Insulin Vial Project

Insulin Vial Project

INSULIN VIALS
WITH TACTILE MARKS: THE PROJECT CONTINUES

by Ed Bryant

Since January 1992, we, the Diabetes Action Network of

the National Federation of the Blind, have led the campaign

to bring tactile markings to the different insulin types.

As long as insulins are packaged in identical vials,

differentiated only by the writing on the label, blind

diabetics (and many sighted individuals as well) are at risk

of mixing the different types, with potentially very serious

consequences. We, and you our readers, have kept up the

pressure.

We have already attended two meetings, along with

representatives from the insulin manufacturers (Eli Lilly

and Company, and Novo Nordisk Pharmaceuticals Inc),

regulators from the Food and Drug Administration, and other

organizations concerned with this issue. A third meeting

was to have taken place some time last July, so we could

finish this business. Lilly has been ready for months.

Novo Nordisk, who asked for and was granted extra time

to test tactile alternatives, agreed, before the second

meeting (held April 10 at FDA headquarters in Bethesda,

Maryland) concluded, to complete its "focus-group testing"

within 3 months. Meeting minutes, prepared by the FDA, are

explicit on this point. But, it appears Novo Nordisk didn't

even begin research until after the date they had promised

to complete it.

Last October I received the following note from Mrs.

Shirley Masters, whose story reminds us that tactile

differentiation of insulin vials will benefit the sighted as

well as the blind. Although her letter is addressed to Eli

Lilly and Company, she sent copies to a number of locations,

including the FDA and me at VOICE OF THE DIABETIC.

TO WHOM IT MAY CONCERN:

My godson is diabetic. Before being diagnosed as

diabetic, he was an athletic, health conscious individual: a

cyclist, a runner, a swimmer, who entered into triathlons; a

student and practitioner of physical fitness. Now, at 31,

he is changing careers and studying to become a nurse while

still enjoying his physical activities.

THE POINT: He is an alert, attentive, very aware

individual who made an easy to make mistake which could have

had dire consequences.

THE MISTAKE: He self-administered the wrong ELI LILLY

HUMULIN. Both Regular HUMULIN and HUMULIN NPH are part of

his prescribed medication. BOTH ARE IDENTICALLY PACKAGED in

orange-capped vials. Under stress from various sources

currently, my godson mistook one bottle of HUMULIN for the

other, with serious consequences. While not requiring

hospitalization, a frightening, grim night was spent

suffering the consequences of administering the wrong

HUMULIN.

SUCH AN EPISODE COULD HAVE BEEN AVOIDED and PREVENTED

HAD THE MEDICATION CARRIED SOME FEATURES IN ITS PACKAGING

CLEARLY IDENTIFYING ONE INSULIN FROM THE OTHER. This

episode could have been avoided simply by having different

colored caps on the medication to identify HUMULIN REGULAR

from HUMULIN NPH.

SUCH AN EPISODE COULD HAVE BEEN PREVENTED HAD THE

CONTAINERS NOT BEEN IDENTICALLY SHAPED; i.e., one medication

packaged as is and the other in a shorter, fatter container,

which would give both a visual and a physical indication of

the contents.

Certainly different colored caps, at least, would be a

cost-effective possibility in packaging and would avoid for

some diabetic ELI LILLY HUMULIN REGULAR and NPH user a

"NIGHT OF FRIGHT" such as the one experienced by my godson.

Please give these repackaging considerations your

serious consideration.

Sincerely,

Shirley W. Masters (Mrs. C. H.)

Redwood City, CA

P.S. Imagine my consternation when I learned from my godson

the problem described here is already known to the industry.

(See article in October 1995 "Diabetes Interview".) IT IS

TIME TO RESOLVE THIS ISSUE!

At Mrs. Masters' request, I forwarded a copy to Novo

Nordisk Pharmaceuticals Inc., the other U.S. insulin

manufacturer. I also included it with the following, which

I faxed, on November 12, to Mr. Randy Hedin, designated

moderator of the next meeting regarding tactile-marked

insulin vials at FDA.

DIABETES ACTION NETWORK
National Federation of the Blind
Columbia, MO
November 11, 1996

TO: Mr. Randy Hedin
Division of Metabolism and Endocrine Drug Research
Food and Drug Administration

FROM: Ed Bryant National Federation of
the Blind

RE: Tactile-Marked Insulin Vials

Dear Mr. Hedin:

On September 25 of this year I reminded you of work

left unfinished.

About five years ago, we, the Diabetes Action Network

of the National Federation of the Blind, started our

campaign to convince the Food and Drug Administration and

the insulin manufacturers to incorporate permanent, easily

detectable tactile markings on insulin vials, sufficiently

prominent that blind diabetics with neuropathy could safely

and reliably use them. We made calls. We wrote a lot of

letters. We seemed to get somebody's attention.

On October 19, 1995, FDA called a meeting of

"interested participants" to discuss this issue. Minutes of

that meeting record that Eli Lilly and Company, and Novo

Nordisk Pharmaceuticals Inc. were to come to the next

meeting (scheduled in 3 months time) "with firm ideas for

short-term solutions, and other ideas for long-term

solutions. ""

The second meeting was held on April 10, 1996, and both

Lilly and Novo Nordisk brought prototype vial markings for

evaluation. At the meeting, all blind participants, and

many of the sighted (who could benefit from tactile markings

as well), agreed Novo Nordisk's dot-markings were too small

to be reliably detected by individuals with neuropathy, and

that bars were much more appropriate than dots.

