Drug Topics - October 15, 2007 - (Page 10)

10 DRUG TOPICS OCTOBER 15, 2007 www.drugtopics.com > > > The Week at a Glance Friday 10/5/07 FDA to hold public meeting on behind-the-counter drugs The FDA has posted a notice in the Oct. 3 Federal Register, announcing a public meeting on Nov. 14 to obtain comments regarding behind-the-counter (BTC) availability of drugs. The purpose of the meeting is to solicit information and views on specific issues associated with BTC availability, including increased patient access to safe and effective drug products. The agency is interested in obtaining public comments as it explores the public health benefit of certain drugs being available BTC without a prescription, but only after intervention by a pharmacist. ly premium for the basic Medicare drug benefit in 2008 is projected to be roughly $25. Walgreens launches AARP health essentials catalogue and Web site Walgreens is launching a new catalogue, “AARP Health Essentials by Walgreens,” and a new Web site at http://aarp.walgreens.com/healthessentials/default.jsp to provide AARP’s 39 million members access to discounted health, beauty, and wellness products. The Novartis launches vaccine gift program Novartis is hoping that this year more people give the gift of health. The drug company is offering the FluGram Influenza Vaccination Program, which enables people to purchase gift cards that can be redeemed for the influenza vaccine at participating pharmacies. On average, up to 20% of the U.S. population contracts influenza, 200,000 are hospitalized, and 36,000 die each year from influenza and its complications. Influenza vaccination is recommended for people, including school-age children, who want to reduce the likelihood of becoming ill with influenza or transmitting influenza to others should they become infected. new catalogue and Web site offer a 5% discount, exclusively for AARP’s members on more than 20,000 products. FDA tightens potency restrictions for levothyroxine Concerns that the potency of levothyroxine may deteriorate faster than its expiration date have prompted the FDA to change the requirement for the drug to meet a 95% to 105% potency specification. The recommendation for the change came from a joint FDA advisory committee after complaints about the drug’s potency were received by patients and healthcare professionals. The agency requested stability data from each manufacturer of all approved levothyroxine preparations. The data showed a trend toward loss of potency with some products approaching 90% of labeled potency by the expiration date. Current specifications say that the drug must fall within a 90% and 110% range, and all tested brands did; however, some products degraded more rapidly over their shelf life than others. The new range will ensure that no product degrades by more than 5% before expiration. The upper specification of 105% is appropriate to address occasional analytical testing variability. More information can be found at www.fda.gov/cder/drug/ infopage/levothyroxine/default.htm. PDPs release details on 2008 Part D plans Prescription drug plans have begun to publicize their 2008 Medicare Part D offerings. Open enrollment for Medicare beneficiaries begins Nov. 15. Both Medco and UnitedHealth offered plans with increased incentives and reduced deductibles for beneficiaries who purchase generic medications through their mail-order facilities. UnitedHealth will continue to offer AARPbranded plans, a relationship that the company announced will last through 2014. The AARP Medicare Rx Preferred plan covers all Medicare Part D approved drugs without a deductible. According to an analysis http://www.drugtopics.com/drugtopics/Medicare+% 2F+Medicaid/CMS-reveals-2008-Medicare-Part-Dplans/ArticleStandard/Article/detail/461445? contextCategoryId=10239&searchString=cms%20p art%202008 from CMS, the national average month- Cetuximab’s label expanded for use as monotherapy A supplemental Biologics License Application (sBLA) has been approved for monoclonal antibody cetuximab (Erbitux, ImClone/Bristol-Myers Squibb). The therapy can now be used as a single agent in epidermal growth factor inhibitor (EGFR)-expressing http://www.drugtopics.com http://aarp.walgreens.com/healthessentials/default.jsp http://www.fda.gov/cder/drug/infopage/levothyroxine/default http://www.fda.gov/cder/drug/infopage/levothyroxine/default http://www.drugtopics.com/drugtopics/Medicare+%2F+Medicaid/CMS-reveals-2008-Medicare-Part-Dplans/ArticleStandard/Article/detail/461445?contextCategoryId=10239&searchString=cms%20part%202008 http://www.drugtopics.com/drugtopics/Medicare+%2F+Medicaid/CMS-reveals-2008-Medicare-Part-Dplans/ArticleStandard/Article/detail/461445?contextCategoryId=10239&searchString=cms%20part%202008

Table of Contents Feed for the Digital Edition of Drug Topics - October 15, 2007

Drug Topics - October 15, 2007 Contents Drugs in the Pipeline for Diabetes Vanquishing Med Errors from Abbreviations What Pharmacy Schools Never Taught You The Week at a Glance What Kinds of Mistakes Do Pharmacists Make?

Drug Topics - October 15, 2007

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