2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC127
Submitter : Mrs. Karenn Hall Date & Time: 11/01/2005 04:11:53
Organization : Mrs. Karenn Hall
Category : Health Professional
Issue Areas/Comments
My personal opinions as an RN in Endoscopy concerning NAPS:

At least one of the gastroenterologists I work for is legislating for NAPS. I, myself, am opposed to it for many reasons, some of which are summarized below:

1. A long-standing tradition of gastroenterologists expectations of the RN performing additional tasks during moderate sedation/analgesia will not be easily changed. I think we will not be given a whole lost of choice and will be expected to assist with abdominal pressure, collection and labeling of specimens, as well as other tasks we are frequently requested to do.
2. Historically, during the administration of moderate sedation/analgesia, the RN is not given sufficient, if any, time to properly interview the patient, review the medical history, and make independent decisions on the patient's suitability for the type and amount of sedation. We are not given the same respect anesthesia personnel are given. We are sometimes falsely told not to worry about it because they (the gastroenterologists) are responsible for the sedation. That is true to some degree, but as an RN I am also independently responsible for my own actions. The physician did not give me my degree and the physician is not the one who allows me to keep my degree. I have to answer to my state BON. I foresee being "forced" to administer propofol to someone I don't think I should or resign my position.
3. Not only is initial proper training essential, on-going training to maintain proficiency is essential. I don't feel adequate on-going training would happen in most cases.
4. If I am going to take on such an additional liability responsibility, I feel my pay should reflect it, especially to cover the cost of liability insurance. I have already been told no additional pay would be given if our nurses administer propofol.
5. I have never seen a patient given propofol who was not under very deep to general anesthesia by ASA's definition. I don't think you can consider propofol sedation moderate sedation in any circumstance, and I do not foresee (even with training) being qualified to rescue someone from general anesthesia, a requirement according to JCAHO.

Karenn Hall, BSN, RN, CGRN