Insulin Vials-Report

Insulin Vials-Report

TACTILE INSULIN
VIALS--PROGRESS REPORT

by Ed
Bryant

For more than five years, we, the Diabetes
Action Network of the National Federation of the Blind, have been leading the
campaign to get the insulin manufacturers and the Food and Drug Administration
(FDA) to reform the way insulin is packaged. Currently, all types of insulin
sold in the United States are packaged identically, either in 10cc vials or
1.5cc pen cartridges, with only the writing on the label to tell them apart.

Insulin mixing has been standard practice
for decades. The welfare of almost all insulin users depends on not confusing
their Regular with their NPH, or their Lente, or their Ultralente, or their
new, quick-acting Humalog. Misidentification can be deadly; you can't afford
to make mistakes.
Where does all this dependence on small
print leave the blind, the visually impaired, children, the aged, overworked
nurses, hospital workers, hurried people, folks who make mistakes sometimes,
and the rest of us? Not in a very safe place. Those of us who cannot reliably
read insulin labels have been forced to depend on impermanent tactile cues like
tape or rubber bands to tell one insulin from another, or else left to depend
on sighted assistance. Tape falls off, rubber bands break, and both can wind
up on the wrong vial. Sighted assistance is not always forthcoming.
There has been some discussion between
the insulin manufacturers and the FDA about "color coding" the different
insulin types. While a universal color-scheme to distinguish the different insulin
durations and mixes will doubtless reduce dispensing errors, and is thus commendable,
it does not address the difficulties faced by those who cannot see the label!
Diabetes is the leading cause of new
blindness in the United States today. The Centers for Disease Control estimates
diabetes costs 15,000 to 39,000 people their sight every year. This is not a
small problem.
The solution has been obvious from the
start. We need standardized, permanently-attached tactile cues, sufficiently
prominent that blind individuals can use them to reliably distinguish between
the insulin types. Knowing this, I have written, faxed, telephoned, and met
with insulin industry executives and FDA regulators, formally and informally
solicited your input on the best means to achieve non-sighted insulin vial identification,
spearheaded several letter-writing campaigns, and pushed for face to face meetings
between insulin industry representatives, FDA regulators, and associations concerned
with blindness or diabetes. You, VOICE readers, helped by writing Dr. David
Kessler, then Commissioner of the FDA, and making your views known on this public
safety issue.
It took a long time, but with your support,
we convinced the FDA to call for a face to face meeting of interested participants.
On October 19, 1995, at FDA headquarters in Rockville, Maryland, we had our
first meeting.
At that meeting, participants agreed
that nonsighted insulin vial identification was a necessity. A general consensus
was reached that such coding should be factory- applied, durable, and sufficiently
prominent that blind diabetics with neuropathy could use it. Minutes of the
meeting record that the insulin manufacturers, Eli Lilly and Company and Novo
Nordisk Pharmaceuticals Inc., were to come to the next meeting "with firm
ideas for short-term solutions, and other ideas for long-term solutions."
Although the second meeting was scheduled
for January of 1996, bad weather in the Washington DC area forced postponement,
and that meeting was not held until April 10, 1996. Both Lilly and Novo Nordisk
brought prototype vial markings to the meeting; Lilly's horizontal lines on
the label and Novo Nordisk's raised dots on the aluminum vial- stopper rim.

By 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. All that should have remained was
to determine how many bars signified which class.
But Novo Nordisk, deeply committed to
a tactile marking system meeting participants had already found unacceptable,
asked for more time, "in which to test alternative prototypes." We
agreed to meet again, some time in July.
Documents discussed in the last issue
of the VOICE reveal Novo did not even begin their research until after the time
they were supposed to have completed it. They were, in marked contrast to Eli
Lilly and Company, in no hurry to get it done.
But finally they did. After months of
delay, including a number of weeks after research was completed, Novo Nordisk
shipped their long-awaited findings to the FDA.
Mr. Randy Hedin, the FDA's Tactile Coding
Meeting Facilitator (who had the responsibility of scheduling the next meeting)
repeatedly told me he'd "get it done." When I spoke to him on September
25, he assured me the third meeting could be scheduled "six to eight weeks
after the study arrives from Novo." I wrote him a long letter on November
11 (published in VOICE Vol. 12, No. 1) outlining what I knew of Novo Nordisk's
study -- and I sent a copy to his supervisor at FDA, Solomon Sobel, MD. When
we spoke, on November 25, Mr. Hedin said he'd like to shoot for about January
13. On December 12, he told me, "...meeting would be some time in February."
But when I reached him on February 3,
he asked, "Did I realize we didn't get the study from Novo Nordisk until
the end of December?" He repeated that he had a lot to do, but said the
meeting looked like it would happen perhaps the first week in March.
On February 24 I received a fax from
Julie Rhee, CSO, DMEDP, of the FDA, who was querying previous meeting participants,
looking for a date amenable to all--but between March 25 and April 17. Four
days later, she sent another--reporting no consensus within the stated range,
and asking each what days were "off limits" in May and June!
The original "rematch" was
to have been (as reported in previous editions of the VOICE) July 1996. The
new meeting (now scheduled for June 3) will take place almost one year late.

Questions remain unanswered. Although
Eli Lilly and Company, once persuaded, did complete their research in a timely
manner, Novo Nordisk's repeated delays seem to me those of a company preoccupied
with market share, industrial politics, and sheer organizational inertia. This
is my opinion.
By statute, the Food and Drug Administration
is charged with the responsibility of protecting the health of all U.S. citizens.
When presented with the specifics, the FDA must act. It is their job.
We have presented them with specifics.
They know the problem, and they know that each week of delay brings more misdosages,
more midnight ambulance rides, perhaps more fatalities. Knowing that insulin
has a two year shelf-life (so any new marking system will take that long to
completely replace the current vial labels), had the FDA exerted itself in 1995,
the four-bars-on-the-label system might be coming on line about now.
But they sat. Perhaps terrified to upset
a big multinational corporation, the FDA regulators were here sorely deficient
in their primary job -- regulating. They could have, for your safety, brought
pressure to bear on Novo Nordisk, but they did not. When presented with interminable
delays, they could have reminded Novo of their agreement, recorded in the minutes
of the April 10, 1996 meeting at FDA headquarters, to have all research completed
and ready for presentation in July 1996. They could have sanctioned Novo Nordisk
for their blatant failure to keep that commitment. They did not.
Once Novo finally got their materials
in, the FDA could have promptly scheduled the meeting. One wonders if their
lackadaisical attitude toward this issue is a reflection of their attitude toward
the blind, or...?