amednews: 1 in 3 patients harmed during hospital stay :: April 18, 2011 ... American Medical News

By Kevin B. O'Reilly, amednews staff. Posted April 18, 2011.

One-third of hospital patients experience adverse events and about 7% are harmed permanently or die as a result, according to a study that detected patient safety problems at a far higher rate than other methods.

The study, in April's Health Affairs, echoes two reports issued in November 2010 that showed rates of adverse events hovering near 25% among hospitalized Medicare patients nationwide and at 10 North Carolina hospitals.

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The findings draw attention to the safety troubles that have lingered in U.S. hospitals in the 12 years since the Institute of Medicine's headline-grabbing report "To Err is Human." The study cited research estimating that up to 98,000 patients die each year due to preventable medical errors.

"This is one of the best studies that now gives us a sense of how much harm is happening to patients in American hospitals," said Robert Wachter, MD, chief of the medical service at the University of California, San Francisco Medical Center, who was not involved in the research. "There is a tremendous amount of harm befalling patients who are admitted to hospitals and humongous opportunities for improvement."

via ama-assn.org

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AIM: Adverse event reporting is on the rise

Although the FDA's Adverse Event Reporting System (AERS) database has been in existence since 1969, more than half of the incidents in it were received in the past decade, according to an article published online March 28 in the Archives of Internal Medicine.

These 2.2 million events represent a 1.65-fold increase from the prior decade, wrote Sheila Weiss-Smith, PhD, from the University of Maryland School of Pharmacy in Baltimore, and colleagues. "Report volume increased from 2000 to 2010 at a mean annual rate of 11.3 percent,” the authors continued.

AERS is a repository of passively reported adverse drug events designed as a safety net so the FDA can monitor all marketed drugs and detect serious safety problems. Weiss-Smith and colleagues sought to characterize the current reporting patterns.

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Rare Fractures Linked To Drugs For Weak Bones : NPR

The study found 716 atypical fractures among more than 200,000 Ontario women over 68. The researchers calculate the risk at one or two atypical fractures for every 1,000 women who took bisphosphonate drugs for more than five years.

Enlarge Courtesy of Dr. Jennifer Schneider

An X-ray of Schneider's right femur (thighbone), which broke suddenly as she was standing on a New York subway train.

Courtesy of Dr. Jennifer Schneider

An X-ray of Schneider's right femur (thighbone), which broke suddenly as she was standing on a New York subway train.

That's fairly rare, and considerably less than the risk of another potential side effect from these drugs, a condition called osteonecrosis of the jaw — the death of part of the jawbone, following a major dental procedure. Still, since tens of millions of women are taking bisphosphonates, the Ontario study suggests thousands of them may suffer devastating atypical fractures every year.

But here's the dilemma: Many women really need these drugs, because they really do work to prevent ordinary hip fractures caused by osteoporosis.

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Drug maker cited for not reporting side effects - Health - Health care - msnbc.com

U.S. health regulators have warned Sanofi-Aventis SA's U.S. unit for failing to submit reports of possible serious side effects in a timely manner.

In a January 28 letter made public on Tuesday, the Food and Drug Administration said an early response from the drugmaker and its "promised corrective actions are inadequate to address the deficiencies."

"We remain concerned that your .... adverse drug experience reporting system has not been fully validated, and may have resulted in inaccurate assessment and untimely submission of 15-day alerts," FDA said.

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