsoever about whether lot FGH5678 of Children’s Tylenol manufactured today is safe 15 years from now. We can assume they will be similar in long-term study. We can expect certain outcomes. But we do not know it for a fact and should not act as though we do.
Not always, no. And you shouldn’t make health and safety related decisions based upon assumptions. That’s how we ended up with Thalidomide.
Products that have a recommended storage condition in the fridge likely failed long-term stability assays at higher temperatures, such as 30C/60% RH or 40C/75%RH over the span of 2-3 years that were studied. Note that those are not extreme temperatures in various parts of this planet. Products that can be stored at room temperature would have passed the higher temperature and humidity criteria over the 2 years that were studied.
Since you don’t know how stability assays actually work, please refrain from posting definitive statements about their results.
" Bubba"? Way to keep this respectful. :rolleyes:
And I cite my BSc in the field including 4 years of organic chemistry classes, two undergrad internships and couple of years working as a stability analyst for pharmaceutical drug products on several hundred different products contracted from all the major Big Pharma companies and several smaller ones. Bubba.
Their research suggests that longer expiration dates can be attained. Their research does NOT state that we can blindly assume what they might be. You are misinterpreting and misreading what the FDA and Harvard have done and the conclusions they obtained.
Note that the current laws regarding stability studies are laws enforced by the FDA. Are they no longer an authority because they don’t support your view?
If by “lot” you mean manufactring lot, that concept does not need to be
introduced here. For longevity no need to test anything but the generic
formula.
I doubt the average amount of lab work would be anywhere 3-4 days
per product, unless staff is prone to dropping test tubes, letting solutions
boil over on hot plates, and the like.
Even if testing did take that long in competent hands we are looking at
60-80 different products tested per chemist per year according to you.
Multiply that by a mere 100-150 chemists and we have 6,000 to 12,000
products tested. Per wiki only 20-30 new drugs are approved yearly, and
if that has been the trend for the last century then there are unlikely to
be anywhere near 6,000 drugs now on the market and needing longevity
testing. Payroll for all these busy chemists is likely to be no more than
$15 million, or a fraction of a cent per pill sold. Then after they clear the
backlog in 10-15 years we can lay most of them off before they are eligible
for full retirement benefits!
We had just such storage facilites where I worked. We could have stored
10s of thousands of pill-sized samples in a space the size of a few house closets.
Samples for every type of medication now on the market could be stored
in one warehouse, even considering the greater volume required for liquid
product. And as the initial backlog is worked down storage requirements would
be much less.
Get back with us when you can document the need for degreed staff for all
tasks required to establish temporal efficacy. But even if a BS is needed, that
should not be a prohibitive cost, as addressed above.
Do not try to tell me that all manufacturers would have to buy any brand
new equipment, or that they could not pool their resources, or make use
of independent labs to do the testing at a reasonable price.
I know, or can obtain all I need for the purpose of this thread.
Fine, test away.
However, if someone’s life or health depends on it in some part of the
developing world I think the greatest good would be served by providing
technically out-of-date product.
On a personal note, I suffer from gout, and use indomethacin and colchicine
symptomatically. Their expirations dates are respectively 12 months and
6 months from date of purchase, which is absurd: speaking from experience
they both last at least two years.
$1 billion going back to the dawn of the industry would probably be an
underestimate, but it seems much more than that amount is now being
wasted by the US military alone evey 1-2 years considering current arbitrary
expiration date assigments.
My citations establish that many expiration dates are far too limiting and if
it proves that the military’s drugs are representative of the whole then large
cost savings are sure to be available.
It is a sound inference based on the sound assumption that the military buys
pretty much the same medicine that the rest of us buy.
If the product has the same chemical formula then there is no need to test
each lot.
It occurs to me that products are not tested on a lot-by-lot basis for therapeutic
efficacy, are they? That is assumed to have been established by trials, isn’t it?
Purchased medicine is going to wind up in either of three and only three places
that I can think of: the patient’s home, his Doctor’s office, or his hospital.
Conditions are not going to vary as far as efficancy is concerned as long as the
possessor is reasonably careful and does not leave the bottle under a bright light,
or some such thing.
The Thalidomide is a poorr analogy since it had nothing to do with product
longevity or storage conditions.
