FDA Says Medication Guides Could Be More User-Friendly--January 2009
New FDA-sponsored research on how helpful the information accompanying new prescriptions is for patients, finds that the handouts still do not meet Congressional goals for usefulness.
A new FDA study has 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 showed that although 94% of patients received CMI with new prescriptions, only about 75% of this information met the minimum criteria for usefulness; in 1996, Congress called for 95% 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, MD, director of the FDA’s Center for Drug Evaluation and Research. “We need to work with pharmacy operators, drug manufacturers, health care professionals, and consumers to come up with a sensible, comprehensive, and more effective solution,” she continued.
CMI has been defined as being useful if it includes scientifically accurate, unbiased information that is presented in an understandable and legible format. For this study by researchers at the College of Pharmacy, University of Florida, shoppers trained to simulate patients collected CMI on prescriptions for 2 commonly prescribed drugs (metformin and lisinopril) at randomly selected pharmacies throughout the United States.
The study did reveal improvement since CMI was last evaluated in 2001, when 89% of patients received information with their new prescriptions, but only 50% of the CMI met minimal criteria for usefulness.
For more information on the study, “Expert and Consumer Evaluation of Consumer Medication Information 2008,” go to www.fda.gov/cder/news/CMI/default.htm. The FDA Risk Communication Advisory Committee will hold a public meeting in early 2009 to discuss the study’s findings. The Web site has a link to receive public comment and solicit feedback on the best ways to provide useful prescription information to patients.
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