# I have lots of drugs and I'm wanting to get rid of them **URL:** \ **Category:** In My Humble Opinion\ **Created:** [January 23, 2012, 3:48am UTC](https://boards.straightdope.com/t/i-have-lots-of-drugs-and-im-wanting-to-get-rid-of-them/610364 "2012-01-23T03:48:17Z")\ **Posts on this page:** 14\ **Page:** 3
**Author:** ![mnemosyne](https://avatars.discourse-cdn.com/v4/letter/m/c4cdca/32.png) [@mnemosyne](https://boards.straightdope.com/u/mnemosyne)\ **Post date:** [January 25, 2012, 12:23am UTC](https://boards.straightdope.com/t/i-have-lots-of-drugs-and-im-wanting-to-get-rid-of-them/610364/41 "2012-01-25T00:23:36Z")
> [@colonial](#): > > Expensive? To store samples and then test them after a few years? > > I worked in QA for a pharmaceutical company myself (bulky adhesive devices) > and I can tell you storage would be no big deal. 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? > [@](#): > > The chemistry might be more so, > but we had undegreed technicians perform most of our wet chemistry, so I need > more than your declaration that that end would be “very expensive”. 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. > [@](#): > > Also, we should by now, 300 years after Boyle’s day, have a pretty good idea > exactly how well a lot of compounds are going to retain their potency without > having to go through any testing whatever, and that includes compounds used > in our medicines. 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. > [@](#): > > Finally, that $1billion that the US military was throwing out must represent a tiny > fraction of the needlessly unused medicine worldwide, so there should be little > doubt regarding the net cost-effectiveness potential of obtaining much later > expiration dates. 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. > [@](#): > > Fine, we are off to a pretty good start with the FDA having signed off on those > 90 drugs the USA-USN-USAF had piled up, which, by the way, probably represent > a pretty fair percentage of all prescribed medicine. 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. > [@](#): > > I think we can assume household storage conditions, can’t we? Not always, no. And you shouldn’t make health and safety related decisions based upon _assumptions_. That’s how we ended up with Thalidomide. > [@](#): > > Also, I notice that refrigeration is recommended as a preservation method. > That makes me wonder about the almost universal room-temperature requirement > recommended for medicine, but I guess that is a topic for another thread. 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. > [@](#): > > Anyway, I have the backing of the FDA and the Harvard Medical School. > Who do you have, Bubba? " 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. > [@](#): > > You think the FDA and Harvard University are both going to go out on a limb > over something as basic as this? I don’t. 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? > [@](#): > > How about you not giving us any more speeches about science and scientific > method until you have provided a few scientific citations of your own? > **[U.S. Food and Drug Administration](https://www.fda.gov/)** > > The FDA is responsible for protecting and promoting the public health [http://www.cgmp.com/](http://www.cgmp.com/) [CFR Title 21 part 11](http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=11) - that would be the strength of US Federal Law, which trumps a newspaper article out of Harvard. > [@colonial](#): > > Judgement call, Moms. > > Respectfully disagree. Dictionary definition of _[respect](http://dictionary.reference.com/browse/respect)_ ---
**Author:** ![colonial](https://avatars.discourse-cdn.com/v4/letter/c/34f0e0/32.png) [@colonial](https://boards.straightdope.com/u/colonial)\ **Post date:** [January 25, 2012, 2:02am UTC](https://boards.straightdope.com/t/i-have-lots-of-drugs-and-im-wanting-to-get-rid-of-them/610364/42 "2012-01-25T02:02:09Z")
Delete reply posted due to misclick. ---
**Author:** ![colonial](https://avatars.discourse-cdn.com/v4/letter/c/34f0e0/32.png) [@colonial](https://boards.straightdope.com/u/colonial)\ **Post date:** [January 25, 2012, 5:30am UTC](https://boards.straightdope.com/t/i-have-lots-of-drugs-and-im-wanting-to-get-rid-of-them/610364/43 "2012-01-25T05:30:05Z")
> [@mnemosyne](#): > > 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. 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! > [@mnemosyne](#): > > 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? 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. > [@mnemosyne](#): > > 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. 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. > [@mnemosyne](#): > > 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. 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. > [@mnemosyne](#): > > Then you don’t know a damn thing about medicine. I know, or can obtain all I need for the purpose of this thread. > [@mnemosyne](#): > > 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. 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. > [@mnemosyne](#): > > 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. $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. > [@mnemosyne](#): > > 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. 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. > [@mnemosyne](#): > > You don’t know that. 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. > [@mnemosyne](#): > > 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. 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? > [@mnemosyne](#): > > Not always, no. And you shouldn’t make health and safety related decisions based upon _assumptions_. 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. > [@mnemosyne](#): > > That’s how we ended up with Thalidomide. 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. > [@mnemosyne](#): > > 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. 