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First antifungal approved for prevention of invasive fungal infections caused by Aspergillus species

Review of agents in late-stage development for the treatment of acute coronary syndrome, angina, and myocardial infarction (October 2006).

National Reports-New Orleans officials recently announced that they believe the city has reached half of its previous population prior to Hurricane Katrina. Some of the city's hospitals have not reopened, and many doctors and allied health professionals have not returned to the city.

National Reports-New Orleans officials recently announced that they believe the city has reached half of its previous population prior to Hurricane Katrina. Some of the city's hospitals have not reopened, and many doctors and allied health professionals have not returned to the city.

There is a growing records management crisis in the world of healthcare. Hospitals are awash with paperwork, as legal, payer and regulatory requirements steadily generate an increasing number of documents per patient visit. Unfortunately, most healthcare information technology (HIT) systems are wholly inadequate to meet these growing documentation requirements.

Among large physician practices and acute care facilities, physicians and healthcare executives widely recognize the value of electronic medical records (EMRs). However, physicians at small or individual practices are just beginning to use the technology, noting high implementation costs as a deterrent.

Insurers are evaluating the costs and benefits of generic testing to determine their level of commitment to the emerging medical discipline.

The growth in high-cost injectable and infusion therapies for the treatment of chronic illnesses is a significant management issue for pharmacy benefit managers and payers, experts say.

Healthcare as a business model defies many typical economic principles, making forecasting somewhat difficult. The federal government is expecting 2006 to end with a slight reduction in healthcare cost growth over last year, and for 2007 to end with a lower growth rate than the previous two years. With an aging population, advances in medical technology and increased utilization, growth is expected to hover at about 7.2% per year.

According to Senator Charles (Chuck) Grassley, the Medicare Modernization Act of 2003 (MMA) has worked out better than expected, but he still keeps a close watch to ensure healthcare dollars are well spent. As chairman of the Senate Finance Committee, Grassley has tremendous clout in Washington. His committee is responsible for tax policy, Social Security, Medicare and Medicaid, which made him a central player in developing and enacting MMA.

Washington, D.C.-The campaign to expand healthcare coverage to all Americans took a big hit this summer. New data from the U.S. Census Bureau indicated that the population without healthcare coverage grew by more than 1 million people in 2005 compared with the previous year. Even though more individuals actually had insurance coverage in 2005 (247.3 million, up from 245.9 million in 2004), the percentage of uninsured rose from 15.6% in 2003 to 2004 to the current 15.9%.

Would you pay $19,900 to add another year to your life? If only it were that simple. The New England Journal of Medicine (NEJM) recently published a study that concluded between 1960 and 2000, we paid an average of $19,900 in medical costs per year of life gained during that time. In 1960, a newborn's life expectancy was 69.9 years, and in 2000, it was 76.87 years, according to the study.

Depressive disorders stand out as a major occupational health issue, and employers are feeling the burden in reduced productivity and higher healthcare costs for their work forces.

A drug use evaluation at Wake Forest University Baptist Medical Center (WFUBMC) was initiated following a change in institution-approved guidelines for the administration of amphotericin B lipid complex injection (ABLC) (Abelcet, Enzon). This study was conducted to determine compliance with the new guidelines among prescribers and to characterize the population of patients receiving ABLC. A total of 153 patients received ABLC from April 2001 through December 2002. One hundred thirty-three patients (87%) met 1 or more of the institutional criteria for ABLC administration and 20 (13%) receiving ABLC did not meet the guidelines. The mean baseline serum creatinine (SCr) value among patients meeting institutional guidelines (n=133) was 2.0 mg/dL (range, 0.5–5.0 mg/dL). Among patients who did not meet the guidelines (n=20), the mean baseline SCr level was 1.7 mg/dL (range, 0.6–2.9 mg/dL). The use of new guidelines, which were less stringent than previous guidelines, resulted in earlier administration..

Review of agents in late-stage development for the treatment of hypertension and stroke (September 2006).

This study evaluates the appropriateness and cost implications of using epoetin alpha for transfusion reduction in Hartford Hospital's (Hartford, Conn) intensive care units (ICUs), with the goal of implementing a protocol for use in this setting. We conducted a literature review to determine the efficacy, safety, and clinical outcomes of epoetin alpha for transfusion reduction in the ICU. We also evaluated the safety and supply of red blood cell (RBC) transfusions and the cost considerations of epoetin alpha. The literature review demonstrated that epoetin alpha can reduce blood transfusions in the ICU setting but its use provided no difference in mortality or any other clinical outcome. Our epoetin alpha expenditure for transfusion reduction was $112,067 annually to theoretically save $14,349 in blood transfusion costs. The pharmacy and therapeutics (P&T) committee subsequently recommended that epoetin alpha not be used for transfusion reduction in the ICUs and requested that a drug use evaluation (DUE) be performed to monitor compliance, adverse effects, and cost avoidance. One year after implementation of the epoetin alpha DUE program, the compliance rate was >90%, there were no reported adverse events with blood transfusions or problems with blood supply, and a cost avoidance of $104,562 was realized. (Formulary. 2006;41:442?449.)

