2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC146
Submitter : Mrs. Lynn Coyne Date & Time: 11/01/2005 04:11:10
Organization : Mrs. Lynn Coyne
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
I am a Registered Nurse who is employed at an outpatient gastroenterology center. I currently administer propofol, under the direct order of a gastroenterologist, whom is present at the time of administration, to patients undergoing upper and lower endoscopies. We use propofol in low dose form to obtain moderate sedation. Our nurses and physicians have had specific training in propofol administration by our on-site anesthesiologist, including pharmacokinetics of propofol, airway management, LMA intubation, ET tube intubation, and emergency pharmacological support. We have not had any emergencies or ill effects, thus far in our practice and feel that we are able to administer it safely in low doses. I feel that properly trained nurses, under the direct orders of physicians trained in propofol use, can safely administer propofol to obtain moderate sedation for relatively short procedures in healthy patients. I feel that the warning should be updated to include safe administration of propofol can be obtained by specially trained persons in moderate anesthesia, under the direct supervision on a physician trained in propofol.