News

FDA's withdrawal of rofecoxib (Vioxx, Merck) in 2004 and other controversies have prompted numerous reports from legislators, the scientific community, and others calling for substantial changes in FDA's and its Center for Drug Evaluation and Research's (CDER's) roles as the nation's overseers of medication safety. The outcry for FDA reform reached another peak in late September when a committee convened by the Institute of Medicine (IOM) of the National Academies released its report, "The Future of Drug Safety," which recommended a "coherent and integrative approach" to transform the agency and a pharmaceutical industry that the committee says has had its credibility "compromised" in the eyes of the public.

Arformoterol

This selective long-acting beta2-adrenergic receptor agonist causes relaxation of bronchial smooth muscle and has 2-fold greater potency than racemic formoterol. Arformoterol was approved on October 6, 2006, for the long-term, twice-daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

A once-daily transdermal patch containing the dopamine receptor agonist rotigotine appears to be well tolerated, provides sustained relief from motor symptoms associated with Parkinson disease (PD), and has few dopaminergic adverse effects, particularly among elderly patients, reported Ray L. Watts, MD, and colleagues at the American Neurological Association 131st Annual Meeting, and Jack J. Chen, PharmD, and colleagues at the 2006 American College of Clinical Pharmacy Annual Meeting. Transdermal rotigotine is currently being reviewed by FDA for the treatment of early PD.

A secondary analysis of data from the Stroke Prevention with Aggressive Reduction in Cholesterol Levels (SPARCL) trial demonstrated that statin treatment can significantly reduce the severity of a second ischemic stroke in patients who had no history of coronary heart disease. With statin treatment, there were fewer fatal and severe strokes, fewer moderate and mild strokes, fewer transient ischemic attacks (TIAs), and more patients who had no events, said Larry B. Goldstein, MD, at the American Neurological Association (ANA) 131st Annual Meeting.

Although use of the cyclooxygenase (COX)-2 inhibitor celecoxib has demonstrated benefit in preventing premalignant colorectal adenomas, generally the agent should not be recommended for this purpose due to the risk of cardiovascular events, according to 1 recent trial. In a second study of celecoxib use and adenomas, treatment with celecoxib 400 mg/d markedly lowered the incidence of colorectal adenomas within 2 years after the removal of polyps.

In a randomized, double-blind, placebo-controlled trial recently published in Lancet, the thiazolidinedione (or "glitazone") rosiglitazone statistically significantly reduced the incidence of new-onset diabetes when given to patients diagnosed with prediabetes but lacking a prior history of cardiovascular disease. The benefits of using thiazolidinediones in the treatment of patients with diabetes are well known, but the current finding that thiazolidinediones can prevent prediabetics from progressing to diabetes is novel.

So far this year, Formulary has examined 10 newly approved or investigational drugs of interest to pharmacy and therapeutics committee members through our "Focus on" articles. Because many readers have expressed that this information is useful when making formulary decisions for their hospitals, health systems, or managed care organizations, Formulary has compiled this late-year review of these new and emerging agents, along with updates on the regulatory status of each.

Lisdexamfetamine (NRP104, Shire/New River Pharmaceuticals) for the treatment of pediatric attention-deficit/hyperactivity disorder (ADHD)

FDA Actions in Brief

FDA granted 2 additional indications for rituximab (Rituxan, Genentech/Biogen Idec) in the treatment of patients with CD-20-positive, B-cell non-Hodgkin's lymphoma (NHL). The agent is now approved as first-line treatment of previously untreated patients with follicular NHL in combination with cyclophosphamide, vincristine, and prednisolone (CVP) chemotherapy, and in the treatment of patients with low-grade NHL with stable disease, or in those with partial or complete response following first-line treatment with CVP chemotherapy.