You really need to support your case by providing examples of expired medication
actually hurting anyone. It is not as though data should be lacking- recall how recently
(1979) expiration dates came into use, although you might have to overcome your
aversion to research, and dig for it.
Excuse me, but the Harvard Medical School made this unqualified statement:
*"Placing a medication in a cool place, such as a refrigerator, will help a drug * remain potent for many years." That is a generalization, and it is not limited
to those products for whichcold temperatures are an essential indication.
I do my best to provide educational citations, and you should try your best to
read those citations more carefully. You might learn something.
Be thankful it was “Bubba” and not something else.
You may cite work experience, but not a Bachelor’s degree in support of your argument. Only MDs and PhDs qualify as experts by virtue of education.
Did you or did you not sign off on any finished product potency during
your 2-year tenure? You should here be able to give us detailed specifics
starting with (generic) brand name.
Now you are trying the semantic-rhetorical approach, but it won’t do you
any good, because the following statement by the HMS is no mere “suggestion”,
it is unequivocal:
“What they found from the study is 90% of more than 100 drugs, both prescription and over-the-counter, were perfectly good to use even 15 years after the expiration date.”
What! A Federal Agency enforcing a poorly conceived law or regulation?!
Egad! when did that start happening???
And whenever or whatever it serves only to expose contradiction within the FDA,
not within any point I have been making.
Here’s an article from the University of Arizona College of Agriculture. They do seem more worried about antibiotics from livestock than humans, but it also discusses the number and amount of several human medications like cholesterol-lowering drugs, beta blockers (hypertension), hormones, narcotics, and chemotherapy drugs. It also mentions that more and more cosmetic products like “nitro musks” and sunscreen ingredients are showing up. Not to mention non-prescription drugs like caffeine and nicotine.
The most obvious risk, to me, is the antibiotics. Even at very low levels - perhaps especially at very low levels - the presence of antibiotics in the water table means that endemic bacteria are practically encouraged to become resistant. The levels are too low to kill them off directly, but the ones with genetic mutations allowing resistance will out compete the ones lacking the same mutations.
According to Wikipedia ethinylestradiol, a prescription oral contraceptive, is a suspected endocrine disruptor - meaning that even in very small amounts (as hormones tend to appear endogenously) it’s possible it may disrupt embryonic and fetal development and gender assignment in multiple species. A peer-reviewed article in Environmental Science and Technology concludes that “This study shows that a mixture of estrogenic contaminants present in WwTWs effluents bioconcentrate in fish tissues, resulting in the induction of vitellogenin, and are likely to contribute to feminizing effects in wild fish living in U.K. rivers. The composition of the mixture of estrogenic contaminants in the bile is species dependent and may determine the susceptibility of fish to the effects of exposure to estrogenic effluents.”
Considering how careful researchers are in wording their conclusions, this is fairly damning.
The problem is not necessarily that we’re going to cause gross mutations of every single fish or amphibian species out there. It’s that even tiny amounts of molecules intended to alter human biological activity will inevitably have an effect on other species because we share so many of the same or similar metabolic pathways. No, we probably won’t see a bunch of Blinkies (three-eyed fish from The Simpsons, but we are probably going to see a subtle yet complex disruption of the ecology we are dependent on and live in the middle of.
Flatlined, if your local pharmacy doesn’t simply accept returned medications (none of mine do), they usually offer a postal service with a prepaid envelope you use to send your unused medications to an approved pharmaceutical disposal site. However, the envelopes are anywhere from $4-12, and they aren’t very large. I’d go broke sending in all the leftover medications in my household. Also, I hate feeling like I’m being punished for doing the right thing. So, for now, one of the cupboards is filled with the extras, the unused, and the untolerated.
I see mnemosyne’s point. There is a lack of systematic research on how stable most of our pharmaceuticals are, how long they are stable in an ideal environment (which the bathroom medicine cabinet is not), what happens when they begin to degrade, whether or not a medication which has lost its efficacy is harmless or harmful, and how to tell if a medication is any good or not.
There is also a non-zero risk that donated medications which are not sent directly from the manufacturer, doctor, or pharmacist have been tampered with.
