Pharmacy & Therapeutics - March 2008 - (Page 181) Failures of Medicare Part D Delivery continued from page 147 Pharmaceutical Approval Update continued from page 157 CONCLUSION The economic influence of PBMs has usurped the wellestablished role of P&T committees and the formularies they have created for use in the outpatient setting. We call for more openness and transparency on the part of PBMs in order to understand how they create, design and implement formularies under Medicare Part D. Acknowledgments. The authors wish to acknowledge editorial assistance from Fred Gebhart. REFERENCES 1. Nash DB. Who will chose your medications (Editorial)? P&T 2005;30(2):77. 2. U.S. House of Representatives Committee on Oversight and Government Reform Report. Private Medicare Drug Plans: Seniors and Taxpayers Hurt by High Expenses, Low Rebates. October 15, 2007. 3. Medicare Modernization Act (MMA), Federal Statute. February 9, 2005. Available at: www.cms.hhs.gov/medicarereform/ mmaregions. Accessed April 18, 2005. 4. Families USA, The Voice for Health Care Consumers. New report shows Medicare prices are 58% higher than VA prices. January 9, 2007. Available at: www.familiesusa.org. Accessed January 16, 2008. 5. Good CB, Valentino M. Access to affordable medications: The Department of Veterans Affairs pharmacy plan as a national model (Editorial). Am J Public Health 2007;97(12):2129–2931. 6. Balu S, O’Connor P, Vogenberg FR. Contemporary issues affecting P&T committees, Part I. The evolution. P&T 2004;29(11): 709–711. 7. Balu S, O’Connor P, Vogenberg FR. Contemporary issues affecting P&T committees, Part II: Beyond managed care. P&T 2004; 29(12):780–783. 8. Elliot, William, MD, Regional P&T Coordinator, Kaiser-Permanente, Northern California Region, San Rafael, Calif., personal communication, January 2008. 9. Williams, Roger, MD, Chief Executive Officer, U.S. Pharmacopeia, personal communication, 2007. 10. Saldana L. Medicare Part D Update 2008. Pharmacist Consultant. CMS Region IX. Presentation to Pharmacists Planning Service, Inc. (PPSI) Program, January 28, 2008. San Francisco, Calif. 11. ‘Medicare Part D glass is half empty,’ critics say. Pharmacy Times (news capsule), December 2007, p 2 12. More PBMs agreeing to pricing transparency. Drug Topics, November 19, 2007, p 20. 13. PBMs agree to disclose what they pay for drugs. Managed Care, November 2007, p 19. I Editor’s note: We invite readers with any other viewpoints on this topic to submit their comments or manuscripts to Sonja Sherritze: ssherritze@medimedia.com. Colesevelam is contraindicated in patients with triglyceride levels above 500 mg/dL. Lipid parameters, including triglyceride and non–HDL-C levels, should be obtained before colesevelam therapy begins and periodically thereafter. This agent should be discontinued if triglyceride levels exceed 500 mg/dL or if hypertriglyceridemia-induced pancreatitis develops. Vitamin K and Fat-Soluble Vitamin Deficiencies. Bile acid sequestrants may decrease the absorption of fat-soluble vitamins A, D, E, and K. No specific clinical studies have been conducted to evaluate the effects of colesevelam on the absorption of coadministered dietary or supplemental vitamin therapy. In nonclinical safety studies, rats receiving colesevelam at doses greater than 30-fold the projected human clinical dose experienced hemorrhage from vitamin K deficiency. Patients taking oral vitamin supplements should take them at least four hours before taking colesevelam. Caution should be exercised for patients with a susceptibility to deficiencies of vitamin K, such as those using warfarin (Coumadin, Bristol-Myers Squibb); patients with malabsorption syndromes; or patients taking other fat-soluble vitamins. Gastrointestinal Disorders. Because of its constipating effects, colesevelam is not recommended for patients with gastroparesis, other gastrointestinal motility disorders, or for those who have had major gastrointestinal tract surgery and who may be at risk for bowel obstruction. Because of its large tablet size (625 mg), colesevelam can cause dysphagia or esophageal obstruction; it should be used with caution in patients who have difficulty with swallowing. Dosage and Administration: The recommended dose of colesevelam, whether used alone or with a statin, is six tablets once daily or three tablets twice daily. Colesevelam should be taken with a meal and liquid. It can be taken at the same time as a statin, or the two drugs can be taken separately. After colesevelam therapy is initiated, lipid levels should be analyzed within four to six weeks. The same recommendations apply for patients with type-2 diabetes. Commentar y: Colesevelam is the first LDL-C–lowering drug that is indicated for improving glycemic control in adults with type-2 diabetes in combination with metformin (Glucophage, Bristol-Myers Squibb), a sulfonylurea, or insulin when used alone or along with other antidiabetic agents. The American Diabetes Association estimates that 20.8 million people in the U.S. have diabetes, and more than 90% of these have type-2 diabetes. Diabetic patients face a significantly higher risk of developing cardiovascular disease. Approximately half of all Americans have elevated blood cholesterol levels that can have a negative impact on their health and quality of life. According to a recent Harris Interactive Survey, 29% of adults with a prior diagnosis of hypercholesterolemia also have diabetes. Given the prevalence of diabetes and high LDL-C levels, a medication that can help lower both glycosylated hemoglobin (HbA1C) and LDL-C can be beneficial for many patients. Colesevelam addresses these two chronic health conditions and provides physicians with a different therapeutic approach for treating patients with type-2 diabetes. Source: www.welchol.com/pdf/Welchol_PI.pdf I Vol. 33 No. 3 • March 2008 • P&T® 181 http://www.cms.hhs.gov/MMAUpdate/01_overview.asp http://www.cms.hhs.gov/MMAUpdate/01_overview.asp http://www.familiesusa.org http://welchol.com/product_info.html
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