Hello Dr. Agar,
I, like many other dialysis patients need erythropoietin to keep my hemoglobin and other blood counts at reasonable levels. Though, I have found my need for erythropoietin going down ever since I have switched to nocturnal. But that is not the point of this post. I have read repeatedly in different places about the need to maintain the injection vials at around 4 degrees centigrade. Otherwise, I believe the drug loses its potency and it is pretty much equivalent to injecting plain water.
I was told by Dr. Rabindranath (I believe you know him, a great nephrologist from Pondicherry, India!) that there is a mechanism followed in Australia where they have some kind of a color strip on the erythropoietin injections that are of a certain color if the temperature is right and turn to another color if the temperature goes beyond the required range.
I have never heard of any supplier in India use this mechanism. I believe that many suppliers have less than effective procedures to ensure that the cold chain is maintained. As a result, though Indian dialyzors spend thousands of rupees on their erythropoietin, they do not get their ‘paisa vasool’ - pardon the Indian slang - which means ‘bang for the buck’!
I wonder if you could throw some light on the subject. What are these color strips? Can we insist that suppliers use these strips to make sure the cold chain is maintained. Such a method would be invaluable in also enforcing accountability as to who was responsible for breaking the cold chain. When the vials or the pre-filled syringes are handed over to the next in line in the supply chain, the lot can be rejected if the color does not match the requirement. More importantly, patients can reject the injection if the color is not right, making sure that he/she gets the required drug and it does make a difference to his/her blood counts.
Thanks so much Dr. Agar!
Thanks for the question … and its a good one … as it suggests a potentially good solution for monitoring of the stability of the cold chain cycle - especially in hot climates.
I do (vaguely) recall that there was some discussion … though this was 10 years back when PRCA was a significant concern … of the addition of temperature-sensitive marker strips to ESA packs (they are easy to get, are relatively common in supermarkets here and are simple technology) … but I dont recall that the manufacturers ever actually went there.
So, no, we don’t routinely use these in Australia to mark our pharmaceutical cold chain items. Perhaps Dr Rabindranath had heard that it was a consideration at one time, but we never actually instigated the practice (at least to my recall or to our service’s knowledge).
It isn’t a bad idea though and it isnt (or shouldnt be) expensive.
We have taken the line of advising ‘temperature awareness’ rather that ‘temperature monitoring’ of ESAs… and I dont think we seem to be getting into trouble - even when the temperatures are high in our summer months.
All patients get cold-pack carry bags to bring with them when they pick up their ESA from the pharmacy … and I must say that most patients are very good with this. We give out other information about taking the ESA straight home rather than stopping on the way for a spot of shopping … etc etc.
As for ‘insisting’ that the suppliers use temperature sensitive strips … I don’t think I have sufficient sway over our pharma’s to so do!
I asked my nurse the same question, because in our case, sometimes epo is mailed to us on ice. She said the manufacturer told her that even if the ice was melted and the epo arrived at room temp it would be fine for 28 days. Also, she said it is not this situation that one should be concerned about, but rather that the epo would get too cold as that does something worse to it. I didn’t get the full technical explanation.
Well, I have heard that for the first time Jane. A quick google search also tells me we should be more concerned about it getting too hot rather than too cold. Maybe the type of EPO we are taking is different? I take alpha EPO.
I agree that over-warming is the greatest concern.
In sharing info from my nurse, I don’t stop there. I always check out info backwards and forwards. Often ppl say that one can’t believe much of what one hears on the internet. Well I always say that I see no difference between the internet and what ppl say in person. The rule should be always check and recheck until the correct answer surfaces. So this is a good ex. I will take this info back to my nurse, ask her to confirm where, specifically, she got her info from ( she said she got it from the Epo manufacturer ), will find out what type we use etc. Anyone can say anything- it has to be backed up by experience and facts for me. Also, I know in the unit, epo is left sitting out while nurses make rounds with all the patients. So, it’s important to know how this affects it’s potency.
Something else I have wondered about is meds we get at the pharmacy. How long is the pharmacy keeping opened bottles of meds and then dispensing it to customers over the course of a year. Or on meds we are given it will say on the bottle that it is good for an entire year. I have read articles about how meds lose their potency.