Update: Insulin packaged in uniquely shaped vials
 would eradicate errors
  
by Ed Bryant

In April 1992, the Diabetics Division of the National Federation of the Blind
began lobbying the Food and Drug Administration (FDA) and both United States
insulin manufacturers to change insulin vial shapes. Currently all insulins
are packaged in identical cylindrical vials, a practice which makes nonvisual
identification of containers impossible. We are seeking to change this. Our
goal is to enable insulin identification by tactile means, to improve both
safety and the prospects for self-mangement.
The Diabetes Control and Complications Trial (DCCT) proved that metabolic
control matters. "Tight control" means multiple insulin injection regimens are
more common, but so is the opportunity for dosing errors. Insulin users who
make dosing errors risk severe hypoglycemia and the possibility of death.
Numerous articles have been published in Voice of the Diabetic, updating
readers on the insulin vial dilemma. The FDA has consistently excluded blind
consumers from the planning process. The bureaucrats and insulin industry,
until recently, have given no consideration to changing insulin containers
and/or label design to help the blind identify insulins. Both groups are fully
cognizant that the Centers for Disease Control estimates each year 15,000 to
39,000 people become blind from diabetes. Unfortunately, they have assumed
that blind diabetics would, of course, have sighted companions to draw up
their insulins. They should know better. The notion that blind individuals are
incapable of self management is false and unsupportable. Thousands of blind
folks manage their diabetes independently and are involved in the mainstream.
On June 21, 1994, Mr. John Short, a consumer safety officer from the FDA, told
me that "someone who is totally blind would have someone else taking care of
medication for them." My reply to this incredible statement was published in
the Fall 1994 issue of the Voice. It said in part: "The time when disabled
people were chained to the bed is long since over. Blindness is not synonymous
with inability. Such discrimination against the disabled led to passage of the
Americans with Disabilities Act in 1990." At the same time, we published the
FDA's response from Solomon Sobel M.D., Director, Division of Metabolism and
Endocrine Drug Studies, the Center for Drug Evaluation and Research. It said
in part: "Subsequent to your conversations with Mr. Short, and in response to
your letter dated June 22, 1994, we have decided to hold meetings with
interested organizations including the National Federation of the Blind and
the insulin manufacturers to determine what can be done to assist blind
diabetics."
In the Voice, Winter 1995, readers learned of a December 1994 meeting I had
with representatives of Eli Lilly and Company, in which we discussed concerns
the blind have in identifying insulins. I was shown prototype vial holders of
different shapes and colors. The company is now working on other possible
solutions.
In January 1995, I met with representatives of Novo Nordisk Pharmaceuticals,
Inc. On that occasion we discussed the same concerns, those the blind have in
identifying insulins. Although we reviewed possible solutions, and the
representatives said they would work on the ideas discussed, they have not yet
developed prototype  designs.
Possible solutions were discussed with representatives of both insulin
manufacturers. Both groups indicated they would work with our Diabetics
Division to alleviate this vexing problem. Placing tactile cues on the
aluminum rings around the tops was discussed. I said I didn't believe bumps on
the rings could provide enough information, but that in combination with
tactile cues on container labels, would be a good start. I requested
prototypes of whatever design(s) were developed. Eli Lilly and Novo Nordisk
representatives were not enthusiastic about changing vial shapes. Both groups
seemed more interested in changes that did not include altering actual bottle
configurations. When more is known, readers will be updated.
The following are samples of letters to: Dr. David A. Kessler, Commissioner,
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. These
Voice readers made their thoughts known!

     

January 2, 1995

Please be advised: 
Identification of insulin vials are long overdue.
I have a blind daughter (developed diabetes at 13 months  now 47 years old)
who is very independent, but not for long, unless vials are specially shaped
or marked.
Yes  yes  yes  I am in support of the needed changes in insulin vial shapes
so they can be identified.

