Tactile Marks on Labels

Tactile Marks on Labels

FDA MEETING REPORT:
INSULIN VIALS WILL HAVE TACTILE MARKINGS

by Ed Bryant

Early in 1992 I was contacted
by a blind diabetic, who informed me that he and his fellows, perfectly capable
of accurately drawing up their insulins, had no reliable way to distinguish
between insulin types. All insulins, fast-, intermediate- or long-acting, could
only be told apart by reading print on the label. This, I was reminded, placed
many in grave danger, as consequences of vial misidentification could be severe.
I conducted a national survey: Was change
needed? Should insulin vials have tactile markings, to help blind diabetics,
those losing vision, the hurried, the elderly, the young, busy medical professionals,
overworked pharmacists, and the rest of us? Survey results were clear and unequivocal--change
WAS needed. For the best of reasons, safety and independence, insulin types
should be identifiable by touch.
Representing the Diabetes Action Network
of the National Federation of the Blind, I campaigned for this goal: to make
tactile-marked insulin vials available. I wrote letters to the U.S. insulin
manufacturers (Eli Lilly and Company, and Novo Nordisk Pharmaceuticals Inc.)
and to the Food and Drug Administration (FDA). Hundreds of you, VOICE readers,
joined me in the letter-writing campaign. Many nurses and other medical professionals
wrote in support, acknowledging the print was so small they had trouble reading
it, and that misdosage mistakes were made in hospitals. Pharmacist error was
covered, too (and this actually happened to me!).
We finally persuaded the FDA to call
a meeting of interested participants: Insulin manufacturers, diabetes educators,
drug packaging/labeling firms, diabetes associations and organizations of the
blind. The first meeting took place on October 19, 1995, at FDA headquarters
in Rockville, Maryland.
At that meeting, participants agreed
that non-sighted insulin vial identification was a necessity, and that such
coding should be factory-applied, durable, and sufficiently prominent that blind
diabetics with neuropathy could use it. The insulin manufacturers were to come
to the next meeting (to be held in three months' time) with both short-term
prototypes and long-term proposals.
Bad weather and scheduling conflicts
forced postponement of the second meeting, which was not held until April 10,
1996. By the close of that meeting, Lilly and the FDA were ready to agree on
a set of one through four tactile bars on the label, as a means of distinguishing
insulin classes. But Novo Nordisk asked for more time "in which to test
alternative prototypes." We agreed to meet again, some time in July 1996.
For reasons still unclear, Novo Nordisk
was not ready by the July deadline, and did not transmit its findings to the
FDA until the end of December. FDA officials attempted to schedule the "rematch"
in March or April of 1997, but scheduling conflicts delayed the final meeting
until June 3, almost one year late.
At the June meeting, the insulin manufacturers
presented their test findings. Lilly related how their researchers had sought
out blind diabetics with differing degrees of neuropathy (mild, moderate, and
severe), then tested their success in distinguishing dot codes, vertical lines,
and horizontal lines on the vial label. Lilly found that although a few individuals
had neuropathy too severe to recognize any system, a series of wide horizontal
bars provided greatest accuracy: over 98% successful tactile recognition. (Note:
This finding mirrors the consensus of ALL consumer groups present at the meeting.)
When the question of tactile-label durability
was raised, Lilly related how they had tested the bars under a wide variety
of conditions, including long-term immersion in alcohol, and experienced no
failures. A representative from CCL Label, a national company that makes vial
labels for pharmaceuticals, confirmed that his company could guarantee durable
tactile bars on vial labels. I pointed out that even if there were the rare
label failure, the system would be more reliable than at present, where blind
insulin users are stuck with rubber bands or tape.
Novo Nordisk, who had tested tactile
prototypes with blind diabetics but not considered the impact of neuropathy
on label conformation, raised a number of objections. In spite of Lilly's tests
and CCL Label's guarantees, in spite of the FDA's satisfaction with the system,
Novo Nordisk continued doubting its appropriateness and reliability. A very
early tactile-label prototype, that had failed "torture tests" over
a year ago, was put forward as "evidence" that the four-bar system
was not sufficiently durable. Perhaps Novo's label-supplier in Denmark is having
difficulties--I find it interesting that Lilly's supplier has mastered the problem.
All organizations present except Novo
Nordisk accepted the four-bar system as presented. A Lilly representative told
me his company was "readying their production line." The FDA stated
that once they had completed the approval process, one company could proceed
without waiting for consensus from its competitor. Because the FDA "didn't
want Novo Nordisk to feel they were being treated unfairly," they suggested
Novo could raise the issue at the International Diabetes Federation (IDF) meeting,
to be held this July in Helsinki, Finland. If they raised sufficient objection,
and there was strong support at that meeting, FDA might reopen the discussion
process.
The FDA promised that on August 1 they
would fax meeting participants their final determination. They stated we would
go with the system as agreed, unless there is substantial international objection.
The above disturbs me greatly. Although
it is unlikely the IDF would support Novo Nordisk in the face of the evidence,
outside the USA Novo Nordisk is a very major provider of funding to diabetes
agencies and foundations. Also, such a decision allows the IDF to "sit
in review" of FDA policymaking, a serious surrender of FDA's statutory
responsibilities to an international body. I hope it doesn't come to that.
To review: At the meeting, we agreed
on the following system of four horizontal tactile bars on the insulin vial
label: One bar = fast-acting insulins such as Humalog; two bars = Regular insulins;
three bars = any mixed insulin (70/30 or 50/50); and four bars = longer-acting
insulins (NPH, Lente, Ultralente).
Once final approval is granted, Lilly
estimates it will take between six and 18 months for the tactile-marked insulin
vials to reach pharmacists' shelves. Insulins have a shelf-life of two years
from date of manufacture, so it may be as long as two years from the start of
tactile- labeled insulin production before all the older, unmarked vials are
off pharmacists' shelves, though the bulk will be replaced far sooner.
It has taken a long time, but hopefully
the next report the VOICE carries about tactile-marked insulin vials will be
a review of the first to reach production, and the impact they have on our safety,
independence, and diabetes self- management.