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.
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.
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.
As of July 1, 2002
as reported January 1, 2003
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.
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.
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 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.
Cholesterol-lowering drug represents new class
Chronic hepatitis C therapy for patients with compensated liver disease
With the threat of bioterrorism, there was a need to reintroduce a smallpox vaccine. FDA has now approved this dried, calf lymph-type vaccine.
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.
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.
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.
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 (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.
Pipeline Preview for November
Microbial resistance is a concern in treating urinary tract infection (UTI) and bacteremia. But analysis of data from more than 200 US hospitals in the Surveillance Network Database-USA from 1999 to 2001 demonstrated bloodstream and urinary tract isolates with the potential to cause urosepsis to be very susceptible in vitro to broad-spectrum b-lactams and aminoglycosides. The study results were reported at the 42nd Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Diego, CA.
Patients with mild chronic heart failure who are treated early on with the beta blocker carvedilol (Coreg) along with the angiotensin-converting enzyme (ACE) inhibitor enalapril demonstrated a significantly greater improvement in left ventricular remodeling than patients receiving either drug alone, according to a 572-patient study presented at the European Society of Cardiology (ESC) Congress in September in Berlin. The results reinforce current treatment recommendations.
Studies presented at the Third European Stanley Foundation Conference on Bipolar Disorder in September in Freiburg, Germany, show two newer antipsychotics are each more effective than standard therapy for preventing mania relapse or reducing symptoms.
NME: Aldosterone blocker approved to treat hypertension
Although a New York court ruled last month that the generic manufacturer KUDCO did not infringe on two AstraZeneca patents relating to the formulation of the antiulcer drug omeprazole (Prilosec), KUDCO cannot move forward because Andrx and Genpharm hold 180-day exclusive marketing rights for various strengths. The court also ruled that Andrx and Genpharm, as well as Cheminor, did infringe on the patents--so the path is not yet clear for generic omeprazole.
A phase III study presented at the 14th annual meeting of the Migraine Trust International Research Symposium (MTIRS) in September in London showed that topiramate (Topamax) significantly reduced migraine frequency at doses as low as 100 mg/d. The onset of efficacy was observed as early as the first month of treatment. Topiramate is already approved in the United States and worldwide as an
NME: Antiviral approved to treat hepaptitis B
Aripiprazole is an investigational atypical antipsychotic that received an approvable status from FDA in September 2002 for the treatment of schizophrenia. The decision on approval could be made as early as the end of this year. Aripiprazole offers a unique mechanism of action as a dopamine system stabilizer. Aripiprazole has been found to be effective in both short-term (4?6 wk) and long-term (26?52 wk) treatment trials. It appears to produce less hyperprolactinemia, weight gain, and extrapyramidal symptoms than other antipsychotics.