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. > [@mnemosyne](#): > > " Bubba"? Way to keep this respectful. :rolleyes: Be thankful it was “Bubba” and not something else. 😛 > [@mnemosyne](#): > > And I cite my BSc in the field including 4 years of organic chemistry classes, 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. > [@mnemosyne](#): > > 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. 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. > [@mnemosyne](#): > > 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. 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.”_ > [@mnemosyne](#): > > 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? > > [www.fda.gov](http://www.fda.gov) > [http://www.cgmp.com/](http://www.cgmp.com/) > [CFR Title 21 part 11](http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=11) - that would be the strength of US Federal Law, which trumps a newspaper article out of Harvard. 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. ---
**Author:** ![phouka](https://avatars.discourse-cdn.com/v4/letter/p/c5a1d2/32.png) [@phouka](https://boards.straightdope.com/u/phouka)\ **Post date:** [January 25, 2012, 6:14am UTC](https://boards.straightdope.com/t/i-have-lots-of-drugs-and-im-wanting-to-get-rid-of-them/610364/44 "2012-01-25T06:14:21Z")
> [@colonial](#): > > I would like to have more of a citation than IIRC, both for the existence of “non-negligible amounts”, and for the unstated thesis that those > amounts are harmful. Here’s [an article](http://ag.arizona.edu/azwater/awr/july00/feature1.htm) 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](http://en.wikipedia.org/wiki/Endocrine_disruption#Other_suspected_endocrine_disruptors) 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](http://pubs.acs.org/doi/abs/10.1021/es048892g) 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. ---
**Author:** ![phouka](https://avatars.discourse-cdn.com/v4/letter/p/c5a1d2/32.png) [@phouka](https://boards.straightdope.com/u/phouka)\ **Post date:** [January 25, 2012, 6:40am UTC](https://boards.straightdope.com/t/i-have-lots-of-drugs-and-im-wanting-to-get-rid-of-them/610364/45 "2012-01-25T06:40:53Z")
But, back to the main topic. **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. ---
**Author:** ![mnemosyne](https://avatars.discourse-cdn.com/v4/letter/m/c4cdca/32.png) [@mnemosyne](https://boards.straightdope.com/u/mnemosyne)\ **Post date:** [January 25, 2012, 5:01pm UTC](https://boards.straightdope.com/t/i-have-lots-of-drugs-and-im-wanting-to-get-rid-of-them/610364/46 "2012-01-25T17:01:35Z")
> [@colonial](#): > > 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. 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. > [@](#): > > 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. 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. > [@](#): > > 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! 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. > [@](#): > > 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. 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. > [@](#): > > 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. 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. > [@](#): > > 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. 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. > [@](#): > > 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. 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. > [@](#): > > I know, or can obtain all I need for the purpose of this thread. No, you don’t. You are misinformed, underinformed and jumping to conclusions that aren’t supported. > [@](#): > > 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. 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. > [@](#): > > 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. 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? > [@](#): > > $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. 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_. > [@](#): > > 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. 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. > [@](#): > > 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. _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. > [@](#): > > If the product has the same chemical formula then there is no need to test > each lot. 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. > [@](#): > > 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? 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. > [@](#): > > 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. 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. > [@](#): > > The Thalidomide is a poorr analogy since it had nothing to do with product > longevity or storage conditions. Thalidomide’s problems were due to an _assumption_ that the drug would be metabolized the same way in different animals. The point was _assumption_. > [@](#): > > 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. 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. > [@](#): > > 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. ’ 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. > [@](#): > > 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. 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. > [@](#): > > 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. 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. > [@](#): > > 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 ABOUT THE REMAINING 10%? That’s the part you are very conveniently repeatedly ignoring. > [@](#): > > 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. 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. > [@phouka](#): > > 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. 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. > [@](#): > > 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. 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. > [@](#): > > 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. 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. > [@](#): > > 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. Perhaps. I wouldn’t generally trust such a system, but perhaps there may be a way to look into it. > [@](#): > > 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. 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. > [@](#): > > 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. 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, risk vs. benefit calculation is an individual responsibility. 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. ---
