In trained hands, propofol is clearly a very safe drug. Many regard the ultrashort-acting sedative-hypnotic as the ideal anesthetic agent for outpatient surgery because it reduces the need for opioids, speeds patient recovery times and is easy to titrate. But in the hands of an RN without the proper anesthesia training or support, propofol can be dangerous - even deadly.

Yet evidence is mounting that RNs in a growing number of outpatient facilities that do conscious sedation are pushing propofol, a practice that not only puts patients at risk - nearly three-fourths of the 148 readers we surveyed felt that RN-administered propofol is a patient-safety risk (74.8 percent) that is outside of an RN's scope of practice (71.2 percent) - but expressly violates the Nurse Practice Act in 13 states and blatantly disregards the warnings printed on the drug's label and package insert.

"The difference between using propofol for sedation and other sedative medications is like the difference between flying a Cessna and an F-15," says William T. Fritz, MD, MBA, the chief of anesthesiology at Conemaugh Memorial Medical Center in Johnstown, Pa. "Just as with an F-15, you can get in an unrecoverable situation faster and make a bigger crater with propofol."

Some argue that nurse-administered propofol sedation (NAPS) could be beneficial, but not everyone is convinced. Most of the nurses we spoke to are uncomfortable administering the drug. One such nurse is Brenda Sammy, RN, MSN, who works in the PACU at the Manatee Surgical Center in Bradenton, Fla.

Readers Survey: Should RNs Push Propofol? Outpatient Surgery conducted an online reader poll (n=148) to obtain opinions about the growing trend of RNs administering and/or monitoring propofol for procedural or minor surgical sedation. Some key findings: 1. Is administration of propofol by an RN or monitoring of a propofol-sedated patient outside of the scope of nursing of the nurses at your facility? * The primary responses among those choosing "other" were that the scope of practice issue depends on the state board of nursing's policy on the issue and/or whether an anesthesiologist is in the room to supervise. Others stated that administration is beyond the scope of nursing practice but monitoring is not for an ACLS-or-beyond certified RN. 2. RN-administered propofol is a patient safety risk. * Those choosing "other" said the safety issue depends on the level of airway management training the RN has received (either ACLS or other specialized training), the level of supervision they receive from an MD (some said either the procedurist or an anesthesiologist, others specified an MDA) and the veracity of the pre-op assessment of the patient. Another reader pointed to facility and practitioner liabilities as the primary risks. 3. Which factors are the most important for why an RN may be asked to administer propofol?

Brenda's story
Ms. Sammy and her fellow nurses were taken aback when an anesthesiologist asked them to administer propofol for pain management and local block procedures. After placing the block, the anesthesiologist would leave the nurses to monitor the patient's airway, cardiac and respiratory statuses. Sometimes, the physician would leave the propofol syringe/needle assembly in the IV port and ask the RN to administer a little more if the patient moved during the eye block. The nurses reluctantly and uncomfortably went along with these requests.

"The physician thinks if he's in the room, it's fine. But it only takes one patient to lose his airway and die," says Ms. Sammy. "A lot of RNs think they can do more than they can do. Sometimes RNs give [propofol] without knowing the implications."

Pain management patients were commonly monitored in the prone position, making patient assessment and airway management difficult. Over in pre-op, patients often needed five to 20 minutes to recover and "many times needed a jaw thrust to maintain their airway," says Ms. Sammy.

When asked to administer propofol, the nurses refused. Ms. Sammy researched the literature on propofol and took the lead on the nurses' behalf when addressing the matter with facility administration and the anesthesia team - and, later, with the Florida Board of Nursing.

A complex problem
Propofol is an enticing drug option for a growing number of outpatient surgical and diagnostic procedures when an anesthesiologist or CRNA is unlikely to be present. GI endoscopy is at the fore of NAPS, but ophthalmology, plastic surgery (especially office-based) and dental surgery are among those grappling with the issue of whether RN-administered propofol is good medicine.