Beverly S. Ney
Mount Hermon, LA

     

January 2, 1995

Dear Dr. Kessler,
As a blind diabetic may I suggest that you consider making mandatory a change
in the insulin vial shapes and the addition of markings such that the variety
of insulin types may be identified tactually. Presently the blind, many of
whom are so due to diabetes, cannot with appropriate certainty know the kind
of insulin in each vial. As a result, harmful dosing and dispensing errors
happen. Therefore as a matter of public health and safety, your consideration
of these simple but vital changes is much appreciated.

Thank you,
Gina Colonna  
Somerville, MA

     

January 4, 1995

Dear Dr. Kessler,
I am writing to express my personal support, and that of my staff, for the
needed changes in insulin vial shapes. This change will not only help prevent
dispensing errors for patients but also for health care providers. It is very
easy for the consumer to grab the wrong vial. It is even easier for the blind
consumer to choose the wrong vial.
By changing the shape of insulin vials by insulin type, we will prevent
unnecessary hospitalizations. I believe the consumer can best be served by
changing the shape of the insulin vials.

Sincerely,
Linda Sterling, RN
Nurse Manager
Southern Wake Hospital
Fuquay-Varina, NC

     

January 12, 1995

Dear Dr. Kessler,
As a doctor you constantly work to prevent illness, injury, and  death to
others. Because it is now impossible for the blind to determine with certainty
the kind of insulin in each vial, dosing and dispensing errors occur.
Please make needed changes in insulin vial shapes to help prevent   
misdosage. It's a cheap, small thing to do in order to prevent severe illness
and death. Please hear our call for help.

Sincerely,
Blanche Schroeder
Virginia, MN

     

January 17, 1995

Dear Dr. Kessler:
Our agency serves blind and visually impaired persons in the metropolitan
Atlanta area and throughout the state of Georgia. A significant number of our
clients have diabetes and have lost their vision as a result of this disease.
The goal for all of our clients is to assist them in attaining independence
with dignity, and to remain productive citizens in their communities. 
Over the past several years, concern has been evident nationally within the
diabetic and visually impaired community over the vital need for appropriate
identification of insulin vials. We have followed correspondence and reports
through various publications such as the Voice of the Diabetic, published by
the Diabetics Division of the National Federation of the Blind, and
publications from the American Diabetes Educators organizations. Within these
publications were copies of correspondence to and/or from Eli Lilly and
Company, Novo Nordisk, Ed Bryant, President of the Diabetics Division of the
National Federation of the Blind, and representatives of the Food and Drug
Administration. 
Our agency would like to support the efforts thus far in changing the current
packaging, labeling, and shape of insulin vials. In addition, we would like to
reiterate the concerns that large print and color coding insulin vials is not
adequate for most blind and visually impaired persons with diabetes. We
support suggestions such as different vial shapes and large, tactile,
geometric shapes for distinguishing different durations and types of insulin.
Of course these will need to be uniform changes applied to all pharmaceutical
companies who make and distribute insulin products. We would also like to see
consumer representation when changes are considered.
We hope that your agency will do whatever necessary to expedite the proposed
changes needed to assist blind and visually impaired persons with diabetes in
caring for themselves safely and independently. We feel that the potential
danger and possible fatal results of confusing insulin types has been made
clear in previous correspondence referenced above. We hope that the lives and
health of visually impaired and blind persons with diabetes will be considered
when weighing the cost of such changes in insulin packaging.
Thank you for your time and consideration regarding the proposed changes that
are so urgently needed.

