Although the powerful sedative propofol (Diprivan) was implicated in singer Michael Jackson’s death in June, administration of the drug by a nonanesthesiologist is safe in trained hands, four major gastroenterology and hepatology societies asserted today.
The singer’s death reignited an old turf battle over who should administer the drug during endoscopies, with anesthesiologists insisting that one of their specialists should do it and gastroenterologists arguing the opposite.
An anesthesiologist can double the cost of elective GI endoscopy without improving patient safety or procedural outcome, according to today’s joint position statement from the gastroenterology and hepatology societies.
The document is appears in the December issues of Hepatology, the American Journal of Gastroenterology, Gastroenterology, and GIE: Gastrointestinal Endoscopy.
A propofol overdose, leading to respiratory depression and cardiac arrest, and aggravated by benzodiazepines and other drugs, caused Michael Jackson’s death on June 25, his autopsy found.
Although Jackson’s personal physician has allegedly admitted administering the drug, the appropriateness of its use by nonanesthesiologists has been debated for more than a decade.
Indeed, deliberations on today’s position statement began about 18 months ago, Sedation Task Force chairman Lawrence B. Cohen, MD, of Mount Sinai School of Medicine in New York City, told MedPage Today.
On one hand, anesthesiology guidelines say there isn’t enough evidence to support safe use by nonanesthesiologists.
In fact, at its October meeting, the American Society of Anesthesiologists reiterated its long held position, in a statement that the group “unequivocally maintains that Diprivan, or its generic name propofol, is a drug meant only for use in a medical setting by professionals trained in the provision of general anesthesia.”
Indeed, the drug’s product label says it should be administered only by “persons trained in the administration of general anesthesia.”
Positioning itself as patient safety advocate, the group cited its specialists’ technological advances, “most notably the pulse oximeter,” as well as standardization of equipment and changes in training for anesthesiologists.
Propofol’s product label also says it should be administered only by “persons trained in the administration of general anesthesia.”
On the other hand, Cohen argued that in recent years, tens of thousands of published cases from every continent have supported the efficacy and safety of administration by trained nonanesthesiologists.
“The data speak quite clear clearly,” he declared in an interview.
The gastroenterologists statement said the group conducted a systematic review and found more than 460,000 published endoscopy cases in which propofol was administered by a nonanesthesiologist — typically a nurse.
Altogether, three deaths were reported, all in esophagogastroduodenoscopy cases considered high-risk for sedation due to the patients’ significant comorbidities, the statement said. One generalized seizure was reported without permanent injury to the patient.
This low rate of serious adverse events suggested safety equivalent to that reported for endoscopists administering standard sedation with regard to risk of hypoxemia, hypotension, and bradycardia for upper endoscopy and colonoscopy, according to the statement.
Nurse-administered case series also showed safety comparable to that of general anesthesia and monitored anesthesia care, it said.
But propofol appeared to have some advantages over standard sedation with a narcotic and a benzodiazepine, Cohen’s group wrote.
Sedation was induced faster, recovery time was shorter, and patient satisfaction was at least as good or slightly superior to standard sedation, based on the reviewed studies.
Nonanesthesiologist-administered propofol was also more cost effective than standard sedation or anesthesiologist administration, and more efficient, the statement asserted.
The position paper recommended that any healthcare professional — nurse or endoscopist — should be formally trained in a program that includes didactic training, an airway management workshop, simulation training, and preceptorship.
It recommended periodic retraining in an airway workshop or human simulation laboratory, as well.
Some state nursing boards specifically exclude propofol administration by nurses, but trained nurses in those jurisdictions should still be able to monitor patients after the endoscopist starts the drug, Cohen said.
A more tricky issue is reimbursement, he said.
“A lot of the current practice of sedation for endoscopy today is driven by the economics,” he told MedPage Today, noting that there is no coding or compensation for administration of propofol by physicians or gastroenterologists.
“That has been a significant deterrent to physicians who would otherwise be interested in using propofol.”
On the other hand, bringing an anesthesiologist into the practice can generate revenue for the GI practice, since the bill generated by the anesthesiologist is often larger than that for the endoscopy itself, he said.
The statement noted that the cost of having an anesthesiologist present in the endoscopy suite for administration ranges from $150 to $1,500 or more.
“This is, I think, one of those examples where spending more for healthcare does not necessarily get you better care,” Cohen said in an interview.
Cohen reported being a consultant for Ethicon EndoSurgery and Eisai Pharmaceuticals. A co-author reported consulting for Ethicon EndoSurgery as well.