Tactile Insulin Vials Update

Tactile Insulin Vials Update

TACTILE INSULIN
VIALS UPDATE
by Ed Bryant

In the past few issues of VOICE OF THE DIABETIC,

I reported how meetings had been held, between FDA regulators, insulin industry

executives, and organizations concerned with blindness and diabetes, about including

tactile codes on insulin vials. Very early, we established that blind diabetics could more

safely and reliably distinguish between insulin types, thus reducing dangerous dosage

errors, if such codes were included.

But big organizations are not fond of change. It

takes time to reach the people in charge, and to persuade them their traditional ways are

not good enough. We have taken the time.

There will be a marking system: One through four

horizontal bars on the label of every vial of insulin sold in the United States. A SINGLE

BAR will identify "rapid acting" analogs (such as Humalog/Lispro insulin); TWO

BARS will mark Regular insulins; THREE BARS will indicate a mixed insulin (70/30 or 50/50

in the U.S.A.); and FOUR BARS will label the longer-acting insulins: NPH, Lente,

Ultralente.

It is going to happen. The FDA informs me there

are no further regulatory hurdles to jump—they are merely waiting for the insulin

manufacturers to come forward with their specific design proposals, so they can formally

approve them.

What will these proposals be? As curious as the

rest of us, I wrote to both U.S. insulin manufacturers, Eli Lilly and Company, and Novo

Nordisk Pharmaceuticals Inc., and asked for information. I followed these queries up with

phone contact. Eli Lilly tells me they will shortly be sending their materials to the FDA.

Unfortunately, there was no response from Novo Nordisk.

We are definitely in the final lap of this race.

As soon as the manufacturers' proposals are "a matter of public record," look

for them in the pages of VOICE OF THE DIABETIC.