The
Next Chapter in the Sedation Story
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Hart walked into my office a few days before Thanksgiving.
He started the conversation with: “You’re
a good politician, and I need some help.” He
didn’t have to tell me the subject, because
Stuart is Ochsner’s point person on sedation
issues and represents our department in that regard.
His concern was the continuing pressure to expand
the number and type of providers allowed to administer
sedation as well as ongoing demands by others to use
drugs traditionally viewed as “anesthetics.”
His concerns are the same as those of other anesthesiologists
across the country as well as of ASA.
As individuals, as departments and as a specialty,
we are inextricably tied to the issue of sedation
administered by others. Centers for Medicare &
Medicaid Services (CMS) regulations contain the following:
“If the hospital furnishes anesthesia services,
they must be provided in a well-organized manner
under the direction of a qualified doctor of medicine
or osteopathy. The service is responsible for
all anesthesia administered in the hospital [emphasis
added].”
But wouldn’t we feel a commitment to protect
all patients regardless of a mandate?
The issues are who can administer sedation and to
what level and what drugs others can use for sedation.
When you throw in the variety of settings —
all the way from unregulated offices to tertiary care
institutions — the number of questions seems
endless.
ASA has seriously grappled with this issue for a good
while, as evidenced by the following list of documents
it has produced on the different aspects of sedation
by others:
• “Guidelines for Delineation of Clinical
Privileges in Anesthesiology”
• “Statement on Qualifications of Anesthesia
Providers in the Office-Based Setting”
• “Statement on Safe Use of Propofol”
• “Guidelines for Office-Based Anesthesia
and Surgery”
• “Guidelines for Ambulatory Anesthesia
and Surgery”
• “Outcome Indicators for Office-Based
and Ambulatory Surgery”
• “AANA-ASA Joint Statement Regarding
Propofol Administration”
• “Practice Guidelines for Sedation
and Analgesia by Nonanesthesiologists”
• “Practice Guidelines for Preoperative
Fasting and the Use of Pharmacologic Agents to Reduce
the Risk of Pulmonary Aspiration: Application to
Healthy Patients Undergoing Elective Procedures”
• “Continuum of Depth of Sedation: Definition
of General Anesthesia and Levels of Sedation/Analgesia.”
This is not a new issue. Our “Practice Guidelines
for Sedation and Analgesia by Nonanesthesiologists”
were first published 10 years ago.
The 2004 House of Delegates mandated that ASA develop
credentialing guidelines for individuals to be privileged
to administer anesthetic drugs to produce moderate
or deep sedation. An ad hoc committee developed an
extensive document and presented it to the 2005 House
as directed.
This report was clearly the most controversial issue
discussed at the most recent Reference Committee meetings
— nothing else came close. Much of the controversy
centered on the concept of credentialing others to
administer deep sedation. ASA developed (and the Joint
Commission on Accreditation of Healthcare Organizations
adopted) a continuum of sedation that recognizes that
deep sedation may likely become general anesthesia,
and those who administer deep sedation need to be
prepared to rescue patients whose deep sedation becomes
general anesthesia. Should we give our stamp of approval
for deep sedation to anyone who has not had formal
training in administering anesthesia? Conversely,
if we don’t set these credentialing standards,
then there likely won’t be any standards. Not
an easy choice, is it?
The House consistently acts in wise ways, and it approved
a much modified document that addresses only moderate
sedation. It has a real tongue twister of a title:
“Credentialing Guidelines for Practitioners
Who Are Not Anesthesia Professionals to Administer
Anesthetic Drugs to Establish a Level of Moderate
Sedation.”
This document, along with all of ASA’s statements,
guidelines and standards, is on the Internet at: <www
.ASAhq.org/publicationsAndServices/sgstoc.htm>.
It is easy to find because it has the longest title
on the page. It was created to give you a starting
point when your institution asks you to develop sedation
credentialing policies. It represents the collective
wisdom of ASA at this point but will likely undergo
revision with time. The question of deep sedation
credentialing remains unresolved, and I encourage
you to e-mail your thoughts to me.
The next issue is our position on the use of specific
drugs by others. There is a petition before the Food
and Drug Administration (FDA) to remove the following
sentence from the propofol label: “For general
anesthesia or monitored anesthesia care (MAC) sedation,
DIPRIVAN® Injectable Emulsion should
be administered only by persons trained in the administration
of general anesthesia and not involved in the conduct
of the surgical/diagnostic procedure.”
ASA has opposed the petition by submitting extensive
written comments as well as by having Immediate Past
President Eugene P. Sinclair, M.D., testify before
the FDA Anesthetic and Life Support Drugs Advisory
Committee on November 10, 2005. Both of these documents
are available at <www.ASAhq.org/news/news111705.htm>.
The issue of drug labeling and restricting the use
of “anesthetic drugs” to anesthesia providers
also is a tricky one. I think we all know in our heart
of hearts that an overdose of midazolam or meperidine
will result in a patient that is just as dead as a
patient given too much propofol. But to me, the best
argument against weakening the package insert is this
sentence from ASA’s comments: “Removal
of the warning label from the propofol package insert
may encourage the use of propofol by practitioners
with inadequate training and experience in nonaccredited
facilities where credentialing is not required, such
as private offices.”
A third sedation issue is an economic one. Many endoscopists
prefer for anesthesiologists to sedate or anesthetize
their patients while others prefer to administer the
sedation themselves. Insurance companies are insinuating
themselves into this process by denying payment for
anesthesiologist sedation for endoscopy. This subject
is too complex for this short update but definitely
injects a very emotional element into the sedation
controversy.
You or your partners will likely get embroiled in
this discussion in your institution if you aren’t
already. Your first step is to become familiar with
all the documents listed above to become educated
and armed. Your second and most important step is
to make all your decisions based on patient safety,
keeping in mind that where patients need our care,
we must find ways to be available to provide it.
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