Archive for the ‘Practice Guidelines’ Category

You may have read about the recent tragic deaths of two healthy children – Marvelena Rady, age 3, and Caleb Sears, age 6 – in California dental offices. Unfortunately, they aren’t the first children to die during dental procedures, and unless things change, they probably won’t be the last.

State Senator Jerry Hill has asked the Dental Board of California (DBC) to review California’s present laws and regulations concerning pediatric dental anesthesia, and determine if they’re adequate to assure patient safety. Assemblymember Tony Thurmond has sponsored “Caleb’s Law”, seeking improved informed consent for parents.

On July 28, I had the opportunity to attend a stakeholder’s meeting at the Department of Consumer Affairs in Sacramento, to hear a presentation of the DBC’s report, and to be part of the delegation offering comments on behalf of the California Society of Anesthesiologists (CSA). We hope this is the beginning of some long overdue upgrades to the current regulations.

By long-standing California state law, dentists and oral surgeons are able to provide anesthesia services in their offices even for very young children or children with serious health issues. They may apply for one of four different types of permits for anesthesia:

General anesthesia

Adult oral conscious sedation

Pediatric oral conscious sedation

Parenteral conscious sedation.

But the route of administration – oral or intravenous – isn’t the point, especially for small children, and oral sedation isn’t necessarily safer. Sedation is a continuum, and there is no way of reliably predicting when a patient will fall asleep. Relaxation may turn into deep sedation, and deep sedation into a state of unresponsiveness which is equivalent to general anesthesia. Oral medications have led to deaths in children, sometimes even before the dental procedure has begun or well after it has finished. There’s no logic in California’s lower standards of emergency equipment and monitoring for procedures done under sedation as opposed to under general anesthesia.

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The best way to avoid being sued for malpractice is to make certain that all your patients are happy and all their outcomes are good.

Reality is seldom so rosy. Patients aren’t necessarily happy even when their clinical outcomes are as good as they can get. In the event of an undesired outcome, an unhappy patient may easily become a litigious one. A 2011 study in the New England Journal of Medicine estimated that 36 percent of physicians in low-risk specialties such as pediatrics, and 88 percent of physicians in high-risk surgical specialties, would face a malpractice claim by the age of 45. Those percentages climb to 75 percent of physicians in low-risk specialties and 99 percent of physicians in high-risk specialties by the age of 65.

Flaws in clinical practice guidelines

Can clinical practice guidelines protect us? We are all beset by the proliferating standards and guidelines of evidence-based medicine. It’s comforting to think that a court may consider adherence to a legitimate clinical practice guideline (CPG) as evidence of reasonable prudence and acceptable practice. At the same time, physicians know that guidelines are imperfect. Many guidelines are debated and revised over time, some are discontinued when they are found to do more harm than good, and some have been found to be contaminated by conflicts of interest.

Some examples:

>  How long should dual anti-platelet therapy be continued after drug-eluting stent placement? Guidelines currently advise dual antiplatelet therapy for six months to a year after stent placement, and aspirin for life. More recently, the Dual Antiplatelet Therapy (DAPT) study suggests that some patients may benefit from extending dual antiplatelet therapy beyond one year in terms of protection against myocardial infarction, but this benefit is accompanied by increased bleeding risk and a possible increase in all-cause mortality. Physicians are advised to “balance risk factors”.

>  Starting in 2001, there was a push toward much tighter control of blood glucose levels in ICU patients. Tight glucose control after cardiac surgery became a quality measure tracked by the Surgical Care Improvement Project (SCIP) and the Joint Commission. The only evidence basis for tight control was a single-center study that associated intensive insulin therapy with improved outcomes including fewer infections, less ventilator time, and a lower incidence of acute renal failure. But the results couldn’t be replicated. In a landmark multicenter report published in 2009, patients receiving intensive insulin therapy with glucose levels kept between 81 and 108 were shown to have more hypoglycemia, higher mortality, and no difference in morbidity or length of stay. Intensive insulin therapy promptly fell out of favor.

>  Many hospitals in the last several years abruptly switched from povidone-iodine antiseptic solution to chlorhexidine-alcohol (ChloraPrep®) for skin preparation before surgery. They did so on the basis of a 2010 study that claimed substantial benefit for ChloraPrep in reducing the risk of surgical site infection (SSI). But in 2014 CareFusion Corp., the manufacturer of ChloraPrep, agreed to pay the government $40 million to resolve Department of Justice (DOJ) allegations that the company paid kickbacks to boost sales of ChloraPrep, and promoted it for uses that aren’t FDA-approved. The DOJ complaint said the company paid $11.6 million in kickbacks to Dr. Charles Denham, who served at the time as co-chair of the Safe Practices Committee at the National Quality Forum and the chair of Leapfrog’s Safe Practices Committee. He championed the use of ChloraPrep without disclosing his relationship with CareFusion. Subsequent studies have not demonstrated the superiority of any commonly used skin preparation agent in reducing the risk of SSI.

Though the evidence may be flawed, evidence-based medicine has shown an alarming tendency to evolve from guidelines into inflexible rules, especially if payment is linked to them. Physicians may come under pressure from regulators and hospital administrators to apply these rules mechanically, with inadequate attention to context or to a patient’s other health issues. As an excellent article in the British Medical Journal last year pointed out dryly, “The patient with a single condition that maps unproblematically to a single evidence-based guideline is becoming a rarity.” A guideline for the management of one risk factor or disease “may cause or exacerbate another—most commonly through the perils of polypharmacy in the older patient.”

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