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January 2006
Volume 70
Number 1

Administrative Update

The Next Chapter in the Sedation Story
Roger W. Litwiller, M.D.er W. Litwiller, M.D.Roger W. Litwiller, M.D.

Orin F. Guidry, M.D.


tuart 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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