However, I think this is a case for balancing risk versus benefit. There are hundreds of millions of people out there who would benefit from donated medication - especially the kind I’ve got stored away in a dark cupboard. Drug manufacturers design drugs to be as stable as possible under less than extraordinary circumstances; it’s in their best interest. All pills are shaped, colored, and marked to be identifiable, even if it does take a book big and heavy enough to kill an ox. There are far, far more people who want to help and have the resources to help than there are psychopaths and sociopaths looking for novel ways to harm people.
So?
While it’s not possible just now, I think we ought to have the sort of review that colonial recommends of all current OTC and prescription drugs, and all pharmaceutical manufacturers should establish a true baseline for recommended storage, expiration date, and degradation hazards as part of their approval trials. I think we, individual prescription holders, should be able to donate leftover medications so long as they are within their efficacy period and are identifiable.
Recipients should be made aware that there is some risk in accepting these medications - that some few may have expired, some few of those expired may be hazardous, and that an even smaller fraction might have been tampered with. The risk in accepting donated medications, though, strikes me as far less than the risk of an untreated disease or injury.
Two last notes:
Aspirin degrades to acetic acid (vinegar). Which is why my two year old bottle of aspirin smelled like vinegar whenever I opened it. However, there was enough aspirin left in my aspirin to treat my mild headaches.
Some [googles Federal statute of limitations] five or more years ago, a very kind acquaintance gave me some leftover narcotics when I was having a storm of migraines - three or four a week, each lasting hours and hours. Because transferring prescription medication is a violation of Federal law, they made sure to scratch off the pharmacy label on the bottle and wrote the medication name and dosage on the lid. That gift got me through a very bad time when I couldn’t afford to see a doctor on my own, no longer responded to the inexpensive migraine medications, couldn’t tolerate or afford the name brand migraine medications, and the public clinic doctors refused to prescribe narcotics to anyone for any reason ever. Again, risk vs. benefit calculation is an individual responsibility.
Nope, not good enough, because the generic tablet might not be manufactured with the same ingredients or via the same process as a brand name tablet. In fact, there’s a damn good chance they aren’t, and so information about one recipe doesn’t tell you anything about another recipe.
A “lot” refers to a manufacturing lot, like a batch of cookies. Representative samples of lots on the market are stored in stability chambers in order to follow up with client complaints and to systematically verify that the manufacturing process is correct. Just because you made the cookies well the first time doesn’t mean you won’t accidentally burn a batch later on. There is a tremendous amount of time and money put into satisfying the existing legal requirements for stability - both continuous quality control and accelerated/development stuff.
That’s because you have no idea whatsoever what goes into testing. You have never done it, you have no clue what instruments or techniques are used, you don’t know what type of preparation, operation or clean-up they use.
In short, you are talking about things that you have no understanding of as if you are an expert. I, at least, have done the work, have written the reports, and have dealt with auditors over the results.
YOU ARE WRONG about so much in this thread, it’s mind-numbing.
I made generalized statements with regards to numbers - I wouldn’t rely on them as a cite. I don’t recall the manufacturing frequencies of anything I worked on, although I can tell you that I tested dimenhydrinate HCL for release at least 6 times in the space of 11 months. That’s at a single company that has many competitors. Lots of Ethanol USP were tested nearly every week - they are small manufacturing lots with rather steady demand.
Also, if 20-30 new drugs are approved yearly, that means that several times that number are being tested for safety, including the very stability studies you are going on about. A certain amount of consistency and stability in the product is established before they start giving it to rats, let alone humans.
So, again, you don’t actually know what you are talking about and are leaping to conclusions based on incomplete information.
But you don’t store individual pills. You store packages - the full bottle-in-a-box-with-info-sheet, the full vial, ampoule, bag, whatever. That takes up a lot more space than you think. You are wrong about this, too.
In one warehouse? So you expect Apotex and Pfizer to get along well enough to share facilities? GSK? Wyeth? Novartis? Teva? This simply isn’t going to happen.
Nice idea, though - it might address the issue. But it’s never going to happen.
I don’t need to do such a thing - I don’t actually think you need degreed staff for a lot of this stuff. But the reality is, the companies currently do think they need degreed staff… they proudly boast the number of PhD chemists they have… and you’ll have a fun time convincing them otherwise.
