FDA Advisory Committee

May 5, 2004




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



  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



  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