Drug Pipeline

Memantine (Namenda, Forest) is the newest medication to receive FDA approval for the treatment of Alzheimer?s disease and the first to be approved with a moderate-to-severe indication. All previously approved Alzheimer?s disease treatments belong to the cholinesterase inhibitor class and are approved with a mild-to-moderate indication. Memantine has been used for more than 10 years in Germany and features a novel mechanism of action: N-methyl-d-aspartate (NMDA) antagonism. It has been shown to be effective in double-blind, placebo-controlled trials as monotherapy and in combination therapy with the cholinesterase inhibitor donepezil in patients with moderate-to-severe Alzheimer?s disease.

Efalizumab (Raptiva, Genentech/Xoma) is a humanized monoclonal antibody of CD11a that exerts its effect through the blockade of the interaction between leukocyte function-associated antigen-1 (LFA-1) and intercellular adhesion molecule-1 (ICAM-1). FDA recently granted approval for efalizumab in the treatment of chronic moderate-to-severe plaque psoriasis in adults aged 18 years and older. Efalizumab does not achieve clinical response rates equal to cyclosporine or methotrexate, but it lacks the systemic organ toxicities of these agents and is associated with a more rapid onset of action (significant improvements in Psoriasis Area and Severity Index [PASI] response after 2 doses). In addition, efalizumab will likely compete with another approved biologic, alefacept, and off-label use of 2 other biologics currently on the market, etanercept and infliximab. At this time, until further studies comparing efalizumab to other drugs indicated for the treatment of psoriasis are completed and post-marketing surveillance is conducted, the agent?s place on the formulary remains unclear.

Triazole antifungal approved for treatment of esophageal candidiasis

New packaging contains PPI and NSAID

Novel therapy for COPD

Atypical antipsychotic receives bipolar indication

New policies expand coverage and promote generics while emphasizing pharmacy care and cost-effectiveness

Letrozole therapy, in follow-up to 5 years of tamoxifen treatment, significantly improves disease-free survival compared to placebo, according to a study published in The New England Journal of Medicine.

A regimen of docetaxel and cisplatin offers better survival and response rates than a combination of vinorelbine and cisplatin in the treatment of advanced non-small-cell lung cancer, according to a phase 3 study published in the online version of the Journal of Clinical Oncology. In addition, the findings demonstrated that docetaxel is as effective as vinorelbine/cisplatin when combined with another platinum, carboplatin.

The clinical benefit of aspirin on first myocardial infarction diminishes with regular-but not intermittent-use of nonsteroidal anti-inflammatory drugs, according to a study published in the journal Circulation.

New Orleans-The results of the Antihypertensive and Lipid-Lowering Treatmentto Prevent Heart Attack (ALLHAT) Trial, along with the highlights of theSeventh Report of the Joint National Committee on Prevention, Detection,Evaluation, and Treatment of High Blood Pressure (JNC 7), were reviewedat an educational session of the recently concluded 38th ASHP Midyear ClinicalMeeting.

The American Heart Association (AHA) Scientific Sessions comprise the largest meeting of its kind held in the cardiovascular field, with several thousand presentations given each year. The recently concluded 2003 AHA Scientific Sessions included presentations of trials that evaluated potential therapeutic compounds, as well as widely used and accepted compounds in new dosages or combinations, for the treatment of cardiovascular disorders. The compilation of clinical news reviewed focuses on the cardiovascular pharmacotherapy trials of greatest interest to formulary decision-makers, including: VALIANT, REVERSAL, SPORTIF V, PAPABEAR, PRIMO-CABG, and CREST.

New Orleans-ASHP is launching a major new effort to help promote bestpractices in health-system pharmacy. The ASHP Best Practices Self-AssessmentTool will provide pharmacy managers with an easy-to-use instrument to identifypossible gaps in relation to best practices.

New Orleans-Providing pharmacy services in nontraditional settings, implementing medication scanning technologies, and developing strategies to improve immunization rates of high-risk patients are just some of the innovations recognized by ASHP's Best Practices Award in Health-System Pharmacy.

New Orleans-The ASHP Research and Education Foundation is offering anew research grant program for the next 3 years focused on the partnershipbetween pharmacists and nurses in fostering a safe medication-use system.The program's goal is to strengthen the relationship between pharmacistsand nurses as they work together to provide safe care to patients. The competitivegrant program will offer $80,000 per year in funding over the next 3 yearsto research teams that investigate new design characteristics and processesin the medication-use system intended to improve medication outcomes forpatients.

New Orleans-ASHP honored Kevin L. Roberg yesterday for his efforts toreduce medication errors in hospitals and health systems. Roberg receivedthe society's Board of Directors Award of Honor during the opening sessionof the 38th ASHP Midyear Clinical Meeting.

New Orleans-The poster sessions at the 38th ASHP Midyear Clinical Meetingencourage attendees to informally discuss current projects in pharmacy practicewith colleagues. The sessions are an opportunity to gather ideas and informationfrom hundreds of successful programs implemented at other health-care systems.

New Orleans-The results of the Antihypertensive and Lipid-Lowering Treatmentto Prevent Heart Attack (ALLHAT) Trial, along with the highlights of theSeventh Report of the Joint National Committee on Prevention, Detection,Evaluation, and Treatment of High Blood Pressure (JNC 7), were presentedon Dec. 9 at an educational session of the 38th ASHP Midyear Clinical Meeting.

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.

Bethesda, Md.-Leaders of the Pharmacists Provider Coalition say theysupport Congress' commitment to medication therapy management services forhigh-risk seniors, calling the provision "a big step forward for patientsafety."

Bethesda, Md.--A new version of the ASHP Drug Product Shortages ManagementResource Center is now available to members and other health-care professionalswho need up-to-date, accurate information on alternatives for drug productsthat are in short supply.

Bethesda, Md.--Health-system pharmacists now have a resource to aid theirongoing efforts to ensure the integrity of drug products. ASHP has developedstrategies that practitioners should follow to help prevent the acquisitionof counterfeit drugs.

Washington, DC-In a victory for Medicare patients, the Centers for Medicareand Medicaid Services (CMS) has decided to continue contributing directlyto the funding of pharmacy residency training in hospitals. The regulationaddresses CMS's annual payment rates for the Hospital Inpatient ProspectivePayment System for fiscal year 2004 that began on October 1.

Bethesda, Md.--The American Society of Health-System Pharmacists (ASHP)endorses the new Medicare Prescription Drug, Improvement, and ModernizationAct passed in late November. ASHP leaders say this legislation takes animportant step forward, adding prescription drug coverage to the Medicareprogram and giving high-risk elderly patients new access to vital medicationtherapy management services.

Rockville, Md.--As of January 1, 2004, all JCAHO-accredited organizations(hospitals and health-care facilities) will be assessed to ensure that theyare implementing JCAHO's National Patients Safety Goals. New goalsare set annually in July and take effect January 1 of the following year.