Drug Topics - October 15, 2007 - (Page 11)

www.drugtopics.com OCTOBER 15, 2007 DRUG TOPICS 11 metastatic colorectal cancer (mCRC) in patients who have failed treatment with both irinotecan (Camptosar, Pfizer) and oxaliplatin (Eloxatin, Sanofi-Aventis). The approval was based on results of a large phase III trial that compared cetuximab and best supportive care (BSC) with BSC alone in 572 EGFR-positive patients. According to Bristol-Myers Squibb, cetuximab is the only approved biologic therapy that has demonstrated improved overall survival as a single agent in patients with mCRC. Cetuximab is also approved for treating mCRC in combination with irinotecan and for treatment of certain types of head and neck cancer. whichever facility received vaccine first. Now, with MyFluVaccine Network, we give providers another innovation that connects them directly with healthcare consumers who are highly motivated to receive the vaccination for themselves and their loved ones, and allows them to conveniently schedule their shots online.” For more information, visit MyFluVaccine.com or call 1-(800) 843-7477. Talecris Biotherapeutics makes Hypermune products without latex Talecris Biotherapeutics has eliminated latex from its line of Hypermune (hyperimmune globulin therapies) products. The move allows doctors to use Talecris merchandise, such as vials and syringes, on patients with latex allergies. “Product safety remains a top priority at all levels of our research and manufacturing organizations,” said Steve Petteway, Ph.D., senior VP of research and development at Talecris. In addition, the company received approval from the FDA to include hyperimmune labeling information on the removal of pathogenic prions during manufacturing. “These two advances provide an improved overall margin of safety for our Hypermunes,” Petteway said. Reminder from CMS issued on mass immunizers/centralized billers CMS has issued a reminder to Part B providers and suppliers that enrollment for mass immunizers is ongoing, but those who would also like to operate as centralized billers must have received permission from CMS to bill a single Medicare contractor for payment. This process requires submission of a written request to the agency by June 1 of each year to participate as a centralized biller. Approval is limited to 12 months, running from September to Aug. 31 of the following year, and must be renewed annually. Mass immunizers are providers and suppliers who offer influenza vaccination to a large number of individuals; centralized billers are those entities that operate in at least three different payment localities. More information can be accessed at www.cms. hhs.gov/MLNMattersArticles/downloads/MM5511.pdf. DEA wants to charge nonregistered meth sellers fee for certification As part of its implementation of the Combat Methamphetamine Epidemic Act (CMEA) of 2005, regulated sellers of nonprescription drugs containing ephedrine, pseudoephedrine, or phenylpropanolamine are required to self-certify with DEA. DEA is proposing to charge regulated sellers, who are not DEA registrants, a fee for self-certification. DEA estimates that there are 42,769 pharmacies that are registered with the agency and certified to sell these products and 1,513 pharmacies that are certified but not registered. For each initial application to self certify and for the renewal of each existing self certification, pharmacies must pay a fee of $16. This fee is only required of nonregistered retailers that are not authorized to distribute controlled substances; it is not required of pharmacies that are DEA registrants. Written comments must be postmarked and electronic comments must be sent on or before Nov. 30. Comments may be sent to dea.diversion.policy@usdoj.gov or filed online at www.regulations.gov. MyFluVaccine provider network launched by FFF Enterprises FFF Enterprises, the nation’s largest distributor of influenza vaccines and human plasma products, has launched the MyFluVaccine Network for vaccination providers. FFF is now accepting applications to MyFluVaccine Network from licensed influenza vaccine providers. The network gives member healthcare providers access to influenza vaccine customers, while reducing the risks historically associated with influenza vaccine acquisition. Patrick Schmidt, FFF’s president and CEO, said that historically, “providers had to wait to find out when they’d receive the vaccine and how much they’d receive, and, in the meantime, they would often lose their patients to Thursday 10/4/07 Many Part D plans increased drug prices during the year According to research from Consumers Union, pub- http://www.drugtopics.com http://MyFluVaccine.com http://www.cms.hhs.gov/MLNMattersArticles/downloads/MM5511.pdf http://www.cms.hhs.gov/MLNMattersArticles/downloads/MM5511.pdf http://www.regulations.gov

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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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