Community Practice

Wyeth Pharmaceuticals has announced the FDA approval of BeneFIX R2 Kit

Zanaflu will be the brand name for ANX-211, also known as chitosan gel, an intranasal/topical antiviral that has demonstrated efficacy against viruses responsible for the common cold, influenza, and other respiratory tract viral infections.

The FDA has created a Web site that will warn patients of the dangers of purchasing isotretinoin on-line.

TennCare, the Tennessee Medicaid program, reduced its overall pharmacy spending from $2.4 billion in 2005 to $1.2 billion in 2006, according to analysis by HealthLeaders-InterStudy.

NACDS has sent a letter to The Wall Street Journal to correct information in an article entitled, "Medicaid Proposal Is Bitter Pill for Pharmacies."

ACPE will be more rigorous in reviewing Pharmacy schools for accreditation. The change is spurred in part by the Department of Education, which surveys ACPE. Thanks to a more demanding DOE, ACPE put two pharmacy schools on probation recently.

HHS has released a 128-page report on realizing the promise of pharmacogenomics (PGx). The report discusses, among other issues, the educational needs of pharmacists, physicians, and other health professionals; PGx tests sold over the counter in drugstores; and the liability to M.D.s and R.Ph.s from off-label use of PGx.

FDA is issuing a final rule establishing that over the counter laxative drug products in granular dosage form containing the bulk-forming ingredients psyllium (hemicellulose), psyllium hydrophilic mucilloid, psyllium seed, psyllium seed (blond), psyllium seed husks, plantago ovata husks, and plantago seed are not generally recognized as safe and effective and are misbranded.

Here is the answer to the Rx Puzzler

What emergency medical countermeasures should the U.S. employ against chemical, biological, radiological, and nuclear threats?

It's not official until AMA publishes its CPT Manual 2008, but APhA officials are confirming that the CPT billing codes for medication therapy management are switching from a temporary to a permanent status.

Recognizing the growing problem of prescription drug abuse among teenagers, the White House Office of National Drug Control Policy (ONDCP) is partnering with pharmacy organizations to combat the problem.

Patients six years of age and older with primary generalized tonic-clonic seizures can now use levetiracetam (Keppra, UCB) as an adjunctive therapy to treat their epilepsy.

Patients with HER2-positive advanced or metastatic breast cancer whose disease has progressed following treatment with an anthracycline, a taxane, and trastuzumab (Herceptin, Genentech) will now have a new therapeutic option. Lapatinib (Tykerb, GlaxoSmithKline) has been approved by the FDA for use in combination with capecitabine (Xeloda, Roche) following a priority review.

CMS has launched a durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) Competitive Bidding Implementation Contractor (CBIC) Web site.

Medicare Part D patients now have detailed instructions on how to appeal decisions.

The next several years are expected to be sweet for the generic drug industry and rather bitter for brand pharmaceutical companies as they gear up to defend numerous patent challenges. This is a list of brand pharmaceuticals that will lose their patents through 2009.

This is the story of my bout with Lyme disease and what a harrowing experience it's been. I hope that by telling my story, I can help you learn from my experience and apply it to your practice.

New Rx New Generics

Welcome to the first installment of our new column, Rx Puzzler.

What follows is a review of the biggest news of 2006 in just a few categories, along with their new product standouts.

The FDA recommends that you counsel patients on the importance of reading product labels carefully to determine the active ingredients and dosing instructions of each product and to discourage them from making assumptions about use based on product names or appearance. The use of similar trade names (so-called "brand-name families") is common practice for OTC products. The products with the trade names "Sudafed" and "Sudafed PE" illustrate specific concerns.

Editor's note: Throughout 2007 this column, which takes a look at some of the most important moments in pharmacy history, will appear in each issue as part of our sesquicentennial celebration. Tied with this column is a pharmacy history contest, which we urge all readers to participate in. Monthly questions based on this column will be posted on the Drug Topics anniversary microsite. Contestants are eligible to win a Visa gift card of $250. For details about the contest, go to www.drugtopics.com.

Pharmacists Planning Service Inc. (PPSI) honors former Surgeon General Richard Carmona, M.D., and Julie Gerberding, M.D., director of the Centers for Disease Control and Prevention.

A group of researchers at the University of Florida College of Pharmacy recently submitted a citizen's petition asking the Food & Drug Administration to increase the maximum allowable dose of phenylephrine (PE) from 10 mg to 25 mg and to withdraw approval of phenylephrine for children under 12 years of age. The petition also called for additional research to validate the safety and effectiveness of the higher recommended dose.