Debate Heightens on Non-Anesthesiologists Administering the Anesthetic Drug Propofol During Office-Based Procedures

NEW ROCHELLE, N.Y. -- As the number of surgeries performed outside of hospitals continues to grow, so does the debate over whether it should be required that only anesthesiologists administer the anesthetic drug Propofol (Diprivan) during office-based procedures.  Office-based procedures have increased approximately 93 percent from 1996 to 2004, according to a 2004 outpatient surgery center market report.  This increase has been attributed to, among other things, improved monitoring and safety devices as well as newer anesthesia medications like Propofol.

Propofol is a potent and rapidly acting anesthetic medication, and has become the anesthesia drug of choice for office-based procedures like colonoscopies because of its fast onset and the ability of patients to recover from it much more quickly than other drugs, according to Somnia executive vice president and chief medical officer Robert C. Goldstein, MD.   However, along with rendering a patient unconscious for surgery, Propofol can often cause patients to stop breathing, he added. Because it can be unpredictable, the Food and Drug Administration label states that Propofol should be "administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedure."

Despite this warning, some gastroenterologists, in an attempt to save costs, are advocating for the elimination of anesthesiologists from administering Propofol to their patients, he said.  In fact, the American College of Gastroenterology is in the process of petitioning the FDA to ease its restrictions on Propofol. If successful, this would allow gastroenterologists and other non-anesthesiologists to administer the anesthetic drug themselves, or a nurse under their supervision.

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.

"The field of anesthesiology has worked diligently to achieve this impressive track record, said Goldstein. "With anesthesiologists looked to as a model for patient safety, it is concerning that any organization would advocate a position that may temp fate and jeopardize patient safety. Somnia believes patients have an ethical right to know that the person administering their anesthesia has received advanced training in the specialty."

He pointed to a case in Florida in December 2004 when a patient stopped breathing during breast augmentation surgery and died as a reason patients need know who is administering anesthesia.  According to the accident report, the surgeon personally administered anesthetic drugs, including Propofol, and overmedicated the patient.

"This death in Florida demonstrates the importance of putting patient safety and better outcomes ahead of cost cutting.  Further, the standard anesthesia morbidity/mortality rate for healthy patients is generally 1 in 300,000. Gastroenterologists, often citing their own experiences, simply do not have enough comparable data," he added.

Some physicians also state that they can just as easily use a registered nurse to administer Propofol.  However, RN-administered Propofol expressly violates the Nurse Practice Act in 13 states, and blatantly disregards the FDA warnings, Goldstein noted.

To reinforce the position of anesthesiologists, the American Society of Anesthesiologists (ASA) released a statement in 2004 on the safe use of administering Propofol.  The statement reads, in part, "due to the potential for rapid, profound changes in sedative/anesthetic depth and lack of antagonistic medications, agents such as Propofol require special attention. Even if moderate sedation is intended, patients receiving Propofol should receive care consistent with that required for deep sedation.  The society believes that the involvement of an anesthesiologist ... is optimal ...failure to follow these recommendations could put patients at increased risk of significant injury or death."

"These facts demonstrate why patients should be asking more questions about the anesthesia portion of their procedure, and not just about the procedure itself," he said.  "Patients may take the anesthesia portion for granted or incorrectly assume that the proper procedures are always being followed."

Goldstein recommends patients ask their doctors the following questions prior to any procedure involving anesthesia:

    1. Who is administering my anesthesia-are they an anesthesiologist or

       certified nurse anesthetist?

    2. What anesthetic drug or drugs will be used and what are the provisions

       for emergencies?

    3. Is the person administering the drug or drugs trained and certified to

       do so, and trained to rescue them if a misadventure ensues?

    4. Is the physician completely focused on my procedure or is he or she

       also performing other responsibilities?

    5. Has the anesthesiologist, at a minimum, completed medical school and a

       residency in anesthesia  or, in the case of a CRNA, nursing school

       with additional training to become a nurse anesthetist?

    6. Do they have the proper training and resuscitation equipment within

       reach?

"The bottom line question is, what is the negative effect of having a trained, professional anesthesiologist administer Propofol?  If the primary answer is related to cost, I would certainly caution patients to know the risks involved," Goldstein said, adding, "Anesthesiologists are medical professionals, and have an obligation to ourselves and our profession to ensure we are providing the utmost level of care to patients."

Source: Somnia