The US Food and Drug Administration (FDA) announced on Wednesday that it has approved the first generic version of the world's top-selling medicine, the cholesterol-lowering drug Lipitor (atorvastatin), currently marketed by Pfizer Inc.

Ranbaxy Laboratories Limited, India's largest pharmaceutical company, has gained FDA approval to make generic atorvastatin calcium tablets in 10 milligram, 20 mg, 40 mg, and 80 mg strengths. The tablets will be made by Ohm Laboratories in New Brunswick, New Jersey, says the FDA.

A statement from Raxbaxy says Ranbaxy Pharmaceuticals Inc, a wholly owned subsidiary of Ranbaxy Laboratories Ltd, will be marketing the generic atorvastatin in the US.

Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, told the press the agency was "working very hard" to ensure patients get generic drugs as fast as the law will permit:

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ScienceDaily (Nov. 30, 2011) — Virginia Commonwealth University researchers have found that an inflammatory mechanism known as inflammasome may lead to more damage in the heart following injury such as a heart attack, pointing researchers toward developing more targeted strategies to block the inflammatory mechanisms involved.

Following a heart attack, an inflammatory process occurs in the heart due to the lack of oxygen and nutrients. This process helps the heart to heal, but may also promote further damage to the heart. The mechanisms by which the heart responds to injury are not fully understood, so researchers have been examining the cellular pathways involved to gain further insight.

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Patients without insurance have significantly shorter hospital stays than patients with insurance, raising concerns that hospitals may have incentive to release these patients earlier to reduce their own costs of uncompensated care, according to a study.

Researchers analyzed nationally representative data on a weighted sample of more than 90 million hospitalizations between 2003 and 2007 of patients ages 18 to 64. They found that across all hospital types (for-profit, nonprofit and government), the average length of stay for preventable hospitalizations — those thought to be avoidable with the use of appropriate preventive care and disease management — was significantly shorter for individuals without insurance (2.77 days) than for those with either private insurance (2.89 days) or Medicaid (3.19 days).

For patients hospitalized for other diagnoses, the average length of stay was also shorter for uninsured patients (2.74 days) than for those with private insurance (2.86) or Medicaid (3.13).

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Electronic health records will become the norm, sooner than later, experts said at a summit hosted Friday by the Office of the National Coordinator for Health IT (ONC).

The bottom line, said many of the speakers at ONC's Grantee and Stakeholder Summit, is that consumers are demanding EHRs. The government is helping with adoption, but this is not nearly as influential as the healthcare consumer's pressure on providers.

National Coordinator for Health IT Farzad Mostashari, MD, said the patient is not just "a ticket holder crammed into economy."

"The patient is the copilot" with his or her healthcare provider, Mostashari said. "Increasingly, we'll hear patients, consumers, people expecting more out of their interactions with others. So we're going to see all of the pieces come together for this."

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WASHINGTON – The Centers for Medicare and Medicaid Services has its work cut out in transitioning to ICD-10. As the largest payer and the force driving the new code sets in the United States, CMS has a task at least as intimidating as anyone else when it comes to implementation.

“Given the extent to which the code set is built into many business and operating processes and systems, the size of CMS operations, and the complexity of its systems,” the challenges CMS faces are indeed formidable, according to a report published last week from the National Research Council, which CMS assigned to help it better understand how to modernize CMS’ own IT.

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November 14, 2011 | Bernie Monegain, Editor

PLYMOUTH MEETING, PA – Hazards from clinical alarms top the list of 10 technology hazards for 2012, according to the ECRI Institute, an independent nonprofit that researches the best approaches to improving patient care.

Now in its fifth year of publication, ECRI Institute bills its annual Top 10 hazard list as a comprehensive report designed to raise awareness of the potential dangers associated with the use of medical devices and systems. Most significantly, the report includes action-oriented recommendations on addressing these risks.

The top 10 hazards on ECRI Institute’s 2012 list are:

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Nationally, more than a quarter of Medicare’s rated prescription drug plans that will be available to seniors in 2012 get poor ratings from federal officials. And in the Washington metro area, 36 percent rate unacceptably low, according to an analysis of Medicare data.

The Centers for Medicare and Medicaid Services is putting these plans on notice that, unless they take steps to improve their performance over the next few years, they face expulsion from Medicare.

CMS this month revised the way it rates Medicare drug plans to focus more on quality, and many plans’ ratings fell from 2011 to 2012. The criteria changed to stress clinical outcomes, such as whether a patient takes his medication the way he is supposed to, in addition to process measures, such as how long a patient is kept on hold when calling the plan. In judging 2012 plans, CMS for the first time considered whether patients kept up with medications for diabetes, hypertension and cholesterol, and it also considered complaints lodged against plans, and the numbers of people who choose to leave plans.

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