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Dueling Over Propofol
GI docs and a small faction of RNs are trying to wrest the propofol syringe from the hands of anesthesia providers.
Stephanie Wasek
Publish Date: October 10, 2007   |  Tags:   Anesthesia

When we last reported on RNs pushing propofol, patient safety was at the heart of the story. And it still is, because the drug's label and several state nursing boards still say that no one other than trained anesthesia providers should be pushing this drug. But the debate intensified when the American College of Gastroenterology petitioned the FDA in June to strike from the warning label of the sedative-hypnotic two key provisions:

  • only those persons trained in the administration of general anesthesia should administer the drug and
  • only those persons not involved in the conduct of surgical/diagnostic procedure should administer the drug.

Official Positions on Propofol

  • Society of Gastroenterology Nurses and Associates. RNs trained and experienced in gastroenterology nursing and endoscopy can administer and maintain moderate sedation and analgesia (conscious sedation) by the order of a physician, as well as monitor and assess the patient.
  • American Society of Anesthesiologists. Whenever propofol is used for sedation, only persons trained in the administration of general anesthesia who are not simultaneously involved in the surgical or diagnostic procedure should administer it. In addition, these persons must monitor patients continuously for oxygen saturation, respiration, heart rate and blood pressure.
  • American Association of Nurse Anesthetists. Because sedation is a continuum, it's 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.
  • Joint Commission on Accreditation of Health Organizations. JCAHO Standard PC 13.20 requires the persons who administer moderate or deep sedation be competent to manage an airway, administer reversal agents and provide ACLS care.
  • American Association of Accreditation for Ambulatory Surgical Facilities. Anesthesia professionals are best qualified to provide supportive care for the sedated or anesthetized patient.

If the FDA changes the label, anesthetists could be squeezed out of GI procedures, gastroenterologists could direct and administer anesthesia, and RNs would be able to freely push propofol. The FDA will accept comments on the petition until December. A spokeswoman says the agency hasn't determined a timeline for ruling on the petition.

Anesthetists are vehemently protesting the petition; among other efforts, they've launched a Web site, Anesthesiologists for the Safe Administration of Propofol (writeOutLink("www.safepropofol.org",1)) and a letter-writing campaign to FDA officials. We obtained a copy of one such letter from Alan Lichtenstein, MD, an anesthesiologist in Seminole, Fla. He writes:

  • "The registered nurses at our facility feel that it is total folly to suggest that RNs ... can provide safe care of these patients using [p]ropofol. They have no desire to do this. In fact, they have stated that they will work elsewhere if requested to do so."
  • "It may be a very small group of gastroenterologists that are behind the petition."

How does it all add up for you? Here's a look at the factors contributing to the continued confusion over just who should be administering propofol in GI suites.

Superior to the alternatives
Propofol is short-acting, which lets patients recover faster and function better post-op, and PONV rates are lower, which means patients are discharged from your facility faster, says Jan Odom-Forren, MS, RN, CPAN, co-editor of the Journal of PeriAnesthesia Nursing. These factors are enticing enough, but especially so for a specialty such as GI, which relies on fast turnover.

On the downside, "a patient can go from sedated to apneic in the blink of an eye," says Thom Bloomquist, MSN, CRNA, chair of the New Hampshire Board of Nursing. If a patient crashes, airway management requirements are extremely demanding - especially for an RN who probably doesn't perform many intubations - and there are no known reversal drugs for propofol, says Michael R. Wray, MSNA, CRNA, the president of the Oregon Association of Nurse Anesthetists.

But is it safe?
GI docs and some RNs say propofol administration can be done safely; it's just a matter of taking the proper precautions (see "A Training Program That Works" on page 36). The ACG cites 31 studies demonstrating the safety of the drug's administration by non-anesthesia personnel in its petition to the FDA. The results of two of the larger studies:

  • One study reported on 9,152 cases of propofol given by registered nurses under the supervision of endoscopists or gastroenterologists. No patient in that study needed endotracheal intubation, laryngeal mask airway or rescue by an anesthesiologist. Seven cases of significant respiratory compromise - three due to apnea, three due to apparent laryngospasm and one case of aspiration resulting in hospitalization - occurred during or after upper endoscopy and not colonoscopy.[1]
  • Another reported that nurses working under endoscopists' supervision safely and effectively administered propofol to 25,200 patients over seven years.[2]

"There's a sufficient amount of evidence that non-anesthesia providers can administer propofol safely," says Douglas K. Rex, MD, a past president of the ACG, and the director of endoscopy at Indiana University Hospital in Indianapolis. His own large-scale study reported that in 28,697 cases in which RNs administered propofol, only 42 cases (0.14 percent) needed assisted ventilatio; no event led to endotracheal intubation or resulted in death or neurological sequelae.[3]

The Labeling Game

The FDA has until the end of December to respond to the American College of Gastroenterology's petition, filed in June, requesting that propofol's warning label be changed. A spokeswoman at the FDA's Center for Drug Evaluation and Research says the agency is not disclosing information on its review or a potential decision date at this time. But manufacturers of the sedative-hypnotic agent say they're keeping an eye out for any results.