**Author:** ![colonial](https://avatars.discourse-cdn.com/v4/letter/c/34f0e0/32.png) [@colonial](https://boards.straightdope.com/u/colonial)\ **Post date:** [January 26, 2012, 6:24pm UTC](https://boards.straightdope.com/t/i-have-lots-of-drugs-and-im-wanting-to-get-rid-of-them/610364/47 "2012-01-26T18:24:58Z")
\*\*phouca: \*\* 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. ---
**Author:** ![colonial](https://avatars.discourse-cdn.com/v4/letter/c/34f0e0/32.png) [@colonial](https://boards.straightdope.com/u/colonial)\ **Post date:** [January 26, 2012, 6:52pm UTC](https://boards.straightdope.com/t/i-have-lots-of-drugs-and-im-wanting-to-get-rid-of-them/610364/48 "2012-01-26T18:52:05Z")
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. > [@mnemosyne](#): > > Nope, not good enough, because the generic tablet might not be manufactured with the same ingredients… as a brand name tablet. 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. > [@mnemosyne](#): > > …or via the same process… 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. 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. > [@mnemosyne](#): > > …Representative samples of lots on the market are stored… Product per lot sample retain procedure is off-topic. > [@mnemosyne](#): > > 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. 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. > [@mnemosyne](#): > > I made generalized statements with regards to numbers - I wouldn’t rely on them as a cite… 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. > [@mnemosyne](#): > > …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. 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. > [@mnemosyne](#): > > 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. 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. > [@mnemosyne](#): > > 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. 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. > [@mnemosyne](#): > > 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. 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. > [@mnemosyne](#): > > 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. 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. > [@mnemosyne](#): > > 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. Validation and “test more” under severe scheduling pressure were what I did for a living. I don’t miss it. > [@mnemosyne](#): > > No, you don’t. You are misinformed, underinformed and jumping to conclusions that aren’t supported. All my conclusions are backed by expert authority or personal experience. > [@mnemosyne](#): > > 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. 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. > [@mnemosyne](#): > > Or you are under-medicating your condition and possibly causing yourself more long-term problems without even realizing it. It’s possible. 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. > [@mnemosyne](#): > > 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. According to my citations most expiration dates are arbitrary. > [@mnemosyne](#): > > 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? I do not know what you mean here. You are not going to find any product for sale with conflicting expiration dates. > [@mnemosyne](#): > > 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. If the effective lifetime of an Rx is inaccurately implied and inaccurately circumscribed then It is reasonable to characterize the situation as “arbitrary”. > [@mnemosyne](#): > > Write letters to the FDA and ask them about changing the study period to 5 years. Maybe one day they’ll do it. 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. > [@mnemosyne](#): > > Then I’ll answer questions about whether a drug is safe after that expiration date, and the answer will be the same… dunno. They do know for those 90 or so drugs involved in the military study. > [@mnemosyne](#): > > 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. 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. > [@mnemosyne](#): > > 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. 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. > [@mnemosyne](#): > > 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. 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. > [@mnemosyne](#): > > 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. 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. > [@mnemosyne](#): > > 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. 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. > [@mnemosyne](#): > > 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. 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. > [@mnemosyne](#): > > Thalidomide’s problems were due to an assumption that the drug would be metabolized the same way in different animals. The point was assumption. “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. > [@mnemosyne](#): > > I don’t need to do anything, and I’m disinclined to do this research. Yes you do need to do something, unless you are inclined to accept that your assumptions lack any sort of empirical basis. > [@mnemosyne](#): > > 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. I have agreed that there are Rx for which short expiration dating does need to be published and enforced. > [@mnemosyne](#): > > 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. Test away, unless the FDA has already gotten to them. > [@mnemosyne](#): > > Now prove it, and then label your drugs accordingly. 