I have a temp job in a factory and it makes a varitey of generic drugs.
Yesterday my assignment was to go on the line and pack pills. These were generic ibuprofen.
So I started out by having the line operator dump a huge box of ibuprofen into the slot. We’re talking tens of thousands of pills in a huge container.
So the pills come out in the bottles and I am at the back of the line where I have to pick up the bottle, put it in it’s box and make sure the label is on straight and there is an expiration date on it (sometimes it fails to print or smudges off)
Anyway this goes on for three hours and I stop the line and tell the operator. Out of packaging. She gets me another three hours worth of boxes and says “Whoa, wait a minute, this next set of boxes has a different expiration date on it.” Then she changes it to a year later.
But she’s using the EXACT SAME pills.
Then three hours later, I run out of packaging and she gets me more and changes the expiration date to yet another year later.
But all the time the pills came from the same box. There was no difference in the pills set to expire in 2011 than the ones set to expire in 2012 or 2013
I asked her about it and the line head says “Mark that box probably has been sitting in the warehouse for at least a year or two before it gets here for us to package it.”
I’d go so far as to say that could or should involve a recall of those lot numbers. How does a consumer know whether or not that 2013 date is even valid? Maybe the liars are selling crap that expired three months ago? Not a good thing on their end.
That is definitely a problem, and totally violates 21CFR Part 11 Pharmaceutical Documentation Guidelines, at least in the US and its territories. ** Note, that Part 11 only applies to electronic records, but in the event that an electronic system is not in place, then the equivalent of hard-copy paper records must be maintained for a number of years, regarding every step of the manufacturing and packing process.
Definitely something wrong there. This would be illegal in Canada too, and, if true, is enough to get the company shut down. Having tested drug products (though not ibuprofen) and seen long term stability data on them, I can assure you that expiration dates do have meaning from the point of view of the chemistry, which, really, is all that matters here.
You can report this anonymously to the FDA/HPFBI and I suspect your company will be due for a surprise audit!
It’s been a long time since I read it, but I recall reading somewhere that the expiration dates were originally required by the US military. They were stockpiling medications for the troops, and asked the manufacturers how long before they lost their effectiveness. The drug manufacturers didn’t have an answer, so they started testing their stockpiles as they aged. When as little as 5% of the supply of pills showed degraded effectiveness, they used that time interval to set the “Use by” date. That meant that 95% were still effective.
I don’t know if this regimen is still in effect, but if I find a bottle of aspirin in the house that’s 6 months past the expiration date, and I have a headache, I’ll still pop a couple of them, and add aspirin to the shopping list.
Well, the breakdown products of the active ingredient in aspirin are acetic acid and salicylic acid–vinegar and willow bark extract, more or less, the latter of which is known to reduce pain and fever. As a result, you probably wouldn’t notice any change other than a vinegar odor and possibly a slight reduction in effectiveness.
The other ingredients could present more of a problem. I think the filler is typically starch, for the most part, but it’s possible that some other components could break down into something harmful. On the whole, it’s probably better to replace your aspirin supply when it starts to smell too much like vinegar.
Other drugs may not degrade so benignly, however. The behavior Mark describes could be anything from simply irresponsible to egregiously dangerous, and would certainly draw unfriendly attention to the company if the proper authorities were informed.
Requirements for long and short-term/accelerated stability are much, much more rigid and complex than this, and while everyone points to aspirin and acetylsalicylic acid as “I take them even expired with no ill effects” examples, for the vast majority of drugs, it isn’t that simple. IME (4 years testing these things), acceptance criteria is in the range of 98.0-102.0% potency, OR No More Than 0.X% of given (potentially toxic/pharmacologically effective) degradation product (note you can have a degradation product cause a problem even if you still have 99.5% of your active ingredient!).
