2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC185
Submitter : Dr. Paul Edwards Date & Time: 01/11/2006 05:01:42
Organization : Fredericksburg Anesthesia Associates
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
Docket #2005P-0267

We are writing in response to the petition from the American College of Gastroenterology. ACOG would like to modify the warning label for Propofol so that practitioners not trained in anesthesia would be able to administer the drug. As a diverse group of fourteen anesthesiologists boarded in Anesthesia, Critical Care, Pain Management and Internal Medicine we are responsible for a wide range of cases. Patient saftey is paramount in all of those cases.

Propofol is unique in its ability for rapid onset allowing procedures to be performed with apparent ease. It is a potent drug that can be unpredictable, has NO reversal agent and can lead to un-intended levels of deep sedation. This use in minimally trained personnel that are also responsible for other facets of patient care during the procedure can lead to potentially life threatening scenarios. Diverting ones attention away from patient care when administering such a potent drug in anyone, let alone in someone that has a modicum of experience in anesthesia is a recipie for disaster.

All of the following distinguished professional organizations and accrediation bodies have recognized and issued statements mandating that anesthesia providers be the only ones qualified to administer Propofol. The American Society of Anesthesiologists, The American Association of Nurse Anesthetists, The Joint Commision on Accreditation of Health Organizations, The American Association of Accrediation for Surgical Facilities and Nursing Boards in the following twelve states: Alabama, Arizona, Connecticut, Florida, Kentucky, Lousianna, Mississippi, Missouri, South Carolina, Tennessee, Texas and Wyoming. All of these Boards recognize the value and saftey profile that we bring to the care of patients
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Anesthesia has been on the forefront in promoting patient saftey since it's exsistence. Vigilance is a part of our logo. We are taught from day one in our training process to observe the patient and techniques to rescue patients from potential harm. This process takes years and thousands of different scenarios before we are allowed to practice on our own. To assume that one can do a procedure and direct another person with minimal training in anesthesia does a disservice to all parties involved. Quality and patient saftey will suffer.

We have a dedicated endoscopy center that does over 8,000 cases per year with over 60% of those cases utilizing anesthesia providers. The gastroenterologists and nursing personnel all wish that we could be involved in a much higher percentage. The reasons are many but not limited to improved patient saftey, satisfaction, speed of turnover and flow of cases. The entire nursing staff have NO desire to increase their liability, responsibility or exposure to a situation that they are not trained or adept at. The gastroenterologists to a great degree recognize and appreciate our involvement in these cases. It allows them to focus their attention on the procedure. Many requests are made by them to increase our support to the center.

We as a group petition that your committee deny the application for label change in the utilization of Propofol.

Respecfully yours,

Fredericksburg Anesthesia Associates