2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC66
Submitter : Dr. kyle wilhite Date & Time: 09/19/2005 09:09:01
Organization : ASAP
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. The organization is requesting that the section pertaining to administration by individuals trained in general anesthesia be removed (see below). 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. Experience administering this medication, as well as observing and treating common and rare untoward events, is a long process?it comes from thousands of cumulative hours spent monitoring subtle clinical clues, cardiac rhythms and observing patterns of clinical response. These comprehensive skills can not be marshaled after a two or three day program such as the NAPS (Nurse Administrated Propofol Sedation) training course. Nor are they gleaned after similar weekend seminars for gastroenterologists or other physicians who may leave with a false sense of security that they are as familiar with potent anesthetics as anesthesiologists. There is absolutely no question that physician anesthesiologists and certified nurse anesthetists have undergone the extensive training required for administration of this anesthetic. Today?s anesthesiologists complete four years of formal postgraduate training, which includes one year of clinical medicine and three years of clinical anesthesiology. Nurse anesthesia programs consist of two to three years of didactic and clinical training in the techniques of administration of anesthetics. There are several professional organizations that recognize the risks involved with Propofol: ? The Joint Commission on Accreditation of Health Organizations (JCAHO) Standard PC 13.20 requires: ?The person administering the medication must be qualified to manage the patient whatever level of sedation or anesthesia is achieved, either intentionally or unintentionally.? (Revised Jan.1, 2004). Further, ?these standards require that individuals who administer moderate or deep sedation must also be competent to perform the rescues described in these standards,? i.e. the ability to manage an airway, administer reversal agents and provide ACLS care.
In the interest of patient safety and quality of care, it is my opinion that your committee denies this petition for a label change. More recently, New Jersey State Supreme Court upheld regulations that even require CRNA?s to be supervised by physician anesthesiologists when practicing in the office setting. The state of Pennsylvania also recognizes the potential dangers associated with administering this drug and is poised to mandate that endoscopy centers using this medication be classified as a ?class-C? facility which, according to the AAAASF, requires an anesthesiologist or CRNA to administer the drug. The possible risk for bad patient outcomes in the ambulatory setting can not be ignored. Nearly 20% of all procedures occur in office-based surgical facilities and Medicare currently offers various programs that encourage the migration of appropriate surgeries to this environment. In front of this backdrop, the reality that this potent anesthetic may be administered by a registered nurse or gastroenterologist on the tenth floor of an office building?far away from the hospital ICU, ER or anesthesia work room?underscores the harrowing nature of this initiative. In the interest of patient safety and quality of care, it is my opinion that your committee denies this petition for a label change.

Respectfully Yours,
Kyle Wilhite M.D.