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Angie Drakulich was editorial director of Pharmaceutical Technology.
A newly released study from the US Food and Drug Administration demonstrates that the printed information retail pharmacies provide to patients regarding medication use and risk of their prescriptions is not easy to read or understand.
Rockville, MD (Dec. 29)-A newly released study from the US Food and Drug Administration demonstrates that the printed information retail pharmacies provide to patients regarding medication use and risk of their prescriptions is not easy to read or understand. Even though 94% of consumers receive consumer medication information (CMI), only 75% of that information met the minimum “usefulness” requirement, said the authors of the Expert and Consumer Evaluation of Consumer Medication Information study.
In 1996, Congress requested that 95% of all new prescriptions be accompanied by useful CMI by 2006. The study does reveal some improvements since a similar study was conducted in 2001. The earlier report found that 89% of patients received CMI but only 50% of that information met the minimum usefulness criteria.
“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, MD, director of FDA’s Center for Drug Evaluation and Research, in a Dec. 16 FDA press release.
CMI is supposed to include the drug’s name and uses, how to monitor for improvement in the condition being treated, contraindications, symptoms of adverse reactions and what to do, and certain general information.
To improve the situation, the FDA Risk Communication Advisory Committee is holding a public meeting in early 2009 to discuss the study’s findings. An agency website is also available for public comment and feedback.
Read the full study here.