2005P-0267 | Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons | |||||||||||||||||||||||
FDA Comment Number : | EC20 | |||||||||||||||||||||||
Submitter : | Dr. Ralph Glasser | Date & Time: | 08/25/2005 11:08:21 | |||||||||||||||||||||
Organization : | Dr. Ralph Glasser | |||||||||||||||||||||||
Category : | Health Professional | |||||||||||||||||||||||
Issue Areas/Comments | ||||||||||||||||||||||||
GENERAL | ||||||||||||||||||||||||
GENERAL | ||||||||||||||||||||||||
I wish to speak strongly AGAINST relaxing the standard of care for Propofol administration.
As an Anesthesiologist with 25 years practice in direct patient care, I have copious experience with drugs such as Propofol and its potentially adverse effects on patients. There is simply no valid argument for putting patients at increased risk by allowing them to receive this potent anesthetic without being cared for by a professional specifically trained in anesthetic care, airway management, resuscitation, hemodynamic management, and rescue. Even trained professionals have had numerous occasions which require their expertise to prevent untoward patient outcomes. To allow patients to undergo such a procedure, receiving potent anesthetics while monitored only by the operating physician and a non-anesthesia nurse would be subjecting the trusting public to an unnecessary risk. People will die. I urge you to consider the horrible consequences of such a misguided proposal and vehemently reject it. Ralph Glasser, MD Professor, Department of Anesthesiology SIU School of Medicine | ||||||||||||||||||||||||