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CDE,LD,MS,RD
Storage of opened insulin vials...what do you recommend and why?
Section:  General Diabetes

I recently sent in my reciepts to my employer for reimbursement from attending the American Association of Diabetes Educators (AADE) meeting in Las Vegas.  When I travel I always ask for a refrigerator in my hotel room for storage of my insulin.  I wear an insulin pump with Novolog insulin.  So I carry and store the vials in the hotel.  Most hotel rooms have a fridge full of extremely overpriced snacks that I can usually find room to put my insulin into.  However, that was not the case at the Luxor.  So I asked for a fridge and they provided one.  And they charged me $25 a night for it!  That is a little steep considering my hotel room was only $50 a night.  I considered not getting the fridge but I really did not want to try and keep my insulin cool by gathering ice from the ice machine constantly.  So I bit the bullet and paid the price.  When I turned in my reciepts I didn't really expect to get reimbursed from my employer for the fridge but they asked for something stating that the insulin needed to be refrigerated and they would reimburse me the $25 per night. I thought sure, no problem.  
But when I looked I couldn't find anything.  The inserts with the Novolog insulin state to store unopened vials in the fridge but once it is opened it can be kept at room temperature.  I know that is common practice but I have always been told to store the vial that I am filling my pump reservoir from in the fridge.  since the vial is only accessed once every three days it is supposed to keep longer in the fridge rather than out at room temperature.  I have never had a problem with insulin going bad.  And I probably use it for longer than 30 days if I am not paying attention.  But where did this advice come from?
I looked in my pump books and found this excerpt in Pumping Insulin 3rd edition by Walsh and Roberts:
"Humalog insulin, in particular, should be kept refrigerated at 36 to 45 degrees Fahrenheit until just prior to use, when it can be warmed to room temperature."  
That is basically the advice I was given but there is no reference noted.  Does anyone know where this advice comes from?  
My boss and I provided this excerpt and I think I will in fact be reimbursed.  I am not necessarily worried about not being reimbursed but I am very interested to discover that I may not necessarily need to refrigerate my insulin vials.  However, traveling across the country and not keeping my insulin cool sounds like a recipe for disaster to me.  I would hate to be stuck somewhere for many days with denatured, worthless insulin.  
Two days later I read an article in  Diabetes Clinical Mastery Series that I get via email.  
It states: 

"An exam review for pharmacists lists the expiration date for opened vials of Humalog as 4 weeks, but other vials of human insulin are listed as 30 days unrefrigerated and 3 months refrigerated (5)."

The reference is:

PoweRx-Pak C.E.: Insulin injection techniques: a review for pharmacists [article online]. Available fromhttp://www.powerpak.com/CE/insulin_inject/tables.cfm. Accessed 16 July 2002 

The article is here: 

http://www.diabetesincontrol.com/articles/diabetes-news/11467-diabetes-disaster-averted-50-how-long-should-insulin-be-used-once-a-vial-is-started


When I clikced on the linke to find the reference it is no longer available online.  
Does anyone know where the advice to store opened vials of insulin for use with an insulin pump in the refrigerator came from?
Thanks.

MEMBER COMMENTS
Re: Storage of opened insulin vials...what do you recommend and why?

Thanks, Micki, for bringing up this very important topic. Insulin storage for people on an insulin pump as well as for injectable insulin using insulin vials, cartridges or insulin pre-filled pens is a very important issue. It is important for glycemic control, and it is also an important cost issue....especially if the patient has to pay out of pocket costs for insulin.

 

In addition, I think that many health professionals are not aware of the potency of the various insulins once a cartridge or vial is opened.  I have had patients tell me that their healthcare professional recommended not storing insulin in the refrigerator at all because injecting cold insulin can make the injection more painful. That is a ridiculous reason to keep the 1,000 unit insulin vial unrefrigerated. I advise patients who do not want to inject cold insulin to draw up their dose in a syringe (from a refrigerated vial) …return the vial to the refrigerator, and let the insulin in syringe get to room temperature before injecting.

 

I do not think there is any debate about the fact that refrigeration of insulin preserves potency. It is my understanding that the stability of insulin in vials used beyond the recommended timeframe depends upon the following factors:

     temperature  

      number of injections per day

      volume of insulin remaining in the vial,

     exposure to light

      agitation

     technique used for dose preparation.