"It may not be a patient-safety risk, but our license is on the line," says Sue Dievendorf, RN, the nursing director of the San Antonio ASC in Upland, Calif. "Here's a question: Who will stand by me if I administer propofol and something happens?"

Anesthesia provider shortages, pressure from surgeons to get cases done and the unwillingness of insurers to reimburse monitored anesthesia care (MAC) for procedures such as diagnostic endoscopy have increased the demand for RN involvement. "Physicians want their surgery to be done - no matter what," says one hospital administrator. "With reimbursement being reduced and CRNAs being so expensive, [facilities] have to find a way to cut costs. This may be one way to do that." The result? Nurses often feel caught in the middle and are unsure of the right thing to do for patients.

Like many, the Gwinnett Hospital System in Lawrence-ville, Ga., is tackling the issue of whether to develop a program for its RNs to give propofol. Mary Ann Ferguson, RN, BSN, CAPA, is an RN clinician for surgical services for Gwinnett, specializing in perianesthesia nursing. She serves as both a nursing policy author and staff educator.

"Some of the physicians think we're making a 'big deal' out of using propofol for procedural sedation, but it's not within my comfort zone," says Ms. Ferguson. "There have been repeated requests by physicians to add propofol to our conscious sedation policy. The pharmacy has managed thus far to deny the request. I suspect, though, that it may be a matter of time before we 'give in.' "

Meanwhile, the nurse manager of a center that instituted NAPS before a statewide ban recalls that her nursing staff was generally uncomfortable with the process when they first were required to push propofol, but "those fears were normally short-lived due to good outcomes. There were times when the anesthesiologist doing eye blocks would move on to the next patient (one bed over) and leave the patient with the pre-op nurse. This displeased the nursing staff because the increased liability worried them and it also increased their workload."

Brenda goes before the board
It wasn't long before the nurses at Manatee Surgical voiced their concerns about propofol administration and monitoring to administrator/risk manager Linda M. Nash, MBA, CASC, LHRM. While anesthesiologists tried to ease the nurses' angst by assuring them that, in the event of a problem, they could stop the procedure and assume management of the patient at any time, Ms. Nash threw her support behind her nurses.

"Propofol is a very safe drug, much safer than some other drugs nurses trained in conscious sedation are allowed to give," says Ms. Nash. "However, the drug manufacturer states on the product insert that it should only be administered by a provider trained in anesthesiology (MD or CRNA). We have some very safe drugs, but regulations have not kept up with technology. Nurses must not be pressured by physicians to administer drugs they are not comfortable with or trained to administer."

Convinced that propofol was unsafe in their hands, the RNs, led by Ms. Sammy, on May 8, 2001, asked the Florida Board of Nursing to issue a declaratory statement denouncing RN use of propofol. The Florida Nurse Practice Act lets RNs administer non-anesthetic drugs for conscious sedation. But propofol, as an anesthetic drug, fell into a gray area because its use as an IV conscious sedation drug vs. a deep sedation/anesthetic drug may be related to dose rather than to an intrinsic property of the drug.

"I thought it would be a simple matter to rectify with the Board," says Ms. Sammy.

But the petition and meeting process consumed much of the next year. First, a month elapsed between the time Ms. Sammy submitted her original petition and a revised version that met the requirements for a declaratory statement petition, which was signed by 26 RNs.

Then the board met to decide if a declaratory statement was warranted - something it initially didn't want to issue. "They said that the Nurse Practice Act was a clear enough directive that it was beyond the scope of a non-CRNA's practice," says Ms. Sammy.

Finally, a board member who was a consumer, not a practicing nurse, spoke up. The petition, she said, presented an opportunity to eliminate doubts and benefit Florida nurses, patients, doctors and facilities. The board agreed, and it would soon be official: "The only people who can push Diprivan are people who've been trained in anesthesia," says Ms. Sammy.

