Each pharmacologic management strategy for atrial fibrillation has limitations and more research is needed to determine which agents are equally effective, yet safer alternatives. Providing thromboprophylaxis to decrease risk of ischemic stroke is a well-validated approach. However, deciding between rhythm or rate control may not be as straightforward.
Despite known contamination with porcine circovirus type 1, an FDA advisory panel recently agreed that Rotarix (GlaxoSmithKline) and RotaTeq (Merck), two approved vaccines to prevent rotavirus infection, should continue to be used.
Agents in late-stage development for the treatment of epilepsy/seizure disorders.
FDA Amendments Act of 2007 included provisions for sponsors to submit Risk Evaluation and Mitigation Strategies for select pharmaceuticals, if FDA considered it necessary to ensure that its benefits outweigh its risks.
On March 10, 2010, FDA announced that its review of data requested in June 2008 from all bisphosphonate drug manufacturers did not suggest an increased risk of subtrochanteric femur fractures (bone breaks just below the hip) in those receiving oral bisphosphonates.
Chemoprevention with dutasteride (a 5-alpha reductase inhibitor or 5-ARI), given at a dose of 0.5 mg daily, reduced the risk of incident prostate cancer detected on biopsy and improved outcomes related to benign prostatic hyperplasia, according to the results published in the April 1, 2010, edition of the New England Journal of Medicine.
The massive health reform legislation approved by Congress in March promises to significantly expand the number of Americans with healthcare coverage and pharmacy benefits.
"At-risk" generic launches refer to generic pharmaceuticals that are approved by FDA based on the review of an abbreviated new drug application (ANDA) and are subsequently launched while patent litigation is ongoing.
New indication: Rifaximin (Xifaxan) was approved in March 2010 for the reduction in risk of overt hepatic encephalopathy recurrence in patients ≥18 years of age.
FDA granted marketing approval for a new formulation of controlled-release oxycodone (OxyContin, Purdue Pharma) on April 5, 2010.
New Formulation: Doxepin (Silenor) was approved in March 2010 for the treatment of insomnia.
According to a systematic review in the April 13, 2010 edition of the Journal of the American Medical Association, noninsulin antidiabetic drugs show similar reductions in glycosylated HbA1c when used in combination with metformin in type 2 diabetics, but differ in their rates of hypoglycemia and weight gain.
Clinical studies of patients with both ST-elevation and non-ST-elevation acute coronary syndromes have shown that ticagrelor, when compared with clopidogrel, reduces the rates of vascular death and myocardial infarction while increasing the rate of non-coronary artery bypass graft-related major bleeding. Ticagrelor was also associated with a higher incidence of dyspnea and ventricular pauses.
Generic drugs approved by FDA (through April 2010): Losartan potassium tablets in 25-mg, 50-mg, and 100-mg, Losartan potassium and hydrochlorothiazide tablets in 50 mg/12.5 mg, 100 mg/12.5-mg, and 100 mg/25 mg, Hydromorphone hydrochloride injection, Mesna injection
Recent FDA approvals (through April 2010) related to Zortress, OxyContin, Exalgo, Kaletra, Provenge, Dacogen, Asclera, Pancreaze, Tarceva, Oravig
Significant progress will need to be made with the sophistication of the electronic medical records now in use.
Insurers should consider greater transparency regarding the calculation of out-of-network reimbursements and insureds' potential liability for excess charges.
Medicaid rolls will be expanded to include those earning up to 133% of the federal poverty level and adults without children.
Almost 13 million young adults did not have health insurance coverage in 2008. Although young adults are less likely to suffer from chronic conditions they have distinct healthcare needs.
It is possible for hospitals to provide high value to Medicare and commercial payers.
About half of healthcare institutions in the United States provide art therapy services, with positive results.
As with any significant market regulation, the provisions in healthcare reform will undoubtedly change over time.
Better management of chronic conditions will be critical to the future of healthcare delivery, according to Tracey Moorhead.
First on the reform agenda is an overhaul of the formula for calculating Medicare Advantage payments.
PPACA promises to eventually close the coverage gap for seniors.
Under pressure from the Obama administration, insurers say they will not deny health coverage for sick children pending new regulations, and would follow the intent of the law, not the exact language of it.
The reform law provides for and expansion of Medicaid recipients and dependent children as well as an expansion of the Children's Health Insurance Program.
In March, Aetna launched Aetna On-the-Go, providing members access to online features, mobile applications, and text messaging.
The new Medicare Advisory Board will have broad responsibility to make recommendations to reduce spending in the Medicare program.
The U.S. Department of Health and Human Services (HHS) has awarded more than $119 million to states and U.S. territories to support public health efforts to reduce obesity, increase physical activity, improve nutrition, and decrease smoking.
