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.
The Services provided by PPO plans are influenced by a number of factors, say industry watchers.
Winona Health, a locally owned and operated nonprofit organization in Winona, Minn., had an outdated and cumbersome technology infrastructure, which hampered its ability to serve its community. With more than 900 employees at Winona Health and its affiliates, Winona's financial and billing systems couldn't keep up with the firm's growth or increasingly complex reporting and tracking requirements. Of particular importance was automating Winona Health's human resources and payroll processes-employee hours were being logged manually, making the maintenance of labor law requirements for overtime, weekends and holidays time-intensive.
The healthcare industry, both nationally and globally, has just scratched the surface of possible uses for telemedicine with potential efficiency enhancements on the horizon as well as a future where homes would have "health security systems," according to some leaders in telemedicine.
With radiology costs in the United States growing to more than $100 billion annually, diagnostic imaging is the second-largest and fastest-growing expense for health plans behind pharmaceuticals. Unmanaged, radiology spending is expected to continue growing at a rate of 20% annually. Factors driving this growth include fragmentation of care, the continual advances in diagnostic imaging technology, the affordability of imaging equipment leading to adoption and utilization in more care settings, direct advertising to patients, and an aging population. As a result, radiology utilization management has become a top priority for health plans.
Telemedicine programs decrease time-to-diagnosis, save financial resources and reduce hospital stays.
One of the things I love about living in the suburbs is the close proximity of retail when I need to get my errands done. In a three-mile stretch, I can eat lunch, hit the ATM, buy a gift, fill up my gas tank and replenish my groceries. At the grocery store, I can buy stamps and drop off my dry cleaning, too.
As the nation faces a healthcare "affordability" crisis, market forces are driving changes such as consumer-directed healthcare, which is fueling the next revolution in healthcare: real-time transactions. At the center of this momentous change sits the health plan and its enterprise systems.
As the healthcare industry strives to establish appropriate and effective standards for the public reporting of clinical data, providers may lose sight of how they can make a critical difference in ensuring new reporting standards do not distract from, but rather aid in, achieving the primary goal of improving patient care.
New incretin-based therapies will soon enter the therapeutic armamentarium for type 2 diabetes. Two dipeptidyl peptidase (DPP)-IV inhibitors in phase 3 clinical trials, vildagliptin and sitagliptin, are oral agents that can be used once daily as monotherapy or in combination with other oral antidiabetic agents to reduce levels of hemoglobin A1c (HbA1c) with few side effects, little risk of hypoglycemia, and no promotion of weight gain, researchers reported at the 66th scientific sessions of the American Diabetes Association (ADA) in Washington, DC.
In response to criticism about the composition of its independent advisory committees, FDA announced it would modify its procedures dealing with committee appointments and clarify the circumstances under which waivers for conflicts of interest occur.
Anidulafungin (Eraxis, Pfizer) is a new echinocandin approved for the treatment of Candida infection in adults. Like other echinocandins, anidulafungin acts on the fungal cell wall by inhibiting 1,3 beta-D glucan synthesis. Studies suggest that among the echinocandins, anidulafungin may have more potent in vitro activity against Candida spp and Aspergillus spp. Further, phase 2 and 3 clinical studies with anidulafungin have supported a high end of therapy success rates for invasive candidiasis, including esophageal candidiasis. Anidulafungin appears to be well tolerated, with headache, nausea, vomiting, phlebitis, neutropenia, and hypokalemia being the most commonly reported adverse effects. Importantly, as anidulafungin is chemically degraded, it has no clinically significant drug interactions and does not require any dose adjustment for renal or hepatic impairment.
The role of cost- and pharmacoeconomic-related criteria in formulary decision-making was assessed in a literature review of 31 studies of hospital (n=18) and managed care (n=13) pharmacy and therapeutics (P&T) committees. In both settings, cost was important, although the elements of cost considered varied. Acquisition cost was mentioned more frequently than pharmacoeconomic or cost-effectiveness information. Other factors, including drug characteristics, quality of life, supply-related issues, and physician demand, also influenced decisions.
Metronidazole topical gel, 0.75% (equiv to Metrogel topical gel)
Hepatitis B immune globulin (human) (Nabi-HB, Nabi Bio-pharmaceuticals) for the treatment of hepatitis B infection
FDA approved the etonogestrel 68-mg implant (Implanon, Organon), a single-rod implantable device that prevents pregnancy for up to 3 years.
This fixed-dose combination tablet contains: efavirenz, a non-nucleoside reverse transcriptase inhibitor (NNRTI); emtricitabine, a synthetic nucleoside analog of cytidine; and tenofovir disoproxil, which is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate.