 

At this time, I would like to share with you the content of two of the slides that I use in my insulin lectures related to storage of insulin in vials and another related to storage of insulin in pen cartridges. I referred to each manufacturer’s advice in preparing the information for these slides:

______________________________________________________________________________

 

After first use, insulin vials if kept out of the refrigerator must be kept at 68-77°F with occasional excursions of 59-86° F

 Potency is then assured for:

     glulisine (Apidra®)……………………….……..28 days

     lispro (Humalog®)&aspart(Novolog®)……….28 days

     Humulin R®……   ………………….…………..28 days

      Novolin R®… (stored below 77°F)……….…42 days

      glargine (Lantus®) …………………..……….29 days

      detemir (Levemir®)………………….……….42 days

      Humulin N…………………………………..….28 days

      Novolin N...(stored below 77° F).….……….42 days

      Humulin 70/30®…………………………...….28 days

      Humalog 75/25®……………………………...28 days

      Novolog Mix70/30®.…………………………..28 days

_______________________________________________________________________

 

And another one:

_______________________________________________________________________

 

After first use, disposable insulin pens & cartridges must be kept out of the

refrigerator at  68-77°F  with occasional excursions of 59-86 °F      

   glulisine (Apidra®)……………………….………………..28 days

    lispro (Humalog®) …………………………….……..…..28 days

    aspart(Novolog®)……………………………………..….28 days

    glargine (Lantus®) ……………………………………….29 days

    detemir (Levemir®)………………………….…………….42 days

     Humulin 70/30®…………………………………………...10 days

     Humalog 75/25®…………………………………………..10 days

     Novolog Mix70/30® ………………………………………14 days

__________________________________________________

 

Another issue to consider: Do patients covered by prescription plans get enough insulin bottles to abide by the manufacturers' recommendations or do they calculate the number of bottles required by how many units the patient takes on a daily basis?  My experience has been that they get enough insulin to cover the prescribed amount on a daily basis. 

 What have you found to be the case?

Re: Storage of opened insulin vials...what do you recommend and why?

As I have noted previously I live and work in the tropics.

 

All of my insulin opened or untapped vials are refrigerated constantly.

 

I have tried Lantus and found it unstable and for some inexplicable reason on 3 separate occasions had overnight hypo issues when used at only 7 u.  I no longer use it and now rely on Levemir for my basal insulin.

Patricia posted the standard recommended effective times for insulin.  I use Novolog for bolus meal coverage.  I also have Humalog (generally 1 vial per year) for use of a quick adjustment if for some reason I have a higher than normal BG reading and need a very rapid drop.

 

While not a "valid" study, observationally I have found that my Humalog vial retains full potency for well over a year and my Novolog and Levemir remain effective until it is time to open a new vial.  What I use for a guide for that is when the insulin level drops to the lower edge of the label when inverted I replace the vials.  Having said that when I am "Back-a-bush" and in the field and my insulin is stored in a Poucho evaporation cooling wallet I just use the insulin until the vial is totally dry as I rarely carry extra with me.

Given I only use 7 u of Levemir 2 x per day at bed time for help with dawn phenomenon and fasting and first thing in the AM, a vial lasts me nearly 4 months.  My Novolog use ranges from 3-4 units 3x per day for normal low carb, minimum protein coverage.  When eating out here in the U.S. I may bump it to 5u and generally that covers occult sugars/starches in sauces etc. with my meals.  If I am still higher than I need to be on return home (a few hours post meal) I will bump a unit or 2 of Humalog.  Recently at a resurant with only a small steak, dinner salad and broccoli the 5 u were not enough and I supect sugar was added to a blue-chees salad dressing.  On return home  I was at 135 mg/dl 2 hour PP.  Yikes! A Humalog alert brought me back down within 1.5 hours to normal range.

Insulin vials so refrigerated maintain efficacy for 4+ months for me.  Humalog well over a year!

I am now fortunate to now have the Veterans Administration supplying my insulin and syringes so they do issue 1 vial of Levemir and 1 vial of Novolog per month.  An artifact of having served in Vietnam and potentially exposed to Agent Orange.


So to answer Patricia's second question do patients receive sufficient insulin to cover needs?

In my case yes.

For those folks less fortunate with employment and or minimal insurance coverage the good news is that prolonged actual efficacy of refrigerated insulin extending 3-4 months rather than arbitrarily tossing it out after 28 days can be a huge savings at +/- $110/ vial.  For those cash strapped individuals reusing syringes is also a possibility.  I have done it repeatedly in the field when I forgot to bring an adequate supply.  One just needs to be very careful never to inject into a vial with a syringe that has been used, only withdraw insulin.

 

Always only use a syringe for Novolog or Levemir for their respective vials.  Air is injected with a clean new syringe at the start. This avoids and potential contamination of the insulin and possible crystallization of oxidized insulin in the needle barrels.