How 'safe' is safe?
According to the experts we consulted, some are citing the rationales for propofol use by MDAs and CRNAs in outpatient surgery as the reasons to let non-anesthesia providers use it:

• Propofol is short acting. That propofol takes effect in 40 seconds and patients wake up faster is the biggest argument in favor of NAPS, says anesthesiologist Barry Friedberg, MD, of Corona del Mar, Calif. "One could argue that propofol is safer than some other sedatives because it's so short-acting," says anesthesiologist Alan Marco, MD, MMM, of the Medical College of Ohio.
• Patients recover faster and function better post-op. Propofol is associated with shorter recovery times than midazolam and meperidine and higher recoveries of baseline activity levels and dietary intake 24 hours after advanced upper endoscopy, says Gregory Zuccaro, MD, the director of the Cleveland Clinic's Center for Endoscopy.
• PONV rates are lower. "It greatly reduces the need for opioids and consequently is associated with less nausea and vomiting," says Beverly Philip, MD, a professor of anesthesiology at Harvard Medical School, the director of the day surgery unit at Brigham and Women's Hospital, and a member of the board of directors for AAAHC.
• Patients are discharged faster. "Patients spend less time sleeping after the procedure and, since they regain function better and faster, they can go home sooner," says Dr. Friedberg.

The problem is that propofol's good reputation as a safe, short-acting drug can, in Dr. Friedberg's words, "tempt people without sufficient airway-management skills to have a false sense of security and think it's safer than it really is." To quote the drug information sent with each bottle of propofol, the product is "for monitored anesthesia care (MAC) sedation," and should be administered "only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical or diagnostic procedure."

When the American Society of Anesthesiologists (ASA) updated its Practice Guidelines for Sedation and Analgesia by Non-Anesthesiologists in 2001, even the task force's 10 members grappled with the complicated clinical issues associated with propofol, methohexital and ketamine induction by non-anesthesiologists. "There is insufficient literature to determine whether moderate or deep sedation with propofol is associated with different incidence of adverse outcomes than similar levels of sedation with midazolam," according to the final ASA report. While the panel agreed that non-anesthesia providers could produce satisfactory deep sedation with propofol, they hedged on whether use of the medications affected the likelihood of satisfactory moderate sedation. The panel also agreed that avoiding these medications decreases the likelihood of adverse outcomes during moderate sedation. It recommended that any practitioner administering these drugs be qualified to rescue patients from any level of sedation, including general anesthesia.[1]

Dr. Philip points to several factors that could severely complicate NAPS in most practice settings:

• Propofol administration is unpredictable. The drug can be tricky for a non-professional to titrate properly. Patients don't react the same way, and you can easily push too much if you are not used to handling the drug. Jay Horowitz, CRNA, of Sarasota, Fla., recalls handling a tough facial laser resurfacing case. Even at high doses of propofol (250 mg/kg/min), the patient still reacted to the thermal stimulation from the laser. Mr. Horowitz gave frequent 50-mg boluses to keep the patient still while letting her breathe on her own. In the 90-minute procedure, she received more than 200 cc's and was still awake and ambulatory after the dressing was applied. She was discharged 30 minutes later. Another patient in for a cheek reconstruction could only tolerate half of the usual induction dose. Such variations make propofol "quite challenging for a non-anesthesia provider," says Mr. Horowitz.
• Airway management requirements are extremely demanding. In the blink of an eye, a patient can go from breathing independently to not breathing at all. Even at low doses, in procedural sedation, the patient can lose the brain's drive and the body's ability to breathe. What's more, it can happen with no overt warning signs gleaned by physically monitoring the patient. The patient may appear to breathe normally when, in fact, the upper airway is obstructed. That is why top-notch personal airway assessment skills and knowledge of monitoring equipment for oxygen saturation and capnography are crucial.
• Propofol has no known reversal drugs. "Unlike midazolam, Demerol, Valium and morphine, where you could give Romazicon and Narcan to reverse, if the patient is given propofol and develops apnea or hypotension, it must be treated by means such as mechanical ventilation and advanced airway support until the drug is metabolized," says Donald Weninger, MD, an anesthesiologist and the medical director of the Medical Group Surgery Center.

