Surgery News - October 2007 - (Page 21)

OCTOBER 2007 • SURGERY NEWS PRACTICE TRENDS Human Thrombin Approved for Intraoperative Bleeding B Y E L I Z A B E T H M E C H C AT I E Else vier Global Medical Ne ws he Food and Drug Administration has approved a thrombin product derived from human plasma to help control bleeding during surgery. The product, which will be marketed as Evithrom, is the first human thrombin approved since 1954 and is the only such product currently licensed by the agency, according to an FDA statement. The approved indication is “as an aid to hemostasis when- T ever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical.” The approval “offers an important additional option for surgeons and their patients to help control surgical bleeding,” and provides surgeons the choice between human thrombin and bovine-derived thrombin, Dr. Jesse L. Goodman, director of the FDA’s Center for Biologics Evaluation and Research, said in the statement. Evithrom is applied to the surface of Panel Says EMTALA Should Apply to Inpatient Transfers B Y A L I C I A A U LT Else vier Global Medical Ne ws WA S H I N G T O N — A receiving hospital with specialized capabilities has the responsibility to accept an unstable inpatient from a transferring hospital, but only if the patient had not been stabilized for the original condition requiring admittance, according to a recommendation narrowly approved by the Emergency Medical Treatment and Labor Act Technical Advisory Group at its final meeting. The EMTALA Technical Advisory Group has met regularly over the last 30 months to advise the Secretary of the Department of Health and Human Services on how to improve guidance on and enforcement of the statute. If the Centers for Medicare and Medicaid Services—which is charged with writing the rules for and enforcing EMTALA— follows the panel’s recommendation, it’s likely the EMTALA interpretive guidelines would be altered, or that a new regulation would be issued under the statute, said panel chairman Dr. David Siegel, an emergency physician and senior vice president at Meridian Health, based in Neptune, N.J. The recommended change came after heated debate over whether EMTALA should apply to any inpatient transfers to Continued from previous page many physicians and surgeons who had formerly relied on sliding-scale regimens in an effort to prevent hypoglycemia. “Let me tell you, people are scared to death of hypoglycemia. If you’re going to introduce an order set, you have to monitor hypoglycemia rates with some passion because the anecdotal reports will increase,” Dr. Maynard observed. All of these improvements were achieved without the use of any special teams. The hospital didn’t even have a diabetes educator at the time of the unfunded project. Dr. Stephen Clement, lead author of the ADA guidelines, said that in speaking to hospital groups around the country, he’s found that the biggest obstacle to implementing measures to improve inpatient hospitals with specialized services, such as a catheterization lab. The four CMS officials on the panel all voted in favor of the recommendation. However, advisory group member Dr. John A. Kusske, chairman of the department of neurologic surgeons at University of California, Irvine, Medical Center, said he was concerned that if EMTALA was applied to these transfers, it might make it harder to find specialists to take on-call duty. The advisory group made several recommendations aimed at strengthening hospitals’ ability to find and retain on-call physicians. And it unanimously supported the recommendation that liability protection be provided to hospitals and physicians who provide EMTALA care. The committee also discussed and voted on issues regarding patients with psychiatric and behavioral disorders. They urged the CMS to refine medical screening exams so they determine if an individual is gravely disabled, suicidal, or homicidal. Even if a patient is determined to be in one of those states, that does not mean that he or she has an emergency medical condition, the advisory group said. The full accounting of the advisory group’s final recommendations will be included in its final report to the HHS secretary, Dr. Siegel said. ■ glycemic control comes from surgeons worried about hypoglycemia. “Somewhere in their training, primum non nocere—‘First, do no harm’—is translated into ‘First, never make the patient hypoglycemic.’ That’s a huge barrier. I think part of it is that hypoglycemia is so graphic. We’ve all seen a patient have a hypoglycemic seizure, but we don’t see what’s happening to platelet function and neutrophils when the blood sugars are 300,” said Dr. Clement, acting chief of endocrinology at Georgetown University Hospital, Washington. For detailed information on how to implement protocols for improved care of hyperglycemic inpatients, Dr. Maynard suggested visiting the Glycemic Control Resource Room at the Society of Hospital Medicine Web site (www.hospital medicine.org). ■ bleeding tissue and can be used with an ab- developed antibodies to bovine thromsorbable gelatin sponge. The safety and ef- bin, and nearly 10% developed antibodficacy of Evithrom was “comparable” to ies to bovine factor V/Va, while none of that of cattle-derived thrombin in a study those treated with Evithrom had deof 305 patients, according to the FDA. In tectable antibodies to human thrombin the study, 63 patients who received or to human factor V/Va. However, the laEvithrom were over bel adds that “cliniage 65. No differences in product THE SAFETY AND EFFICACY OF cal significance of safety or efficacy EVITHROM WAS ‘COMPARABLE’ these findings is unknown,” since the were documented TO THAT OF CATTLE-DERIVED detection of antibetween elderly and younger patients, alTHROMBIN IN A STUDY OF 305 body formation is “highly dependent” though “greater susPATIENTS. on the sensitivity ceptibility of older and specificity of the patients to adverse assay used, and a reactions cannot be positive result can be affected by several ruled out,” according to the label. The label cites immunogenicity data factors. Evithrom is made from pooled human from the study, which compared the presence of antibodies to bovine throm- plasma from U.S.-licensed plasma collection bin, bovine factor V/Va, human throm- centers, using carefully screened donors, bin, and human factor V/Va at baseline and other measures have been taken to reand 5 weeks after surgery in most of the duce risks of transfusion-transmitted dispatients. About 3% of those who re- eases, according to FDA and the label. Evithrom will be launched in the fourth ceived Evithrom developed antibodies to any of these four antigens, compared quarter of 2007, according to Johnson & with nearly 13% of those who received Johnson Wound Management (a division of Ethicon Inc.), which will be distributbovine-derived thrombin. Nearly 8% of those in the latter group ing it in the United States. ■ Evidence-based Management of Postoperative Ileus The American College of Surgeons and The Chatham Institute invite you to participate in a free CME activity consisting of 3 e-newsletters that focus on evidence-based management of postoperative ileus. Case studies will be included to allow learners to make clinical decision choices. LEARNING OBJECTIVES Upon completion of this activity, participants will have an increased awareness of: • The nature and prevalence of adverse effects associated with opioid use in the surgical setting • The clinical outcomes and pharmacoeconomics of medication management for postoperative ileus • Emerging agents, and their mechanisms of action, that may ameliorate certain adverse effects of opioids • The effectiveness of proactive, multidisciplinary, surgical care team management strategies for postoperative ileus TITLES • The Role of the Surgeon and the Surgical Care Team: Proactive Strategies for Preventing Postoperative Ileus • The Use of Opioids in the Surgical Setting: Emerging Agents to Ameliorate Adverse Effects • The Management of Postoperative Ileus: Pharmacoeconomics and Cost Containment FACULTY Ronald S. Chamberlain, MD, MPA, FACS (Chair) Chairman of the Department of Surgery and Surgeon in Chief Saint Barnabas Medical Center Robert G. Martindale, MD Professor of Surgery Oregon Health & Science University James P. Rathmell, MD Director, Massachusetts General Hospital Pain Center Harvard Medical School The e-newsletters are available online at: http://www.ce-university.org/surgery The Chatham Institute is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The Chatham Institute designates this educational activity for a maximum of 1.5 Category 1 Credits™ toward the AMA Physician's Recognition Award (0.5 credits per e-newsletter). Physicians should claim credit commensurate with the extent of their participation in the activity. Supported by an educational grant from Wyeth Pharmaceuticals http://www.ce-university.org/survey http://www.hospitalmedicine.org http://www.hospitalmedicine.org

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Surgery News - October 2007

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