The independent contract pharmaceutical lab that I worked for charged about $150 an hour for simple physical chemistry testing, and much more for dissolution and HPLC or GC work. This was cheaper for the companies that outsourced their work to us, but the cost of owning and maintaining equipment basically remains the same. If you increase the number of samples to be tested, you increase the demand on the equipment - you might need to buy more simply because you can’t get access to some stuff in a reasonable amount of time.
Equipment breaks down. Some testing gums up chromatography columns, and you need to replace them nearly every month (at a couple hundred bucks a pop). An HPLC can only run so fast - if it needs to go overnight, you can’t even get a second shift into the lab. You can’t share columns and mobile phases across products in most cases because their analytical methods are different - you need to clean, reset and start new for every drug.
Look, I’m not a lab manager and I’ve been out of the lab for years, but it’s not as simple as " test more". There’s a LOT of validation and scheduling that needs to be considered that you are overlooking. It is a lot more complex than you think.
No, you don’t. You are misinformed, underinformed and jumping to conclusions that aren’t supported.
Would you take the product? A week past it’s expiration date? A month? A Year? 10 years? Pick a date, whatever deadline you’d no longer feel safe taking a drug.
Now ask yourself why your morals are such that you’d give something that you would no longer take to a poor person?
IMHO it’s a reprehensible approach to a very real problem. I agree we need to get medicine to developing parts of the world, we need to find ways to do this cheaply. I don’t feel that this is one of them.
Or you are under-medicating your condition and possibly causing yourself more long-term problems without even realizing it. It’s possible.
I can’t address the specific reasoning behind any given drug’s expiration date because I don’t have any information to look at. I doubt the manufacturers will give me access to their records.
The one-year-from-purchase dates are set by pharmacy associations and individual state laws; they do not necessarily match the label expiration date. How about you address your questions to them?
They are not arbitrary. The time-frame for mandated study might be somewhat arbitrary at 2-3 years (I believe that depends on the dosage form), but the label dates that come out of that are backed up by science.
Write letters to the FDA and ask them about changing the study period to 5 years. Maybe one day they’ll do it.
Then I’ll answer questions about whether a drug is safe after that expiration date, and the answer will be the same… dunno.
Your citations prove cost savings for the purchaser. They do not address expenses from the manufacturing/supplier side.
There may be cost savings, there may not be.
shrug Perhaps.
But, and I’ve said this before, you are ignoring the FACT that 10% of drugs were not stable at the time of study, and the various “cites” do not make it clear that a significant amount of them made it to 15 years, only that at least one did.
There is very reasonable reason to suspect that expiration dates can be extended. What there isn’t is reason to consume current products as though it’s a given that they have longer stability. That’s the part that I take issue with… push and lobby for the requirements to change and wait for the data to come in. Until then, you are advocating potentially dangerous behaviour.
Birth control pills are very heat and light sensitive. If someone takes an expired and potentially degraded pill and ends up pregnant, do you consider that acceptable performance from the drug? Not all degraded products are necessarily toxic… undermedicating a condition can be just as bad as not medicating at all.
What about the excipients, binders and coatings? Those vary significantly, even across drugs with the same active ingredient. The average tablet has 5-6 ingredients in it, IIRC. Do you know that all possible combinations all behave the same? Because I sure as hell don’t, and it’s not an assumption you’ll find that any formulation chemist will make.
The recipe - the formulation - has been tested for therapeutic efficiency. Quality control and continuing long-term stability studies investigate whether the production plant is making the recipe in the same manner at all times. Any change in ingredient, even changes in supplier of the same ingredient, are investigated. Just as you can’t substitute raisins for chocolate chips and claim to have chocolate-chip cookies, you can’t substitute lactate for malate in your formulation for 100mg Ibuprofen and claim to have the same drug.
Except that people do all kinds of stuff like leave pills in their car on a hot summer day, or keep things in the bathroom where there are severe humidity fluctuations, or leave things on a windowsill for it to heat up, or…
Just getting the product to the end-user could mean spending a month in a freezing cold or scorching hot truck or shipping container.
