2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC129
Submitter : Dr. Timothy McClellan Date & Time: 11/01/2005 04:11:15
Organization : Wichita Falls Endoscopy Center
Category : Health Professional
Issue Areas/Comments
After learning about Dr. John Walker's physician directed, nurse administered propofol program in Medford, Oregon, we began to investigate the possibility of propofol administration by non anesthesia trained personnel in our endoscopy facility in Wichita Falls, Texas. After thoroughly researching the laws and nurse practice act in Texas, we decided to develop a prtotocol based on Dr. Walker's Dr. NAPS( nurse administered propofol sedation) program. We trained with Dr. Walker and subsequently implemented the program in our facility.

We have providing this service for 4 months. To date, we have had no adverse patient events. The patient satisfaction has been excellent. Both the physicians directing the sedation and the nurses administering it feel propofol to be superior to what was previously used.

Our program is working extremely well and we have had excellent patient outcomes at the Wichita Falls Endoscopy Center. I have no intention of ever using anything but propofol for sedation of my patients unless a particular patient presents with a contraindication. I think that the FDA should change the label regarding the administration of propofol.

Thank you for your consideration.