Following the addtional guidelines Dr. Bernstein provides (both videos and his book) injecting correctly is painless and I have never noted any issue with refrigerated insulin.  The very rare occurrence of discomfort from injecting has happened when eating out and not paying close attention or too much pre meal wine :-) and not having the needle angled enough for a nice subcutaneous and into a small fat layer injection.  When too sharp of an angle is used with longer needles one can nick the muscle a bit which is a minor Owie Fo Tru :-).

This is all injected at the table through the clothes, so quite discreet, by the way.  No fussing with alcohol swabs that just dries the skin etc.

As usual I likely rambled more than necessary to address the main question/issue posted.

Bruce Miller, PhD.


-- Bruce W. Miller, Ph.D.
Conservation Ecologist
Neotropical Bat Project office details
Gallon Jug, Belize
Mailing address
P.O. Box 37, Belize City
Belize, Central America
Phone +501-220-9002 
Re: Storage of opened insulin vials...what do you recommend and why?

I have my own comment on this topic, but first my story.  I spent two weeks on vacation this summer, a week long cruise and a week in mexico.  I brought my insulin and extra (just in case) and before I left I inquired with the cruise line and they suggested that rather than trusting the cabin refrigerator, I should check my insulin with guest services and it would be stored in the infirmary fridge.  Well on the third day of the cruise when I needed a new basal pen I went to pick up my insulin and was handed my insulin FROZEN.  It all turned out ok in the end, but it was a harsh lesson.  And in case you wonder, my insulin was all ruined.  I was unable to observe any changes in it, but the insulin was severely degrated in effectiveness.

This best reference I found is referred to in the DiabetesInControl publication and is this commentary in Diabetes Care from 2003.  Although most insulins suggest that they are fine for 28 days at room temperature, it is noted that the key things which damage insulin are heat and light.  Lantus insulin is considered by many to be the most fragile of all with the other basals following behind.  Bernstein considers Levemir to be markedly robust than Lantus.  Walsh considers Humalog to be more susceptible to heat

There is often confusion about the different storage and usage times.  Expiration times are often two years and reflect the amount of time that the insulin can be stored under controlled refrigerated conditions.  Then there is the storage guidelines when not controlled, in most cases (and with Lantus in particular), if the insulin is warmed to temperature, it is considered "opened" and should be used within 28 days.

So in my practice (pen based MDI), I always keep my basal in the fridge and away from light and I maintain a stock of up to 3 months of insulin.  For my bolus insulin, I mark the start date in permanent ink on the pen and carry the insulin in a Frio cooling pack all the time.  If I know I am going to be in very hot temperatures, I'll take precautions.  And for the most part, I will continue to use my pens beyond the 28 days.  But I do so knowing that I need to be alert for degradation.  I've never (in my limited one year) had insulin that was handled well go bad (except for that freezing incident).

And I have no problem submitted expenses to my employer for any required room fridge.   I also will visit gyms in cities where I travel on business and I will submit walk-up fees for the gym.  That is part of the expense of my travel.

Re: Storage of opened insulin vials...what do you recommend and why?

 I have used the refrigerate to expiration date, but opened use in 28 days-30 days then discard rule, except with the pre-mixed as you have already listed Patricia.
  Not sure in temp extremes, but in usual room temp vials and cartridges and pens once opened are good for the 28-30 day time frame (or expiration date if pertinent). 
  The amount that people receive is usually ok unless it is a low dose user.  They are the ones that really prosper using pens, or opening smaller amounts of insulin at a time, to keep it fresher.  When they go to vial and syringe because it is cheaper, it is hard to get buy in to the loss of potencty after 30 days unless they have witnessed it themselves.

Re: Re: Storage of opened insulin vials...what do you recommend and why?

 


Brian,
I am dying to know how 'everything turned out ok in the end' when all your insulin for a 2 week vacation was frozen!  Yikes.  

To all,
Thanks for your input.  It sounds like we all agree that keeping insulin in the fridge is the best practice from experience.  That is, when a bottle is opened it should be kept in the fridge until used.  Does anyone know if this is in writing anywhere?   In the literature or elsewhere?  
Thanks and keep the stories and experiences coming.  I like hearing about your experiences with insulin going bad or the differences among the different brands too.  Very interesting.  

Re: Storage of opened insulin vials...what do you recommend and why?

Thanks to you, Micki, for bringing up this topic....and thanks to everyone who contributed their own experiences and knowledge. We all learned a lot from this blog for sure

Re: Storage of opened insulin vials...what do you recommend and why?

