FDA study says printed Rx information not as helpful, consistent as it should be

ROCKVILLE, Md. Printed consumer medication information provided voluntarily with new prescriptions at retail pharmacies does not consistently provide easy-to-read, understandable information about the uses and risks of medications, according to a study released Tuesday by the Food and Drug Administration.

The study, “Expert and Consumer Evaluation of Consumer Medication Information,” showed that while 94 percent of consumers received printed CMI with new prescriptions, 75 percent of this information met the minimum criteria for usefulness, as a panel of stakeholders defined it. 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,” FDA Center for Drug Evaluation and Research director Janet Woodcock said. “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.”

The FDA said that useful CMI includes scientifically accurate, unbiased information presented in an understandable and legible format, and it should include the drug name and uses, how to monitor for improvement in the condition being treated, situations in which the medicine should not be used, symptoms of serious or frequent adverse side effects and what to do, as well as general information such as encouragement that patients talk to their healthcare professionals.

“We need to work with pharmacy operators, drug manufacturers, healthcare professionals and consumers to come up with a sensible, comprehensive and more effective solution,” Woodcock said.

The FDA Risk Communication Advisory Committee will have a public meeting to discuss the study’s findings early next year.