News

In other drug safety news, FDA has announced the selection of Gerald J. Dal Pan, MD, MHS, as director, Office of Drug Safety in the Center for Drug Evaluation and Research (CDER). Dr Dal Pan, selected from a strong field of candidates as part of a nationwide search, will lead the agency's post-marketing drug safety program.

Judith Cahill, executive director of the Academy of Managed Care Pharmacy (AMCP), gave testimony in early November during FDA's public hearing on direct-to-consumer advertising (DTC) of pharmaceutical products.

Evaluation of newly released medications for potential formulary inclusion should focus on clinical benefit over product price or rebate. Dossiers are invaluable to the evaluation process, but it's important to note that dossiers obtained from pharmaceutical manufacturers are often incomplete, according to presenters at AMCP's 2005 Educational Conference last month in Nashville, Tenn.

Incremental cost-effectiveness ratios produced by pharmacoeconomic modeling are the gold standard for evaluating drug alternatives, but the result of such an analysis often requires a value judgment on the part of the managed care organization (MCO), Daniel C. Malone, PhD, RPh, said at the Academy of Managed Care Pharmacy's (AMCP's) 2005 Educational Conference last month in Nashville, Tenn.

Accumulating data have demonstrated that the endothelin axis plays a role in the progression of many malignancies. Endothelin-1, which is produced by prostate cancer cells, can stimulate new bone formation. It can also act synergistically with a number of growth factors promoting cancer cells growth and proliferation. Over-expression of endothelin-1 and diminished capacity for its clearance have been seen in prostate cancer cell lines. The highest concentration of endothelin-1 is found in patients with hormone refractory metastatic disease. Atrasentan (Xinlay, Abbott) is a member of a new class of drugs called the selective endothelin-A receptor antagonists (SERAs). The safety and efficacy of atrasentan in hormone refractory prostate cancer (HRPC) have been evaluated in several clinical trials. Atrasentan demonstrated some efficacy in delaying the progression of disease and improving patients' quality of life while having an acceptable safety profile. An NDA for atrasentan was submitted in December 2004 for..

FDA extended the Prescription Drug User Fee Act action date to January 7, 2006, for lenalidomide (Revlimid, Celgene). The drug is intended to treat patients with transfusion-dependent anemia resulting from low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality.

Amlodipine tablets 2.5, 5, and 10 mg (equiv to Norvasc tablets).

Muraglitazar (Pargluva, Bristol-Myers Squibb, Merck) for the treatment of type 2 diabetes.

This tablet formulation of lopinavir and ritonavir provides several advantages over the capsule formulation.

This recombinant IgG1 monoclonal antibody exerts its therapeutic effect through inhibition of human tumor necrosis factor (TNF).

The prodrug of a cytotoxic deoxyguanosine analogue, nelarabine inhibits DNA synthesis and leads to cell death.

In each issue, Formulary's "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 so far in 2005, along with updates on the status of each agent.

Inhaled insulin (Exubera, Pfizer/Sanofi-Aventis) could be an effective therapy and alternative to rosiglitazone (Avandia, GlaxoSmithKline) for individuals who are early into the course of type 2 diabetes, according to a study published in Diabetes Care.

HEPATITIS B AND C are serious viral diseases that can lead to lifelong infection, cirrhosis, liver cancer, liver failure and death. They often produce chronic, hidden infections. An estimated 1.25 million Americans are infected with hepatitis B, and about 30% of them have no signs or symptoms. An estimated 2.7 million Americans have chronic hepatitis C, and about 80% of them have no signs or symptoms. Both diseases are transmitted through blood and other bodily fluids.

Medicare Part D is the first large scale example of a true consumer healthcare product

As a result of the Medicare Modernization Act (MMA), Medicare HMOs are well positioned. As MA-PDs gain traction, the increased publicity will drive awareness among the senior population, further increasing enrollment, according to industry experts.

Companies in service industries are busy trying to please their customers, but do they pay the same attention to their own employees? A resounding "yes" is the answer from health plans, many of which claim they spend time and energy on attracting and retaining their employees. In a labor market where available jobs outnumber potential employees, healthcare organizations and other companies are vying for top-notch people.

