Latest Fda Approved Drugs Information Systems

August 20, 2012 — A combination of fluticasone furoate and vilanterol (FF/VI) inhaled once daily improves pulmonary function and has a duration of action of longer than 24 hours, according to the findings of a new  study published  in the August issue of  Clinical Therapeutics . The phase 3 multicenter study, led by Joseph A. Boscia, MD, from CU Pharmaceutical Research, Union, South Carolina, included 54 patients randomly assigned to "1 of 18 three-course sequences of placebo and 2 of 3 dose combinations of FF/VI (50/25 μg, 100/25 μg, and 200/25 μg), dosed once daily in the morning." The researchers found that all 3 strengths of FF/VI showed improvement in forced expiratory volume in 1 second (FEV 1 ) compared with placebo: adjusted mean improvements from baseline for FF/VI were 220 to 236 mL (all,  P  < .001). Improvements in serial FEV 1  measurements were observed at each time from 0 to 25 hours and with each strength of drug compared with plac...

August 16, 2012 (Washington, DC)   — Preliminary data from the  PINNACLE  registry focusing on patients with atrial fibrillation (AF) suggest that just under half of patients with AF are treated with anticoagulants [1]. Interestingly, of patients in the registry who received oral anticoagulation, 87.4% were treated with  warfarin  in 2011 while just 12.6% were prescribed one of the two newly available oral anticoagulants. "We were a little bit surprised," said  Dr William Oetgen  (Georgetown University, Washington, DC) in reference to the relatively high number of patients who remained on warfarin. "The efficacy and the safety of the novel oral anticoagulants, the two of them that are on the market, are better than Coumadin. The ease of administration is much better than Coumadin. . . . On balance, the drugs seem to be a therapeutic advancement, but the uptake has been slower than we thought it would be." The PINNACLE-AF regi...

August 23, 2012 — Twenty percent of medicines for elderly people in primary care are inappropriately prescribed, despite recent efforts to improve the quality of medical prescriptions for seniors, according to a study  published online  August 22 in  PLoS One . Dedan Opondo, a PhD student from the Department of Medical Informatics, University of Amsterdam, the Netherlands, and colleagues conducted a systematic review of published literature on inappropriate medical prescription (IMP) for elderly people in primary care, with the last search conducted on March 8, 2012. IMP can be defined as prescriptions that subject patients to significant risk for adverse drug reactions when evidence exists that another medication is equally or more effective, or a prescription of a medication that fails to achieve optimal effects. IMP can be characterized as under-, mis-, or overprescribing. Of 946 articles screened, 19 were included in the final analysis, meeting the criteria o...

August 21, 2012 — Physicians who dispense pain medications and other commonly used drugs to workers' compensation (WC) patients charge up to 3 times more than pharmacies in some states, according to a recent study from the not-for-profit Workers Compensation Research Institute (WCRI). That kind of mark-up could explain why physician dispensing for WC patients has grown at a rapid clip in recent years, and why some states now limit how much clinicians can charge. However, a desire for profit may not be the only reason why physicians charge more than pharmacies. Another factor may be wholesale prices that physicians pay to obtain the drugs that they sell. The WCRI study, published in July, compares 23 states, including 3 (Massachusetts, New York, and Texas) in which physician dispensing in general is prohibited. Author Dongchun Wang, a senior researcher at WCRI, examined WC claims for work-related injuries that were submitted and paid during 2 periods: from 2007 to 2008 and fr...

Question What should I do if I suspect that a coworker is impaired in the workplace? Are there various means to address it without being the bad guy? Response from Michael G. O'Neil, PharmD Professor, Department of Pharmacy Practice, Consultant, Drug Diversion and Substance Abuse, South College School of Pharmacy, Knoxville, Tennessee Impairment may be defined as an inability to complete job-related activities and consistently communicate or think rationally without error while performing professional duties. Traditionally, impairment in the healthcare work environment has been characterized by individuals with drug or alcohol addiction, abuse of illicit substances, or misuse of prescription drugs. It has been estimated that 10%-15% of all healthcare professionals may abuse drugs or alcohol in their lifetime. [1] Kessler and colleagues [2]  reported that about 30% of individuals between 15 and 54 years of age reported having at least 1 psychiatric disorder, including ma...

  August 20, 2012 — Supplementing vitamin D in the diets of school children may cut the incidence of acute respiratory infections (ARIs) by as much as half, according to results from a randomized controlled trial carried out in Mongolia. "This double-blinded [randomized controlled trial] of Mongolian children in winter found that vitamin D 3 supplementation with only 300 IU daily led to a clinically and statistically significant reduction in risk of parent-reported ARIs," Carlos Camargo Jr, MD, DrPH, from the Harvard School of Public Health, Boston, Massachusetts, and colleagues write in their article,  published online  August 20 in  Pediatrics . The authors note that a growing number of epidemiologic studies link vitamin D deficiency to heightened risk for ARIs. Other studies have suggested that supplementing vitamin D might cut risks for ARIs and also influenza, but results from those trials have not been consistent. To find out more, Dr. Camargo a...

August 17, 2012 — All people born between 1945 and 1965 should be screened at least once for hepatitis C virus (HCV) infection, according to new guidelines from the Centers for Disease Control and Prevention (CDC). Bryce D. Smith, PhD, from the CDC's National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention at the CDC's National Center for Environmental Health, Atlanta, Georgia, and colleagues  published the new guidelines  in the August 17 issue of the  Morbidity and Mortality Weekly Report . "CDC estimates that although persons born during 1945–1965 comprise an estimated 27% of the population, they account for approximately three fourths of all HCV infections in the United States, 73% of HCV-associated mortality, and are at greatest risk for hepatocellular carcinoma and other HCV-related liver disease," Dr. Smith and colleagues write. Previous recommendations for HCV testing, issued in 1998, stated that only persons with known risk factors and c...