Infliximab

Infliximab acts through the inhibition of tumor necrosis factor (TNF)-alpha, which is responsible for the induction of inflammatory cytokines, the enhancement of leukocyte migration, and the activation of neutrophil and eosinophil functional activity. Infliximab was approved on September 27, 2006, for the treatment of adult patients with chronic severe (ie, extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.

Vorinostat

This agent targets the overexpression of histone deacetylase (HDAC) or the aberrant recruitment of HDACs to oncogenic transcription factors in cancer cells. Vorinostat was approved on October 6, 2006, for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent, or recurrent disease following 2 systemic therapies.

Many new web-based decision support tools and care management solutions have emerged, aimed specifically at the member to complement other resources available at plan web sites. Forward-thinking health plans already have begun launching online support tools within their member portals or are actively planning to do so. Even those who have already begun to roll out such tools are thinking of new, more powerful ways to integrate them into their overall member platform. Here is a quick review of what the field looks like:

Many new web-based decision support tools and care management solutions have emerged, aimed specifically at the member to complement other resources available at plan web sites. Forward-thinking health plans already have begun launching online support tools within their member portals or are actively planning to do so. Even those who have already begun to roll out such tools are thinking of new, more powerful ways to integrate them into their overall member platform. Here is a quick review of what the field looks like:

The influenza immunization rate is a closely watched HEDIS measure among plans. Influenza vaccine is about 80% effective in preventing infection in general, although its effectiveness is lower in the elderly. In addition, its effectiveness can vary from year to year, depending on the match between the vaccine and the particular strains of influenza circulating that year.

Insurance fronting arrangements are more commonly utilized in the property and casualty industry. However, MCOs also have uses for these structures in certain circumstances. For example, many HMOs discover that they have a need to offer products on insurance paper (PPO plans) but do not have the resources to form a separate insurance company. Or, a provider organization may ask an HMO to front for it with respect to a particular product line or sector.

Insurance fronting arrangements are more commonly utilized in the property and casualty industry. However, MCOs also have uses for these structures in certain circumstances. For example, many HMOs discover that they have a need to offer products on insurance paper (PPO plans) but do not have the resources to form a separate insurance company. Or, a provider organization may ask an HMO to front for it with respect to a particular product line or sector.

Medication therapy management (MTM) has long been a part of the pharmacy lexicon and is based on the premise that the right medication in the right dose gets to the right patient. This is to ensure that optimal outcomes are achieved with the highest safety. Numerous examples of pharmacy programs in diverse settings utilize the skills of the pharmacist to optimize drug therapy and improve outcomes and assure safety. The Veterans Administration, academia, health plans, as well as community pharmacies have all been settings where medication management of the patient has occurred.

Pay-for-Performance (P4P) provides home health agencies an opportunity to show their value and expertise to the healthcare industry. The primary goal of home health has always been to educate the client and family on how to proactively manage a chronic illness and avoid the reoccurrence of an acute illness. Home health nurses are the eyes and ears of the physician, often recommending modifications to the plan of care based on their knowledge of the patient's medical condition and home environment. With the advancement of healthcare technologies and pending P4P regulations, this knowledge becomes a more important basis for assessing patient and family compliance to care recommendations.

A 0.5-mg/kg dose of a low molecular weight heparin, enoxaparin, resulted in less non-coronary-artery bypass grafting (CABG) bleeding compared with unfractionated heparin in the first 48 hours after elective percutaneous coronary intervention (PCI), according to a prospective, open-label, multicenter, randomized trial reported in the New England Journal of Medicine.

Intensive lipid lowering with high-dose 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) provides a significant benefit over standard-dose statin therapy in preventing nonfatal cardiovascular outcomes and also may reduce the incidence of cardiovascular death, according to results of a meta-analysis published in the Journal of the American College of Cardiology.

Intensive lipid lowering with high-dose 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) provides a significant benefit over standard-dose statin therapy in preventing nonfatal cardiovascular outcomes and also may reduce the incidence of cardiovascular death, according to results of a meta-analysis published in the Journal of the American College of Cardiology.