I got an Express Scripts shipment from UPS at my door a few minutes ago. I replenished both my Lantus as well as my Apidra two nights ago, and here they are. But, it's 100ºF here this afternoon (maybe a bit higher), and the 'pillow package' they came in was hot to the touch. I opened it up and the two Koolit packs were warm and had slid to the bottom of the package, with only one side of one of the packages of Apidra cooled by them. The other packages were warm, and the surface of the Lantus package at the opposite end -- the first one I pulled out -- was hot to the touch. Uh oh...
Alarm bells went off in my head. On a x-country trip over the summer of 1982 (six months after I was dx'ed), I let a vial of Regular get really hot in a cooler (oxymoron, that). I put it back in a fridge to cool it down, and later started using it when we crossed Utah, headed for Vegas, not thinking much about it. Until very weird things started happening -- you could draw a line across my arm, and in a few minutes, a welt almost a half inch high along the line drawn would rise up. I was swelling up like the Pillsbury doughboy. My face started to contort with puffy areas. It was wicked. And really scary. Eventually, we (my doc and I when I got home to SoCal later that day), deduced that the insulin was at fault. I threw it away and started a new vial, and was 100% fine. But, I digress.
Because of what happened just now, I called Express Scripts and ended up on the phone with a Pharm D. He read to me from the manufacturer details he had that both insulins have been tested in extreme heat -- Lantus to 104ºF for 30 days, and Apidra to 102ºF for 28 days -- and both were fine and still usable up to those limits. Wow.
In fact, he said the REAL problem with both kinds of insulin is freezing of the insulin, which then renders it inert and no longer usable. Much more of a prob than heat.
Good luck with your insulin. I hate mail order prescriptions. Especially insulin. I had an issue several years ago where I came home from work and had a second notice of attempt to deliver my insulin. Never got the first notice. Bottom line is my insulin sat in a delivery truck for two nights in August in Maryland. I eventually got a new batch, don’t remember details. Now I am able to get my insulin locally and I take advantage of that.
I can certainly understand your concerns… And I would share them… But when I take a step back and think about it— isn’t that how the insulin also gets from the manufacturer to the distributor to a local pharmacy? Through shipping?-- such as the mail?
Insulin exposed to temperatures higher than 98.6°F (37°C) should be discarded.
I woud not want to use Apidra insulin that has been exposed to temps higher than 98.6 degrees F. for any length of time. Why should you accept this risk?
Will the pharmacist be willing to put it in writing that the insulin s/he shipped to you and exposed to heat greater than 98.6 degrees F. is safe for you to use?
Unless he was outright lying to me, he said that Apidra has been tested at 102ºF for 28 days without failure, and that anything shy of that has been deemed safe to use by the manufacturer. This is apparently information coming directly from the manufacturer, just like you apparently have.
So, we seem to have diametrically opposed potentially true (or false...) information on hand. Hmmm.
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I see now that your quote above is in reference to insulin pumps. I'm on MDI, using the pens, so perhaps things are different between the two?...
As an insulin dependent diabetic for 23 years, pumper for 17, I've found insulin in a pump degrades, and I believe it would be true for insulin in general.
I feel that medical doctors and pharmacists want us to believe otherwise, but I think insulin is affected by heat, not just extreme heat.
1 - Call the Sanofi toll-free Apidra number 1-800-633-1610, ask them about the studies. Can they provide you the info in writing.
2 - Call ExpressScripts and ask them to provide you the literature in writing.
FWIW, the (FDA-approved) leaflet that comes with Apidra pens only speaks to two conditions. Either unopened vials/pens which should be refrigerated @ 36-46 F, or opened vials/pens that should NOT be refrigerated, but kept @ temps UNDER 77 F for 28 days.
Good morning Michael. I would be very careful about using your shipment. Freezing kills it totally, overheating degrades to some extent. If you use it keep close check on your bg numbers and don't be surprised if your IC ratio changes. Apidra on the third day of pod wear was greatly reduced hence why I quit using it. Didn't stop but greatly reduced. Arm temp 92 today. Best of luck. I wonder who tried that batch after 102 for 28 days to confirm?
I also use express scrips!
I have had issues with my insulin being delivered to the wrong home and not getting it till two days later then another time it being melted down. Both times I insisted they give me new supplies because there was no way of knowing both times if they were usable . That’s the risk of the mail order company if you ask me. Both times were in the summer, I am sure that when the drug stores or whom ever gets the supplies that they send to, are keep cool and delivered to them properly . At least that’s the only way I can sleep at night is to believe that lol … I would insist I received new products at express scrips expense not yours or your insurance . They need to take it up with fed ex or ups whom ever they had get it to you. Stand your ground you have enough to deal with every day trying to keep your level good why should you also have to add the question of is my insulin doing it’s job … Good luck.
The prescribing information on Apidra is very clear. It can be stored in the fridge til expiration, once exposed to higher temperatures but below 77 deg F then the insulin should be good for up to 28 days. Once exposed to even higher temperatures but below 98.6 deg F then it is good for up to 2 days. Once exposed to temperatures greater than 98.6 deg F then the insulin should be discarded.
That is the manufacturers standards for storage. If Express Scripts failed to adhere to the manufacturer specified storage conditions when delivering it to you that is their problem. They don't get to rewrite the manufacturers FDA approved prescribing information. If the insulin was overheated due to shipping failure then they need to replace it.
I live in Minnesota and it can be very stressful when supplies are going to be delivered in freezing temps in the winter or hot temps in the summer. I am lucky that I get my insulin from a local pharmacy. However, my sensors and test strips come from a distributor. I use Edgepark and get an email when supplies are on the way. If you live in a medium or large city with FedEx Office store and/or UPS Store, you can have your deliveries rerouted to the stores rather than delivered to your home.
There is no question in my mind- I would absolutely not use that insulin and I would insist on a new set ASAP. For this reason, I refuse to get insulin from mail-order delivery services and only fill my prescription at my local pharmacy. Yes, I know they all go through the mail somehow but I don't trust mail-order and shipping companies who will leave a package anywhere. I've had the insulin in my pump degrade/denature in extremely hot weather and become unusable with crazy hyperglycemia as proof.
So a while ago I took a two week move from New York to California along with about a 4 vial supply I had stocked up - lantus and humalog. We had no air conditioning in the car. I had a tiny insulpak with space for an ice pack and a thermometer to monitor it. At times, it would get kind of high (around 78) before putting in an ice pack. At a few distinct one or two hours periods going through the desert portion of the west, it got up to around 85 or so.
For the next two to three months, the insulin reacted VERY strangely on my BG. My basal dosing was all over the place. I was taking about double the amount of insulin I would have before the moved. Every time I switched vials there were noticeable differences in my basal and bolus dosing. As soon as I got new vials, my dosing nearly halved itself. I really should have just tossed all of them but I get really anxious about getting rid of any insulin (I have a bag of potentially degraded products sitting around in case of some horrible emergency).
Based on my experience I do not believe at all that insulin could survive those temperatures for that long. I bet there is data claiming this and I will guarantee the labels say the insulin lasts longer at higher temperature or can last through small spurts of high temperature, but the T1s out there will tell you this is not the case. And I think they should know better than what the label claims.