At the close of the second meeting, the FDA and Lilly

were ready to agree on a set of one through four horizontal

tactile bars to distinguish insulin classes. Novo Nordisk

asked for more time "in which to test alternative

prototypes," and we agreed to meet again in three months,

some time in July.

July came and went without a word from Novo Nordisk.

On August 5, 1996, I received a fax from Jon Evans,

president of "Prognosis", an independent medical research

organization (copy attached) [published in VOICE, Vol. 11,

No. 4].

Mr. Evans had been hired, by Novo Nordisk, to survey

the response of blind diabetics to their proposed tactile

marking systems. I helped him arrange a meeting with

students at the Colorado Center for the Blind, a rehab

center established by the National Federation of the Blind.

Although Prognosis had been instructed to interview

insulin- using blind diabetics, Mr. Evans told me Novo

Nordisk had given him no instructions to recruit individuals

with neuropathy for the test. I was astonished at this

omission, as the subject, and its importance, had been

thoroughly covered at all previous meetings. Lilly had made

certain that blind individuals with neuropathy were part of

their test population.

When I spoke again with Mr. Evans, later that month, he

reported almost all of his test population (a total of 25

students from several locations) voted enthusiastically for

the horizontal tactile bars, finding them easiest to detect.

Note: His findings echo Lilly's, so there is absolutely no

reason Novo Nordisk should not agree to the adoption of

raised horizontal lines to mark the different classes.

On August 19, I called Mr. Alan Scobie, Director,

Diabetes Care Marketing, Novo Nordisk Pharmaceuticals Inc.

He was not available, but his secretary promised to have him

return my call. He didn't.

On September 11, I received further communication from

Mr. Evans at Prognosis, in which he informed me that Novo

Nordisk's research had been completed.

On September 25 I called you, making you aware of the

above. I believe your response was: "Good. Now it sounds

like we are in agreement, and I can arrange a meeting in the

next 6 to 8 weeks, and all we should need is to agree which

bars mean which types."

But nothing more happened.

On October 17, still without word of a meeting, I

reached Mr. Alan Scobie at his office. He told me the

results of Prognosis' research were in, had been tabulated,

and had been sent to Novo Nordisk's home office in

Copenhagen, Denmark. He said he would try to get them

moving on this project.

I have heard nothing more from Mr. Scobie, or from

anyone at Novo Nordisk. Have you? When we spoke, you said

you'd contact them, and get this process moving. Has Novo

Nordisk responded to your call?

I do not understand the delay. Regularly I hear from

concerned individuals (such as Mrs. Masters, whose letter is

attached) asking "why the hold up?" Lilly was ready to

institute the system we discussed, one through four tactile

bars, at the last meeting. Novo Nordisk has their answer;

blind diabetics found horizontal bars on the label to be

more efficient tactile cues than Braille-like dots. There

is no further reason for delay. This should have been

resolved some time ago.

The question becomes: "What do we need to do to break

out of this situation?"

In the past, to get things moving, we started a mailing

campaign, asking our readers to write and express their

support for our position, to make their feelings known to

FDA Commissioner Kessler and the insulin manufacturers.

Should we "call out the troops" again?

Mr. Hedin, you probably have this already resolved.

The meeting promised for last July may now be scheduled. I

may just not have heard yet...

I hope this is the case. I would not wish to think

that any manufacturer, in the face of evidence such as we

have presented, would engage in gratuitous stalling, hoping

we'd get bored and go away. I would not wish to think that

a Federal regulatory agency, having extracted promises to

comply, would fail to intervene after such stalling. Mr.

Hedin, there are a lot of diabetics waiting to see these

tactile markings happen.

I HOPE WE CAN HAVE OUR MEETING, AND CONCLUDE OUR

BUSINESS, THIS YEAR.

Hoping to hear from you soon, I am,

Ed Bryant
First Vice President
Diabetes Action Network
National Federation of the Blind
cc: Solomon Sobel, MD

Director, Division of Metabolism and Endocrine Drug

Research

Food and Drug Administration

Since I sent the above fax, I tried on several

occasions to reach Mr. Scobie at Novo Nordisk. On November

21, he returned my call. At that time he stated that Novo

had completed their research, and had passed their findings

on to Randy Hedin at FDA; that it was all up to him now;

they had fulfilled their responsibilities.

I called Mr. Hedin at FDA on November 25. I made him

aware of Novo Nordisk's position; but he stated he had

received no communication from Mr. Scobie, or anyone else at

Novo Nordisk, relative to completion of research or

readiness for a meeting. Mr. Hedin hoped a meeting could be

scheduled for mid-January. He was waiting to hear from Novo

Nordisk.

I phoned him again on December 12. He told me he had

reached Novo about one week before. The FDA had definitely

not received Novo Nordisk's study results! Novo confirmed

this, and said they didn't want to forward the information

`til the end of December! Mr. Hedin said he expected the

meeting will take place some time in February (as Novo

Nordisk wanted). I still do not understand why Novo told me

one thing, and told the FDA another. Also, as stated above,

FDA minutes clearly show Novo Nordisk had agreed to complete

their studies by July of 1996! Why the delaying?

Hopefully, the April issue of the VOICE will be the

last in which you will have to hear about tactile insulin

vials. Much more time has been taken than was promised, but

the February meeting should see the end of it.

++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++

If you or a friend would like to remember the Diabetes

Action Network of the National Federation of the Blind in

your will, you can do so by employing the following

language:

"I give, devise, and bequeath unto the Diabetics Action

Network of the National Federation of the Blind, 1800

Johnson Street, Baltimore, Maryland 21230, a District of

Columbia nonprofit corporation, the sum of

$estate" or "the following stocks and bonds:___________") to

be used for its worthy purposes on behalf of blind persons."