Outpatient Surgery Magazine

Manager's Guide to Surgery's Ambulatory Anesthesia - July 2015

Outpatient Surgery Magazine, providing current information on Surgical Services, Surgical Facility Administration, Outpatient Surgery News and Trends, OR Excellence and more.

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1 2 S U P P L E M E N T T O O U T P A T I E N T S U R G E R Y M A G A Z I N E J U LY 2 0 1 5 Also in 2015, urologic surgeons performed a randomized prospective study of Exparel against 0.25% bupivacaine in laparoscopic urologic surgery patients. The researchers found no difference in pain scores or opioid consumption between the 2 groups. Several institutions have conducted their own private studies of Exparel and found little benefit. Last December, Baptist Health System in San Antonio, Texas, removed Exparel from its formulary, saying in a memo to the med- ical staff that after 2 years of evaluation, "no additional benefit could be attributed to Exparel ... compared to the use of other pain medications." Rothman Orthopaedic Specialty Hospital in suburban Philadelphia also removed Exparel from its formulary earlier this year after using it in hip and knee replacement surgeries for close to 2 years. "The surgeons were not seeing the projected block of 72 hours. It was much less than what was expected: 36 hours, if that," says John R. Karwoski, RPh, MBA, of JDJ Consulting, which pro- vides pharmacy services to Rothman, the Philadelphia region's largest orthope- dic specialty group. "We went back to plain bupivacaine." Duke University re-searchers tested Exparel on 150 total knee patients. Finding that the effects of the drug didn't last as long as expected, the hospital discontin- ued the study and returned to nerve blocks. Anesthesiologist Vince Kasper, MD, the director of regional anesthesia at United Anesthesia Services in the Philadelphia area, calls Exparel "an attempt at a shortcut: a very expensive, non-efficacious shortcut. The results are not pre- dictable. The only thing predictable about the drug is its instability." Pivotal studies have demonstrated the safety and efficacy of EXPAREL in patients undergoing bunionectomy and hemorrhoidectomy procedures. The clinical benefit of the attendant decrease in opioid consumption was not demonstrated. EXPAREL is a liposome formulation of bupivacaine indicated for administration into the surgical site to produce postsurgical analgesia. Important Safety Information: EXPAREL is contraindicated in obstetrical paracervical block anesthesia. EXPAREL has not been studied for use in patients younger than 18 years of age. Non-bupivacaine-based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. Other formulations of bupivacaine should not be administered within 96 hours following administration of EXPAREL. Monitoring of cardiovascular and neurological status, as well as vital signs should be performed during and after injection of EXPAREL as with other local anesthetic products. Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations. In clinical trials, the most common adverse reactions (incidence ≥10%) following EXPAREL administration were nausea, constipation, and vomiting. Reference: Gorfine SR, et al. Dis Colon Rectum. Dec 2011;54(12):1552-1559. For the Management of Postsurgical Pain The only single-dose local analgesic to UÊ Reduce or eliminate opioids with pain control for up to 3 days UÊ Without the need for catheters or pumps EXPAREL ® (bupivacaine liposome injectable suspension) ©2013 Pacira Pharmaceuticals, Inc., Parsippany, NJ 07054 EXP-AP-0039-201302 Please see brief summary of Prescribing Information on reverse side. For more information, visit www.EXPAREL.com Patient-Focused Pain Control That Lasts For Up To 72 Hours z FALSE AND MISLEADING The FDA said Pacira Pharmaceuticals "overstated the efficacy" of Exparel in this ad, which claimed that the drug offered 72-hour pain relief when in fact it was only deemed effective for a 24-hour period.

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