FDA study finds medication information fails to meet usefulness criteria

A study by the US Food and Drug Administration has found that the consumer medication information (CMI) provided with new prescriptions by pharmacies does not consistently provide easy-to-read, understandable information about the use and risks of medicines.

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

Janet Woodcock, director of the FDA's Centre for Drug Evaluation and Research, 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."

CMI has been defined as being useful if it includes scientifically accurate, unbiased information that is presented in an understandable and legible format. It should include the drug name and uses, how to monitor for improvement in the condition being treated, contraindications, symptoms of serious or frequent adverse reactions and what to do, and certain general information, including statements encouraging patients to talk to their healthcare professional.

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

In early 2009, the FDA Risk Communication Advisory Committee will hold a public meeting to discuss the study's findings. In addition, the FDA has created a website to receive public comment on the study.

The FDA regulates prescription drug labelling written for healthcare professionals and Medication Guides and Patient Package Inserts written for consumers, but does not review or approve CMI leaflets.

The FDA study was conducted by the National Association of Boards of Pharmacy, with researchers at the College of Pharmacy at the University of Florida.