Thalidomide’s problems were due to an assumption that the drug would be metabolized the same way in different animals. The point was assumption.
I don’t need to do anything, and I’m disinclined to do this research.
I can tell you this, though - I’ve seen a product fail the final testing point of a stability trial - a degradation product that was, itself, a medicine had exceeded it’s limit. This product had a very short expiration date and was being used in clinical trials in healthy adults. It was a shitstorm of paperwork and research and panic that wasn’t yet resolved when I left the contract company that did the analysis. I can’t tell you more about it because of NDA issues, but it DOES happen.
As I said, it’s not always a toxicity issue. Undermedicating is a bigger risk. Drugs like coumadin need to be tightly controlled and titrated… if someone thinks they are taking 10mg of coumadin but they are really only taking 6.5, that could have severe consequences for their health. Undermedicating epilepsy, undermedicating diabetes, undermedicating cancer…all very, very bad things.
When you buy a drug and it says there’s 100mg of X per tablet on the bottle, that comes with a guarantee that you are getting 100mg +/- 2.0mg of that drug in each tablet. Not 50mg, not 110mg. That’s what stability and expiration dates gives you…a guarantee. After that, all bets are off.
’ will help" is pretty qualified to me. It’s a generalized statement. It’s generally true.
Now prove it, and then label your drugs accordingly.
And your expertise is what, exactly?
My FIL and MIL are both doctors - they don’t know much about the details of stability studies, because it’s not their job to do so. I know a ton of chemists with MScs and PhDs who have never worked in pharmaceuticals, or work in drug design and discovery… they don’t know much about stability assays either, because it’s not their jobs.
It was my job, for 4 years.
No detailed specifics, but I did a potency assay or two nearly every other day, and yeah, my name is on the certificates of analysis. Potency, impurities, dissolution, hardness, friability, water content, pH, volume, mass..whatever was required. Most drugs have about 5 tests, minimum, required for their CofA - some have more, depending on their dosage form or if there are particular ingredients/issues to track.
For generic names, I’ve already mentioned dimenhydrinate and ethanol. Morphine, hydromorphone, oxycodone,fentanyl and various other products for injection. Ophthalmics, creams, ointments, suppositories, tablets, capsules, nasal sprays…Painkillers, dandruff medication, birth control, hormone replacement, HIV drugs, antibiotics, vitamins, parkinson’s medication, cholesterol drugs… I’ve worked on hundreds of things, many of which I can’t mention because they are in development and/or NDAs prevent me from doing so.
WHAT ABOUT THE REMAINING 10%? That’s the part you are very conveniently repeatedly ignoring.
Oh, so it is true that the FDA serves only as a cite if it supports your argument. Talk to the lawmakers, talk to the FDA, change the law.
But don’t act as though you already know the outcomes of countless studies.
This is incorrect. The research is incredibly systematic and thorough over the required study period. When you buy a drug, you know that it is stable, has maintained it’s potency and will not degrade… and is therefore “good” because that’s what is required to be proven before it hits the shelf. Every lot gets tested for potency and impurities as part of it’s release testing.
Harmless or harmful come into the pharmacology of the drug - that’s been shown through clinical trials and through long-term monitoring and adverse effects reporting. No drug is free from side effects - it’s an impossible standard. Many drugs degrade into molecules that have pharmacological action - your " side effect" in an expired drug might be, essentially, the effect of taking a secondary drug in the same tablet. Not to mention, as I’ve said, the risks of undermedicating.
So, again, the data is very thorough and sound over the 2 years on the label. After that, though, the problem becomes one of “their is no data.” Perhaps we should be gathering it, going longer in the required study time, but there will always be a finite deadline…2 years, 4 years, 10, whatever and the same issue will remain. Past that date, THERE WILL BE NO DATA.
If you no longer want to take the drug because it’s expired (not because you no longer have the condition that requires it), why is it ethical to give it to someone else?
It’s incredibly easy to fake the appearance of a drug - the only way you know what you’re getting is to test it and ensure the integrity of the product. Heck, I’ve seen manufacturing mistakes where 100mg tablets were labelled as 10mg tablets… if mistakes can happen in the plant, do you trust everyone to keep things properly labelled and to not get confused?
