2005P-0267 Remove from label for propofol (Diprivan) the warning that propofol should be administered only by trained persons
FDA Comment Number : EC43
Submitter : Dr. John Flanagan Date & Time: 08/29/2005 12:08:49
Organization : North Florida Anesthesia Consultants
Category : Drug Industry
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 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. In addition, these persons must monitor patients continuously for oxygen saturation, respiration, heart rate and blood pressure.?

? 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. This restriction is concordant with specific language in the Propofol package insert and failure to follow these recommendations could put patients at increased risk of significant injury or death.?

? 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.

? The American Association of Accreditation for Ambulatory Surgical Facilities (AAAASF) states: ?Propofol is a very poten