I see that the instructions for the epipen say not to store it in a refrigerator. I cannot for the life of me think of any way that this could be bad for the drug.
It also states that it should not exposed to heat greater than 88 degrees. I know for an undeniable fact that the optimal temperature for epinephrine is 98 degrees. So what is this warning for?
I have the distinct impression that the makers of epi-pen are trying to make already nervous parents so paranoid that they keep shelling out hundreds of dollars for pennies worth of drug.
I know for an undeniable fact that human meat is best kept at 98 degrees, but every time I leave it out in my garage on a hot day it goes rancid and attracts maggots.
Perhaps epinephrine is only good at 98 degrees between the time it’s produced and the time it’s used or the body has some mechanism for storing it besides just letting it sit there.
You say you “know for an undeniable fact”, do you have a cite for this undeniable fact and since I assume your talking about inside the human body, what makes you so sure this would translate to clear glass bottle, diluted in saline, exposed to light, sitting on shelf, in 98 degree room?
Sigh, you should do some research and see if you can come up with how much it cost to develop the drug. There may very well be millions or even a billion in research behind it, they have to recoop ALL of that money (plus the money in any failed drugs that never made it to market) before it goes generic or there won’t be any point in them making another drug.
Everyone wants a cure for cancer, no one wants to pay for it.
Yes, my statement was based on normal body temperature. Your point is well taken, although common sense says I am much more likely right than you are. The meat degrades because of bacterial action. There is no bacteria in the epinephrine, or if there is potency is the least of the problem. The body only stores epinephrine within cells. And just to nitpik, the epi in the vial is not diluted, but ultra concentrated.
And while your second point is true concerning many drugs, it is not true for epinephrine. The drug itself is very simple and easily synthesized. The actual drug in the epipen is worth pennies. You are paying solely for the delivery system. And that is just a convenience. A huge premium for convenience.
Epinephrine is not stored, long term, in the body. It’s made as needed, and quickly degraded, with a half life of around 2 minutes, according to Wikipedia. The behavior of a hormone in the body is very very different from the desired behavior for long-term shelf storage. If you buy epinephrine, I’m assuming you’d like to have it around for more than, say, a half hour or so.
Chemicals decompose faster at higher temperatures. In the body, its produced then used almost immediately. It doesn’t sit there for weeks. If you could keep it in the freezer without freezing it, that would be great for shelf life.
So why can’t you keep it cooler in the refrigerator? It’s probably because the packaging is not rated for that storage. When things are cool, they contract and get brittle. This can cause leaks which will cause contamination problems.
Primatene inhalers contained epinephrine, obviously they were intended to be carried on your person so no way could the storage requirements be that picky.
There’s also going to be springs and buttons and plungers in there that aren’t going to work as smoothly if they’re covered in condensation from taking them out of the fridge on a warm summer day to take with you when you go to work or school.
Why is it that whenever someone actually invokes common sense, they are often arguing from ignorance with people that know better? Le sigh.
The cost of producing epinephrine has very little to do with the sales cost. That’s basic economics, and until you grasp that, arguing about the price is useless.
I believe the storage requirements are the way they are because, in the massive amounts of testing that drugs have to go through, that was found to be the most effective.
Experiments there included essentially cooking the stuff. In general, keeping it above or below the recommended temperature has no effects on potency. So there is no reason to worry about short term environmental effects, although common sense says the recommendations should be followed as closely as is reasonable.
Because Joey P gave you a concise and clear reason why simply being at 98 degrees Fahrenheit is not good for epinephrine, and you dismissed it with “well, common sense says otherwise”. You’re arrogantly ignoring someone else because you don’t like the explanation, however correct it may be. That is extremely frustrating for a number of posters here.
Also, just because creating epinephrine involved high heat (I didn’t read your link so I won’t comment on the accuracy of that statement), doesn’t mean it lasts at that temperature. Cooking a steak requires high heat too, but leaving it on the grill for 5 hours is not going to maintain the steak’s taste.
Bolding mine.
IOW, if it wasn’t kept at room temperature, it degraded.
It then goes on to test what you were talking about.
Epi Pens are 1:1000, so if you bring them up to 158 (hardly ‘cooking’) or cool them to 41 (not freezing) you seem to be okay.
From what I can gather, it’s not the controlled heating and cooling that’s a problem. It’s sticking them in a corner somewhere and forgetting about them for months.