You might feel the risk is small, but I can understand how the industry doesn’t want to take such a liability risk.
They do. Over 2-3 years, as legally mandated.
Extend that timeframe if you like, but it will never be an infinite amount of time. The effort required to show precisely when Drug A goes out of specification vs when Drug B does, and then Drug C, etc is enormous. That’s why there’s one set of standards applied to dosage forms, and companies comply. You get your X-year guarantee, but that’s it.
Perhaps. I wouldn’t generally trust such a system, but perhaps there may be a way to look into it.
I don’t believe that the average person is intelligent enough to truly understand what the risks are. The average person will assume that if tampering had occurred, it will happen to someone else. The average person will assume that they are getting the correct dose. I don’t think medical decisions should be left to the average person.
Good for you - that’s one of the lucky ones. Do not assume that what’s true of aspirin is true of cetirizine, or valium, or anything else someone might take in their lives. THAT’S my entire message.
Again, I don’t believe most individuals are capable of making that calculation, because most individuals don’t know what goes into manufacturing a drug in the first place. Most individuals don’t know much about chemistry, biochemistry, pharmacology or medicine.
I don’t think we ought to be letting individuals harm or kill themselves because they are too stupid to understand the true risks of risky behaviour.
Thank you for the citations in reply #45. I wish the entire article
by R. Gibson et al was available. IMO the evidence cited stops short
of damnation if by that word species propogation rate and life
expectancy are shown to be affected.
On he other hand, I had not thought of the possibility of antibiotic
dilute acting to increase resistance in microbes. The possibility is
troubling enough to make me consider classing antibiotics in a no-flush category.
I also had no idea that many medications could pass intact through
the digestive tract. That makes me wonder if there is any way short
of incineration to keep them out of the marine environment.
I beleive with what follws i must I will have fully expressed my view
of this subject, so I will not have anything else to say unless some new
and novel point is raised.
By “generic” I meant the active ingredient formula, which must be
identical for all brands, right? I won’t argue with the FDA if it
for scientific reason requires new studies due to inactive ingredient
change, although I doubt such a reason would exist in all cases.
I speak from 15 years hands-on QC/QA/Process Engineering experience.
Although process may vary from company to company there is an underlying assumption that whatever the process, properly conducted in-house manufacturing
trial and inspection will furnish efficacious and homogeneous product. This
does not mean that any safeguard is perfect, so some non-conforming product
inevitably reaches the market.
Product per lot sample retain procedure is off-topic.
If I am wrong about anything it is not because of any point you have raised.
Also my experience, though extensive, does not matter since I deferred to
your 3-4 day per product testing timeline.
First you cite yourself, now you retract the citation, and below you cite
yourself again. Make up your mind.
I suspect retraction is only because you belatedly realize your timeline
supports my side of the argument rather than yours.
This is not coherently related to our discussion. Think over again exactly
what it is you are want to say, and then try to improve on the composition.
Most samples I worked with were taken individually off the lines pre-packaged.
However, entire bottles are fine and dandy. I have one sitting right in
front of me. It is 4x4x8cm. The kitchen shelf I had it on is 42x28x21cm.
Well over 100 bottles could be stored in that space without squeezing them
in too tight. That one shelf is about 10% of my total kitchen shelf space.
Ergo my little residential kitchen has enough shelf space for over 1000 bottles.
Then there is my walk-in closet plus a smaller closet (keep in mind that the
closets, unlike the kitchen shelves are floor-to-ceiling) and then there is
the rest of my apartment, so it sounds like one bottle of every Rx ever
approved by the FDA might be housed right here in my ~1000 square foot apartment.
Any potential cost saver could happen, especially if it addresses a real issue.
However, what I had in mind was (1) all samples might be housed by one
or a few independent testing contractors or (2) Each manufacturer would
only need a few hundred square feet out of their millions of warehousing
square feet total if they want to keep everything on site.
Ah, so you agree after all that an undegreed technician can do a lot of
the work. I am not degreed, but degreed staff where I worked had no qualms
about me doing almost all of the identity testing on our incoming adhesive
components. With all the cost-cutting pressure at work these days I wonder if
my experience is all that unusual.
Now the section above is actually informative and interesting. Please use it
as a model for the rest of your replies.