When Minalkumar Patel, MD, MPH, the president and COO of Horizon Healthcare Insurance Company of New York, feels fear along his career path, he welcomes the alarm as a hint of the challenges he craves. Just a year ago, at the age of 33, Dr. Patel accepted the challenge to lead Horizon Healthcare of NY, a rapidly growing health plan in a tough market that he was unfamiliar with. He says that if he weren't petrified, he wouldn't have taken the job.

In today's world, health insurance is a necessity for sound financial planning.With medical expenses soaring, lack of insurance could prove financially ruinous. Moreover, the uninsured population faces a greater mortality risk than adults with coverage. According to a recent census report, 45 million Americans do not have health insurance—almost one in five. Studies have shown that cost is the primary reason for the lack of coverage.

We all seem to be taking a wait-and-see approach.

Quick rules of thumb for managing e-mail across a practice

When a crisis strikes, all involved should have a plan to follow

The ACE inhibitor perindopril significantly reduced left ventricular remodeling in a well-treated population of older patients with acute myocardial infarction (MI) and preserved ejection fraction, said Roberto Ferrari, MD, PhD, lead investigator of the Perindopril Remodeling in Elderly with Acute Myocardial Infarction (PREAMI).

Review of prophylactic vaccines in late-stage development for the prevention of selected infectious diseases (October 2005).

FEDERAL AND STATE GOVERNMENT ACTIONS AND THEIR IMPACT ON DRUG DECISION-MAKERS

The growing trend for women to wait later in life before having their first child has placed many women at a higher risk for difficult conception. There are numerous classes of medications available to assist women who have been diagnosed with infertility.Agents that are used in the treatment of infertility include: clomiphene citrate, aromatase inhibitors, gonadotropins, chorionic gonadotropins, gonadotropin-releasing hormone, gonadotropin-releasing hormone agonists, gonadotropin-releasing hormone antagonists, follitropins, and other miscellaneous agents. Medications chosen for a patient will vary depending on the identified cause of the infertility. Additionally, economic factors will play a role. It is important for healthcare professionals to be aware of treatment options and have a basic understanding of the role these medications play in the treatment of infertility. (Formulary. 2005;40:329–341.)

Ranolazine (Ranexa, CV Therapeutics) is a partial fatty acid oxidase inhibitor that increases the amount of ATP produced from glucose and increases the ability of the myocardium to retain functionality despite a reduced oxygen supply. Ranolazine is under FDA review for the treatment of chronic stable angina (CSA). Ranolazine was first reviewed in the August 2003 issue of Formulary. Since the initial review of ranolazine by FDA, additional data have emerged that merit an update in this journal. Clinical trials have demonstrated the efficacy of ranolazine as both monotherapy and combination therapy in patients with CSA. Recently published clinical trials (MARISA and CARISA) have shown an improvement in symptom-limited exercise duration. The results of the ERICA trial demonstrated a reduction in weekly anginal attacks when ranolazine was added to maximum-dose amlodipine therapy. Headache and generalized weakness were the most commonly reported adverse events in clinical trials. Prolongation of the QT interval has raised concerns; however, a lack of development of ventricular tachyarrhythmias-specifically Torsade de Pointes-remains an important safety finding. (Formulary. 2005;40:323–328.)

Initiating therapy with the ACE inhibitor quinapril within the first 7 days after coronary artery bypass graft (CABG) surgery does not lead to better outcomes among patients already receiving optimal therapy, said Wiek H. van Gilst, MD, lead investigator of IMAGINE (Ischemia Management with Accupril Post Bypass Graft via Inhibition of Angiotensin Converting Enzyme).

Early use of clopidogrel, started prior to rather than at the time of angioplasty, reduces the risk of death, MI, or stroke by nearly half, reported Marc S. Sabatine, MD, MPH, lead investigator of PCI-CLARITY (Clopidogrel as Adjunctive Reperfusion Therapy).

An antihypertensive regimen of amlodipine with added perindopril significantly reduces all-cause mortality and most major adverse cardiovascular outcomes compared with a regimen of atenolol with the addition of a diuretic, according to the final results of ASCOT-BPLA (Anglo-Scandinavian Cardiac Outcomes Trial Blood Pressure Lowering Arm).