I think it's maybe not such a good idea to tell patients to extend the life of insulin beyond 28-30 days, as a general rule--I've had several patients whose MDs did not inform them of throwing out the insulin monthly and of course their glucose numbers were terrible after they switched to my care, even on a Bernstein diet, supplements, good dosing and exercise.  When I asked them naturally if they opened a new bottle of insulin each month, each patient just stared at me clueless.  Vials were up to three months old and the insulin was dead. They had no idea that the weren't to use each and every drop of insulin in the vial before changing.   If people have insurance, a monthly changeover of insulin makes good sense; it's safe, responsible and preventive.  Especially in hot climes and during the 6 months of high temps in spring/summer here in Phoenix.  However, keeping open insulin in the fridge and such is fine, as many folks here cannot afford to keep their homes cooled under 80F; but in general, in my experience with patients,  I do think insulin does fine up to the mid-80s. 

 

Re: Re: Re: Storage of opened insulin vials...what do you recommend and why?
Quote:

 


Brian,
I am dying to know how 'everything turned out ok in the end' when all your insulin for a 2 week vacation was frozen!  Yikes.  

To all,
Thanks for your input.  It sounds like we all agree that keeping insulin in the fridge is the best practice from experience.  That is, when a bottle is opened it should be kept in the fridge until used.  Does anyone know if this is in writing anywhere?   In the literature or elsewhere?  
Thanks and keep the stories and experiences coming.  I like hearing about your experiences with insulin going bad or the differences among the different brands too.  Very interesting.  


Well, I wrote of the whole story over on tudiabetes.org.  The opinion of most of the veteran type 1s was that most simply keep their insulin totally under their control and that I perhaps worried too much about the environment on the ship (room temp was fine).  So in the end, the ship provided temporary insulin and syringes for the remainder of the cruise and I bought replacement insulin and syringes in Mexico (altho I took care to buy from a large national chain rather than a corner shop with odd boxes of strange medications on the shelves).

My experience with insulin going bad suggests that the real problem is that you can't tell the difference between insulin degradation and other factors which affect control.  My basal insulin was totally worthless, but despite being frozen, my Humalog was degraded and had perhaps 1/2 to 1/3 the strength.  If you routinely use insulin past it's expiration and don't track it's age, then you won't be alert to insulin degrading.  Only a very astute patient would recognize after a few days what was wrong.  Most patients would probably spend weeks figuring out why their blood sugar control has gone haywire.  First they would think they made a few errors, miscounted the carbs, or something.  Then they would think that maybe they are sick or stressed.  And only after all that time would they consider insulin problems.

ps. The other thing I would also like to note is that Bruce above noted he never only uses a new clean syringe to inject air.  Dr. Bernstein is even more stern.  He believes that insulin can polymerize in needle and that reusing a syringe can taint the entire vial.

Re: Storage of opened insulin vials...what do you recommend and why?

Yes Brian noted (see below)  I mentioned I ONLY use new syringes to inject air, never a used one.


"One just needs to be very careful never to inject into a vial with a syringe that has been used..." I may have worded that awkwardly.

I have only used that method when I forgot to bring exta syringes when traveling or in very remote areas where I do not hav ehte luxury of carrying in loads of extra gear.  The Frio AKA Poucho evaporative wallet seems to keep it OK for a week or so w/o electricity.


Generally I use new syringes all the time as I have more than enough as supplied by the V.A.  Sharper as well.  Poses a bit of an issue when we return to Belize from the U.S. 

Trying tio convince the customs agent at entry that the bags (10 syringes @) that come 10 bags or 100 syringes per box are for me and not resale is always anissue.

In the end I stuff these in every available slot in the suitcases and boxes we take back.  Usually leaving 500-600 behind which are then added to small packages mailed to us with US mail etc..

All my insulin is hand carried in a cooler with ice packs.  One meter always travels in carry on as well with my spare in checked bag.

TSA is also increasingly interesting. Air travel ain't what it used to be.

Oddly in the 3 years I have been doing this TSA agents often get thier respective shorts in a bundle from time to time about the cooler in our carry on, but ignore the plethora of electronic bat detectors, compents and asscoated electronics that I assume would spark interest.

 

Bruce


Re: Storage of opened insulin vials...what do you recommend and why?

To re-visit this topic.

 

Diabetes in Control recently annouced this link for Insulin Stability Charts.

Most of you likley subscribe to this newsletter as well, but if not this May be useful for others.

Great run this morning. 6.2 km 75°F!


Cheers from Belize,

Bruce


http://www.diabetesincontrol.com/articles/56-tools-for-your-practice/11530-insulin-stability-charts