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Re: [IP] Re: Managing Your Diabetes question



Michael:

I made a similar request this summer to Eckerd Drugs, after discarding two
bottles of Humalog from the same prescription which I suspected were bad. I
was told by the Eckerd rep that with their "usual" shipping procedures, the
insulin sat in un refrigerated trucks "typically no more than twelve
hours", sometimes overnight, if the shipment was scheduled for first thing
in the morning. It was then received at the drugstore and "usually placed
in refrigeration upon receipt, usually not sitting out more than a couple
hours".

Remember now, this is a national drugstore chain handling this drug in this
fashion. I cannot imagine what happens when the postal carriers and
assorted contracted shippers handle it.

My rough estimate was that it is not unusual for the temps in the backs of
these trucks to exceed 120 degrees during the summer (upstate New York)
when the outside temps exceed 80 degrees, as was common this summer. This
is clearly outside the storage parameters for this drug.

At that point I called Eli Lilly and started discussing Humalog in a pump.
It was a fairly pointless call, since according to Eli Lilly the problems
involved a drug being used in a "non approved fashion". Their exact words
were "Humalog is not indicated for use in pumps". End of story.

My point here is that Eli Lilly is responsible for the safe dispersal of
the drug *IN PARTNERSHIP WITH* the shippers who are contracted for this
service and the pharmacies / clinics, etc. who store, handle and dispense
this drug.

I agree fully that this matter requires the utmost attention from Lilly
(and the FDA). The scope of this issue extends beyond those of us who use
it in insulin pumps, and poses a grave threat to all Humalog users.

Bob Burnett

mailto:email @ redacted

no snipping here, because this is too important:

>Dear unresponsive person at Eli Lilly Company,
>
>1st, the question posed is real and represents a serious health 
>threat to all individuals who receive insulin by mail.  It is my 
>understanding that as a manufacturer you are the one responsible for 
>the effectiveness of the drug you supply to the general public.
>
>A diabetic who uses only Humalog and receives a batch that has been 
>overheated or frozen stands the risk of serious diabetic ketoacidosis 
>if this insulin is used unknowingly.
>
>The post office states that BULK 
>MAIL stands at the bottom of their priority for delivery.  It may be 
>left for a week or more in a parked truck, a warehouse, in fact... 
>anywhere they might leave it lying around. Delivery delays of several 
>weeks are not uncommon during heavy seasonal mail delivery times.  
>That implies that in the summer, daytime storage temperature would be 
>over 100 degrees, and for vehicles left outside in the winter, 
>temperatures well below freezing.  This could be for DAYS or WEEKS.
>
>Am I to assume that you approve this method of distribution of a 
>temperature sensitive perishable pharmacutical product that has a 
>limited shelf life at 83 degrees F ?
>
>This method is common and becomming more so thanks to HMO's
>
>In the absense of a response from you, I must assume you at least 
>tacitly approve this method of distirbution.
>
>
>We have a large national base of diabetic members an the website gets 
>a couple of thousand hits a day. This letter is being posted to the 
>mail list and I am sure the members will be interested in you 
>response.
>
>Get your ass in gear! and get me an answer.
>
>> Dear Michael,
>> 
>> Thank you for your inquiry concerning the recommended shipping method
>> for Humalog.
>> While we are unable to provide recommended shipping instructions to
>> you through our "Managing Your Diabetes" Website, we are nonetheless
>> pleased to provide you with storage guidelines for all Lilly insulin
>> products. To access and view this material, just point your browser 
>> to the following URL:
>> 
>> > What is the recommend method to ship Humalog.
>> > 
>> > Specifically, your comments on shipment by
>> > 'Bulk Mail' and the handling received by that
>> > type of mail are requested.
>> > 
>> > 
>> > 
>> > Michael Robinton
>> 
>> 
>email @ redacted
>