2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC162
Submitter : Dr. Edward Zane Date & Time: 11/17/2005 01:11:21
Organization : New Milford Hospital
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
As a practicing anesthesiologist, I am very familiar with the use propofol. I use it in my practice daily in the operating room and in the endoscopy suite. A patient's level of consciousness can very easily move from mild sedation, to deep sedation, to unresponsiveness and general anesthesia. It is essential that a person administering propofol be qualified to manage a general anesthetic including knowledge and PRACTICAL experience in advanced airway management techniques including endotracheal intubation (being able to immediately secure the airway with a breating tube). A brief course or practice on a dummy is not enough training nor does it provide real world knowledge and experience. This is even more important when using propofol since there is no drug to reverse the effects of propofol. The drugs usually used by non-anesthesiologists are easliy reversed, so if they get into trouble there is a rescue medication to get them out of trouble. This is not the case with propofol. If they get into trouble, they need to be able to manage the airway with the same skill and competence that would be required to manage a general anesthetic. In addition, the person administering the anesthetic drug (propofol), and responsible for monitoring and resuscitating the patient, needs to be a different person than the person doing the procedure. The endoscopy person cannot safely do a procedure and manage the sedation with propofol at the same time. A seperate person trained in the administration of general anesthesia should be administering the propofol. If there ever was a patient safety issue, this is it!