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Monday, 29th December 2008

Expert and Consumer Evaluation of Consumer Medication Information, 2008

Expert and Consumer Evaluation of Consumer Medication Information, 2008
From press release:

A study released today by the U.S. Food and Drug Administration found that the printed consumer medication information (CMI) voluntarily provided with new prescriptions by retail pharmacies does not consistently provide easy-to-read, understandable information about the use and risks of medications.

The study, Expert and Consumer Evaluation of Consumer Medication Information, showed that while most consumers (94 percent) received CMI with new prescriptions, only about 75 percent of this information met the minimum criteria for usefulness as defined by a panel of stakeholders. In 1996, Congress called for 95 percent of all new prescriptions to be accompanied by useful CMI by 2006.

"The current voluntary system has failed to provide consumers with the quality information they need in order to use medicines effectively and safely," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "Because the congressional goals have not been met, the FDA intends to seek public comment on initiatives that can be used to meet the goals."

+ Executive Summary (PDF; 64 KB)
+ Full Report (PDF; 2.4 MB)

Source: U.S. Food and Drug Administration


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