Statement
FDA Advisory Committee
Thank you for
the opportunity to present to you today.
My name is Karen J. Stewart and I am a registered respiratory
therapist. I have been a respiratory
therapist since 1971. I am here today as
the spokesperson for the American Association for Respiratory Care representing
respiratory therapists from around the county.
Respiratory
Therapists like all other health care professionals are very concerned about
medication errors. In recent years since
the elimination of most paper labels on unit dose vials of medication, it has
become increasingly difficult to determine the content of the unit dose
vials. I will share with you pictures
later in this presentation.
Now not only is
the print on the vial difficult to read, the size and shape of the vial,
contributes to the difficulty.
In 2001 the
American Association for Respiratory Care completed a human resource
survey. At the time of the survey the
average age of a respiratory therapist was 44, another contributing factor in
the difficulty of reading the content of the medication vial. While I may have just emphasized the current
relative age of the respiratory therapist, and the difficulty the older
therapist experiences in reading the labels, I also want to clearly state that
deciphering respiratory medication labels is a problem that cuts across all
ages of respiratory therapists. The
problem is how many medications are labeled, or in the case of respiratory
medications not labeled adequately.
The workflow of
a respiratory therapist typically includes delivering medications and
treatments to a number of patients for a local geographic region of a
hospital. The patients that are assigned
may have a variety of medications prescribed.
Once the medication is checked by a pharmacist for drug interactions,
the therapist typically carries the medication with them as they begin
rounds. It would not be unusual for the
therapist to carry 14 or 15 doses of medications with them. The medications must be under control so many
therapists carry medications in a fanny pack.
In some
institutions the medication is obtained through a medication delivery system
like Pyxsis. In this situation the
medication can be placed in a medication drawer specific for a patient or can
be obtained from a stock supply of many medications.
Another concern
facing respiratory therapists is the lack of bar coding on the vial. Many hospitals are moving toward the scanning
of medication bar codes. The driving
force for this use of technology is to identify the correct patient, identify
the correct medication, confirm the correct dose of medication, confirm the
correct route and to record the time of medication delivery.
I am going to
read some comments from respiratory therapists that I have received in recent
weeks;
• Staff complained about the inability to
clearly see the medication
information. For this reason, we switched to a different
product that is
individually wrapped in clearly labeled,
color-coded foil packaging. The
current situation with raised letter
labeling is an accident waiting to
happen.
• I complained bitterly when the look-alike
vials came out. We did not
leave them for any nurses to confuse. We do not know of any medication
errors because of the look-alike. Doesn’t mean it didn’t happen. We just don’t
know.
• We have had problems with the unit dose
Xoponex and Atrovent looking
alike and labeled the same in the clear
package. We use the Pyxsis and it
is still a problem.
• One encouraging thing I have seen is
differing shapes and sizes on VERY
FEW medications. Since the death of the multi-dose vial of
Albuterol, we
have a supplier who sends us 0.5ml UD vials
of Albuterol that actually
have a very distinctive teardrop shape and
a much smaller size and look
for the actual vial of medicine. Bravo!
A similar thing has happened with
the small octagonal UD vials of Pulmicort
we get. But still, the most
common medications, Atrovent and Albuterol,
and also Levalbuterol,
come in UD vials that one can’t tell apart
without the eyes of a teenager or
the magnifying glass of an older codger!
• We color the ends with a color code so no one
gives the wrong dosage. So
far, this has worked for us but I don’t
understand why a company would
not place a label that you can see well.
• I have no specifics, but mainly because it
can happen without the therapist
realizing it and the side effects are
relatively mild. I don’t think we
realize
how often it is occurring. I helped out on night shift and was amazed at
the difficulty I had. As an over 40 worker, I have come to realize
I have to
be cognizant of the shapes and the colors on
the vials, because the reading
is next to impossible. This is an important issue. We appreciate your help
and efforts in improving our field. Part of the issue I see is that there
ISN’T any labeling on the vials any
more. I remember when the unit dose
(UD) vials had a paper label, with
contrasting colors, stuck on to the
individual vial. Ah….there’s a rare example of the good old
days actually
being good!
Nowadays the master goal of cost cutting has apparently
mandated that this practice is long
dead. To add to that confusion, the vast
majority of the UD vials come packaged
LOOKING exactly the
same…five vials in a row, held on a plastic
molding piece. You have to
tear the vials off the molding exactly the
same way. A 2.5ml – 3ml vial is
essentially the same size and feel, no
matter what chemical is in it, and no
matter what the clear-on-clear lettering
says. So now all of us old folks
with changing vision we to deal with clear
plastic vials that have color
plastic slightly raised letters as the only
labeling, and that labeling is
BARELY 1mm in height!! My God!
How much harder do they think
they can make it to see what medication
you’re about to make somebody
inhale into their lungs???
On behalf of the
American Association for Respiratory Care I appreciate the opportunity to share
our Association’s comments, and those comments of concerned respiratory
therapists. Here are a few brief
pictures to illustrate what I have presented.
I also have with
me some of the inventory from my hospital of the common medications that a
therapist will carry while delivering treatments. Missing from the bag of medications is
Xopenex, which requires refrigeration.
Respectfully
Submitted,
Karen J.
Stewart, MS, RRT
For
the American Association for Respiratory Care
Employed
By: Charleston Area Medical Center
Job Title: Associate Administrator – Medicine
Services
Address: 516 Wyoming Street
Charleston, WV 25302
e-mail: Karen.stewart@camc.org