Palonosetron: A novel 5-HT3 receptor antagonist for chemotherapy-associated nausea and vomiting
July 1st 2003Nausea and vomiting are among the serious complications of chemotherapy and can be associated with medical and psychological complications. Palonosetron (Aloxi, MGI Pharma/Helsinn) is a new agent in the class of serotonin type 3 (5-HT3) receptor antagonists that have become a standard of care for the prevention of chemotherapy-induced nausea and vomiting. Palonosetron has a much longer half-life (~40 h) than typical 5-HT3 receptor antagonists and potentially improved efficacy in the prevention of delayed nausea and vomiting associated with moderately and highly emetogenic chemotherapy. Clinical trials of palonosetron in patients with cancer demonstrate its efficacy in the control of acute nausea and vomiting and its superiority to 2 agents in this class, dolasetron and ondansetron, in the control of delayed nausea and vomiting. Palonosetron is well-tolerated, with an adverse effect profile similar to other 5-HT3 antagonists. Its efficacy in the prevention of both acute and delayed nausea and vomiting makes palonosetron an attractive option for patients receiving chemotherapy. Further studies need to be conducted to determine the role of palonosetron among its competitors. (Formulary 2003;38:414?430.)
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Pharmaceutical marketing practices and generic drugs in the spotlight
July 1st 2003Formulary committees, pharmacy benefit managers (PBMs), pharmacists, and physicians face increased scrutiny of their relationships with pharmaceutical manufacturers under a final fraud policy statement from the Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS).
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Making the move: Bringing pharmacy benefit management in-house
July 1st 2003Controlling the rate of growth in prescription drug expenses continues to be a challenge. The cost of offering healthcare insurance benefits, including prescription drug benefit programs, has increased to a rate of nearly 20% in 2003. Costs are expected to rise by double digits over the next 5 years. This daunting trend has influenced HMOs and other benefit providers to consider moving pharmacy benefit management in-house to cut costs.
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July DTR Analysis: There's more to Medicaid than meets the eye
July 1st 2003With state governments hemorrhaging with budget deficits across the country,states have become equally focused on adopting and expanding Medicaid solutionson one hand, and generally cutting back on benefits on the other.
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After attending the delivery of a baby in a community hospital in Louisville, Ky., Dr. Larry Cook paused for a moment in the hallway, still in his green hospital scrubs. The new baby's grandmother, a woman in her 50s, beaming with joy, approached Dr. Cook and threw her arms around him instinctively. Hugging him she said, "Dr. Cook, 21 years ago you attended the delivery of my daughter and provided her newborn care. And just now, you've attended the delivery of her child."
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A clinical review of montelukast in the treatment of seasonal allergic rhinitis (PDF)
June 1st 2003Seasonal allergic rhinitis is a disease characterized by sneezing, nasal congestion, rhinorrhea, and itching, conventionally treated with intranasal corticosteroids and antihistamines. The leukotriene receptor antagonist montelukast (Singulair, Merck) recently gained FDA approval for the treatment of seasonal allergic rhinitis. While studies have shown the efficacy of montelukast in the treatment of seasonal allergic rhinitis, there are no published clinical efficacy trials to date to support the use of montelukast alone or in combination with antihistamines as a superior therapy to intranasal corticosteroids in the management of seasonal allergic rhinitis. When combined with current economic considerations, the primary role of montelukast appears to be as an adjunct agent in patients whose seasonal allergic rhinitis symptoms cannot be controlled with intranasal corticosteroids or nonsedating antihistamines alone.
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Micafungin: A new echinocandin antifungal (PDF)
June 1st 2003A new echinocandin, micafungin (Mycamine, Fujisawa), is currently under review for the treatment of systemic mycoses. If approved, micafungin would be the second agent in the echinocandin class available for use in the United States. It is believed to exhibit fungicidal or fungistatic activity against a variety of commonly encountered fungal pathogens including Candida and Aspergillus species. In addition to its broad spectrum of activity, initial clinical studies with micafungin have identified relatively few side effects and drug interactions. Micafungin exerts its antifungal activity at the level of the fungal cell wall via inhibition of 1,3 b?d-glucan synthase. Plasma concentrations follow a 2-compartment model with a half-life of 10 to 15 hours and a volume of distribution of 0.2 to 0.27 L/kg. Dose adjustments of micafungin due to hepatic or renal dysfunction appear to be unnecessary. Adverse events associated with micafungin are infrequently encountered and are generally mild in severity. Micafungin has been available in Japan since late 2002 and is also currently under review in Canada and Europe. Micafungin may offer advantages over other recently approved antifungal agents because of its excellent tolerability and minimal drug interactions.
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Finicky travelers seek five-star hotels; avid movie-goers-two thumbs up. And now, healthcare consumers who once thought they'd never have a reliable rating system for hospitals and physicians will be pleased with the progress of the many organizations that now are providing user-friendly quality reports.
