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In each issue, the Focus On article reviews a newly approved or investigational drug of interest to pharmacy and therapeutics committee members. Because so many readers have told the editors of Formulary that they reference this column frequently when making formulary decisions for their hospitals, health-systems, or managed-care organizations, the editors have compiled this review of all the Focus On articles published in 2004, along with updates on the status of each agent.

As initiatives to legalize the importation of prescription drugs draw more attention, the concern over counterfeit drugs is growing. The possibility of receiving counterfeit drugs has created an emerging dilemma for health-care professionals. FDA is relying on pharmacists to help ensure the integrity of drug products before they reach health-care consumers. Pharmacy and therapeutics committees can play a key role in achieving this goal by reviewing policies for medication acquisition and ensuring that necessary controls are in place to help prevent the acquisition of counterfeit drugs. FDA is also taking steps to help alleviate counterfeiting by mandating bar codes on all hospital drug packaging and implementing electronic pedigree papers to track distribution. FDA leaders project that by 2007, all prescription drugs will be tracked electronically to help ensure their authenticity. Formulary decision-makers, pharmacy directors, and clinicians must continue to be educated about the problem to help prevent counterfeit drugs from polluting the drug supply.

Government, industry provide pharmaceutical policy outlook for 2005; $139 million to advance information technology, records; Rofecoxib hearings point to failures in clinical testing design, decision-making transparency; New guidance for generic drugs clarifies protocol, increases speed to market

New molecular entities: erlotinib, solifenacin, natalizumab

Worldwide study finds that fluoroquinolones are still effective against CAP; Weekly nesiritide may have greatest benefit in highest-risk heart failure patients

Valdecoxib meta-analysis finds increased cardiovascular risk

Agencies encourage development of more affordable treatments and take steps to ensure safer product use

December DTR Analysis: National HMO Enrollment by State

Cultural competency improves outcomes

DTR Chart: National HMO Enrollment by State

With one in five residents of the United States unable to speak English or speak it well, according to the U.S. Census Bureau, healthcare organizations have started to launch language services programs.

Coromary heart disease (CHD) is the leading cause of death for men and women in the United States. There's a direct relationship between cholesterol levels and the risk of death due to CHD. Statin medications inhibit cholesterol synthesis and reduce cholesterol levels substantially.

Health literacy is the next frontier in effective delivery.

George Halvorson helps to bring Kaiser Permanente to the leading edge of healthcare's own industrial revolution with a massive new EMR system.

New York Attorney General Eliot Spitzer recently pursued investigations focused on a common industry practice utilized by insurers and the brokers that represent corporate buyers of commercial insurance. At issue is whether bids are being rigged, prices fixed, and whether brokers are steering business to insurers that pay them the highest fees without getting the best deal for their corporate clients.

The National Inventors Hall of Fame is located in Akron, Ohio, about 45 minutes from the MANAGED HEALTHCARE EXECUTIVE offices. It's interesting how many of the modern day Hall of Fame inductees are researchers who were honored for their discoveries in medicine, while historical creators offered more electronic or industrial solutions.

Next-generation solutions for reducing healthcare costs resulting from obesity

Chronic obstructive pulmonary disease (COPD) is a disease state characterized by the progressive development of airflow limitation that is not fully reversible. The airflow limitation is associated with an abnormal inflammatory response of the lungs to noxious particles or gases. It affects approximately 15 million Americans and is associated with high morbidity and mortality. Previously, pharmacologic therapeutic options were limited by relatively short durations of action in the first-line medications and limited efficacy data and/or a high rate of adverse effects in the second-line medications. Today, there are several new and emerging medications to treat this disease state, and new guidelines have been published for disease management. This review examines current therapeutic options, compares efficacy data, and highlights the recommendations from international guidelines.

Nebivolol is a beta-blocker under FDA review for the treatment of hypertension. Nebivolol has unique pharmacologic properties, including high specificity for the beta-1 receptor and a nitric oxide-mediated vasodilatory effect. The agent provides significant blood pressure reduction from baseline values and as compared to placebo. Clinical trials have demonstrated that nebivolol reduces blood pressure similarly to atenolol, bisoprolol, amlodipine, nifedipine, lisinopril, and hydrochlorothiazide. The tolerability of nebivolol is similar to or better than that of these agents. If approved, nebivolol would likely be a viable alternative therapy for hypertension; however, additional studies are needed in patients with heart failure and coronary artery disease.

Suit alleges FDA overstepped jurisdiction in regulating compounding pharmacies; Report lists steps to improve product quality regulatory system; ASHP, AMCP recommend criteria for Medicare formulary design, formulary decision-maker responsibilities; Illinois, Wisconsin specify safeguards, provisions in state-sponsored WWW prescription drug pharmacy

Medicare Fraud: The OIG IS Watching

In 2001, with annual healthcare inflation in the double-digits nationwide, Humana CEO Michael McCallister formulated the plan's new strategy to put more information and choice in the hands of employees and healthcare consumers.

One of the biggest drains on productivity is presenteeism, a term used to describe "the working sick"-employees who are at work but who aren't as productive as usual.

PHCS President and CEO Joe Driscoll takes on healthcare's Big 3 with a proprietary PPO network.

The practice of medicine continues to become more effective, and all of the players in managed care seem to have found a way to (somewhat) peacefully coexist.

November DTR Chart: Top States by Medicare HMO enrollment

November DTR Analysis: Medicare HMO enrollment varies dramatically

As the spiraling cost of healthcare continues to strain federal and state budgets, state Medicaid agencies are looking for powerful, workable solutions to the crisis.