Dr. Philip notes that while ACLS certification lets non-CRNA nurses and non-anesthesiologist physicians rescue patients who are not breathing, "ACLS alone doesn't quite cover it well enough from a safety standpoint, when you are talking about potential general anesthesia." For instance, she says, rescuing a patient involves not only mask ventilation but also such advanced practices as endotracheal intubation and placing a laryngeal mask airway (LMA). These intervention skills, while teachable, go well beyond the training of most RNs, even ACLS-trained nurses.

Do such competency requirements clinically preclude NAPS? Most of the anesthesia professionals we consulted say such standards elevate safety expectations considerably higher than those many facilities, RNs and surgeons can clear.

"Properly trained folks can administer sedation in select populations. There's nothing special about doing it with propofol," says Dr. Marco. "The central challenge is still whether the person administering the drug is truly competent to do so. Credentialing is a huge challenge. Just as importantly, what is the level of actual physician oversight?"

Making the case for NAPS
The rise of formally instituted protocols and training requirements for RNs using propofol has sparked heated debated among clinicians. Many view this debate as part of the natural evolution of medical practice, especially in the field of GI endoscopy. As one administrator puts it, "If you are giving propofol, it seems a lot more sensible and safer to train ACLS-certified nurses to do it rather than the procedurist. The physician's attention is divided, whereas a nurse can be assigned to the single task of sedation and monitoring."

Several facilities in states in which the boards of nursing let RNs push propofol - particularly Indiana and Oregon - are leading the move to incorporate propofol administration by non-CRNA RNs into ORs and endo suites that do endoscopy with procedural sedation.

"As more studies are done, I believe you will see increasing acceptance of developing competencies for RNs to administer and monitor propofol in gastroenterology and perhaps other specialties," says Donna Beitler, RN, of Johns Hopkins University Hospital in Baltimore.

Ms. Beitler says that paradigms shift in endoscopic sedation because more gastroenterologists feel they can adapt propofol to their specialty as an alternative to midazolam and other agents, regardless of whether an anesthesiologist or CRNA is working the case. Proponents say the biggest holdup is propofol's cost. That's where RNs get involved.

Dr. Zuccaro echoes Ms. Beitler's assertions. Dr. Zuccaro has extensively researched sedation, including propofol sedation, by non-anesthesia providers and worked on the task force that developed the ASA's Practice Guidelines for Sedation and Analgesia by Non-Anesthesiologists. He says that numerous studies show that, with properly trained personnel and extended monitoring by capnography, propofol is safe and effective for gastroenterology without an anesthesiologist or CRNA. The total cost per case is higher with propofol, but "the costs can conceivably be made very similar to standard sedation costs if a registered nurse administers the drug rather than a physician."

The University of Indiana Medical Center's NAPS program is arguably the best developed in the nation for GI endoscopy. The center conducted a retrospective study of 2,000 healthy ASA category 1 and 2 endoscopic cases with NAPS and no involvement by an anesthesia specialist. No cases necessitated endotracheal intubation or hospital admission. The study, published in the May 2002 American Journal of Gastroenterology, concludes, "propofol can be given safely by appropriately-trained nurses under supervision by endoscopists."[2]

At May's Society of Gastroenterology Nurses and Associates (SGNA) conference, a presentation on NAPS concluded, "NAPS is in its infancy but shows considerable promise. Many questions remained unanswered ' [but] the safety database to support NAPS in routine clinical practice is being rapidly accumulated. State laws or local institutional policies may prohibit NAPS but should relax as authorities and anesthesiologists become aware of the evidence base supporting NAPS." [3]

AORN and ASPAN do not have formal policies on NAPS, but officials with both groups say neither organization recommends it. Even within the field of gastroenterology nursing, the position is one of caution, rather than endorsement of NAPS. SGNA does not recommend that nurses be given the responsibility of administering or monitoring propofol until more clinical studies are conducted to prove its safety. "We need to ask, 'Why are we giving propofol, and do the benefits outweigh the risks?' There is a fine line to be walked with propofol, and we need to respect the risks," says Jo Harbaugh, BS, RN, CGRN, the president of SGNA.

