Drug Topics - June 30, 2008 - (Page 6) 6 DRUG TOPICS JUNE 30, 2008 www.drugtopics.com > > >NEWS Roundup Government & Law AMCP: Don't require Part D plans to include all drugs for serious conditions The Academy of Managed Care Pharmacy (AMCP) has sent a letter to key Democrat and Republican Senate leaders strongly objecting to Section 176 of S. 3101, the "Medicare Improvements for Patients and Providers Act of 2008." The provision would require the Department of Health & Human Services to identify classes of drugs used to treat major or life-threatening conditions and require formularies of Medicare Part D drug plan sponsors to include "all or substantially all" of the drugs in that class. AMCP believes this provision would undermine the current process mandated by the Medicare Modernization Act by which drugs are evaluated for clinical effectiveness and safety. AMCP also believes this provision is unnecessary and inconsistent with the competitive structure that forms the foundation of the Part D benefit. patients’ prescription and over-the-counter drug use, “using an individual who has specialized education and training in drug management, such as a pharmacist,” to address patients’ individualized plan of care. The final rule takes effect on Dec. 2. Chains and Business Daiichi and Ranbaxy to tie the knot Ranbaxy, the largest drug company in India, has agreed to sell a majority stake of its firm to the Japanese drugmaker Daiichi Sankyo for up to $4.6 billion. The deal will vault Daiichi into the top ranks of generic companies in this country. Industry insiders believe this move makes sense when generic drug sales are growing like topsy in the United States while brand drug sales have slowed. Two lots of Daytrana recalled Two lots of methylphenidate transdermal system (Daytrana, Shire) have failed to meet their release liner removal specification, leading to a voluntary recall by the manufacturer. Both lots 2750211 and 2764111 are affected and may cause difficulty removing the liners for both patients and caregivers, but do not pose any safety concerns, according to the company. Shire said it will continue to perform quality assurance monitoring to ensure no new cases of liner failure occur and that current supply levels of the patch should be sufficient despite the recall. Pharmacists with questions should direct them to the Daytrana customer service line at 1-(888)-879-8218. Needy assisted living seniors should be spared drug co-payments, says ALFA If seniors who live in nursing homes don’t have to pay co-payments to obtain their Medicare Part D drug benefit, is it fair to require those who live in assisted living facilities to do so? The Assisted Living Federation of America (ALFA) doesn’t think so. So it has submitted written testimony to the Senate Special Committee on Aging, asking for this requirement to be eliminated for the 100,000 needy seniors who live in assisted living communities. ALFA says co-payments of as little as $1 to $5 can impose considerable hardship on many assisted living seniors. Rx Care Boxed warning is added to Regranex label The Food & Drug Administration has announced the addition of a boxed warning to the prescribing information for becaplermin (Regranex gel 0.01%, Ethicon) following data from a retrospective study that showed a five-fold increased risk of cancer mortality in patients who used three or more tubes of the product. Becaplermin is a recombinant human platelet-derived growth factor indicated as an adjunct to the treatment of lower extremity diabetic neuropathic ulcers. The data did not identify any specific type of cancer. In March 2008, the FDA issued an Ongoing Safety Review Communication on the product, promising a safety review of becaplermin and follow-up communication. The agency cautions healthcare professionals not to use the product in patients with known malignancies and to report adverse events to MedWatch. The Centers for Medicare & Medicaid Services has released a final rule on the conditions of participation for hospices in the Medicare and Medicaid programs. The final rule addresses the 200-plus comments CMS received on the proposed rule, published back in 2005. A considerable part of the standards in this final rule relate to medication use. Hospices are required to review Photo: Getty Images/Anderson Ross/Stockbyte CMS issues final rule on standards hospices must meet under Medicare, Medicaid http://www.drugtopics.com http://www.amcp.org/amcp.ark?c=news&type=splashpage&id=557 http://www.alfa.org http://edocket.access.gpo.gov/2008/pdf/08-1305.pdf
Table of Contents Feed for the Digital Edition of Drug Topics - June 30, 2008 Drug Topics - June 30, 2008 Contents Is Your Patient Getting His Oxycontin Filled Elsewhere? Top 200 Drugs Used in Hospitals in 2007 Latest News Roundup Drug Topics - June 30, 2008 Drug Topics - June 30, 2008 - Contents (Page 1) Drug Topics - June 30, 2008 - Contents (Page 2) Drug Topics - June 30, 2008 - Is Your Patient Getting His Oxycontin Filled Elsewhere? (Page 3) Drug Topics - June 30, 2008 - Is Your Patient Getting His Oxycontin Filled Elsewhere? (Page 4) Drug Topics - June 30, 2008 - Top 200 Drugs Used in Hospitals in 2007 (Page 5) Drug Topics - June 30, 2008 - Latest News Roundup (Page 6)
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