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Saturday, August 2, 2008

Highmark/Blue Shield Criticism

Heard in our household this morning:

"They [Highmark Blue Shield] send there bills out in two seconds and their payments in two years."

It makes me wonder if all their clerical errors which delay payments to providers are a strategy rather than a mistake...

Not So Fast, Sugammadex

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."

Friday, August 1, 2008

Not So Fast, Sugammadex

Saturday, May 24, 2008

DepoDur Warnings

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.

Saturday, April 19, 2008

Excellent resource on screening for von Willebrand Disease

From the National Heart Lung and Blood Institute: The Diagnosis, Evaluation and Management of von Willebrand Disease [PDF]

Saturday, March 29, 2008

ASA: Details on Malignant Hyperthermia

From our national organization, the American Society of Anesthesiologists, Details on Malignant Hyperthermia which may in part explain the recent tragic death of a high school student.
"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...."

Friday, March 7, 2008

Anesthesiology: Adverse Respiratory Events in Children Who Are Obese.

Incidence and Risk Factors for Perioperative Adverse Respiratory Events in Children Who Are Obese.

"[O]bese children had a higher incidence of difficult mask ventilation, airway obstruction, major oxygen desaturation (>10% of baseline), and overall critical respiratory adverse events. Logistic regression analysis revealed several risk factors for adverse events, including procedures involving the airway, obesity, age younger than 10 yr, and a history of obstructive sleep apnea."

Wednesday, February 27, 2008

Aetna doing the right thing (at least temporarily)

Aetna to Still Pay for Colonoscopy Drug

"Bowing to critics who contended it was putting profits before patients, Aetna said Wednesday that it has suspended — at least temporarily — a plan to stop paying for routine use of a powerful anesthetic in a procedure to screen for colon cancer. "

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