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.

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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."