FDA issued a proposed rule late last month that would allow pharmaceutical manufacturers to register and list products electronically in an effort to minimize the paper-based element of the process, allowing the agency to host a comprehensive national database of medications and to be more flexible in its role of monitoring the safety of medications for sale, according to officials.

Intravenous (IV) moxifloxacin followed by oral (PO) moxifloxacin, both dosed once-daily, is at least as effective in the treatment of complicated intra-abdominal infections (cIAIs) as piperacillin-tazobactam and amoxicillin-clavulanate comparator regimens dosed multiple times per day, researchers reported in the Annals of Surgery.

Three studies presented at the 10th International Conference on Alzheimer's Disease and Related Disorders in Madrid, Spain, yielded new data regarding the relationship between diabetic and pre-diabetic conditions and the subsequent development and treatment of Alzheimer's disease (AD).

The selective estrogen-receptor modulator (SERM) raloxifene reduces the risks of invasive breast cancer and vertebral fracture in postmenopausal women but also increases the risks of venous thromboembolism and fatal stroke, a study in the New England Journal of Medicine (NEJM) concluded.

Raloxifene, a second-generation selective estrogen receptor modulator (SERM) approved to treat osteoporosis, fared as effectively against breast cancer as tamoxifen in 2 related comparison studies published in the Journal of the American Medical Association (JAMA).

Intensive therapy with atorvastatin 80 mg/d, in comparison with the same medication at 10 mg/d, significantly reduced the rate of major cardiovascular events by 25% in patients with clinically evident stable coronary heart disease (CHD) and diabetes, according to a study published in Diabetes Care.

Atorvastatin showed no statistically significant difference in the reduction of a composite cardiovascular disease (CVD) end point in type 2 diabetes patients, according to a randomized, double-blind, parallel-group study.

A drug use evaluation at Wake Forest University Baptist Medical Center (WFUBMC) was initiated following a change in institution-approved guidelines for the administration of amphotericin B lipid complex injection (ABLC) (Abelcet, Enzon). This study was conducted to determine compliance with the new guidelines among prescribers and to characterize the population of patients receiving ABLC. A total of 153 patients received ABLC from April 2001 through December 2002. One hundred thirty-three patients (87%) met 1 or more of the institutional criteria for ABLC administration and 20 (13%) receiving ABLC did not meet the guidelines. The mean baseline serum creatinine (SCr) value among patients meeting institutional guidelines (n=133) was 2.0 mg/dL (range, 0.5–5.0 mg/dL). Among patients who did not meet the guidelines (n=20), the mean baseline SCr level was 1.7 mg/dL (range, 0.6–2.9 mg/dL). The use of new guidelines, which were less stringent than previous guidelines, resulted in earlier administration..

A variety of clinical approaches are utilized in the management of poor glycemic control in patients with type 2 diabetes. Sitagliptin (Januvia, Merck), a novel drug in a new medication class known as dipeptidyl peptidase-IV (DPP-IV) inhibitors, offers a new mechanism by which to achieve glycemic control. Although stimulation of receptors by the glucagon-like peptide-1 (GLP-1) enhances the body's ability to produce insulin in response to elevated blood glucose concentrations, rapid degradation of GLP-1 by DPP-IV limits its clinical effectiveness. The development of medications to reduce this degradation is being pursued by numerous manufacturers. An NDA for the first of these medications, sitagliptin, was submitted to FDA in February 2006. Currently available clinical studies have demonstrated improved glycemic control with sitagliptin therapy in patients who have not achieved target glucose levels with diet and oral medications. (Formulary. 2006;41:434–441.)

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

When CEOs talk about leading their organizations through difficult times, they often refer to financial challenges or operational logistics. When Joseph A. Frick, president and CEO of Independence Blue Cross (IBC), talks about leading through a difficult time, his voice is low as he describes the legacy of his predecessor.

When the Academy for International Health Studies traveled to Prague in April for its annual trade/study mission, little did the delegates know they were about to enter a healthcare war zone. Weeks in advance of a contentious national election, the country's prime minister recently had fired the minister of health and named a successor with a mandate to implement some quick fixes. Insurers managed their strained cash flows by slowing payments to providers while the new minister, seemingly arbitrarily, mandated price reductions. The result was a physician-organized strike and thousands of angry, untreated patients.

As CMS has begun to promote its quality agenda through pay-for-performance (P4P) initiatives, private payers should consider certain regulatory issues in establishing such programs.

Clever approaches can help patients adhere to drug regimens, and managed care organizations are increasingly adopting the technologies that enable those approaches.