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. > [@mnemosyne](#): > > ’ will help" is pretty qualified to me. It’s a generalized statement. It’s generally true. “Might” help = qualified. “Will” help = unqualified. > [@mnemosyne](#): > > 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. I described my own experience earlier. Perhaps I was too generous to MDs and PhDs and not generous enough to you. > [@mnemosyne](#): > > 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. Very interesting. What can you tell us about the stability of the products mentioned above, assuming they meet storage requirements? > [@mnemosyne](#): > > WHAT ABOUT THE REMAINING 10%? That’s the part you are very conveniently repeatedly ignoring. 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. > [@mnemosyne](#): > > Oh, so it is true that the FDA serves only as a cite if it supports your argument. Of course. And it is true that no authority, no matter how lofty, gets everything right every time. (Except maybe for Cecil Adams) > [@mnemosyne](#): > > 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. Addressed. ---
**Author:** ![mnemosyne](https://avatars.discourse-cdn.com/v4/letter/m/c4cdca/32.png) [@mnemosyne](https://boards.straightdope.com/u/mnemosyne)\ **Post date:** [January 26, 2012, 8:05pm UTC](https://boards.straightdope.com/t/i-have-lots-of-drugs-and-im-wanting-to-get-rid-of-them/610364/49 "2012-01-26T20:05:32Z")
:smack: 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. ---
**Author:** ![LaurenB442\_yahoo.com](https://avatars.discourse-cdn.com/v4/letter/l/dec6dc/32.png) [@LaurenB442\_yahoo.com](https://boards.straightdope.com/u/LaurenB442_yahoo.com)\ **Post date:** [September 17, 2012, 9:05pm UTC](https://boards.straightdope.com/t/i-have-lots-of-drugs-and-im-wanting-to-get-rid-of-them/610364/50 "2012-09-17T21:05:17Z")
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. ---
**Author:** ![BigT](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/bigt/32/12044_2.png) [@BigT](https://boards.straightdope.com/u/BigT)\ **Post date:** [September 21, 2012, 11:08am UTC](https://boards.straightdope.com/t/i-have-lots-of-drugs-and-im-wanting-to-get-rid-of-them/610364/51 "2012-09-21T11:08:18Z")
\*\*Note: This is an old thread. \*\* > [@mnemosyne](#): > > :smack: > > 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. 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. ---
**Author:** ![grude](https://avatars.discourse-cdn.com/v4/letter/g/e47774/32.png) [@grude](https://boards.straightdope.com/u/grude)\ **Post date:** [September 21, 2012, 11:19am UTC](https://boards.straightdope.com/t/i-have-lots-of-drugs-and-im-wanting-to-get-rid-of-them/610364/52 "2012-09-21T11:19:59Z")
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 . The US has a strategic reserve: [http://community.seattletimes.nwsource.com/archive/?date=19930916&slug=1721425](http://community.seattletimes.nwsource.com/archive/?date=19930916&slug=1721425) Its been there since 1955 and is still considered good enough for sale, if they were allowed to. ---
**Author:** ![Broomstick](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/broomstick/32/246_2.png) [@Broomstick](https://boards.straightdope.com/u/Broomstick)\ **Post date:** [September 21, 2012, 12:27pm UTC](https://boards.straightdope.com/t/i-have-lots-of-drugs-and-im-wanting-to-get-rid-of-them/610364/53 "2012-09-21T12:27:57Z")
> [@mnemosyne](#): > > It’s not a time bomb - clearly they don’t “go bad” the day after the stamp on the box. But they do - and will - go bad…eventually. _And no one know when that will be_. There is no data, so you cannot claim they are safe and to do so is unscientific and irresponsible. > > Obviously manufacturers want turnover. That’s a given. > > But the expiration dates and the rules and testing procedures in place with regards to them come from the regulatory agencies. These might even vary country-to-country. This pharmacist is an idiot if he doesn’t know that. It is the FDA that establishes and enforces the rules…if they want longer expiration dates they can change the laws and wait for the data to come in. Perhaps many drugs will be shown to have longer shelf lives. Some won’t. 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) > [@](#): > > Why on earth would a company continue to test something indefinitely just to see how long it’s good for if it’s not required to do so? Do you have any idea how expensive this sort of testing is? 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. > [@](#): > > That gallon of milk in your fridge…will you drink it on the day of the Best Before date? How about the next day? The day after that? A week? A month? A year? You can rather easily tell when the milk has gone bad, and you don’t even think about shipping it off to Africa to feed the poor starving children. The timeline is longer, but the same thing applies to drugs. Properly stored, milk should be good for one week past the “best buy” date, because the best buy date _is not_ an expiration date. This is a common misunderstanding. ---
**Author:** ![Michael63129](https://avatars.discourse-cdn.com/v4/letter/m/3da27b/32.png) [@Michael63129](https://boards.straightdope.com/u/Michael63129)\ **Post date:** [September 21, 2012, 1:46pm UTC](https://boards.straightdope.com/t/i-have-lots-of-drugs-and-im-wanting-to-get-rid-of-them/610364/54 "2012-09-21T13:46:47Z")
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). [Previous page](https://boards.straightdope.com/t/i-have-lots-of-drugs-and-im-wanting-to-get-rid-of-them/610364.md?page=2)