Lilly – Get with the program

As I have (and we all have) learned in school, a bottle of Humulin R or N is good for 1 month if kept at room temperature or if refrigerated good until the expiration date on the bottle.  Right?

Not according to the Lilly Reps.

They are telling doctors and other retarded janitor-types who can write Rx’s that once a bottle of insulin has been opened, it is good for 28 days upon which it must be trashed.  That really great for the cash customer who is on about 10 units a day and gets to shell out the 40+ bucks a month for a new bottle (as they toss out a 3/4 full one).

This bullshit started about 4 years go.  The formula for Humulin R and N have not changed since god was a boy.  What the hell caused this?

Heres the kicker.  There are no studies to back this data up.  Thats straight from the Lilly mothership.  Turns out that Europe (thanks assholes) have this law that states that all injectables must have an expiration date of one month from the time of penetration (har har har).  HOWEVER if the product was made before 1990 this law does not apply.  Thats why Humalog and Lantus have the warning in the package insert to discard after 28 days.  Humulin R and N do not have this warning (also stated directly from the mothership).  The good ole USA just decided to adopt this standard without any studies to show that its even half way legit.  Yeah, lets just do what Europe does, it worked so well for thalomide didn’t it?

Does this stop Lilly reps from spreading the gospel of ‘discard R & N after 1 month’ to every doctor and nurse out there?  Hell no.  Higher sales for Lilly!  Fancier pens!  Lower tops!  Higher heels!

Lilly, you are fucking retarded.  I hope all of you become cash paying diabetics who are forced to sleep in your own shit.

Comments #

Comment by rph3664 on 2008-01-20 11:10:41 -0800 #

We have been doing this in the hospital, but I was not aware that it had come down from on high or anything. I just thought it was a way to prevent contamination, since it’s accessed by and used for multiple patients.
We really don’t throw much insulin out because of this, except on the psych units.

Comment by Kathleen on 2008-01-20 11:42:11 -0800 #

I hate to tell you this, but I’m a diabetic, have used the Lily products, Novalog, Symlin, and Apidra and the ALL tell us, once we put a needle in a vial or pen, we have to toss it after 30 days.
The good news, mine never last that long.

Comment by IAPhrmr on 2008-01-20 14:26:47 -0800 #

HA! That is what I have been bitching about to my patients! Although it is nice to be able to use that excuse when getting insurance to cover 3 bottle for my patient for a 3 month supply when it will really last them about 6 months. But, it says that it is good for 28 days after opening so that is what I use when doing days supplies. Now, it is not our fault if they do not follow recommendations!
Also, back when I was doing my rotations for school (3 years ago) I was talking with some nurses and I was showing them how to use the fancy opti-click lantus pen, and I was talking about how long it was good for. They said “Really? The rep told us the cartride has to be thrown away after 7 days!” C’mon insulin only good for a week after you open it…BS!

Comment by MrIncognito on 2008-01-20 15:51:24 -0800 #

Our friends at the University of Montana published this:
http://www.ncbi.nlm.nih.gov/pubmed/1814206?ordinalpos=5&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum
They assayed insulin as well as the preservatives and determined, “Phenol concentrations were less affected than m-cresol concentrations; greater decreases occurred in samples stored at room temperature. No significant decreases in insulin potency or m-cresol or phenol concentrations occurred in control samples stored in vials kept under similar conditions.”
I wouldn’t be overly worried about stability in the vial either.

Comment by Melody on 2008-01-21 06:45:26 -0800 #

There may be a grain of truth in Lilly

Comment by Brent on 2008-01-21 06:53:42 -0800 #

Patient safety means EVERYTHING to Lilly–as long as the patient is made to pay for it.
And not to worry–Lilly will soon have these products off the market as new, pricier, less-proven but more highly-touted analogs are created and approved by our Fatal Drug Administration.

Comment by The Ole’ Apothecary on 2008-01-21 19:24:11 -0800 #

Melody,
You must remember the days of beef insulin. I had a patient who used to come in to ask for her “all beef special.” No, it wasn’t Arby’s insulin.
To all:
How might Lilly and Novo feel about stem cell research to restore pancreatic function? I often wonder why so many drugs are not replaced by biological breakthroughs the same way photographic film was virtually eliminated by digital photography, or the same way oil hasn’t been replaced by renewable sources of energy.