Although the $150-plus per hour fee is much greater than I expected it is
still only about $5000 per product tested @ 4 days @ 8hr per day. Considering
that the yearly number of individual Rx doses purchased must be in the 100s
of billons the cost per dose should still be way under one cent. And don’t
forget the big Rx boys might have the option of hiring someone undegreed
like me to a lot of the work on site.
As for equipment, I must have tested well over 10,000 individual samples
of various kinds, and I never had any problem with traffic or maintenance.
What you did must have been more demanding on the tools you had to use.
Still, 60 products per chemist per year = 4 days per product for 49 weeks
which does not sound like a workload likely to exhaust the machinery,
particularly if maintenance could be performed at night.
Validation and “test more” under severe scheduling pressure were what
I did for a living. I don’t miss it.
All my conclusions are backed by expert authority or personal experience.
Sorry, but that approach is not going to work, because knowing what
I do now I would take any product not closely related to one contraindicated
by the FDA study if it was up to 5 years past the expiration date. Naturally,
though, If I have to pay US prices then I am entitled to new product.
No it is not possible. I know from experience when an attack has been sufficiently
medicated, and I know from experience that dosage requirements do not vary with
product age up to two years.
According to my citations most expiration dates are arbitrary.
I do not know what you mean here. You are not going to find any product
for sale with conflicting expiration dates.
If the effective lifetime of an Rx is inaccurately implied and inaccurately
circumscribed then It is reasonable to characterize the situation as “arbitrary”.
The FDA is perfectly aware of the issue. It is behaving arbitrarily for reasons
I cannot fathom and cannotbe changed through one person’s letter-writing campaign.
They do know for those 90 or so drugs involved in the military study.
Supplier cost saving is not the reason for making changes, it is customer
cost saving we are striving for, especially that of 3rd world charity cases.
Obviously suppliers can only lose money by having to run tests to prove
their product need not be as frequently repurchased due to constraint
imposed by expiration dates.
I have not ignored those facts, and I have not advocated using
the 10% drugs past their expiration dates and I have not advocated
considering 15 years as a baseline.
It is reasonable to start by changing the requirements for the 90 drugs
that the FDA has already shown to be excessively stringent. It may be also
reasonable to make inferences from them to other closely related drugs.
It may also be possible to rely on patient feedback such as mine in re
indomethacin and colchicine. None of that constitutes dangerous behavior.
I thought all medicine was supposed to be kept out of heat and light.
Failure to do will render medicine ineffective regardless of its other
stability characteristics, won’t it? BC pills might (or might not) be a
category of medicine for which expiration dating should be retained.
There are sure to be others. Hence the need for some stability testing.
Addressed at the start of this reply. Let me add that I would be astonished
if anyone dared to introduce an inactive ingredient with any conceivable
potential for degrading the active ingredients. Neither of us is an expert
in the combinations of these things, but those PhDs the big Rx are so proud
to have on their staffs ought by now to know enough to make an reliable
assumption or two.
Customer disregard for product instruction is off-topic, and I guarantee
all US prescription medication is shipped temperature-controlled if there
is any chance of climate-induced product degradation.
“Assumption” can only mean premise, inference or some combination
of the two. By attacking the word “assumption” you are attacking
reason itself, and that is a battle you cannot win, given the stupendous
record of various reasonable assumptions in contributing to human progress.
Without looking it up let me guess some people fed some lab monkey
some drugs and she metabolized them the same way humans do in
X out X cases, producing healthy offspring while at it. Acting on the
premise (assumption A) that X number of cases were sufficient to establish
that the monkey’s metabolism was identical to human metabolism they
then fed the monkey some Thalidomide. Since the monkey did not get sick
and since her babies were normal they inferred (assumption B) that
Thalidomide was safe for humans.
All science proceeds thus, doesn’t it? And the falsity of assumption A
in the Thalidomide case does nothing to dispel the need to make assumptions
during all rational discourse and throughout the search for truth.
Yes you do need to do something, unless you are inclined to accept that your
assumptions lack any sort of empirical basis.
I have agreed that there are Rx for which short expiration dating
does need to be published and enforced.
Test away, unless the FDA has already gotten to them.
