Showing posts with label Adverse Drug Experience Reporting System. Show all posts
Showing posts with label Adverse Drug Experience Reporting System. Show all posts

Wednesday, June 8, 2011

Side Effects? These #Drugs Have a Few - NYTimes.com

Dr. Jon Duke of Indiana University was trying to figure out why his patient’s blood platelets were abnormal. Could it be a side effect of one of the dozen drugs the man was taking, a number that is not uncommon among elderly people?

Mark Pernice/Ashley Nodar

He began reading the label of each and every drug. “I was just overwhelmed,” Dr. Duke said. The lists of possible adverse reactions went on and on.

Now he knows why. In a new paper in the Archives of Internal Medicine, Dr. Duke and two colleagues report that the average drug label lists 70 possible side effects and some drugs list more than 500. “This was beyond even what I’d expected,” he said.

For anyone who has ever had to watch an entire Flomax commercial, the listing of a drug’s side effects is almost a joke. But the question is, why does the list continue to grow?

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Tuesday, April 26, 2011

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.

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."

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Andrew Lopez, RN
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Wednesday, February 23, 2011

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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******************************************************

Sincerely,

Andrew Lopez, RN
Nursefriendly, Inc. A New Jersey Corporation.
38 Tattersall Drive, Mantua New Jersey 08051
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856-415-9617, (fax) 415-9618

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