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I work for a company that has some periphery exposure to FDA-regulation, and as a result we have to do a lot of very similar scientific calculations to satisfy
by Greed 9y ago
I work for a company that has some periphery exposure to FDA-regulation, and as a result we have to do a lot of very similar scientific calculations to satisfy their archival records. A big part of why most medicines still expire (at least for medicines available over the counter) much earlier than they should is that a majority of the testing is done to determine the expiration date at a controlled temperature, pressure, and humidity.
They test how it degrades under stress to determine a maximum viability under perfectly stable conditions. They are not accounting for the typical medicine storage places: a bathroom cabinet where the temperature and humidity will vary wildly within a matter of minutes, a cool, damp fridge, or even the reading table next to your bed-- constantly exposed to UV light from the windows.
I'm relaying this secondhand from a former FDA contractor, but I can only surmise that for a company with the litagative risk level that any pharmaceutical entity incurs, the old adage of "Better Safe Than Sorry" is a major part of the story that's missing here.
- beebmam 9y agoGreat comment, and I couldn't agree more.
- lostcolony 9y agoBeyond that, what is the incentive on the part of the company? No one is evaluating medications based on shelf life. Longer expiration dates -at best- do nothing favorable for the company, and at worst both reduce the purchase of more of the drug, -and- open the company up to litigation in the even it's dangerous. Why take that risk? There is simply no economic pressure to.
- Spooky23 9y agoI don't think there's an economic pressure to have a longer shelf life either. It's not any more efficient to stockpile drugs, and it doesn't make sense to do so, as your need for prescription drugs is likely not going to be multiple years.
- sliverstorm 9y agoWell, although supposedly the Army specifically liked Cipro because of the shelf life, so that's one case counter.
- collyw 9y agoMost medicines are sold in blister packs these days. Won't that prevent a fair bit of the environmental stress from affecting them?
- dragonwriter 9y ago> Most medicines are sold in blister packs these days. Won't that prevent a fair bit of the environmental stress from affecting them? Well, it keeps out humidity, and might prevent air-exposure effects. It won't prevent heat effects and some other environmental effects. Also, quite a lot are sold in bottles of pills or other non-blister-pack forms.
- BrandoElFollito 9y agoI live in France and cannot remember the last time I saw pills not in a blister pack. I remember vaguely having seen pills in bottles maybe 20 or 30 years ago. Again this is for France, I know that e.g. in the US one gets refills. Which by the way I find great because the waste of pills is tremendous. It would have been much better to get the specific number prescribed.
- cwsx 9y agoThis varies quite a bit throughout the world (I think). I've had both blisters and bottles in New Zealand/Australia.
- emmelaich 9y agoYeah, I think USA is atypical for bottles. I was surprised to see bottles of 1000 Tylenol* tablets at the CVS chain. In Australia the only thing in bottles are vitamins and similar, though it is possible to get small bottles. * acetaminophen / paracetamol
- sliverstorm 9y agoIt is a waste of pills- but in many cases the marginal production cost of a pill is incredibly small. See generic asprin, many hundreds of pills for a few dollars at an ordinary grocery store. More than you need, but the packaging & marketing probably still costs more than the pills. Over here, benadryl is the main over-the-counter drug I see in blister packs. They say it's to slow down the meth cookers.
- StavrosK 9y agoI don't understand your comment. You say they test at a controlled pressure, whereas conditions in the typical medicine cabinet vary wildly, and then say that that's why the drugs expire much earlier than they should. Do you mean that varying conditions make medicines last longer? You can't mean that medicines would last much longer if stored in perfect conditions, because that's not expiring "earlier than they should", it's expiring exactly on time for the poor conditions they are kept in. Can you clarify?
- johnnyhillbilly 9y agoI'll chime in. Most chemical processes happen faster with a higher temperature. Some drugs decay into harmful substances (e.g. Aspirin). Other factors, such as humidity or UV, may play a part as well. Rather than testing every permutation of storage conditions over time, manufacturers put a safety margin. Individual consumers aren't in a position to remember exactly how they treated any given container of pills. Even if the manufacturer knew how a given sequence of storage practices affected their drug, nobody would be the wiser.
- StavrosK 9y agoAh, I see, thanks.
- BurningFrog 9y agoHere's a startup idea: Develop an "indicator pill" that changes color at the same rate as an individual medication. It would be in (or part of) the bottle with the other pills, and be customizable to react to humidity, temperature and time in the same way as the particular medication.
- Lordarminius 9y ago> Here's a startup idea:... How feasible would that be for thousands of different drugs with hundreds of thousands of different formulations and chemical compositions and various storage factors ?
- arkades 9y agoIn fairness, about 200 drugs account for the majority of stuff sitting on Americans' countertops. No need to hit thousands to get pretty good coverage.
- readams 9y agoThe main problem is that there just isn't data on how much these drugs degrade. The expiration date is based on some preliminary measurements and conservative guesstimates. Neither the FDA nor the drug companies really cares or wants to see these dates extended.
- BurningFrog 9y agoThere probably is no data in part because there is no good way to use such data.