News

FDA began 2006 by unveiling a long-anticipated final rule that significantly overhauls approved labeling for drugs and biologics. This new rule has been in the works for years, delayed by manufacturer concerns that the revisions will expose companies to more liability suits. Although the new labeling's basic framework came as no surprise, compliance will require significant investments by manufacturers to meet the new design and content requirements, which will double the length of many package inserts (PIs).

A single day of famciclovir started within 6 hours of a genital herpes outbreak shortens the duration of recurrent genital herpes lesions, said Fred Y. Aoki, MD, at the 45th ICAAC meeting in Washington, DC.

Vancomycin may be overused for the treatment of hospital-acquired pneumonia, perhaps because of physicians' perceptions that patients are at high risk for methicillin-resistant Staphylococcus aureus (MRSA), according to a study by Robert H. Eng, MD, and colleagues at the Veterans Affairs New Jersey Health Care System in East Orange, NJ. The study was presented at the 45th ICAAC meeting in Washington, DC.

The use of acid-suppressive drugs, particularly proton pump inhibitors (PPIs), was associated with an increase in the risk of community-acquired Clostridium difficile-associated disease (CDAD) in the United Kingdom, reported Sandra Dial, MD, MSc, at the 45th ICAAC meeting in Washington, DC.

A study analyzing pharmacy claims among patients who receive chronic medications via 3-tier prescription drug plans found that patients who were prescribed generic or preferred medications by their physicians were the most likely to adhere with their treatments.

A study of 155 patients examining the effects of statins on patients diagnosed with acute coronary syndrome (ACS) suggests that statin therapy may increase survival rates and potentially extends the results of larger, recently performed randomized trials to those with low-density lipoprotein cholesterol (LDL-C) levels of 80 mg/dL and below.

Rheumatoid arthritis patients, hindered by an inadequate response to tumor necrosis factor-alpha (TNF-alpha) inhibitors, may find some relief in the form of a drug that belongs to a new class of selective costimulation modulators.

A prospective, double-blind, randomized, controlled trial comparing the effectiveness of levofloxacin and moxifloxacin in treating community-acquired pneumonia (CAP) among 394 hospitalized elderly patients (aged 65 years and older) demonstrated that moxifloxacin resulted in faster recovery than levofloxacin.

Topiramate safely decreases body mass, hypertension. Topiramate reduces body weight and blood pressure with generally mild-to-moderate adverse effects, according to a randomized, placebo-controlled trial involving obese subjects with hypertension.

Colesevelam/fenofibrate combination boosts efficacy in treatment of hyperlipidemia. Fenofibrate significantly reduced low-density lipoprotein cholesterol (LDL-C) in patients with mixed hyperlipidemia when used in combination with the specifically engineered bile acid sequestrant (SE-BAS) colesevelam, according to a study published in Current Medical Research and Opinion.

Two recent studies in The New England Journal of Medicine (NEJM) focused on the breast cancer drug trastuzumab, a recombinant monoclonal antibody (Herceptin, Genentech/Roche).

Tight glucose control for a mean period of 6.5 years produces long-lasting cardiovascular benefits in patients with type 1 diabetes, according to a study published in the New England Journal of Medicine (NEJM).

Isradipine capsules 2.5 and 5 mg (equiv to Dynacirc capsules)

Hepatitis B immune globulin (HepaGam B, Cangene) was approved for the treatment of acute exposure to blood containing the hepatitis B surface antigen (HbsAg), perinatal exposure of infants born to mothers who are positive for HbsAg, sexual exposure to individuals who are HbsAg-positive, and household exposure to individuals with acute HBV infection.

By increasing intestinal fluid secretion, lubiprostone increases motility in the intestine, thereby increasing the passage of stool and alleviating symptoms associated with constipation. Lubiprostone was approved on January 31, 2006, for the treatment of chronic idiopathic constipation (CIC) in adults.

The anti-anginal and anti-ischemic properties of ranolazine are not dependent on reductions in heart rate or blood pressure. Ranolazine was approved on January 27, 2006, for the treatment of chronic angina. Because ranolazine prolongs the QT interval, it should be reserved for patients who have not achieved an adequate response with other anti-anginal drugs.

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A review of agents in late-stage development for the treatment of Parkinson disease (March 2006).

The challenges of medical versus pharmacy benefits faced by payers are unique and vary by category, say industry watchers (See Desktop Resource, March 2006). Some of the following drug classes can fall under both benefit arrangements.

Putting consumers in charge is both the good and the bad of consumer-directed healthcare (CDHC). For those who know how to make good choices, CDHC is great.

Implementing an Electronic Medical Records (EMR) system is more critical and more complicated than most physician practices expect.

News that Blue Cross and Blue Shield affiliates have begun funding the formation of Regional Health Information Networks (RHIOs) should serve as a wake-up call for all managed care organizations (MCOs).

Savvy executives note challenges in pharmacy versus medical benefits, say industry experts.

Advanced specialty pharmaceuticals are increasingly used to treat a wide range of conditions. They require close clinical monitoring. With a relatively short shelf life and limited stability, they call for special handling and timely distribution.

There are indications that the industrywide adoption of electronic medical record (EMR) technology has begun to move forward at something more than the glacier-like pace of the past few years.

In the United States today, 10 million people have osteoporosis (bone density that's about 25% less than a healthy young adult). In addition, 34 million more people have low levels of bone mass, placing them at increased risk. Osteoporosis is responsible for more than 1.5 million fractures annually, including 300,000 hip fractures, approximately 700,000 vertebral fractures, 250,000 wrist fractures, and more than 300,000 other fractures. About 68% of those affected by osteoporosis are women.

As the U.S. healthcare industry continues its evolution from paper toward electronic medical record-keeping, a trend is emerging: The payers are leading the way, but the consumer ultimately will benefit from -- and actively participate in -- the shift toward industrywide computer-based medical-record databases.

The tools may have changed -- from cookie jars and ledger books to electronic spreadsheets -- but keeping a family household budget is nothing new. As healthcare costs rise and traditional cost-sharing disappears, consumers need to wear the hat of a healthcare financial planner.