2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC152
Submitter : Ms. Cathi Galvin Date & Time: 11/08/2005 08:11:26
Organization : Ms. Cathi Galvin
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
Attention Docket Management:

A petition is now before the FDA that has the potential to put patient safety at unwarranted risk. On June 28, 2005, the American College of Gastroenterology (ACG) filed a petition to modify the warning label of the sedative drug, Propofol.
In the hands of trained professionals, Propofol can be a very safe and efficient drug, but patient reactions can at times be very unpredictable during surgery. Because there are no reversal agents for this anesthetic, it is crucial that a formally educated and trained anesthesia provider, with primary and sole responsibility for advanced airway support and resuscitative support, be responsible for its administration. There are several professional organizations that recognize the risks involved with Propofol:
? The American Society of Anesthesiologists? (ASA) position on Propofol is: ?Whenever Propofol is used for sedation; it should be administered only by persons trained in the administration of general anesthesia who are not simultaneously involved in the surgical or diagnostic procedure
? The American Association of Nurse Anesthetists? (AANA) issued a joint statement with the ASA, which read: ?Because sedation is continuum, it is not always possible to predict how an individual patient will respond. Due to the potential for rapid, profound changes in sedative/anesthetic depth and the lack of antagonistic medications, agents such as Propofol require special attention. Whenever Propofol is used for sedative anesthesia, it should be administered only by persons trained in the administration of general anesthesia, who are not simultaneously involved in the surgical or diagnostic procedures. ? The American Association of Accreditation for Ambulatory Surgical Facilities (AAAASF) states: ?Propofol is a very potent drug capable of rapidly producing a state of general anesthesia even when a state of sedation is the intended effect. Anesthesia professionals are best qualified to provide such supportive care for the sedated or anesthetized patient.
? Boards of Nursing in 12 States (Alabama, Arizona, Connecticut, Florida, Kentucky, Louisiana, Mississippi, Missouri, South Carolina, Tennessee, Texas and Wyoming) have issued either a declaratory statement or an advisory opinion that procedural sedation administration and/or monitoring with Propofol or other anesthetic agents is beyond the scope of a non-CRNA nursing practice.
The possible risk for bad patient outcomes in the ambulatory setting can not be ignored. Outpatient Surgery Magazine conducted a survey and found that 74.8% of its readers felt that RN-administered Propofol is a patient safety risk and 71.2% responded with it being outside of an RN?s scope of practice
The ACG has cited a recent study which shows that nearly 100,000 patients have been anesthetized by registered nurses, under physician supervision, without any adverse outcomes. The morbidity and mortality rate for anesthesia is approximately one death per 250,000 cases. At this time, there have simply not been enough cases performed in the various surgical settings to warrant such a potentially drastic label change. Taking Propofol out of the hands of skilled anesthesia providers and into the hands of registered nurses and gastroenterologists does not seem to build on these accomplishments.
In the interest of patient safety and quality of care, it is my opinion that your committee denies this petition for a label change.