Surgery News - February 2009 - (Page 11) FEBRUARY 2009 • SURGERY NEWS OPINION formance in millions of patients in real time. Privacy concerns are resolved under Medicare guidelines for handling patient care information. But most of these sources are claims data, which register only when a physician or hospital is seeking payment; are not risk adjusted; and are far less accurate than an actual health record. As an example, a hospital bill for a heart attack doesn’t mean the patient actually had one. And Medicare patients use an average of 28 prescriptions annually compared with an average of 13 among all Americans. Figuring out which medication caused the problem or whether it resulted from the underlying disease will not be easy. So far, MedSun is not a part of the initiative. The FDAAA has been called the law inspired by 27,000 lawsuits since that was Merck’s experience after Vioxx was withdrawn. But as irritating as these suits can be, they are the only way to force the disclosure of clinical experience manufacturers would prefer to hide. A recent Supreme Court decision favoring industry (Riegel v. Medtronic, U.S. Court of Appeals for the 2nd Circuit, No. 06-179, Feb. 20, 2008) preempted a product liability 11 networks to track device problems in homes, cardiac cases, ophthalmology, pediatric units, and laboratories (see www.fda.gov/cdrh/medsun). The FDA also has announced plans for a “Sentinel Initiative” to monitor the safety of medical products using a new system that taps into large databases to detect early signs of emerging problems. By partnering with the Centers for Medicare and Medicaid Services, the Department of Veterans Affairs, the Department of Defense, and selected private health care organizations, it should be possible to monitor a product’s per- claim in state court based on the federal supremacy clause in the Constitution. As a result, device manufacturers who gain FDA approval are now immunized against any subsequent liability suit. You certainly wouldn’t want to see a manufacturer forced to change or withdraw a product that injured or killed someone. A similar drug case (Wyeth v. Levine) is on the agenda of the Supreme Court (N. Engl. J. Med. 2008;358:1883-5). Patient safety is not. DR. GREENFIELD is editor in chief of SURGERY NEWS. ENTEREG accelerates GI recovery 1 The first and only FDA-approved agent indicated to accelerate the time to upper and lower GI recovery following partial large or small bowel resection surgery with primary anastomosis • Reduced time to recovery by up to 1 day • Reduced time to discharge order written (DOW)—by approximately 13 to 21 hours Important Safety Information • ENTEREG should be administered with caution to patients receiving more than 3 doses of an opioid within the week prior to surgery. These patients may be more sensitive to ENTEREG and may experience GI side effects (eg, abdominal pain, nausea and vomiting, diarrhea) • ENTEREG is not recommended for use in patients with severe hepatic impairment, end-stage renal disease, or in patients undergoing surgery for correction of complete bowel obstruction • ENTEREG is available only to hospitals that enroll in the E.A.S.E. Program. To enroll in the E.A.S.E. Program, the hospital must acknowledge that: –Hospital staff who prescribe, dispense, or administer ENTEREG have been provided the educational materials on the need to limit use of ENTEREG to short-term, inpatient use –Patients will not receive more than 15 doses of ENTEREG –ENTEREG will not be dispensed to patients after they have been discharged from the hospital For more information on the E.A.S.E. Program, contact Adolor Corporation at 1-866-4ADOLOR (1-866-423-6567) or visit www.entereg.com. Please see Brief Summary of Prescribing Information on next page. ENTEREG is a registered trademark and E.A.S.E. is a trademark of Adolor Corporation. © Copyright 2008 Adolor Corporation. All rights reserved. Printed in USA. ETG186R0 November 2008 http://www.fda.gov/cdrh/medsun http://www.entereg.com http://www.entereg.com
Table of Contents Feed for the Digital Edition of Surgery News - February 2009 Surgery News - February 2009 Contents The 20/20 Vision ICD-10 Looms News From the College: MedPAC Flak Oncology: Best for Breast General Surgery: Weighty Problem Surgery News - February 2009 Surgery News - February 2009 - Contents (Page 1) Surgery News - February 2009 - Contents (Page 2) Surgery News - February 2009 - Contents (Page 3) Surgery News - February 2009 - Contents (Page 4) Surgery News - February 2009 - The 20/20 Vision ICD-10 Looms (Page 5) Surgery News - February 2009 - The 20/20 Vision ICD-10 Looms (Page 6) Surgery News - February 2009 - The 20/20 Vision ICD-10 Looms (Page 7) Surgery News - February 2009 - News From the College: MedPAC Flak (Page 8) Surgery News - February 2009 - News From the College: MedPAC Flak (Page 9) Surgery News - February 2009 - News From the College: MedPAC Flak (Page 10) Surgery News - February 2009 - News From the College: MedPAC Flak (Page 11) Surgery News - February 2009 - Oncology: Best for Breast (Page 12) Surgery News - February 2009 - Oncology: Best for Breast (Page 13) Surgery News - February 2009 - Oncology: Best for Breast (Page 14) Surgery News - February 2009 - Oncology: Best for Breast (Page 15) Surgery News - February 2009 - Oncology: Best for Breast (Page 16) Surgery News - February 2009 - Oncology: Best for Breast (Page 17) Surgery News - February 2009 - Oncology: Best for Breast (Page 18) Surgery News - February 2009 - General Surgery: Weighty Problem (Page 19) Surgery News - February 2009 - General Surgery: Weighty Problem (Page 20)
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