AstraZeneca, the manufacturer of Diprivan, will not state that the product may be used in the absence of MAC performed by an anesthesiologist or CRNA. In an August 2002 letter obtained by Outpatient Surgery, AstraZeneca Medical Information Manager Tiffany Gall, PharmD, writes that "AstraZeneca does not recommend the use of Diprivan in any other manner than as described" in the package inserts. The drug's packaging clearly states that Diprivan is for use by anesthesiologists and CRNAs only.

Without the weight of widely peer-recognized standards of care for NAPS and the manufacturer referring queries to the package inserts, if your facility were to have an adverse outcome associated with NAPS and end up the defendant in a liability suit, it could be difficult to defend the practice, even if your state's board of nursing does not explicitly prohibit NAPS, says Caryl Serbin, RN, BSN, LHRM, the president of Surgery Consultants of America. Here's why: In a medical liability suit, one of the major components is breach of standards of care (the others are duty, causation and damages). "The problem is that technology and medical practice often move faster than the standards of care and the law," says Deborah Krohn, Esq., RN, a former nursing supervisor at Johns Hopkins University Hospital in Baltimore and now a practicing lawyer. "Obviously, if the board of nursing has already declared a specific practice beyond the scope of care spelled out in the Nurse Practice Act, you've got major trouble defending a claim because your facility is clearly in violation of the standard of care in the state. Your nurses are also risking disciplinary action from the Board. But when the Nurse Practice Act is ambiguous in your state, as many are on this issue, you may be treading a fine legal line."

"The law doesn't set standards of care. Medicine does," says Gene Blumenreich, Esq., of Nutter, McClennan and Fish in Boston "The law interprets whether standards of care are met. But when the standards of care are in their infancy, there are many gray areas."

The Florida board makes a ruling
On Feb. 20, 2002, the board rendered its decision: It is beyond the scope of practice of an RN in Florida to administer propofol, even if an anesthesiologist is in the room. The board ruled that an RN may not administer a maintenance dose of propofol, even under anesthesiologist's orders. It also ruled that an RN may not monitor a propofol-sedated patient, even if the anesthesiologist remains in the room.

"I am relieved that the Board of Nursing set a clear standard of care that an RN can't give propofol in Florida," says Ms. Sammy, who still works at Manatee Surgical. She recounts a recent complication during a procedure that underscored the importance of the ruling: A sedated, prone patient stopped breathing on his own and the anesthesia provider, monitoring the patient, calmly restored the patient's airway. "We were so relieved that there was an anesthesia professional monitoring the patient," she says. "The problem was handled immediately. And routinely."

References
1. American Society of Anesthesiologists, Task Force on Sedation and Analgesia by Non-Anesthesiologists. "Practice Guidelines for Sedation and Analgesia by Non-Anesthesiologists." October 2001.
2. Rex, Douglas, MD, Christine Overley, et al., "Safety of Propofol Administered by Registered Nurses with Gastroenterologist Supervision in 2,000 Endoscopic Cases." Am J Gastroenterology 2002 May; 97 (5): 1159-63.
3. Rex, Douglas, MD, Christine Overley, RN, and John Walker, MD. "Registered Nurse Administered Propofol Sedation (NAPS) for Upper Endoscopy and Colonoscopy: Why? When? And How?" Paper presented at SGNA meeting, March 2003.