There is no such thing as scientific proof. There are only degrees of confidence
based on the interplay of theory and observation. The FDA seems to have
spoken with a high degree confidence and the HMC article may be considered
favorable peer review.
“Might” help = qualified.
“Will” help = unqualified.
I described my own experience earlier.
Perhaps I was too generous to MDs and PhDs and not generous enough to you.
Very interesting. What can you tell us about the stability of the products
mentioned above, assuming they meet storage requirements?
There should be no need for me to agree explicitly that expiration dating
should be enforced for any product having a legitimate need for it. Since
the point has become contentious let me now explcitly agree.
Of course. And it is true that no authority, no matter how lofty, gets everything
right every time. (Except maybe for Cecil Adams)
I’m not going to reply to that line-by-line. I have better things to do.
Suffice it to say that you don’t understand the science, you don’t understand the basis for stability, you don’t understand what information is actually obtained in the laboratory. You don’t understand what information the companies and the FDA are obtaining and how they are using that to make decisions.
You are not well-versed enough in this subject to come to any conclusions about it, and so should not be making statements based upon it.
I suggest that anyone reading this thread disregard colonial’s posts with regards to the safety and efficacy of drugs well past their expiration date.
Contact the Starfish Foundation at Presbyterian Hospital, New York City. They will send a pre-paid label. No charge. They re-label meds and use in third world countries.
Seeing as none of his argument had anything to do with the science, I don’t see why I have to disregard anything. His entire argument is that we need to do testing to find out how long these drugs last and stop wasting them. Your entire argument is that, since we don’t know for sure how long things last, we have to put our heads in the sand because we don’t have exact scientific proof, without stopping to realize that we don’t need it, save for drugs that actually become dangerous.
He also made it clear that he wasn’t going to respond again, so it’s rather lazy not to go back and comment on it. The fact that you didn’t comes across as if you didn’t have anything against it. Especially seeing as what you did say didn’t address it at all.
Also, did no one else assume this was about narcotics, and that giving the drugs to someone with a back problem would just be enabling an addiction, since they’d also be able to get their own prescription? (Thus if they are out, they must be taking more than they need.)
And, yeah, if any of you find yourself in a similar situation as the OP, donate. Worst that can happen is that the medicine doesn’t work. (save for a couple medications where we can predict the breakdown.) Since that’s no worse than what they’d be without it, you might as well donate.
Also to be fair the OP was specifically talking about narcotic pain killers, not antibiotics. Everything I’ve read suggests that properly stored opiates are good for decades if not centuries
.
According to my father, who was a pharmacist for over 50 years including a few decades in manufacturing, there is a built in “cushion” in the expiration dates because drugs are not normally kept in pristine conditions in actual use. So, for example, if the test data indicates a drug will keep fine for two years the expiration date might be given as 18 months. This does not applies to some pharmaceuticals, which must be kept in carefully controlled conditions and will degrade rapidly if not properly cared for, but yes, for the vast majority of medications using them a month or two past expiration isn’t going to be a problem. More than 6 months? I wouldn’t do it. Actually, I prefer not to use past expiration at all, but if it’s only a week I’m not going to be concerned at all for what I have in my medicine chest.
There actually IS data out there, but no one has paid the money for formal research studies and/or the paperwork required to make it official. The pharmaceutical companies have no interest in pursing this because they want turnover to keep their sales up. That doesn’t mean no one else has looked into the matter (like the military, but also private third parties)
Sometimes, drug company employees will perform tests just out of curiosity, but of course that’s not official regardless of the results, even when performed by calibrated equipment by trained and competent personnel. Informal testing of this sort is much less expensive, not requiring large batches or intensive paper trails.
Or maybe that was more common in my dad’s day, when if he found something four years old in the back of the medicine cabinet he could take it to work and test it himself to satisfy his own curiosity.
Properly stored, milk should be good for one week past the “best buy” date, because the best buy date is not an expiration date.
On the flushing/improper disposal of medications, a lot of what is being found in water actually comes from medications that were properly taken; that is, excreted in urine and feces, or applied topically and washed off. Although you still shouldn’t flush them since you’ll be putting a very large amount in at once, and some of what passes through your body will be broken down (though metabolites can still be harmful).
