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In the News - December 5, 2005
Wake-up call needed on nurse-administered anesthesia
Advocates warn of medical malpractice liability risks in administration of popular sedative
SAN ANTONIO, TX - A popular sedative with no known antidote poses a huge medical malpractice liability risk for hospitals and health care providers because it often is administered under conditions that contradict the manufacturer's warning, say an attorney and a nurse manager. Compounding the problem is an effort by some physicians to persuade federal regulators to remove the warning label from the general anesthetic, according to the two advocates for keeping and following the warning label. The pair warned hospital risk managers of the risks created by ignoring the label during a session at the American Society for Healthcare Risk Management's annual conference, held Oct. 23-26 in San Antonio. The patient sedation procedure that the pair opposes is known as NAPS, short for nurse-administered propofol sedation. The general anesthetic propofol, which was introduced in 1986, is manufactured by London-based AstraZeneca P.L.C. under the brand name Diprivan.
The anesthetic is popular among health care providers for several reasons, according to attorney and endoscopy nurse Deborah A. Krohn. Ms. Krohn practices law at Siegel & Krohn P.C. in Towson, Md., and is a nurse at The Johns Hopkins Hospital in Baltimore. Ms. Krohn noted that propofol works within two or three minutes, which is a fraction of the time required by other anesthetics; it is easy to administer; and patients recover quickly from the sedativee. The anesthetic is used in hospitals, ambulatory centers and physician and dentist offices during a variety of procedures, including minor surgeries, minor bone fracture repairs, burn debridement, plastic and reconstructive surgery and dental surgery. The risks to patients who are sedated by the drug are collapsed airways, reduced blood pressure, reduced heart rates and low oxygen saturation, according to Ms. Krohn.
To date, the drug has a good safety record, noted Laura A. Kress, a nurse manager and the assistant director of nursing at Johns Hopkins. But Ms. Krohn suggested that safety studies are somewhat misleading. She said the studies compare the risks of propofol, which has been used on relatively healthy patients, to the risks of other anesthetics used to sedate patients who are sicker. An important medical issue with the drug is that there is a 19-fold difference among patients in how the drug metabolizes, Ms. Krohn noted. That unpredictability in a patient's reaction to the drug is not correlated to any factor such as age, weight or illness, she said. ``Perhaps the scariest thing of all'' is that there is no known agent that can reverse the effects of the drug, Ms. Krohn said. Unlike with other anesthetics, a patient sedated with propofol ``cannot be rescued pharmacologically. There is no antidote,'' she explained. Therefore, patients who are sedated with the drug need ``airway management'' by a specialist in this area. ``Airway protection is everything.'' Ms. Krohn said.
Indeed, the drugmaker's warning label states that the drug should be delivered by a person trained in administering general anesthesia. The anesthetist should not be otherwise involved in the patient's procedure, the label also warns. But propofol often is administered by nurses who have no special training in either anesthesia or airway protection, Ms. Kress and Ms. Krohn said. Indeed, risk managers should be aware there is no consensus in the medical community about the level of educational and clinical competency that nurses should have before administering propofol. Only in Oregon and Indiana are there institutional programs designed to educate nurses who administer the sedative, Ms. Krohn said. The lack of training for nurses compromises their ability to rescue patients who have bad reactions to the drug, Ms. Kress said. ``I'm worried about that,'' she said. One in 10,000 patients under sedation will have a problem, she said. ``The question is, `Do you have the right people in the room if that happens?''' ``In my experience, this is below the radar of nurse managers,'' Ms. Krohn said. ``I've seen it go bad.'' But earlier this year, the American College of Gastroenterology petitioned the U.S. Food and Drug Administration to remove the manufacturer's warning label. Anesthesiologists recently filed their objections. The debate over how the drug is administered is driven by economics, Ms. Krohn asserted. ``As a nurse, I'm repulsed by that,'' she said. Ms. Krohn explained that because propofol sedates patients much more quickly than other anesthetics, physicians and dentists can perform more procedures each day. And by using nurses to sedate patients, physicians do not have to share their fees with anesthesiologists, she said. As the FDA considers whether to remove propofol's warning label, NAPS is being opposed by a growing number of state nursing boards, according to Ms. Krohn. Nonetheless, around half the states either permit it or have unclear positions, she said. Meanwhile, Ms. Krohn noted, the Joint Commission on Accreditation of Healthcare Organizations, a nonprofit organization that accredits more than 15,000 U.S. health care organizations, requires health care organizations to be prepared to rescue patients.
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