2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC26
Submitter : Dr. Leopoldo Rodriguez Date & Time: 08/26/2005 07:08:57
Organization : Panhandle Anesthesiology Associates PA
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
PRIMUM NON NOCERE (FIRST DO NO HARM)
Perhaps the people who propose that that Propofol (Diprivan) can be administered by Healthcare providers that are not trained in Anesthesiology should first read the Hypocratic Oath: ...'and I will seek the counsel of particularly skilled physicians where indicated for the benefit of my patient'... ...'I will follow that method of treatment which according to my ability and judgment, I consider for the benefit of my patient and abstain from whatever is harmful or mischievous. I will neither prescribe nor administer a lethal dose of medicine to any patient even if asked nor counsel any such thing nor perform the utmost respect for every human life from fertilization to natural death and reject abortion that deliberately takes a unique human life'... I am an Anesthesiologist. I have been asked to provide sedation to patients that will undergo ERCP, EGD, Colonoscopies, Closed Reductions, Dressing Changes thousands of times by Non-Anesthesia Care Providers. The reason: they know that they have absolutely no idea of how to Assess the patients Respiratory Status, Support, Maintain, Manipulate and or intervene the airway in order to keep the patients safely sedated. I literally laugh at people that think that because they took a 6 hour ACLS Course, suddenly they have become experts in Airway Management. Most non-Anesthesia care providers do not know the difference between: Conscious Sedation, Deep Sedation and Anesthesia. They don't have the experience that we have using this drug and/or managing the Airway. How can a Gastroenterologist, Orthopedits and/or any other Medical Professional pretend that he/she can have as much expertise in the above as an Anesthesia Care Provider when we have at least 2 years of training (CRNA) or 4 years of training (MD Anesthesiologists) and just doing that. It is like an Anesthesiologists pretending to be able to do EGDs, Colonoscopies and ERCPs based on having seen a Gastroenterologist do a few without complications. The incredible thing is the Gastroenterology Community is using as an argument that Anesthesiologists want to have control over sedation due to Economical Reasons. If this is the case, why don't we just eliminate Residencies. Let's all do what ever we want like it used to be in the early 1900's.
Perhaps, if we are all responding to Economical Reasons, I wonder what is more cost effective, the savings of a few dollars in the use of a trained professionals vs the loss of a life and the lawsuits that come with it.
If the FDA Approves the use of Propofol (a very good but potentially lethal drug in the wrong hands) for sedation by non-Anesthesiologists, I will loose all respect for an organization that is supposed to keep the American Public Safe. I will then really question if there are pollitical and or monetary agenda behind their reasoning.
I would also like to add that I wonder if anybody would like their mother or child to be sedated with a drug that could potentially kill them if given by the wrong person at the wrong time of the day when no one will be there to rescue them from a sure death?
Propofol does not have Antagonists once you give it you can't reverse it, thus you must be prepared to deal with the consequences.
Another fact of medicine was introduced by Claude Bernard:... We don't treat diseases, we treat patients.... Every patient is different, I have personally provided Anesthetics to thousands of patients. In one day, for the same procedure I can give a patient 400 mg of propofol for a 15 minute sedation and later give another patient only 50 mg. This is a drug that you learn to respect very early in training. There is no room for error.

I hope that you make the right decision in the name of the American Public.
Primum non nocere and don't treat diseases, treat patients...

Leopoldo Rodriguez MD FAAP
Pediatric and Cardiac Anesthesiologist
leorodriguez3@yahoo.com