Formulary Watch |

Bush budget outlines healthcare priorities

The central healthcare initiative in the administration's $2.2 trillion budget proposal for fiscal year 2004 is to establish a Medicare prescription drug benefit. President George W Bush proposes to spend $6 billion as a "down payment" on a $400 billion/10-year Medicare drug benefit and "modernization" plan.

Evidence-based Antimicrobial Therapy: Responsible Use of Fluoroquinolones in Today?s Clinical Practice (PDF)

Treatment strategies from: Vincent T. Andriole, MD, Professor of Medicine, Yale University School of Medicine Attending Physician, Yale-New Haven Hospital, New Haven, Connecticut

Prozac (Fluoxetine hydrochloride) Eli Lilly

Antidepressant now approved for use in pediatric patients

Serious respiratory adverse events may be associated with salmeterol in patients with asthma

Glaxo-SmithKline (GSK) has advised prescribers of salmeterol (Serevent) about rare, but potentially serious, respiratory adverse events in patients with asthma.

Restasis (Cyclosporine ophthalmic emulsion, 0.05%) Allergan

New formulation: Drug increases tear production in patients with chronic dry eye due to ocular inflammation

Changes in Congress and FDA shape healthcare policy

The recent selection of Sen Bill Frist (R-Tenn), MD, to lead Senate Republicans has moved healthcare policy up the priority list in the Senate. As a physician, Dr Frist has played a lead role in assessing federal health programs and policies.

Humira (Adalimumab) Abbott Laboratories

NME: New treatment for rheumatoid arthritis

Atorvastatin may inhibit clopidogrel activity

Ann Arbor, Mich-Atorvastatin, especially at higher dosages, may preventactivation of the antiplatelet agent clopidogrel, according to researchat the University of Michigan, Ann Arbor.

Extraneal (Icodextrin peritoneal dialysis solution) Baxter

NME: New solution for home-based peritoneal dialysis

Atomoxetine: A nonstimulant therapeutic option for children and adults with attention-deficit hyperactivity disorder

Atomoxetine, a norepinephrine reuptake inhibitor, is the first nonstimulant agent approved for the treatment of ADHD (Strattera, Lilly). It has been approved for use in pediatric and adult patients. Atomoxetine improves ADHD symptom severity versus placebo, as evaluated by the ADHD Rating Scale (ADHD RS), and its efficacy appears comparable to immediate-release methylphenidate. Atomoxetine requires dosage titration and may be administered once or twice daily. Common side effects seen in both pediatric and adult patients include nausea, decreased appetite, and dizziness. Dosage adjustments are necessary for patients receiving atomoxetine and cytochrome P450 2D6 inhibitors. Based on average wholesale price (AWP), atomoxetine is more costly than existing ADHD therapies. Atomoxetine provides an alternative ADHD therapy for patients who may fail or cannot tolerate conventional treatments.

An overview of the pathophysiology and treatment of secondary peritonitis

Intraabdominal infection was first thoroughly described by Hippocrates. Centuries later, despite advances in surgical and supportive therapies, this disease state continues to be associated with significant morbidity and mortality. This article reviews the literature on intraabdominal infections. It describes the pathophysiology, classification, and etiology of intraabdominal infections, focusing primarily on secondary peritonitis. The bacteriology of the gastrointestinal tract in both the normal and infected host is reviewed. Treatment options, including newly approved antimicrobial agents and agents under clinical investigation, are reviewed.

FDA to speed up DTC regulatory actions

Direct-to-consumer (DTC) advertising is boosting prescription use, pharmaceutical companies are spending more on DTC ads, and FDA needs to act more quickly to remove false or misleading commercials from the air.

Atorvastatin may inhibit clopidogrel activity

Ann Arbor, Mich-Atorvastatin, especially at higher dosages, may prevent activation of the antiplatelet agent clopidogrel, according to research at the University of Michigan, Ann Arbor.

Eye on Literature: New treatment guidelines have been released for the management of acute migraine attacks and for preventing migraine headaches.

The American Academy of Family Physicians and the American College of Physicians­American Society of Internal Medicine, with assistance from the American Headache Society, released the migraine treatment guidelines. Migraine headaches affect 18% of women and 6.5% of men in the United States and are a major cause of absenteeism and reduced productivity.

ASHP, AMA ask for federal assistance to resolve drug shortage problem

Washington, DC-Representatives from the American Society of Health-SystemPharmacists and the American Medical Association met with the Health andHuman Services assistant secretary for health Eve Slater, MD, and FDA'sdeputy commissioner Lester Crawford, DVM, PhD, in late January to discussdrug shortages and ask for federal assistance in resolving the problem.

An overview of the pathophysiologyand treatment of secondary peritonitis

Intraabdominal infection was first thoroughly described by Hippocrates. Centuries later, despite advances in surgical and supportive therapies, this disease state continues to be associated with significant morbidity and mortality. This article reviews the literature on intraabdominal infections. It describes the pathophysiology, classification, and etiology of intraabdominal infections, focusing primarily on secondary peritonitis. The bacteriology of the gastrointestinal tract in both the normal and infected host is reviewed. Treatment options, including newly approved antimicrobial agents and agents under clinical investigation, are reviewed.

