News

An insightful man named Blake Segal once said, "It is not a parent's job to protect their kids from life, but to prepare them for it." Wise words indeed, and ones that Bob Greczyn has taken to heart. Although he has three children of his own, he wants to help prepare yours for a healthy future, and everyone else's as well.

Bethesda, Md.-The daily activities of health-system pharmacists are greatlyaffected by the Health Insurance Portability and Accountability Act of 1996(HIPAA). To help keep practitioners up-to-date with current regulationsand other important information, ASHP has developed an online resource centeron its website, www.ashp.org.

Meeting Preview

James E. Orlikoff (pictured at right), an expert in health-care governance,organizational development, and leadership quality, will be the keynotespeaker during the meeting's Opening General Session that takes place from9 a.m. to 11 p.m. on Monday, Dec. 8, in Hall D. He is president of Orlikoffand Associates, Inc., a consulting firm specializing in health-care governanceand leadership quality, organizational development, strategy, and risk management.He is the National Advisor on Governance and Leadership to the AmericanHospital Association and Health Forum.

An intravenous formulation of lansoprazole has been developed and is under review by FDA. If approved, lansoprazole will be the second IV proton pump inhibitor available in the United States, providing an alternative to the currently available pantoprazole IV. The pharmacokinetic and pharmacodynamic properties of lansoprazole IV have been found to be comparable to the oral form. Until more data are available the agent, if approved, should be reserved as an option for patients unable to take lansoprazole via the oral route.

Atazanavir is a novel azapeptide protease inhibitor (PI) that has been approved by FDA for use in combination with other antiretroviral agents in treatment-naïve and treatment-experienced HIV-infected individuals. Atazanavir has a low pill burden consisting of 2 capsules administered once daily and it has an adverse effect profile that is not associated with clinically relevant lipid effects. In clinical studies of up to 48 weeks, atazanavir demonstrated comparable antiretroviral efficacy to nelfinavir and efavirenz in treatment-naïve patients. The most common adverse effect associated with atazanavir is a reversible dose-related increase in unconjugated (indirect) bilirubin.

State governments and enforcement agencies have become more active in efforts to regulate drug sales and marketing and have addressed a number of pressing issues:

December FDA Pipeline

New molecular entities and new formulations, FDA actions and generic approvals

Genetic guidance

Bea Leopold knows only too well how traumatic and potentially life-altering genetic testing can be. Having a sister with ovarian cancer and a mother who died of breast cancer convinced Leopold to be tested three-and-a-half years ago for the BRCA gene, which is predictive of both kinds of cancer.

All too often, the fundamentals of a sport, industry or discipline are learned at the early stages but then forgotten as an individual advances in knowledge and sophistication. And that, according to Joe Anderson, is the problem that has caused so many healthcare headaches over the years.

The continuing rise of resistance rates among bacteria today has led to the need for the development of new antibiotics with the ability to circumvent current resistance mechanisms. Daptomycin (Cubicin, Cubist Pharmaceuticals) is an injectable novel lipopeptide antibiotic shown to have excellent in vitro bactericidal activity against gram-positive organisms, including resistant isolates. First in the new class of lipopeptide antibiotics, daptomycin possesses a unique mechanism of action. Daptomycin was recently approved by FDA for the treatment of complicated skin and skin structure infections caused by susceptible strains of specific gram-positive microorganisms. Daptomycin may offer an alternative in the treatment of gram-positive infections, especially when resistance is suspected.

The continuing rise of resistance rates among bacteria today has led to the need for the development of new antibiotics with the ability to circumvent current resistance mechanisms. Daptomycin (Cubicin, Cubist Pharmaceuticals) is an injectable novel lipopeptide antibiotic shown to have excellent in vitro bactericidal activity against gram-positive organisms, including resistant isolates. First in the new class of lipopeptide antibiotics, daptomycin possesses a unique mechanism of action. Clinical studies in patients with complicated skin and skin structure infections have shown daptomycin to be similar in clinical cure rates compared to standard therapy. Daptomycin was recently approved by FDA for the treatment of complicated skin and skin structure infections caused by susceptible strains of specific gram-positive microorganisms. Daptomycin may offer an alternative in the treatment of gram-positive infections, especially when resistance is suspected.

The direct and indirect healthcare costs associated with multiple sclerosis are high. In the managed care setting, before treatment is initiated, these costs must be reconciled with other factors such as the epidemiological and clinical features of MS and current recommendations for pharmacologic management. Managed care organizations (MCOs) have the opportunity to improve the outcomes of MS through a system of care. MCOs can also manage the costs of the 2 first-line therapies (glatiramer and agents from the interferon class) used to treat MS by using stepped care and preferred formulary designations. In addition, improved outcomes can be achieved by establishing a disease management approach to treat MS.