Taking an expired drug has an increased risk of the patient either a) undermedicating their illness or b) consuming an unknown amount of degradation products which may or may not be harmful. There is no data existing at the pharma company or anywhere else to tell you what happens to the drug once it’s gone past the legally required study period (2-3 years, IME). It might be safe. It might not. No one can tell you either way.
I’ve posted extensively about product expirations and stability studies over the years here - do a search for my username if you want to know more. I’m not in the mood to post more right now, but feel free to ask questions if you have any.
mnemosyne and I reply to the same type of questions when it comes to this, and we always agree… The problem with taking drugs past their expiration date is that no one knows what really happens after the drugs are studied. They could be less effective, or they could be toxic to the patient. It is never a good idea to take a drug that is past it’s expiration date. If it is a month or so passed, that’s one thing, but I would NEVER take one that is significantly passed it’s beyond use date.
Also, the shorter the expiration date, the less likely I’ll take something. If it is a 14 day beyond use date, I wouldn’t dare touch it on the 15th day, but if it is a 3 year date, I wouldn’t hesitate to take on the 1096th day… But would replace ASAP.
I apologize, I did not mean to imply that all drugs are safe well beyond their expiration date. Thank you for the additional information. I had known that pills and such contained fillers in addition to the active ingredients, but had always assumed that they were either stable, or if they broke down, would do so into other benign compounds. I guess I thought the same about the active ingredients, too.
Campp, you are correct - the OP’s comments SHOULD be raising red flags. Where would someone go to report this? The local FDA office? Their website? Or just the local TV station?
The FDA is the authority in charge. They are supposed to be overseeing the correct record keeping of the manufacturer. There may be more to the situation than the OP described, as he is admittedly new to the job. Maybe he doesn’t know the whole story yet? Anyway, that’s what we pay the FDA to look at and fix.
They will act on a tip from the public.
I wouldn’t call the local TV station. I just wouldn’t. :rolleyes:
True enough. I think an awful lot of it would have to break down before it really had a noticeable effect from a normal dose, though. Maybe if your stomach were already sensitive, you’d notice a difference.
No need to apologize! I just tend to jump on such comments in order to address them - it’s kind of the only topic around here I know much of anything about, so I take the opportunity to! I know pharmaceutical companies have a bad reputation and people always assume everything, including expiry dates, comes down to trying to make money, but at the end of the day, people are putting chemicals into their bodies and there is a lot of work done to try and make those chemicals are as safe as possible, but anything that is intended to change how your body is behaving (i.e. medicine!) can, of course, change how your body behaves, and there are risks associated with that. The fillers are very rarely the issue; it is specifically the breakdown of the active ingredients that is the risk, and they very, very rarely break down into benign compounds. Lucky for the patient, though, prior to their expiration date, they have been shown to not break down into significant/dangerous amounts of stuff.
The FDA website is www.fda.gov. There is a “Report a Problem” tab on the lower right of the front page…the “report suspected criminal activity” looks like the most straightforward way to report this. The laws applicable to drug manufacture are part of the federal criminal code (or whatever it’s called in the USA), and companies (but not low-level employees) can be held criminally liable for breaking them. Markxxx if what you say is true, I sincerely hope you report your company to the FDA.
How about the distilled water I bought - it’s got expiration dates on it - do I have to use it by then or toss it?
Well, I think expiration dates on water are probably nonsense, but it points to a real problem with things like this. There seem to be forces that cause unnecessary restrictions and warnings to get added to things, and that undermines the credibility of the whole system. I have a Material Safety Data Sheet for Borden’s skin cream that says to avoid prolonged contact, and one for rubbing alcohol that says to seek a doctor’s care if you get any of it on you. If the references say everything is dangerous, then the references don’t really say anything about danger, and there is no way to find out what is dangerous other than rumors and experimentation, and the system has ruined its own goal.
I think it is not so unreasonable to conclude that all expiration dates are insignificant if you see what the OP saw, though the conclusion might be wrong. Thanks to anybody who is actually trying to inject real and useful information into the system.