Comment by rph3664 on 2008-01-21 20:41:26 -0800 #

TAP, if Novolin N and R have been the same “since God was a boy”, then He would have still been a child in 1983, when these products entered the market. I was a hospital volunteer in 1987 before going back to school (long story) and when I saw Humulin, I asked if they took pancreases out of dead people and extracted the insulin (really, I did), and the pharmacist explained that the insulin producing gene had been spliced into E. coli bacteria, and you can guess the rest.
Diabetes message boards are FULL of people who were stable on Velosulin and other animal insulins for decades, and only started having problems when the “improved” insulins came along.
I was told in school in the early 1990s that unopened insulin is stable at room temperature for 18 months, but people are told to refrigerate it so they don’t do things like store it in the glove compartment with the condoms. rotfl

Comment by Christine on 2008-01-21 21:42:48 -0800 #

I never throw out a bottle of insulin just cause it’s been a month. In fact, I never know if it’s a month. I know if it’s working, or if I have high blood sugars, in which case I start over. But yeah, I’ve heard all that before too.
When I was on Lantus I took 8 units of the stuff a day. I was glad when I started pumping, because then I only had 1 bottle of insulin to worry about using up in a month.
I think I have 4 vials open now though, probably at least 1 of them that’s been open more than a month. And I’m still alive!

Comment by rph3664 on 2008-01-22 08:14:34 -0800 #

Christine, I may work with you. I work with a pharmacist named Christine who is diabetic and said pretty much the same thing a couple weeks ago. I don’t know if she uses Lantus, however.

Comment by peej on 2008-01-22 08:36:30 -0800 #

Arent you guys pharmacists???
This is standard hosptial practice.
You are sticking a potenitally contaminated needle into a vial a couple times a day, compromising the vial, potentially making holes that dont commpletely seal – you can certainly introduce some bacteria that might eventually discover a nice protien solution to munch on and keep them alive. I doubt though, that the problem will be loss of potency as much as potential contamination.
If you dont think a month is adequate – then how long? Two months? six months? forever?

Comment by MrIncognito on 2008-01-22 10:17:01 -0800 #

Insulin stability in hospital settings is not a concern. We go through anywhere from one to five bottles of regular insulin per day for our 450 beds. If an insulin vial lasted 28 days we would have to celebrate a 2nd Hanukkah or something.
This thread was about home insulin users. The study above measured the concentrations of the preservatives as well as the API and found that, although the m-cresol did degrade at room temp, the concentration in the vial did not change over a 30 day period.
Establishing an expiration date is a matter of stability studies. The drug companies obviously have no interest in helping anyone out, and if a patient asked me, I would tell them to use a new vial every month. But if it’s my dime, I would have no problem using a vial for 2 or 3 months if it’s refrigerated.

Comment by Christine on 2008-01-22 15:58:36 -0800 #

RPH, you don’t know me. I’m not a pharmacist. I’m in nursing school.
I hang out in diabetes online communities somewhat often, and have only met a handful of people who did better on animal insulin, and the rest of the people, who developed allergies and had to take doses 5x what they take on human insulins just sort of think they’re out there.

Comment by rph3664 on 2008-01-24 15:30:30 -0800 #

Okay, Christine, you and she are not the same person. I don’t think she uses a pump anyway. Ever heard of http://www.allnurses.com ? They have a huge message board that is open to anyone as long as they contribute to the conversation.
When I worked at the grocery store, we had several people who purchased Humulin for their pets and were quite surprised that human insulin worked for their kitties and doggies, but yes, it does. Did you know that insulins made from fish and whales were once marketed in Japan because those were their biggest sources of fresh pancreas?

Comment by Linsay on 2008-02-08 09:30:13 -0800 #

I went to school in Indianapolis (town run by Lilly), so we learned about the 28 day rule for insulin. Now I live on the east coast and the pharmacists out here did not know about that. Maybe it’s a regional thing. I think it’s better to be safe than sorry — there is no way to know how disgusting these people’s homes are or how bad their “sterile” technique is.