First-time generic approvals

As of July 1, 2002

Pipeline Preview as reported January 1, 2003

as reported January 1, 2003

Incorporating an ethical template into pharmacy benefit decision-making (PDF)

J Russell Teagarden, MA, RPh, vice president of clinical practices and therapeutics at Medco Health Solutions in Franklin Lakes, NJ, explains how using an ?ethical template? for pharmacy benefit decisions can make those decisions consistent and fair, reducing patient displeasure, conflict, and litigation.

A comparison of the newer treatment options for ADHD (PDF)

Psychostimulant drugs have consistently demonstrated efficacy in the treatment of attention-deficit/hyperactivity disorder (ADHD). Innovative technology has fueled the development of novel release mechanisms and isolation of active enantiomer components with the hopes of enhancing the duration of action and improving the safety and effectiveness. As a result, several new stimulant agents have recently been added to the arsenal of ADHD treatment options. Formulary selection is complicated by the high costs and small but distinct differences among these agents. The five newest FDA-approved stimulant agents for the treatment of ADHD are detailed, and a brief summary of future treatment options, including a recently approved nonstimulant agent, is provided.

Incorporating an ethical template into pharmacy benefit decision-making

If asked, could you present the underlying rationale for your pharmacy benefit coverage decisions? When considered from the consumer or employee perspective, why should they consider the payors or providers of their drug benefit legitimate decision-makers in limiting their healthcare policies?

Duloxetine: An antidepressant that inhibits both norepinephrine and serotonin uptake

Duloxetine is a reuptake inhibitor at serotonergic and noradrenergic neurons and appears to have low affinity for other neurotransmitter systems. In three published clinical trials in patients with MDD, duloxetine was well tolerated and more effective than placebo. Further study is needed to compare its efficacy with that of other antidepressants, to prospectively assess time to onset of antidepressant effect, and to clarify effects on somatic symptoms and potential adverse cardiovascular and sexual effects. Duloxetine is also under investigation for the treatment of stress urinary incontinence in women (trade name to be determined, comarketed by Lilly and Boehringer Ingelheim). Preliminary information suggests that duloxetine therapy reduces the number of incontinence episodes. Duloxetine has been deemed ?approvable? for the treatment of MDD and will be comarketed under the trade name Cymbalta by Eli Lilly and Company and Quintiles.

Zetia: Ezetimibe

Cholesterol-lowering drug represents new class

Pegasys: Peginterferon alfa-2a

Chronic hepatitis C therapy for patients with compensated liver disease

Dryvax: Smallpox vaccine

With the threat of bioterrorism, there was a need to reintroduce a smallpox vaccine. FDA has now approved this dried, calf lymph-type vaccine.

Healthcare at the forefront on federal, state levels

GOP control of both the Senate and House has pushed efforts to establish a Medicare drug benefit to the top of the legislative agenda. It also has moved proposals to reimport pharmaceuticals from Canada or Mexico and reform generic drug policy down the priority list.

Humana's four-tier benefit design: What does it look like, and how has it been working?

It's been a year and a half since Humana, Inc, made the move to a four-tier benefit design. Humana's rationale for evolving to the four-tier model, the technology and programs developed to support this benefit structure, and the initial success were discussed by James Stines, director of pharmacy sales for Humana.

From the literature: Adverse reactions to drugs are culprits in many deaths and injuries forchildren under 2

Adverse reactions to drugs are a significant cause of death and injuryin infants and children younger than 2 years, according to a report in theNovember issue of Pediatrics. The potential for adverse reactions in childrenis higher than it is in adults because young children have immature detoxificationmechanisms and because doses must be adjusted over a very wide range ofbody size and weight.

Migraine therapy: balancing efficacy and safety with quality of life and cost (PDF)

Successful management of migraine attacks and their symptoms leads to economic benefits such as decreased reliance on healthcare resources, decreased employee absenteeism, and increased productivity. Appropriate treatment includes prophylaxis with lifestyle changes and drug therapy, and acute therapy with drugs. Over-the-counter analgesics can be effective acute therapy for mild migraine; for moderate to severe attacks, the 5HT1B/1D agonists, or triptans, offer significant efficacy and cost-effectiveness.

Ezetimibe: a novel cholesterol absorption inhibitor (PDF)

Ezetimibe (Zetia), approved in late October, represents the first new class of cholesterol-lowering drugs in 15 years. Ezetimibe, an intestinal cholesterol absorption inhibitor, has a unique mechanism of action, distinct from those of statins and bile acid sequestrants. When used as monotherapy, ezetimibe lowers low-density lipoprotein cholesterol (LDL-C) levels up to 18.5%. Coadministration of ezetimibe with statin therapy reduces LDL-C levels up to an additional 22%. The article reviews ezetimibe?s chemistry, pharmacology, pharmacokinetics, and clinical trial results.