2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC167
Submitter : Dr. viola devany Date & Time: 11/17/2005 01:11:37
Organization : Dr. viola devany
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
I am a board certified Pediatrician and Anesthesiologist. I would like to address 2005P-0267, that would allow physicians not trained in general anesthesia to deliver propofol. I think this is a very dangerous proposal, specifically for gastroenterologists to be using propofol. I have worked with many GI doctors and not one of them felt it was important to be ACLS certified to give deep iv sedation. It is so easy for propofol to induce apnea and airway obstruction and the GI doctors would not only be giving the anesthetic but also performing the procedure. I can't think of a more ominous situation leading the airway and respiratory comprimise. And then the patient is in the hands of someone not trained in airway management or trianed to recognize the difficult airway, but also in the care of someone who minimizes the need to have this training. Even if the physician had ACLS training and spent time learning airway management and proper doses, it would still be dangerous for the same person to be doing a gi procedure and giving the propofol. It simply requires to much vigilance to do the sedation safely, and a provider cannot be doing a procedure also.
Thank you for continuing to regulate safe pharmaceutical practice.
Sincerely, Viola Devany, MD