Nancy Miller
Diabetes Education and Management Specialist

W. Scott McCall 
Executive Director 
Center for the Visually Impaired
Atlanta, GA

     

January 20, 1995

Dear Dr. Kessler,
This letter voices the strongest support possible for the campaign being
conducted by the National Federation of the Blind to incorporate tactile cues
in insulin vial packaging. As you are aware, in the not too distant past, the
bottle shapes varied for each type of insulin. This allowed blind diabetics an
easy way to determine which insulin was in hand. Now, with all insulin vials
indistinguishable from one another except by reading the label, the ability of
blind diabetics to self manage their care is impaired, making medication
errors during insulin preparation more likely. For safety reasons, FDA should
change necessary regulations to insist that tactile cues be reinstituted. 
The Institute for Safe Medication Practices is an FDA MedWatch partner. ISMP
cooperates with both USP and FDA by providing independent practitioner review
of all medication errors submitted to the USP Medication Errors Reporting
Program. In addition, under an FOI request, we obtain and review all FDA
MedWatch reports coded as medication errors. Material from error reports is
used to provide education about medication safety to nearly two million nurses
and pharmacists monthly through various professional journals and newsletters.
If it would be helpful, we would ask our readers to support regulatory changes
to allow blind diabetics a better way to differentiate insulin types and
reduce potential for user error. I will be in touch with pharmacy officer Tom
McGinnis of the FDA Medicine Staff to follow up on this situation.  

Sincerely yours,
Michael R. Cohen, MS, FASHP
President
Institute for Safe Medication Practices
Warminister, PA

     

February 20, 1995

Dear Dr. Kessler:
Since the discovery of insulin more than seventy years ago, insulin
manufacturers have worked continually to provide the best insulin product
possible. Today, through the use of advanced technology, the purest insulins
ever are available for use by persons with diabetes and by health care
providers. The manufacturers need to go one step further in their service to
the large diabetes population  the insulin packaging needs to be
user-friendly for visually impaired people with diabetes. 
Diabetes is the leading cause of new blindness in the United States. It is
responsible for about 12,000 cases of legal blindness each year with an even
greater number who develop severe visual impairment. These are insulin-taking
diabetics!
There are many adaptive products on the market to assist a visually impaired
person with daily diabetes cares  devices to help them measure and mix
insulin, audible insulin pumps, "talking" blood glucose meters  to name a
few. The missing link in providing the means for accurate insulin dosing and
preparation is a standard way for the visually impaired person to correctly
identify the type of insulin being used. The problem is the current labeling
policies which provide no alternative to reading the label.
At present, despite all the adaptive devices available, visually impaired
persons still have to use tactile cues such as rubber bands or tape on certain
insulin vials to identify which type they are using. Others have had to make
arrangements for relatives, neighbors, etc. to prepare their insulin  often
an inconvenience for all involved. Worse yet, there are some who must enter an
assisted living facility, because they can not safely manage their insulin
needs due to their vision loss.
The bottom line for all directly and indirectly involved is the assurance that
the visually impaired person can safely prepare and administer insulin.
Insulin accuracy plays a major role in helping to achieve better diabetes
control  a goal for all with diabetes to reduce the risk and/or severity of
additional complications. The Minneapolis-St. Paul Diabetes Educators group, a
chapter of the American Association of Diabetes Educators, has written both
Eli Lilly and Company and Novo Nordisk Pharmaceuticals, the primary
manufacturers of insulin, regarding our serious concern for appropriate
labeling of insulins for use by visually impaired persons with diabetes. We
have received replies from both companies acknowledging the need for improving
insulin labeling and the varying degrees of effort to do so.
Now, your support and influence is needed in modifying regulations and/or
policies regarding packaging and use of tactile cues to be incorporated into
the insulin vial. We urge your earnest consideration of this important request
which directly impacts the lives of so many persons with diabetes. Please
direct your response to our request to our chapter president: Tammy Scott, c/o
Health East. ... You may also contact her if you would like additional
information pertinent to our request.

Thank you.
The Minneapolis-St. Paul Diabetes Educators
American Association of Diabetes Educators
St. Paul, MN

     

 I have received a great deal of comments and correspondence on insulin
container configurations. Consensus is overwhelming  vial shapes need to be
changed! If you are interested in diabetes and have any input on this matter,
please make your thoughts known to FDA Commissioner Kessler at the following
address and please send me a copy at the Voice office:

Dr. David A. Kessler, Commissioner
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857 n