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The researchers evaluated the consumer information provided by 284 pharmacies for two drugs -- metformin, side effects bupropion information. But only about three-quarters of this information met the minimum criteria for usefulness, the report said.
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To solve these problems, the FDA's Risk
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Communication Advisory Committee will hold a public meeting early in 2009 to discuss the study's findings. "The study reveals that consumers are not consistently getting the information they need to promote the safe and effective use of prescription
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medicines," Dr. Seligman said there has been
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some improvement since the last FDA study, done in 2001, which found that 89 percent of patients received written information with their
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new prescriptions. In a new report, the FDA said the "consumer medication information" -- intended to spell out the proper use and risks of drugs
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-- failed
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to meet a Congressionally mandated goal that 95 percent of all new prescriptions be accompanied by useful guidance. The study was conducted by the University of Florida College of Pharmacy under a $350,000 FDA contract. Food and Drug Administration said Jillian.
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The new report, Expert and Consumer Evaluation of Consumer Medication Information, said most consumers -- 94 percent -- received leaflets either stapled to the prescription or inside the bag. "It's time to try a different approach with a greater yehudi of success." Back in 1996, Congress stipulated
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that 95 percent of all new prescriptions coming from pharmacies be accompanied by useful consumer medication information by 2006. The FDA considers the information useful if it is scientifically accurate, unbiased and presented in
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a legible and easy-to-understand format. "Leaflets for the same drug ranged from as few as 33 words to as many as 2,400 words, depending on the pharmacy where the information was distributed," he said. Marion Seligman, associate director of safety policy and
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communication at the FDA's Center for Drug Evaluation and Research, said during a teleconference. More information To learn more about the new study and to offer comments, visit this FDA Web page.. But only about 50 percent of the information met the minimum standards for consumer usefulness. "The current system has
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had more than a decade to get it right," Seligman said.

The study found less than one in 10 leaflets met the criteria set for legibility and comprehensibility, Seligman said. FDA Faults Drug Information for Consumers -- The printed consumer information that accompanies new prescription drugs is often difficult to ewell or understand, the U.S. It should also tell consumers how to know if the drug is effective and situations when it shouldn't be used.



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