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Evidenced-Based Guidelines Today, Malpractice Tomorrow

Mon, 02/24/2014 - 5:39am
Karen S. Sibert, M.D.

We hold these truths to be self-evident:

A hospital administrator with a clipboard is in search of a physician who isn’t following “evidence-based guidelines.”

There are fads in medicine just as there are in fashion — today’s ”evidence-based guidelines” may be tomorrow’s malpractice.

Did your hospital, like so many, abruptly switch from povidone-iodine antiseptic solution to ChloraPrep for cleaning a patient’s skin before surgery?  If so, I’m sure the staff was told that ChloraPrep would be more effective and cheaper.  No doubt, they were also warned of the extra precautions that must be taken with ChloraPrep to prevent operating room fires, since ChloraPrep contains highly flammable 70 percent isopropyl alcohol in addition to chlorhexidine.  Even the fire risk apparently wasn’t enough to make hospitals think twice before switching antiseptics.

You (and your hospital’s staff) may not have heard this news. The US Department of Justice (DOJ) announced last month that CareFusion Corp. would pay the government a $40.1 million settlement to resolve allegations that the company violated the False Claims Act by paying kickbacks to boost sales of ChloraPrep and promoting it for uses that aren’t FDA-approved.

Who received kickbacks?  According to the DOJ’s press release, the complaint alleged that “CareFusion paid $11.6 million in kickbacks to Dr. Charles Denham while Denham served as the co-chair of the Safe Practices Committee at the National Quality Forum, a non-profit organization that reviews, endorses, and recommends standardized health care performance measures and practices.”  Another physician with close ties to CareFusion, Dr. Rabih Darouiche, was the lead investigator on a 2010 NEJM article which concluded (not surprisingly) that Chloraprep was “significantly more protective” than povidone-iodine against surgical site infections.

The Leapfrog Group, launched by the Business Roundtable in 2000, claims that its hospital survey is “the gold standard for comparing hospitals’ performance on the national standards of safety, quality, and efficiency.”  On January 30, Leapfrog announced that it accepted the resignation of Dr. Denham, who had served as chair of Leapfrog’s Safe Practices Committee since 2006, amid concerns that Dr. Denham had failed to reveal his “potentially compromising relationship with CareFusion.” At the same time, Leapfrog said it would undertake “a thorough scientific review of its full slate of endorsed safe practices.”

Are you still feeling good about evidenced-based guidelines?

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