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Fosamprenavir: A novel protease inhibitor and prodrug of amprenavir

Fosamprenavir (Lexiva, GlaxoSmithKline/Vertex) is the latest protease inhibitor (PI) approved by FDA for the treatment HIV-1 infection. A prodrug of amprenavir (APV), fosamprenavir has improved solubility and bioavailability over the parent PI, allowing for once- or twice-daily dosing and a decreased pill size and burden. In clinical trials, fosamprenavir was studied alone or boosted with ritonavir (RTV) in both HIV treatment-naïve and -experienced patients. In both patient populations, fosamprenavir decreased HIV RNA, increased CD4 cell counts from baseline, and increased the proportion of patients reaching undetectable viral loads (<400 and <50 copies/mL). Patients who received treatment with fosamprenavir demonstrated protease gene mutations different than those commonly seen with other PIs (except APV). Fosamprenavir appears to have an adverse effect profile similar to that of other PIs.

Pharmacotherapeutic options to prevent radiocontrast-induced acute renal failure

One of the primary etiologies of acute renal failure (ARF) is nephropathy secondary to the administration of radiocontrast dye. In the United States alone, the cost of ARF-related expenses is estimated at more than $8 billion per year. Since ARF contributes such a substantial burden to the cost of healthcare and may be associated with significant morbidity and mortality, initiatives to educate pharmacists, physicians, and other health-care providers about how to decrease the incidence of radiocontrast-induced ARF are warranted. It is important to identify patients at risk for developing this pathology and to play an active role in disease state prevention. This review covers the pathogenesis, signs and symptoms, and current treatment options for reducing the risk of radiocontrast-induced nephropathy. Current pharmacotherapy focuses on the use of aggressive hydration before and after the administration of a contrast agent. Clinical trials evaluating the application of periprocedural drugs are also reviewed.

Symbyax (Olanzapine and fluoxetine capsules) LILLY

First combination approved specifically for bipolar depression

Lexapro (Escitalopram) FOREST

SSRI approved for generalized anxiety disorder

Oral Contraceptives: The Extended Cycle Regimen

Authors Derek Van Amerongen, MD, MS Chief Medical Officer Humana Health Plan of Ohio Cincinnati, Ohio DonnaChiefari, RPH Director, Clinical Services NMHC Rx Latham, NY The views and opinions expressed in this supplement are those of the faculty and do not necessarily reflect the views of Advanstar Communications, Inc., publishers of Formulary, or Barr Laboratories Copyright 2004 Advanstar Communications, Inc., All rights reserved.

Oral Contraceptives: The Extended Cycle Regimen (PDF)

Extended use of combination monophasic oral contraceptives (OCs) used to treat women with menstrual disorders, such as endometriosis and dysmenorrhea, has been proven to be safe, effective, and acceptable to women. Even women without a medical indication for menstrual suppression may find that extending OC therapy may yield an improvement in their quality of life by diminishing menstrual symptoms associated with hormone withdrawal during the placebo interval. Most physicians and many women are aware of how to extend OC therapy, and commonly manipulate their cycles to avoid unwanted menstruation at inopportune times, such as during a honeymoon, vacation, or exams.

An update on oral contraceptive options (PDF)

The oral contraceptive marketplace has undergone evolutionary changes over the years. Early oral contraceptive formulations contained higher doses of estrogen and progestin, which were associated with several safety concerns. Consequently, scientists returned to the laboratories to develop lower-dose formulations that would minimize risk without compromising efficacy. To date, numerous formulations have entered the marketplace that allow for tailored dosing to meet a woman?s clinical and individual needs. In order to provide additional treatment options and create more convenient oral contraceptive regimens, monophasic, multiphasic, extended-cycle, progestin-only, and chewable regimens have emerged. This article will review the main health risks and benefits of oral contraceptives, the concept of extended-cycle regimens, and the financial implications associated with oral contraceptive use.

Oral Contraceptives: The Extended Cycle Regimen

Extended use of combination monophasic oral contraceptives (OCs) used to treat women with menstrual disorders, such as endometriosis and dysmenorrhea, has been proven to be safe, effective, and acceptable to women. Even women without a medical indication for menstrual suppression may find that extending OC therapy may yield an improvement in their quality of life by diminishing menstrual symptoms associated with hormone withdrawal during the placebo interval. Most physicians and many women are aware of how to extend OC therapy, and commonly manipulate their cycles to avoid unwanted menstruation at inopportune times, such as during a honeymoon, vacation, or exams.

Extended-release formulation of oxymorphone effective for pain relief in osteoarthritis

The opioid oxymorphone (Numorphan, Endo) delivered in a new extended-release (ER) formulation significantly improves standard measures of pain and physical function in osteoarthritis (OA) patients, researchers reported at the American College of Rheumatology 67th Annual Scientific Meeting.

Memantine: An oral NMDA antagonist for the treatment of moderate-to-severe Alzheimer?s disease

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: A new biologic therapy for the control of chronic plaque psoriasis

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.

Vfend (Voriconazole) PFIZER

Triazole antifungal approved for treatment of esophageal candidiasis

Prevacid NapraPac (Lansoprazole delayed-release capsules and naproxen tablets kit) TAP

New packaging contains PPI and NSAID

Advair Diskus 250/50 (Fluticasone 250 µg and salmeterol 50 µg inhalation powder)

Novel therapy for COPD

Risperdal (Risperidone) JANSSEN

Atypical antipsychotic receives bipolar indication

PBMs, formularies to play central roles in delivering Medicare drug benefit

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

As post-tamoxifen therapy, letrozole cuts breast cancer recurrence 43%

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.

Docetaxel/platinum combinations are efficacious in treatment of NSCLC

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.

Repeated NSAID use inhibits aspirin benefits to first MI.

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.

ALLHAT and JNC 7: Health-system applications and economic considerations

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.

Clinical news updates from the 2003 AHA Scientific Sessions

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.

ASHP provides tool to assess, close gaps in relation to best practices

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.

Health-system pharmacists receive 2003 Best Practices Award

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.

Medication safety research grants available to pharmacist/nurse teams

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.

Award and grants focus on medication safety

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.

ASHP poster presentations encourage sharing of ideas

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.

ALLHAT and JNC 7: Health-system applications and economic considerations

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.

ASHP offers guidance on implementing HIPAA regulations

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.

Pharmacists Provider Coalition supports enhanced role of pharmacistsin Medicare drug act

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."

ASHP introduces audio resource to help prevent verbal prescribingerrors

Bethesda, MD-Verbal medication orders pose more risk for errors thanthose that are electronic or written, due to sound-alike drug names. Tolower that risk, ASHP has introduced "AudioMeds: Medication Use andPronunciation," the first audio/print guide to pronunciation of bothgeneric and brand names for nearly 200 frequently prescribed medications.