Drug Topics - June 16, 2008 - (Page 10)

10 DRUG TOPICS JUNE 16, 2008 www.drugtopics.com Latebreakers FDA to take new tack on postmarketing surveillance Until now, the Food & Drug Administration had to wait for post-market reports of adverse events to reach the agency before it could remove unsafe drugs or devices from the market. Now under a new Sentinel Initiative it is launching, the agency will be able to promptly evaluate claims data from Medicare, other federal programs, and participating private insurers to identify safety problems. In addition, final regulations published by the Centers for Medicare & Medicaid Services state that researchers can access claims data from Medicare Part D, with patient identity shielded, for research purposes. Medicare announces over 320 winning suppliers for DMEPOS bid program The Centers for Medicare & Medicaid Services released the names of the 325 suppliers that have signed contracts with Medicare to provide certain durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) to beneficiaries in 10 communities across the United States at significantly lower prices than patients are paying now. The competitive bidding program for this first round goes into effect on July 1. In order to participate in the Medicare DMEPOS Competitive Bidding Program, suppliers must meet quality standards and be accredited by a CMS-approved Deemed Accreditation Organization. Suppliers that are interested in bidding in the second round of the program must be aware of changes to two key deadlines: Suppliers must be accredited or have applied for accreditation by July 21 (change from May 14) to submit a bid for the second round. Suppliers will need to be accredited to be awarded a contract. The accreditation deadline for the second round is January 14, 2009, (change from October 31, 2008). New guidelines spell out how to use biologics to treat psoriasis New guidelines on how to treat psoriasis and psoriatic arthritis from the American Academy of Dermatology focus on the use of biologics. Published in the May issue of the Journal of the American Academy of Dermatology, the guidelines state that there are five biologics available now to treat psoriasis, with three out of the five good for psoriatic arthritis. Besides using biologics, vaccinations should also be deployed, since both approaches target the immune system. However, once biologic therapy has begun, patients should avoid vaccinations with live vaccines under all circumstances. The academy added that in a second phase, guidelines featuring topical therapies and nonbiologics will be released. (CellCept, Roche) or mycophenolic acid (Myfortic, Novartis). Both drugs are FDA approved as immunosuppressants used to prevent organ transplant rejection and are used off-label to treat systemic lupus erythematosus, rheumatoid arthritis, and erythema multiforme. Providers should confirm that patients are not pregnant and are using effective birth control measures to prevent pregnancy prior to treatment. In addition, women who are planning to become pregnant should discuss the risk with their physicians and whether or not an alternate immunosuppressant may be necessary. The FDA revised the labeling for both drugs in November 2007 to include boxed warning information concerning spontaneous abortion and birth defects. New DEA rule lets docs treat more recovering patients Until now, prescribers in group practices could only dispense or prescribe narcotics for maintenance or detoxification purposes to 30 patients at one time after they notify the Secretary of Health & Human Services of their plan to do so. Under a final rule, which takes effect on June 23, prescribers can order controlled substances for up to 100 patients as long as they submit a supplemental notification to HHS. This supplemental notification can only be made a year after the initial notification is filed with HHS. This final rule from the Drug Enforcement Administration was published in the May 22 Federal Register. FDA warns of birth defects linked to immunosuppressants The Food & Drug Administration has issued a warning to healthcare professionals about an increased risk of spontaneous abortion during the first trimester of pregnancy and an increased risk of birth defects for women taking mycophenolate mofetil CDC: Give shingles vaccine to all over 60 A single dose of zoster vaccine live (Zostavax, Merck) is now recom- http://www.drugtopics.com

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Drug Topics - June 16, 2008 Contents Latebreakers Letters Latebreakers in Depth Pharmacists Lose in Final ESRD Rule New Drug Helps Palliative Patients on Opioids Take Care of Business Oral Treatment Reduces Multiple Sclerosis Flare-ups Beware of Inflammatory Masses From Implantable Infusion Systems Safer Therapeutic Options Emerging for Atrial Fibrillation Congressional Committee Chair Calls for Action Against Hospital Infections This Software System Helps Hospitals Manage Anticoagulation Therapy Rx Care Community Practice JP at Large Self-Care Cover Story Long-Term Care Chains and Business Technology Technology Update Continuing Education New Products Advertisers Index Classified Viewpoint

Drug Topics - June 16, 2008

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