Attention Docket Management:\
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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).\
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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.\
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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:\
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• 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."\
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• 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."\
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• 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.\
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• 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. If this should occur, the patient's
protective reflexes- for example, control of the airway, breathing, and
circulation are lost or dangerously depressed. A life-threatening
condition would exist in the absence of proper supportive care.
Anesthesia professionals are best qualified to provide such supportive
care for the sedated or anesthetized patient.\
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• 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. IN other words, registered nurses are
discouraged or prohibited from administering.\
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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 that is predicated, according to the ACG, on pecuniary
grounds.\
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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\
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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. We also do not know how the controlled circumstances of these
study patients would be translated by gastroenterology specialists
across the country---most of whom have little or no airway management
training.\
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According to a front-page Wall Street Journal article on June 21, 2005,
anesthesiologists serve as a model in healthcare of how to improve
patient safety and lower insurance premium costs. The article discusses
how over the last two decades anesthesiologists have advocated for
devices monitors and medications that have saved lives, improved safety
and lowered healthcare costs. 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.\
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In the interest of patient safety and quality of care, it is my opinion
that your committee denies this petition for a label change.\
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Respectfully Yours,

Joseph Deck, M.D.

President, Bellingham Anesthesia Associates, P.S.