2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC175
Submitter : Dr. John Hoagland-Scher Date & Time: 11/18/2005 02:11:06
Organization : Group Health Permanente
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
Greetings!

I am board certified in Family Medicine but I work in an urgent care. I am closely following the ACG petition before the FDA regarding use of propofol by non-anethesiologists. My peronal view is that the use of propofol should be treated just like any other drug used for procedural sedation and anesthesia (two credentialed persons present, a provider attending to the procedure and an assistant, with all the attendant equipment and protocols at hand, no 911 on the speed dialer). I am disappointed that the ASA (Google 'ASA propofol' to review their formal response to the FDA) does not single out physicians who routinely provide emergency care as uniquely qualified to use propofol, citing only an editorial (Ann Emerg Med 2003 42(6): 792-7). I am also terrified of the idea that endoscopy might be conducted using propofol in the outpatient setting by a gastroenterologist without a qualified procedural sedation and anesthesia assistant.

All new drugs need to go through a breaking in period. In the Emergency Department, propofol is in common use. Anesthesia patients can't be compared to ours with respect to just about any parameters, since we have no control over patient selection, pre-procedural morbidity, or even the time since the patient's last meal. Propofol makes things safer for some of our patients.

John Hoagland-Scher MD
jhdoc@nventure.com