Also, as I mentioned earlier, I’d be worried about condensation on the plunger, buttons, springs etc if they were in and out of the fridge every day.
Furthermore, from your link it says:
IOW, we (the people that wrote the article) don’t know for sure how letting your meds get out of the temp range specified by the manufacturer will affect them, so lets just do our best to keep it in that range and replace the meds from time to time. Basically, just follow the directions on the box. As far as what the box says. The manufacturer did their best to give you the most leeway to handle the meds and give you the best shelf life they could. It takes lots of testing and the numbers aren’t arbitrary.
But you read the whole report, right? I know I just did.
The whole thing started for me when someone I know was getting very worried about a trip to the beach and how he couldn’t take the epipens to the shore since they couldn’t be refrigerated and/or would get too hot. I said he was being ridiculous, since common sense told me he was.
No, I not only read the whole report, I even posted some of the things that YOU should have posted that you commented on.
You don’t actually read the things you post do you.
Why don’t you quote the part you think is relevant from that page.
Common sense not required, just read the directions that came with it. “Store at 20° to 25°C (68° to 77°F);
excursions permitted to 15°C-30°C (59°F-86°F)” If you want to follow the actual directions, you he could take it to the beach as long as it stayed under 86F. I have some injectable meds as well and knew to look for this because I’ve read the prescribing info on them in the past. I could be wrong, but IIRC an ‘excursion’ is 24 hours. If they’re going to be out longer then that or in a temp hotter then that, maybe keep it in a cooler (with or without an ice pack depending on what it’ll take to keep it in the proper range) or just go without the epi pen for a little while. Unfortunately, having such severe allergies means some lifestyle changes. Though, if it were me, I’d probably just take the pen to the beach with me and hope for the best…or leave it at home and hope for the best.
Here: I found that an egg will cook on a surface that’s only 55 Celsius (130 Fahrenheit). It just takes time – almost 20 minutes. So indeed, it can be hot enough to fry an egg on the sidewalk.
Excursion is not a good word. They are going to be at the shore for a week. And is is reading the insert and worrying that if the epinephrine gets to 95 degrees it will be useless, but he won’t know it until he tries to use it and then will die.
I said not to worry about it, keep it in the shade and it will be fine. We are only talking a week here.
One last thing, if it was mine and I couldn’t be without it, I would probably just take it with me if it was going to be 95 degrees. I’d imagine it isn’t going to be 95 degrees for the entire week, 24 hours a day, right? I might even call a pharmacist and ask them. The epipen website says not to expose it to ‘extreme temperatures’. It’s not until you read the prescribing info that you get the exact range. I may just keep it in a cooler with an icepack in such a way that it won’t get too cold.
However, I wouldn’t use my ‘common sense’ to decide that their claim that you shouldn’t refrigerate it is baseless or that 98 degrees is a better storage point. That’s…odd.
I am sorry to interrupt but may I point out that 95 degrees isn’t good and refrigeration probably isn’t optimal either, room temp is best. Consistency is what it needs as do all the EMS drugs.
That’s why we bring our drugs in when it’s hot, heat the inside of the squad when it’s cold, because not only do the drugs get hot and cold but the truck does too and a cold truck means ice on the windshield which delays response time. A hot truck just isn’t comfortable for us and isn’t conducive to treating a hyperthermic patient.
Epinephrine aside for the moment, consider that in that same drug bag is IV fluids that also get very hot or very cold. Any Fire department or ambulance service that doesn’t make accommodations for keeping the temperatures of their drugs and fluids neutral is negligent.
Quite honestly this magazine, I don’t know where they got their “facts”. I’m not saying the information is fabricated but it goes against what I know to be true as a 20 year Paramedic. That and you might be hard pressed to find something other than JEMS laying around quarters so I am really not too familiar with this magazine’s reputation. What I see on line looks good but I remain skeptical.
Lastly, most ambulances don’t carry EPI-PENS due to the cost. We make a kit of an amp of Epi 1-1,000 and a syringe which drops the cost to about $6 because when you have multiple units that you have to supply with “EPI-PENS” that don’t get used because if there is a call for an allergic reaction or anaphylaxis, a Paramedic is dispatched and will draw from the drug bag before resorting to the EPI-PEN they just aren’t practical.