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The Food & Drug Administration recently approved sunitinib (Sutent, Pfizer) for the treatment of gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib (Gleevec, Novartis). Sunitinib was also granted accelerated approval for the treatment of metastatic renal cell carcinoma (MRCC). This is the first time that the agency has approved an oncology drug for the treatment of two indications simultaneously.

In an attempt to eradicate hepatitis B virus (HBV) from the United States, the Centers for Disease Control & Prevention Advisory Committee on Immunization Practices (ACIP) issued updat-ed guidelines for vaccination against the disease.

Pharmacies already reeling from the botched implementation of Medicare Part D took another body blow Feb. 1, when Congress narrowly approved federal Medicaid reimbursement cuts of $3.6 billion over the next five years. Just five days later, the Bush Administration's new budget proposed lopping an additional $1.3 billion from Medicaid reimbursement.

In remarks about his proposed 2007 budget and deficit reduction, President Bush said, "People talked about how the decision to reform Medicaid was immoral. Well, it's not immoral to make sure that prescription drug pharmacists don't overcharge the system.... It turns out that there was inflated markups for people who had government help to buy drugs. That doesn't make sense, so we reformed that. The people are still going to get their drugs, but the taxpayers aren't going to pay inflated prices." Bush's accusation about pharmacy overcharging came the same day HHS secretary Michael Leavitt repeated his praise of R.Ph.s for their "heroic" efforts to help patients get their Medicare Part D drugs.

The HealthWell Foundation, a nonprofit organization that assists indigent patients in meeting their cost-sharing obligations for Rx medications, has launched four new programs to help patients afford the medical treatments they need. The new programs will assist patients with colorectal cancer, moderate to severe asthma, non-small cell lung cancer, and non-Hodgkin's lymphoma.

NCPA has urged CMS to not allow drug plans and drugstore chains to co-brand Part D identification cards. Independent pharmacists contend that the co-branded Rx cards confuse beneficiaries into mistakenly thinking they can get their medications only at the drugstores shown on their ID cards.

Charfoos & Christensen has filed a lawsuit against Walgreens on behalf of Michael Wells in U.S. District Court, Eastern District of Michigan. Attorney Douglas Peters of Charfoos & Chistensen told Drug Topics that Wells' surgeon prescribed the antibiotic Duricef (cefadroxil/cefadroxil hemihydrate, Warner Chilcott) to prevent the development of postsurgical wound infection.

First DataBank has introduced the OrderView Med Knowledge Base CPOE-ready drug database designed to be physician-friendly by reducing mouse clicks and drug pick lists, according to the San Diego technology firm. One component of the system is Orderable Meds, which focus only on data necessary for ordering, not for dispensing, administration, research, or billing.

The American College of Apothecaries (ACA) has created the American College of Hospice Pharmacists for R.Ph.s interested in strengthening their knowledge and skills in hospice care and pain management. Programs being developed for the specialty college include separate newsletters for pharmacists, prescribers, and patients/caregivers, as well as a 20-hour didactic certificate program to be offered during ACA's annual meeting and a lab-based 16-hour certificate program to be offered at ACA's Research & Education Center.

Physicians will be able to securely access patient medication histories through pharmacies that belong to the SureScripts electronic prescribing network. Physicians will be able to see a patient's medication records and pharmacy data, such as allergies and when drugs were dispensed, across all prescribers.

CMS has ruled that prescription niacin products, such as Niaspan and Niacor, are prescription vitamins and are, therefore, excluded from Part D coverage. After May 31, the two products cannot be included in Part D formularies.

A group of pharmacists has launched USGenerics, an on-line pharmacy offering patients FDA-approved generics for 30-day and 90-day scripts. To keep prices low, the Wisconsin-based firm does not accept any insurance plans.

The iPLEDGE program, a risk management plan to prevent pregnancy during isotretinoin therapy, is being called too cumbersome and difficult to manage by dermatologists. The program's start date is set for March 1.

Parents of infants suffering with fungal-infected diaper rash will now have a new form of treatment available. Vusion ointment containing 0.25% miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum has been approved by the FDA and is the first product for diaper dermatitis complicated by candidiasis.

The March of Dimes applauded the new FDA iPLEDGE program. The March of Dimes urged the agency to monitor the program's effectiveness and to create comparable programs for other oral retinoid medications.

Forty-four states will participate in a CMS program to reimburse them for drugs and administrative costs associated with dual eligibles in the Part D benefit. CMS will reconcile each state's drug payments with Part D plans and pay the difference between the plan reimbursement and the state's Medicaid costs, as well as the administrative tab.

Since its home state has no pharmacy school, Community Pharmacies is offering a one-year scholarship to a Maine resident attending the Massachusetts College of Pharmacy and Health Sciences in Boston. The scholarship covering the winner's final year of tuition is currently worth about $25,000.

The Commission for Certification in Geriatric Pharmacy (CCGP) will switch to computer-based testing beginning March 15. Candidates will be able to take the certification test at the nearest H&R Block Premium Center and receive immediate exam results.

The Generic Pharmaceutical Association (GPhA) outlined its priorities for 2006 at its annual meeting, held recently in Boca Raton, Fla. Priorities include the codification of a flexible and definitive abbreviated approval process for generic biopharmaceuticals, a halt to the practice of authorized generics, the creation of a biodefense pharmaceutical sector, and reform of the Medicaid program.

Par Pharmaceutical has launched an advanced formulation of megestrol acetate, Megace ES 625 mg/5 ml (megestrol acetate) oral suspension. Megace ES is indicated for the treatment of anorexia, cachexia, or a significant, unexplained weight loss in patients with a diagnosis of AIDS.

DrugMax announced it has signed a letter of intent to acquire the stock of Carmichael Cashway Pharmacy, operator of three pharmacies known as Carmichael Pharmacy Infusion Therapy & Medical Equipment, (The Carmichael Pharmacy Group). The Carmichael Pharmacy Group provides specialty pharmacy; institutional pharmacy services; and respiratory and related medical equipment, including products and therapies requiring infusion compounding, to patients and physicians.

Walgreens Home Care has agreed to acquire Canadian Valley Medical Solutions. Based in Oklahoma City, CV Medical Solutions is an accredited provider of home infusion therapy, respiratory services including home oxygen, customized mobility and seating products, and home medical equipment.

Seniors enrolled in the Medicare drug benefit filled 11% more scripts in January than seniors without Part D coverage, according to Verispan, a healthcare informatics firm based in Yardley, Pa. The average Part D beneficiary aged 65 and older filled 3.38 scripts, compared with 3.05 scripts for nonbeneficiaries of the same age cohort.

PharMEDium Services, a provider of outsourced hospital pharmacy compounding solutions, announced that syringe admixtures will now ship with enhanced bar-coding. The new composite bar codes include a lot number and expiration date along with the drug's NDC number, which can all be read with one scan.

Mead Johnson Nutritionals has initiated a voluntary recall of one batch of Gentlease powder infant formula in 24-oz. cans, batch number BMJ19. This action is being taken because a portion of the batch was found to contain metal particles.

The Medicare Part D drug benefit has hurt cross-border drug sales by as much as 30%, according to the Canadian International Pharmacy Association. The group also contends that U.S. authorities have stepped up enforcement of laws against drug importation in recent weeks.

Procter & Gamble has filed a lawsuit against Vi-Jon Industries. The lawsuit, filed in the U.S. District Court for the Southern District of New York, alleges that Vi-Jon infringed and diluted the unique trade dress of P&G's Crest Pro-Health, "a highly effective antiplaque/antigingivitis oral rinse, and also engaged in false advertising of its mouthwash product."