Formulary Watch |

Assessing the impact of outcomes projects: Take your lead from the AHRQ approach (PDF)

To retain resources or to justify allocation of additional resources, it's essential to demonstrate the value that outcomes projects bring to organizations. The Agency for Healthcare Research and Quality's project review process serves as a useful model for how to do so. This month's column explores the AHRQ process for following up and communicating the results of outcomes projects conducted at various practice settings.

ACR issues new rheumatoid arthritis guidelines

Prompted by the proliferation of new therapies in the field, the American College of Rheumatology has updated its guidelines for the management of rheumatoid arthritis.

Warfarin plus aspirin no better than aspirin alone after MI

Contraryto hypothetical additive benefits, a combination of aspirin and warfarinappears to be no more effective than aspirin alone for preventing vascularevents and death after acute myocardial infarction (MI). So concludes arandomized, open-label Department of Veterans Affairs study in 5,059 post-MIpatients.

Direct thrombin inhibitors top heparin in ACS

Direct thrombin inhibitors are superior to heparin in preventing death or myocardial infarction (MI) in patients with acute coronary syndromes (ACS), according to a meta-analysis of 11 randomized trials.

WellPoint to roll out reference price-based benefit design for commercial clients

WellPoint Health Networks plans to take reference drug pricing into new territory-commercial pharmacy benefits.

Teriparatide: A recombinant human parathyroid hormone fragment with anabolic actions for treatment of osteoporosis (PDF)

Medications currently available to treat osteoporosis slow the rate of bone loss primarily by reducing bone resorption. The purported advantage of the anabolic agent teriparatide is that it actually promotes new bone growth. Clinical trials have shown the drug to be effective for vertebral fracture prevention in postmenopausal women at high risk. Additional evidence is accumulating to support teriparatide's use in other populations (including men) with osteoporosis. This injectable is likely to receive FDA approval in the second half of this year.

Review and assessment of pharmacologic management strategies for reflux esophagitis (PDF)

Pharmacologic therapy is the second cornerstone of the medical management of reflux esophagitis. Because the merits of various drug classes for reflux esophagitis have been widely discussed, the focus of this article is on differing strategies for using these classes. The management strategies - and the rationale and evidence for promoting or rejecting them - are discussed for step-up therapy, empiric therapy, ste-down therapy, on-demand proton pump inhibitor use, combination therapies, and other considerations.

Success of a P & T policy for use of a second ACE inhibitor before switching to an ARB (PDF)

VA Medical Center, Miami-ACE inhibitor therapy is recognized as the gold standard treatment for congestive heart failure (CHF) as well as diabetic nephropathy due to its effect on the morbidity and mortality associated with these conditions.

FDA Actions in Brief

FDA actions in brief as reported February 1, 2002

Advicor (Niacin extended-release/lovastatin tablets), Kos

New combination: Fixed niacin/statin combination for second-line lipid therapy

Elidel (Pimecrolimus cream 1%)

NME: Topical nonsteroid for second-line eczema Tx

Dutasteride (Dutasteride soft-gelatin capsules), GlaxoSmithKline

NME: 5-alpha reductase inhibitor for treatmentof benign prostatic hyperplasia

Clarinex (Desloratadine tablets)

NME: Loratadine successor for symptoms of seasonal allergic rhinitis

Pipeline Preview

as reported February 1, 2002

Formulary acceptance rates for atypical antipsychotics and cholinesterase inhibitors (PDF)

Atypical antipsychotics withstand strong Geodon debut; Reminyl slices into formulary presence of Alzheimer rivals

Valdecoxib: A COX-2 inhibitor for treatment of osteoarthritis, rheumatoid arthritis, and primary dysmenorrhea (PDF)

With its FDA approval in November, valdecoxib becomes the hird COX-2 inhibitor to gain US market clearance. This Focus article examines valdecoxib's pharmacologic, pharmacokinetic, and therapeutic aspects and considers its role in relation to other COX-2 inhibitors and traditional NSAIDs. Special attention is devoted to its comparative COX-1:COX-2 inhibitory ratio and an array of unpublished efficacy and safety trials.

Huge meta-analysis refines role of antiplatelet therapy in high-risk patients

This 287-study meta-analysis aimed to address unanswered questions about antiplatelet therapy in patients at high risk for occlusive vascular events. It yielded several new findings or clarifications, including these: (1) Antiplatelets protect against vascular events in patients with unstable angina, intermittent claudication, and atrial fibrillation. (2) Antiplatelet therapy can be started promptly during acute ischemic stroke and continued long-term. (3) Daily aspirin doses of 75 to 150 mg seem to be as effective as higher doses for long-term treatment.

UTI scripts trend away from drug of choice

Fluoroquinolones and nitrofurantoin have surpassed trimethoprim-sulfamethoxazole (TMP-SMZ) as the most frequently prescribed antibiotics for uncomplicated urinary tract infections (UTIs) in women, according to a new national analysis. This is despite well-established recommendations (from the Infectious Disease Society of America and others) that TMP-SMZ is the drug of choice for UTIs due to cost and concerns about antibiotic resistance.

Three-tier benefit cuts Rx costs without unintended consequences

A three-tier pharmacy benefit can reduce prescription drug spending without increasing other medical resource use or fueling medication discontinuation rates. So concludes the fully published report of an analysis whose preliminary results were presented last year and reported by Formulary (2001;36:522). It is the first well-designed, controlled study to explore such consequences of three-tier benefits.

Study cautions against overtreatment when adopting new NCEP III guidelines

Clinicians must use caution in adopting newly revised national guidelines for treating elevated cholesterol, concludes a new study from the University of Maryland Pharmaceutical Health Services Research Department.

Investigational antiviral reduces duration, eases severity of viral respiratory infections

An experimental antiviral medication can shorten the duration of colds and reduce the severity of cold symptoms, reported Frederick Hayden, MD. He presented a pooled analysis of data from two phase III trials of the drug at the 41st annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), held recently in Chicago.

Update on the benefits and risks of hormone replacement therapy (PDF)

Emerging data are continually refining our understanding of the risks and benefits of hormone replacement therapy (HRT) in postmenopausal women. This review assesses the current state of evidence on these various risks and benefits, concluding with an outline of what's established and where varying degrees of uncertainty remain. Algorithms for use of HRT for several established indications are featured.

Drug development gets budgetary boost as regulatory updates start to emerge

While government agencies and private health plans struggle to deal with rising pharmacy bills, the federal government is expanding support for biomedical research and FDA

Pharmacy services in an ambulatory FFS setting can increase physician revenue

Idaho State University, Pocatello-Evidence in the literature has suggested that a pharmacist-run clinic provides quality care in chronic disease state management. In addition

Success of a P & T policy for use of a second ACE inhibitor before switching to an ARB

VA Medical Center, Miami-ACE inhibitor therapy is recognized as the gold standard treatment for congestive heart failure (CHF) as well as diabetic nephropathy due to its effect on the morbidity and mortality associated with these conditions.

Ortho Evra (Norelgestromin/ethinyl estradiol transdermal system) Ortho-McNeil

New combination, NME as component: Weekly contraceptive skin patch

Focalin (Dexmethylphenidate HCL Tablets) Novartis

New formulations: Single isomer form of methylphenidate for treatment of ADHD

Coreg (Carvedilol Tablets), Glaxosmithkline

New indication: Beta blocker cleared for severe HF

Xigris (Drotrecogin Alfa, Activated) Lilly

Biologic: Biologic for adults with severe sepsis at high risk of death

Tracleer (Bosentan film-coated tablets) Actelion

NME: First oral agent for treatment of pulmonary arterial hypertension