Drug Topics - May 12, 2008 - (Page 6)

6 DRUG TOPICS MAY 12, 2008 www.drugtopics.com Latebreakers NCPA, NACDS expand scope of AMP suit The Centers for Medicare & Medicaid Services did not contest the decision to add its new final rule on multiple-source drugs to the average manufacturer price suit filed last year by the National Association of Chain Drug Stores and the National Community Pharmacists Association. In the amended complaint, the plaintiffs charged that the new definition for multiple-source drugs represented a substantial change and that would shift a new burden to pharmacists, requiring them to prove that a medication was not available in their state, a responsibility previously handled by CMS. By adding the new rule to the original complaint, NACDS and NCPA ensured that the rule would also be subject to the court’s decision, which is not expected until later this year, at the earliest. FDA clears way for new Crohn’s biologic A new agent for reducing the signs and symptoms of Crohn’s disease (CD) will soon be available. UCB Inc. has received word from the FDA that certolizumab pegol (Cimzia) has been approved in CD patients with moderate to severe active disease who have an inadequate response to conventional therapy. According to the company, the biologic targets tumor necrosis factor alpha (TNF-alpha), a cytokine that plays a key role in mediating pathological inflammation, and represents the first and only PEGylated anti-TNF-alpha on the market. The new treatment is dosed subcutaneously once every four weeks after the initial dosing of one injection every two weeks for the first three injections. Certolizumab utilizes Nektar Therapeutic’s PEGylation platform. According to Nektar, pegylation increases a drug’s circulation time in the bloodstream, leading to decreased immunogenicity and dosing frequency as well as increased bioavailability and improved drug solubility and stability. Cimzia must be dispensed with an FDAapproved Medication Guide. legislation. The Safeguarding America’s Pharmaceuticals Act of 2008 mandates national e-pedigree requirements. Recently, the start of a California e-pedigree rule was delayed from 2009 until 2011 (see page 74). The National Association of Chain Drug Stores urged Congress to “carefully review this legislation and refrain from mandating serialization, e-pedigrees, or track and trace requirements.” The National Community Pharmacists Association, on the other hand, stated that it supported the “intent” of the bill, but insisted that the bill should include full funding of the costs of implementing the mandates. The Health Industry Distributors Association and the Healthcare Distribution Management Association issued statements offering their strong support for the legislation for creating a single, national pedigree standard. Vaccines, inhaled insulin in, ED drugs out of Part D The Centers for Medicare & Medicaid Services has issued a final rule clarifying its policies for the Medicare Part D program. According to the rule, devices for the inhalation of insulin will now be included in the program. In addition, any drug when used for the treatment of sexual or Pharmacy split over e-pedigree legislation Pharmacy organizations are divided over whether to support new federal electronic pedigree EDITORIAL ADVISORY BOARD MEMBERS Philip P. Burgess, R.Ph., M.B.A. Mary E. Inguanti, R.Ph., M.P.H. Dennis Burton, B.S.Pharm., MBA Jack Rosenberg, Pharm.D., Ph.D. National Director, Pharmacy Affairs Walgreen Co. Deerfield, Ill. Perry Cohen, Pharm.D., FAMCP Vice President of Operations Saint Francis Hospital and Medical Center Hartford, Conn. James A. Jorgenson, R.Ph., M.S., FASHP The Pharmacy Group LLC Glastonbury, Conn. David J. Fong, Pharm.D. Senior Vice President Pharmacy & Family Care Safeway Inc. Pleasanton, Calif. Director of Pharmacy Services University of Utah Hospitals & Clinics Associate Dean for Clinical Education University of Utah College of Pharmacy Salt Lake City, Utah Professor and Director of International Drug Information Center Arnold & Marie Schwartz Frederick S. Mayer, R.Ph., M.P.H. College of Pharmacy & Health Sciences President Pharmacists Planning Service Inc. Long Island University Brooklyn, N.Y. San Rafael, Calif. Vice President Specialty Pharmacy Services Specialty Scripts Pharmacy Fall River, Mass. Gene Memoli Jr., R.Ph., FASCP Director of Customer Development Omnicare Cheshire, Conn. Stephen W. Schondelmeyer, Pharm.D., Ph.D. Director, PRIME Institute College of Pharmacy University of Minnesota Minneapolis, Minn. http://www.drugtopics.com

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Drug Topics - May 12, 2008 Contents Latebreakers Letters R.Ph.s Say More Needs to be Done to Prevent Pediatric Drug Errors There's a New School of Thought on Use of Beta-Blockers for Hypertension Cover Story Guest Spot Letters Clinical Practice Special Report Professional Practice Broad Label for New Leukemia Therapy Looks Promising Treating Asthma During Pregnancy Safer than Not, Says New Guide In the Pipeline Clinical Q&A APhA Leader's Plan to Leave Office Takes Center Stage at its Conference Policies Passed at a Glance Giving a Talk to the Community? Check Out These Materials This Foundation has Funds to Spare JP at Large Cover Story: Employers and R.Ph.S: A Win-Win Combo FDA's Ilisa Bernstein Discusses Pharmacy Affairs Legal Q&A Manufacturers Unleash a Rash of Poison Ivy Treatments Are OTC Cold Remedies Safe for Kids? Probiotics are All the Rage: How You Can Capitalize on It CMS' Prices for Round One of DMEPOS Competitive Bidding Raising Concerns CVS Caremark's Mentoring Program Recruits and Retains R.Ph.s Antibiotic Resistance Among Community Pathogens Technology Update New Products Advertisers Index Classified Viewpoint

Drug Topics - May 12, 2008

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