A new FDA study found that printed consumer medication information – the literature accompanying a dispensed prescription drug – does not sufficiently educate consumers about the use and risks of the medication.
The study, Expert and Consumer Evaluation of Consumer Medical Information, found that 94% of consumers received the information with their prescriptions, but that only 75% of this information (dubbed "CMI" by the agency) met criteria for usefulness.
That criterion (established by a steering committee including healthcare professionals, consumer groups, pharma manufacturers, and others) was set after Congress enacted a law in 1996 requiring the private sector to distribute useful CMI with 95% of all new prescriptions by 2006. The 1996 criteria for useful CMI called for the materials to be scientifically accurate, unbiased, specific and comprehensive, understandable, timely, and useful. In 2001, FDA updated the criteria to include more specific CMI requirements, such as drug name, use, contraindications and frequent adverse reactions, among others.
“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, director of the FDA's Center for Drug Evaluation and Research, in a statement.
FDA has created a website to receive public comment on the study, and to solicit feedback from consumers regarding the best ways to provide useful CMI.
In July, the National Consumers League filed a petition with the FDA asking the agency to consolidate the materials consumers receive with a prescription drug, and provide a single, concise document.