At AstraZeneca, which produces the drug under the trademark Diprivan, "we stand by our prescribing information," says spokeswoman Valerie Bomberger. "Our prescribing information for Diprivan does not specifically limit its use to anesthesiologists and nurse anesthetists."

At Baxter Healthcare, "we don't have a corporate position on the issue, but we're watching the situation closely," says spokeswoman Erin Gardiner. A Baxter executive further notes that since its propofol product is a generic formulation, the company cannot change its prescribing information unless the FDA mandates such a change or the company that holds the brand - AstraZeneca - originates the change.

Bedford Laboratories, which also manufactures propofol, declined comment.

- David Bernard

Paying out of pocket for sedation
Feeling the safety data are behind them, the GI docs are asking the FDA to remove the words "should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the ? procedure" from the propofol label (see "The Labeling Game" on page 34). In effect, the FDA will be deciding whether propofol is a sedative or a general anesthetic - and therefore whether RNs will be allowed to administer it.

Were the FDA to decide in favor of the petition, the GI docs would experience some welcome financial relief, says J.S. Rawson, MD, a gastroenterologist and one of the physician-owners of Columbus Endoscopy Center in Columbus, Miss.

"Anesthesia personnel increase the total cost of the procedure by at least 25 percent," he says.

According to the GI societies' joint statement, there are three key points about reimbursement for conscious sedation.

  • Reimbursement for conscious sedation is included within the codes covering endoscopic procedures.
  • The OIG has targeted billing separately for conscious sedation as possible fraud and abuse.
  • Complex procedures and procedures in high-risk patients may justify the use of an anesthetist to provide conscious or deep sedation. In such cases this provider may bill separately for his professional services.

CRNAs earn an average salary of $134,000, anesthesiologists earn an average of $255,451, and RNs average $52,000, according to a 2005 FASA survey.

"If you tack on another 20 percent in benefits costs associated with each hire, you'll have a good idea of the costs for [GI] centers," says John Gleason, the administrator at the Berks Center for Digestive Health in Wyomissing, Pa.

Even if facilities contract with anesthesia groups on a fee-for-service basis, the fee may still come out of the facilities' pockets, because in some states there's no Medicare payment for the group to seek separately - as would happen in a typical fee-for-service model.

The Medicare problem
While Medicare determined in the late 1980s that the sedation the endoscopist provides is part of the total service, the agency "generally did not reimburse an additional amount for sedation, whether administered by an anesthesiologist, or by a gastroenterologist," according to "Sedation for Gastrointestinal Endoscopy: New Practices, New Economics," published in the May American Journal of Gastroenterology.[4]

But it's the local carriers' rules that ultimately matter and affect practice at the ground level. Some local carriers, like Noridian Medicare (which covers 12 states), don't reimburse a separate anesthesia provider fee. Others, like GHI Medicare, "provide for the reimbursement of patients undergoing endoscopic procedures utilizing propofol."[4]

Third-party payers also vary, but tend to follow Medicare's lead. This has resulted in a huge disparity in the use of propofol by region. According the American Journal of Gastroenterology article, in the Northeast, "where carrier policies are unfavorable toward anesthesiologists, only 7 [percent] of gastroenterologists are utilizing propofol, versus 43 [percent] in the mid-Atlantic states, where favorable policies prevail."[4]

Further, that means some GI facilities are more financially able than others to either hire or contract with anesthesia providers to use the drug the GI societies feel is most appropriate for sedation.

"This convoluted mix of payment systems doesn't help," says Dr. Rawson. "Most centers that are using propofol are contracting with anesthesia groups that bill separately for the service. But most payers now don't pay [the anesthesia fee], and with endoscopy you're working on a very tight margin. Paying an anesthesiologist or a CRNA for the service in that situation would be cost-prohibitive."

A Training Program That Works

Since 1998, the Surgery Center of Southern Oregon in Medford has trained 40 nurses to administer propofol - and the ASC has done so with a perfect safety record over about 36,000 cases. The keys, says Val Charley, RN, the endoscopy manager, are ensuring that RNs who administer propofol are ACLS and PALS certified, and that RNs pass the following eight-step training program.

