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FDA criticizes medication information

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WASHINGTON, Dec. 16 (UPI) -- The U.S. Food and Drug Administration says it has found flaws in the printed consumer medication information voluntarily provided with new prescriptions.

The FDA said a study of the information provided by retail pharmacies showed it does not consistently provide easy-to-read, understandable information about the use and risks of medications.

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The FDA said its study -- Expert and Consumer Evaluation of Consumer Medication Information -- "showed that while 94 percent of consumers received such information with new prescriptions, only about 75 percent of the information met the minimum criteria for usefulness."

"The current voluntary system has failed to provide consumers with the quality information they need in order to use medicines effectively and safely," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. "We need to work with pharmacy operators, drug manufacturers, healthcare professionals and consumers to come up with a sensible, comprehensive and more effective solution," said Woodcock.

"Specifically," the FDA said, "CMI should include the drug name and uses, how to monitor for improvement in the condition being treated, contraindications, symptoms of serious or frequent adverse reactions and what to do, and certain general information, including statements encouraging patients to talk to their health care professional."

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