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Washington, D.C.-The need to reauthorize the Prescription Drug User Fee Act (PDUFA) before it expires Sept. 30, 2007, has set the stage for Congressional action on broader legislation to enhance government regulation of drug safety. Bills under consideration aim to expand Food and Drug Administration (FDA) oversight by establishing new requirements for postmarket risk assessment, for posting information on active clinical trials and the resulting study data, and for completing agreed-upon postmarketing studies.

Harvard Pilgrim Health Care in Massachusetts has been calling itself "America's highest rated health plan" for the past several years. And it's got industry studies to back it up.

A joint collaboration between a small hospital in Indiana and an Indianapolis-based picture archiving and communications systems (PACS) and complete radiology provider enabled the small hospital round-the-clock access to radiologist services. Upon its opening in October 2006, the Monroe Hospital in Bloomington, Ind., joined forces with the PACS and radiology provider to supply the facility with radiologists to cover all of the hospital's general and subspecialty radiology services through both on-site and remote radiologists.

Most Medicare Advantage and Part D sponsors share a common goal: make Medicare a more profitable line of business. To help alleviate some of the challenges associated with enrollment practices, consider the following tips:

Postmenopausal women with hormone-sensitive early-stage breast cancer who have received at least 2 years of adjuvant treatment with tamoxifen can benefit in overall survival from a switch to anastrozole, according to the results of a meta-analysis published in the journal Lancet.

A review of agents in late-stage development for the treatment of genitourinary disorders (March 2007).

The Institute of Medicine (IOM) issued a report in September 2006 urging FDA to make major changes to better balance the agency's assessment of the risks and benefits of new drugs. FDA commissioner Andrew von Eschenbach, MD, has responded with a report that details the agency's plans to improve procedures for detecting and assessing drug safety problems. "The Future of Drug Safety" describes proposals for developing safety "report cards" on new drugs to better inform prescribers and patients about new safety concerns and to more quickly detect drug safety signals.

Due to pressure from regulators, the pharmaceutical industry is working to implement Radio Frequency Identification (RFID) technology in pharmacies, hospitals, and healthcare facilities to help prevent medication errors. This technology is also being used in a variety of ways to help meet FDA drug pedigree requirements.

Drugs that act to increase dopamine activity are the mainstay of pharmacologic treatment for restless legs syndrome (RLS), a sensomotor disorder that usually manifests as an urge to move the legs, with or without other uncomfortable sensations.

Intra-arterial administration of thrombolytic therapy (mainly tissue-plasminogen activator [t-PA]) has demonstrated significant and immediate clinical improvement, dubbed the "Lazarus phenomenon," in about one-fourth of patients with acute ischemic stroke. Factors associated with the Lazarus phenomenon are a shorter time to treatment, a high reperfusion score, and formation of good pial collaterals.

A panel of former FDA commissioners convened recently to exchange ideas on improvements to the agency, tackling issues ranging from restructuring FDA funding to enhancing the agency's legal authority to ensure drug safety.

Enoxaparin is superior to unfractionated heparin (UFH) for prevention of venous thromboembolism (VTE) in acute ischemic stroke patients with partial paralysis, according to David G. Sherman, MD, lead investigator of a trial known as PREVAIL (Prevention of VTE After Acute Ischemic Stroke with LMWH Enoxaparin).

Measures in Florida and Massachusetts that require paramedics to transport qualifying patients to certified stroke centers helped to increase the number of patients who received tissue plasminogen activator (t-PA) for the treatment of ischemic stroke in both states.

Emergency physician-directed treatment of patients with acute stroke using tissue plasminogen activator (t-PA) is as safe as treatment directed by an acute stroke team, according to the results of a retrospective study presented at the American Heart Association's (AHA's) International Stroke Conference 2007 in San Francisco, Calif.

A meta-analysis published in the journal Current Medical Research and Opinion suggests that women may not achieve the same cardiovascular (CV) benefits from statins as men.

In a systematic review and meta-analysis published in the Annals of Pharmacotherapy, oral phenylephrine was demonstrated to be ineffective for the treatment of nasal congestion as measured by nasal airway resistance (NAR).

In a randomized, double-blind, parallel-group trial published in the American Journal of Respiratory and Critical Care Medicine, the combination of fluticasone and salmeterol (SAL) statistically significantly reduced the number of chronic obstructive pulmonary disease (COPD) exacerbations by 35% compared with SAL alone.

Two studies published in the journals Lancet (Elliott et al) and the Archives of Internal Medicine (Barzilay et al) help to answer questions about the effect some antihypertensive agents can have on the development of diabetes mellitus, but these studies have also raised some new concerns about cardiovascular disease.

In a large, multi-center, randomized, open-label, prospective trial named the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial, monotherapy with the anti-thrombotic agent bivalirudin, when administered to patients experiencing an acute coronary syndrome (ACS) (eg, unstable angina or myocardial infarction without ST-segment elevation), was demonstrated to be as efficacious as the current standard-of-care therapy but with nearly a 50% lower risk of bleeding. The results of the trial were published in the New England Journal of Medicine (NEJM).

First-time generic approvals

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Once-daily oral formulation of anti-inflammatory agent approved for the induction of remission in patients with active, mild-to-moderate ulcerative colitis

Sterile, lyophilized powder concentrate of antihemophilic factor and von Willebrand factor complex for surgical and/or invasive procedures in patients with von Willebrand disease

With the increasing trend toward consumer-directed healthcare, providers can add another specialty to their list: bill collector.

The primary cost to patients with hospital-acquired infections is a prolonged stay and additional therapeutic interventions. But because of the high financial costs, there is increasing outside pressure to decrease infection rates.

Effective maintenance of patient records, registration information, human resources documentation, and reimbursement forms are critical to the IT success of the four-hospital Saint Clare's Health System, in northwestern New Jersey. The hospital system, which houses more than 475 active beds, serves 23,000 inpatients and 250,000 outpatients annually.

With the increasing trend toward consumer-directed healthcare, providers can add another specialty to their list: bill collector.

Surgical site infections are a significant problem in hospitals today. They occur in 2% to 5% of patients who have clean operations outside the abdomen, and in up to 20% of patients with intra-abdominal procedures. They account for about 15% of hospital-acquired infections.