  • Complete a sedation clinical competency program consisting of nine written exams.
  • Complete a 10-case rotation in the OR to learn about anesthesia gases, carts, and induction and emergence techniques. They must also demonstrate knowledge of the physiological effects of anesthesia, the phases of anesthesia (in both children and adults), the effects of paralytics and reversal agents, and emergency-call protocol.
  • Perform three successful LMA insertions under an anesthesiologist's supervision.
  • Perform heart, lung and airway assessments, as well as show knowledge of vital signs.
  • Attend an annual, five-hour airway class that involves circulating to competency stations and a written exam.
  • Observe a competent RN administer propofol during a week's worth of cases. The nurse-in-training demonstrates the location and knowledge of emergency drugs and monitoring equipment.
  • Administer propofol under the direct supervision of the surgeon and a competent RN.
  • Remain qualified to administer propofol by annually completing airway modules of the sedation clinical competency program; the OR rotation with the medical director; the airway management class; and performance in a case observed by the medical director.

- Daniel Cook

The provider should matter
The cost of ensuring patient safety should not have a price tag, and the experts in anesthetic drugs and techniques should be the ones to push the propofol, anesthesia providers say. Pharmacology and medication interactions are no doubt the domain of anesthesia providers, but there are other aspects of patient safety that the studies cited by the ACG don't take into account, they say.

For one, patients presenting in outpatient settings are increasingly less healthy.

"The rate of obesity is staggering and patients are presenting for procedures with undiagnosed obstructive sleep apnea at alarming rates," says Mr. Wray. "Poor patient outcomes will occur if they are not properly evaluated, monitored and cared for by appropriately trained personnel."

Physician supervision won't prevent complications, and the multi-tasking required of RNs and physicians in the procedure room prevents one person from focusing singularly on the patient.

"The doctor in those doctor-patient-RN procedure rooms probably doesn't know how to manage a failing airway, and if he did, he would be too preoccupied wielding his scope to detect or appropriately treat a pending emergency," says Adam F. Dorin, MD, MBA, an anesthesiologist and the medical director of the Grossmont Plaza Surgery Center in San Diego.

Another problem is that airway training is not required. Though facilities and accreditation bodies may require it, "there's no standard that says nurses who perform moderate sedation must be ACLS-certified," says Ms. Odom-Forren. "And [JCAHO] wants you to be able to rescue a patient that moves one step further than where you are. If the patient is under deep sedation - and I've never seen a patient under propofol who's not in deep sedation - that means you have to be able to rescue from general."

That means more than physicians' and nurses' being trained in intubating patients, says Mr. Wray. It means competency in real emergency situations.

"Intubating someone who's 300 pounds, with an 80 percent O2 saturation under the gun is completely different from doing it on a healthy patient, in a calm environment with someone watching over your shoulder," he says.

And situations can go from calm to emergent unpredictably, literally in a heartbeat.

"There is a nineteen-fold variation in the metabolism of propofol among patients," says anesthesiologist Barry Friedberg, MD. "Even when you think you're giving a safe dose, you might not be. It's a very powerful tool that's dangerous in the hands of an untrained provider."

Can there be compromise?
Until the FDA rules on the petition, state nursing boards are the linchpin. As things stand in 38 states, the nurse practice acts may be interpreted such that RNs are allowed to push propofol. Boards of nursing in 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 monitoring with propofol or other anesthetic agents is beyond the scope of non-CRNA nursing practice.

The New Jersey State Supreme Court upheld regulations that require anesthesiologists to supervise CRNAs in the office setting. Pennsylvania 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.

As the Oregon Board of Nursing works to revise its nurse practice act, Mr. Wray is pushing for a compromise: Facilities would have to show they have the proper training and emergency systems in place, and individuals would have to prove their proficiency with drug and airway maintenance techniques. Unlike an outright ban, this kind of system would allow a regulatory body to let a hospital system continue nurse administration of propofol in ERs and ICUs.

But when it comes to the endo suite, says Dr. Dorin: "How much would an anesthesiologist or CRNA bill for a 20 minute case? Probably about $100. Not much, but just enough to save a life."

References:
1. Walker JA, McIntyre RD, Schleinitz PF et al. Nurse-administered propofol sedation without anesthesia specialists in 9152 endoscopic cases in an ambulatory surgery center. Am J Gastroenterol. 2003;98: 1744-1750.
2. Tohda G, Higashi S, Sakumoto H, Sumiyoshi K, Kane T. Propofol sedation during endoscopic procedures: safety and effective administration by registered nurses, supervised by endoscopists [abstract]. Gastrointest Endosc. 2005;61:ABI23.
3. Rex DK, Heuss LT, Walker JA. Nurse administered propofol sedation: safety record among individual nurses and physicians in 3 centers [abstract]. Am J Gastroenterol. 2004;99:S300.
4. Aisenberg J, Brill JV, Ladabaum U, Cohen LB. Sedation for Gastrointestinal Endoscopy: New Practices, New Economics. Am J Gastroenterol. 2005;100(5):996-1000.

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