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Over the next few years, more health plans and employers will investigate covering the physician-administered injectable drugs under the pharmacy benefit as a way to control the costs and manage appropriate utilization, says Kathryn Lindhorst Canaday, PharmD, director of pharmacy analysis, Pharmaceutical Strategies Group (PSG), based in Dallas.

Millions of people's lives have been influenced by the work of Mollie Orshansky, even though very few people know who she is. Dozens of health-related programs throughout history have benefitted from Mollie's contributions, including programs through HHS, charitable agencies, private companies and managed care. In 1963, it was Mollie-an accomplished mathematical genius and daughter of a poor immigrant family-who developed the U.S. government's official measure of poverty and the guidelines for what we call the Federal Poverty Level (FPL) today.

When you're the most populous state in the union, any extraordinary policies you sketch out could likely become a national catalyst for change. California has begun working on its state initiative for comprehensive healthcare reform, not simply for lack of a national proposal, but also because the health of its 36.1 million residents is at stake.

The Illinois Supreme Court recently confirmed that the corporate practice of medicine doctrine is still alive and well in the state of Illinois. In Vine Street Clinic, et al. v. HealthLink Inc., the court concluded that percentage-based fees charged by the owner of a healthcare provider network were illegal under the state's medical practices act.

Rising pressure to reduce federal spending for Medicare has put the spotlight on payments and policies governing the Medicare Advantage program. MA plans are "vastly overpaid," according to Rep. Pete Stark (D-Calif.), chairman of the House Ways & Means Health subcommittee, largely because they sign up more healthy beneficiaries. Senate Finance Committee chairman Max Baucus (D-Mont.) is looking closely at whether "funneling dollars into private plans gets us the most bang for our healthcare buck."

Many Americans suffer from insomnia regularly, but clinicians often do not address this issue. A variety of factors may contribute to insomnia, including medical conditions such as gastroesophageal reflux disease, Parkinson disease, and heart failure. Medications such as amphetamines, theophylline, and beta agonists could also precipitate insomnia.

Combination therapy with an antimuscarinic agent (tolterodine extended release [ER]) and alpha1-receptor antagonist (tamsulosin) provided symptomatic benefit in men with moderate-to-severe lower urinary tract symptoms and overactive bladder, according to a large-scale, randomized, double-blind, placebo-controlled study published in the Journal of the American Medical Association (JAMA).

Many Americans suffer from insomnia regularly, but clinicians often do not address this issue. A variety of factors may contribute to insomnia, including medical conditions such as gastroesophageal reflux disease, Parkinson disease, and heart failure. Medications such as amphetamines, theophylline, and beta agonists could also precipitate insomnia.

A public forum scheduled this month will help to solidify proposals FDA unveiled in January for reauthorization of the Prescription Drug User Fee Act (PDUFA). Once public comment from the February 16 meeting is received and incorporated into the finalized proposal, negotiations between the agency and the federal government over the fourth incarnation of this important funding mechanism will be key in determining FDA's fiduciary future.

Direct-to-consumer advertising (DTCA) of prescription drugs has been a source of debate since its US approval by FDA in 1997. A primary source of debate among experts is the methods advertisers use to attempt to influence the consumer and the consumer's subsequent reaction. Despite the controversy, authors of a recent content analysis of televised DTCA say there has been no systematic analysis of DTCA's influence on consumers to date.

The American Gastroenterological Association (AGA) has issued a consensus statement on the safe and efficacious use of nonsteroidal anti-inflammatory drugs (NSAIDs), including nonselective, nonsteroidal anti-inflammatory drugs (nsNSAIDs), cyclooxygenase-2 enzyme inhibitors (coxibs), and aspirin (ASA).

A cross-sectional study of selective serotonin reuptake inhibitor (SSRI) use by community-dwelling older women aged ≥71 years with or without depression demonstrated that SSRI use in that population was strongly associated with sleep disturbance. The study, which relied on data collected from 4 centers throughout the United States, was recently published in the Journal of the American Geriatrics Society.

Rifaximin has demonstrated global improvement of the symptoms of irritable bowel syndrome (IBS) in patients for ≤10 weeks after the discontinuation of therapy. Rifaximin is a nonabsorbed (≤0.4%), broad-spectrum antibiotic that was approved by FDA in 2004 for travelers' diarrhea.

A post-hoc analysis of the large, randomized, double-blind, placebo-controlled Physicians' Health Study found that the use of low-dose aspirin (ASA) on alternating days reduced the risk of adult-onset asthma by a statistically significant 22%.

A randomized, double-blind, placebo-controlled trial published in the Journal of the American Medical Association (JAMA) found that women who discontinued alendronate after 5 years demonstrated a moderate decline in bone mineral density (BMD) and a gradual increase in serum markers of bone turnover compared with women who continued taking alendronate for an additional 5 years, but mean levels among patients who discontinued therapy remained at or above baseline levels measured 10 years earlier. In addition, no greater fracture risk other than for clinically detected vertebral fractures was seen in the discontinuation group compared with patients who continued alendronate for 10 years.

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Approvable designations; Nonapprovable designation; Fast-track designation; Priority review; Orphan drug designations

Bronchodilators play an important role in the management of stable chronic obstructive pulmonary disease (COPD). Although bronchodilators do not prevent the decline in lung function in patients with COPD, their efficacy in improving disease-related symptoms, reducing the frequency and severity of disease exacerbations, and improving patients' quality of life has been demonstrated in clinical trials. Arformoterol, the (R,R)-enantiomer of the selective beta2-agonist formoterol, is a potent, highly specific, nebulized long-acting beta2-adrenergic agonist recently approved by FDA for the long-term maintenance treatment of bronchoconstriction in patients with COPD, including chronic bronchitis and emphysema. In 2 large, 12-week, phase 3 studies, arformoterol demonstrated an efficacy superior to that of placebo and comparable to that of salmeterol in patients with COPD. In these trials, arformoterol was well tolerated, with a safety profile similar to that of other inhaled long-acting beta2-agonists when used at..

Last year acknowledged the 25th year since AIDS was first recognized, and to coincide with that anniversary, the U.S. Centers for Disease Control and Prevention (CDC) revised its recommendations for HIV testing for adults, adolescents and pregnant women in healthcare settings. The new guidelines remove the onus of determining who is at high risk for HIV infection and makes testing a routine part of medical care for all patients between ages 13 and 64 years.

As the managed care industry continues to consolidate, not-for-profit and provider-sponsored plans haven't lost their niche in the marketplace. They compete on demonstrated quality and the added value of community accessibility, which would, on the surface, seem to be exactly what politicians and healthcare advocates are begging for.