Is this pen safe to use? Or more importantly, would you be happy to use it?

[Mj4me]

Issue with royal mail so my pen took 4 days to arrive, its been warm here over the last few days, upto 24 degrees.

The pen arrived and the packs were completely melted. They were room temp and the box/pen itself didnt feel cool, just room temp. The wool felt warm!

Pharmacist has told me to just use it.

Im not feeling great. Its an expensive product and I don't want any issues!

Would you be happy to just use it?

If I was using the first dose within the next few days, yes, no issue for me. It had ice packs and wool, so would have been cool for some time before slowly reaching room temp.

I wasn't planning on using it till after my dads birthday in July 1st, but ordered whilst I had the spare cash. So i feel like i wouldnt get the full 30 days as its already ticking down now?

But you haven't started using it yet.
The 30 days is from first use.

If its kept refrigerated, which it hasnt been.

My understanding is that it’s 30 days from opening and first use, if refrigerated. I had a similar issue with Royal Mail. I used the pen and it was fine.

Was it actually out for delivery for 4 days?

I’d use it from now, not wait until July. Then you’ll get 4 doses from it. It’s not been warmer than 30 degrees yet.

Personally, I'd refrigerate it now, store it in the fridge and use it. I understand that you can also contact Lilly to ask their opinion on safety.

I don't think I have seen one individual delivery with so many threads before! Is this the 3rd one? 🤣

I replied on your other thread @Mj4me , it appears Eli Lilly using their assessment tool says it will be ok.

I had this issue and pharmacy didn’t replace the pen, so I ended up with only two doses out of the pen

I have now switched back to previous provider when stuff always arrived a lot cooler. Though if this summer is going to be hot I might swop to a pharmacy where I can pick up directly and take my own cool bag.

I’d use it as long as it’s not cloudy

I disagree. This counts as breaking the cold chain and Eli Lilly’s guidance to providers states that they cannot use any part of the 30 days as delivery - they are required to get it to you cold. Most of us order ahead of planned first injection usage and if the pen gets warm the clock has started. They can’t tell you to inject the day it’s arrived because it got warm.

https://medical.lilly.com/uk/products/answers/how-should-the-mounjaro-tirzepatide-kwikpen-be-stored-217607

Whilst if you make your own fuck up, then I agree it’s on you to risk assess what you are ok with - but if I’m paying that much to a company I expect it to arrive cold as per their side of the deal. If my fridge breaks or I forget to put it in there that’s where it becomes my responsibility.

@wlinewbie0425looks like Eli Lilly has an assessment tool for UK to decide if medication is ok for the patient to use which the OPs provider has used. If the details of the OPs delivery are entered (assuming 2 days out of cold chain as packaging protects for first 48hrs, and temp max 30) it is ok.

https://tempex.lilly.com/uk/

That is interesting as it contradicts the statement on their own website that I linked to which says quite clearly:

“How should wholesalers, HCPs and pharmacies store Mounjaro KwikPen?During shipping and storing by wholesalers, health care professionals (HCPs) and pharmacies, Mounjaro must be kept between 2°C and 8°C.

“The 30-day room temperature exposure allowance refers to the used pen, and wholesalers, distribution Centers, HCPs and pharmacies cannot use any part of this allowance”

below is what it says when you run the scenario using your link above - making same assumptions about temp and time.

“Lilly cannot recommend the use of its products in any manner other than stated in the product Summary of Product Characteristics. The information from the Lilly Temperature Excursion Assessment tool is not intended to offer an opinion regarding the use of the product in a manner inconsistent with the product label. This temperature excursion assessment tool is intended to provide Healthcare Professionals with additional stability data to enable them to make their own risk assessment regarding the suitability of the medicine for use. It is up to the Healthcare Professional to make a clinical decision on the use of a product that has experienced a temperature excursion.”

my opinion stands I think the point of that tool is so if you have a temperature ‘excursion’ at home - forget to put in the fridge etc, you can call them for advice and they can run this and advise it’s still ok to take. I still expect mine to arrive between 2-8C - when you see the mark up the pharmacies charge this is a minimum requirement. If my prescriber were to make the clinical decision it was still ok and refuse to replace, they would not remain my supplier. If it’s royal mail’s fault they need to take it up with them.

Agree partly@wlinewbie0425but it does give me more confidence Eli Lilly has assessed as ok rather than worrying the provider is pushing boundaries to save themselves losses.

Depending on what you enter it sometimes says it needs used within 30 days and the time over temperature needs subtracted from those 30 days, if it returned that assessment I would insist on a replacement, otherwise I think you might struggle to get a provider to agree to a replacement when Eli Lilly says ok until expiry date.

I would use it now