Heard in our household this morning:
It makes me wonder if all their clerical errors which delay payments to providers are a strategy rather than a mistake...
The U.S. FDA has declined to approve Sugammadex secondary to concerns over rare allergic reactions. From Schring-Plough:
KENILWORTH, N.J., Aug. 1 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today announced that the U.S. Food and Drug Administration (FDA) has issued a "not-approvable" letter for sugammadex sodium injection for the reversal of muscle relaxation during general anesthesia.
"We are surprised and disappointed with this action, especially given that sugammadex received a unanimous recommendation for approval by the FDA Advisory Committee on Anesthetics and Life Support in March of this year," said Thomas P. Koestler, Ph.D., executive vice president and president of Schering-Plough Research Institute. "Sugammadex represents the first major pharmaceutical innovation in the field of anesthesia in two decades. We remain committed to bringing this important medical advance to those who are waiting for it in the United States, and plan to work with the agency to address the issues, which are primarily related to hypersensitivity/allergic reactions." There were no issues related to the efficacy of sugammadex."
I was preparing to submit a pharmacy request to add DepoDur (liposomally encapsulated epidural morphine) to our formulary what I ran across this nugget:
FDA Warns of Settings That Increase Risk for Respiratory Depression From Morphine Sulfate Extended-Release Liposome Injection (DepoDur)
On December 14, 2007, the FDA approved safety labeling revisions for morphine sulfate extended-release liposome epidural injection (DepoDur; Skye Pharma Inc) to warn of settings associated with an increased risk for respiratory depression.
Although the formulation is intended for administration by the epidural route only, postmarketing reports have included cases of intrathecal use. In all cases, signs of prolonged respiratory depression required use of a narcotic antagonist (naloxone) or ventilatory support.
Because a breached dural membrane can lead to intrathecal leakage, particularly when the epidural drug is administered in a bolus, vigilant monitoring of respiratory function for a prolonged period (48 hours) is advised when extended-release morphine sulfate liposome injection is administered after a recent dural puncture. Provision should be made for emergency ventilation to minimize the risk for serious respiratory depression.
Subarachnoid puncture during epidural administration of the product has also been linked to cases of prolonged and serious respiratory depression or apnea, occurring within 12 hours of injection and after apparent recovery from anesthesia. Respiratory depression can be successfully treated with a naloxone bolus or, more commonly, a naloxone infusion; intubation and mechanical ventilation may be necessary in some cases.
Morphine sulfate extended-release liposome injection is indicated for single-dose epidural administration at the lumbar level to treat postoperative pain; it is given before surgery or after clamping the umbilical cord during cesarean delivery. The injection is not intended for intrathecal, intravenous, or intramuscular administration.
"In light of the recent tragic death of a Florida teenager from a reported case of malignant hyperthermia, ASA recognizes the importance for patients to know the facts behind the occurrence of this rare genetic disorder...."
Incidence and Risk Factors for Perioperative Adverse Respiratory Events in Children Who Are Obese.
Aetna to Still Pay for Colonoscopy Drug
Effectiveness and Efficiency of Root Cause Analysis in Medicine
(Via JAMA current issue.)
I suspect that there is much more to Aetna's recent decision (pdf) to stop paying for Propofol for all (exceptions exist) colonoscopies than either Propofol or colonoscopies. At first glance it just look like they're trying to save themselves the additional cost the anesthetist or anesthesiologist that is needed if endoscopists want their patients to receive propofol adds. But I think there's more to it than that.
Let me state at the outset that my practice does not derive significant income from providing anesthesia for colonoscopies. The vast majority of colonoscopies done with propofol use RN's with anesthesia training (CRNA's) to provide the service. I point this out because it seems that having any financial involvement at all is cause for discounting ones opinion--it should not be, but it is.
Using propofol allows colonoscopies to be done without patient awareness of discomfort, true, but the real advantage is that patients recover from the drug fast. By way of example, if a colonoscopy is done the 'old fashioned way' using the sedative midazolam and the narcotic demerol or fentanyl, the patient will likely need to remain in the center for one to two hours before they meet discharge criteria (assuming they don't have any nausea). Propofol allows them to go home in about 30-45 minutes. Roughly twice as fast from completion of colonoscopy to discharge. That means they occupy a recovery bed for less time and that's the limiting step for many centers. Once all the recovery beds are full, you can't do any more procedures until one opens up. Being able to quickly discharge patients after their exam allows much greater throughput in terms of exams per day that can be done .
Here is where I think the policy change will have its real effect. Either endoscopy centers will continue to provide the option of propofol sedation but charge the patient for it (in which case the insurance company will pay less), will provide it as part of the facility fee as a way to compete more effectively for patients (in which case the insurance company will pay less), or centers will go back (and I do mean back) to using older drugs but sacrifice throughput (in which case the insurance company will pay less).
Is having a colonoscopy easier with propofol? Don't take my word for it. Ask any endoscopy nurse which way he or she would prefer having a colonoscopy done.
Aside from cost and cost savings there's the issue of who decides what appropriate care is. If insurance companies are allowed to dictate who can and cannot get a certain kind of anesthesia, what will they do next? Get rid of anesthesia payments for cataract surgery? How about for trigger finger releases and carpal tunnel surgery. Vasectomy? See where I'm going with this?
Is there a consensus concerning the routine use of BIS monitoring during general anesthesia?
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