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If there's one thing Regina Herzlinger understands, it's the relationship between risk and benefit. Her home in Belmont, Mass., sits high on a hill and offers a stunning view of the Boston skyline across the Charles River. But there was a price to pay for that unobstructed view, and after a very frightening near-accident involving her car and some black ice, it didn't take Regina and her husband George-with doctorates in business and physics, respectively-long to realize that the risks were too high.
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Special Alert: The Preliminary Implications of SARS
May 15th 2003The epidemic of Severe Acute Respiratory Syndrome has barely touched upon U.S. soil. This briefing by an expert in the public health and economic consequences of infectious diseases clearly outlines the facts and the possibilities.
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The application of pharmacodynamics in the optimization of antibiotic therapy
May 1st 2003Antibiotic therapy has undergone enormous changes since the discovery of penicillin by Sir Alexander Fleming in 1928. 1. Today, clinicians face increasing reports of antibiotic resistance. Optimizing antibiotic regimens can maximize effectiveness and minimize adverse effects while decreasing the likelihood of the development of resistance. The task of designing optimal antibiotic dosing regimens incorporates pharmacodynamics (PDs), pharmacokinetics (PKs), and microbiological principles. PKs consist of absorption, distribution, metabolism, and excretion, with these parameters reflecting drug exposure over time. The relationship between drug exposure and the physiologic effect of the drug encompasses the principles of PDs. With antibiotic therapy, PDs incorporate exposure to the antibiotic and antimicrobial effect. The intricate relationship between these principles enhances the understanding of the efficacy of antibiotic therapy.
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The application of pharmacodynamicsin the optimization of antibiotic therapy (PDF)
May 1st 2003Pharmacodynamics, the relationship between drug exposure and physiologic effect, helps to differentiate the killing activity of antibiotic classes through various markers of outcome. Antibiotics are characterized by time-dependent or concentration-dependent bacterial killing activity. With antibiotic therapy, pharmacodynamics consists of an intricate relationship between drug exposure, bacterial susceptibility, and the antimicrobial effect of the drug. Due to increasing reports of resistance, many investigators and healthcare institutions are focused on the optimal use of antibiotic therapy. Studies on antimicrobial pharmacodynamics have been increasing in the hope of defining and establishing break points that are associated with various outcome markers to optimize therapy, but the application of these studies in clinical practice is still limited. Incorporating pharmacodynamics into the study of antibiotic therapy can enhance the design of rational and optimal dosing regimens and improve the understanding of the emergence of resistance.
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Adalimumab: A fully human monoclonal anti-tumor necrosis factor-alpha antibody (PDF)
May 1st 2003Adalimumab is the newest addition to a class of medications called tumor necrosis factor-alpha (TNF-a) inhibitors. Adalimumab (Humira, Abbott) is the first fully human monoclonal antibody approved to treat rheumatoid arthritis, distinguishing it from the other TNF inhibitors. FDA approval was received in December 2002, which was earlier than expected, based on clinical trial results that demonstrated a slowed progression of joint damage in addition to an improved quality of life in adalimumab-treated RA patients. Adalimumab has been found to be effective when used alone or in combination with methotrexate and/or other disease-modifying antirheumatic drugs. Existing TNF inhibitors for RA are associated with inconvenient or complicated dosing schedules. Adalimumab offers patients the convenience of an infrequent dosing schedule. In the absence of clinical trials directly comparing adalimumab with other biologic therapies, choice will largely depend on patient factors. Pricing information places adalimumab in line with its competitors.
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The application of pharmacodynamics in the optimization of antibiotic therapy
May 1st 2003Antibiotic therapy has undergone enormous changes since the discovery of penicillin by Sir Alexander Fleming in 1928. 1. Today, clinicians face increasing reports of antibiotic resistance. Optimizing antibiotic regimens can maximize effectiveness and minimize adverse effects while decreasing the likelihood of the development of resistance. The task of designing optimal antibiotic dosing regimens incorporates pharmacodynamics (PDs), pharmacokinetics (PKs), and microbiological principles. PKs consist of absorption, distribution, metabolism, and excretion, with these parameters reflecting drug exposure over time. The relationship between drug exposure and the physiologic effect of the drug encompasses the principles of PDs. With antibiotic therapy, PDs incorporate exposure to the antibiotic and antimicrobial effect. The intricate relationship between these principles enhances the understanding of the efficacy of antibiotic therapy.
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Partnerships between public health entities and private managed care systems have proven crucial for tracking public health trends. Now that the Centers for Disease Control and Prevention (CDC) is preparing to go live with its National Bioterror Syndromic Surveillance Demonstration Project, MCOs continue to shape the country's ability to recognize and respond to health threats, including ones posed by biological, chemical and radiological agents.
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Michael Cascone Jr. must be a big fan of Charles Darwin. When asked to identify the single most important issue facing healthcare today, the CEO of Blue Cross Blue Shield of Florida (BCBSF) replied, "Keeping the government out of benefits definition, and allowing people to shape the marketplace according to the benefits they want."
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