• Email:
  • Password:
  • Remember Me
 
Print   Subscribe    Share
MD
Why is Humulin N (Eli Lily) shelf life different in different countries?
Section:  General Diabetes

In the ADA insulin practical guide 1st and 2nd edition, the insulin shelf life for humulin N is only 10-14 days. But, in the European Union it is at 28 days. Why is there such a discrepancy? What criteria are being used to determined the shelf life and which one to follow?

MEMBER COMMENTS
Re: Why is Humulin N (Eli Lily) shelf life different in different countries?

Hello Dr Yong!
You might find the following article of interest: http://care.diabetesjournals.org/content/26/9/2665.full

Thank you. Isabella,RN/CDE

Re: Why is Humulin N (Eli Lily) shelf life different in different countries?

Well, it took a little digging, but I believe a key source of confusion is a lack of good information from Lilly.  Patient information on the 3ml Humulin N pen says to throw out the pen after two weeks.  On the other hand, the basic information on Humulin N prescription information on vials (or here) says nothing about how long in-use insulin is good for .  Neither of these is technically "shelf life," which is how long it lasts in storage (which is until expiration if properly stored).

Re: Why is Humulin N (Eli Lily) shelf life different in different countries?

Very interesting questions and Brian points out that the information is not easy to find directly.

 

I know from experience that there is Third World Dumping, as it is called.

 

Whereby expired products or those with a limited shelf life, at best 30 prior to expiration hit the market here.

Developing countries are happy to have any source of pharmaceuticals and often will accept even expired products.

 

When I first started my insulin  regimen with Novolin-R Insulin and NPH I was told by the pharmacist to be very careful about transport and keep it cool.  Also I was warend to be sure to use it all within 30 days.  Clearly I was not needing huge doses for a full vial per month. So it was a communication issue that really meant after 30 days discard the vials.

 

Now that I am on Novolog and Levemir I import a years supply at one time. Hand carried in a cooler myself and it is stored in the refrigerator.  One vial of Humalog last year did seem to lose potency even refrigerated after 6 months.  I only used that to rapidly bring down any spikes due to unexpected/unpredictable diet related issues or when a dental infection caused spikes.

 

Many pharmaceuticals as well as food items that should be stored cold, are frequently not during transport even if stored "properly" on arrival at the destination. Pharmaceuticals in developing countries are suspect in my book.