The US Food and Drug Administration (FDA) says it will take steps to improve the quality of printed consumer medication information (CMI) provided by pharmacies with new prescriptions, after finding that much of the currently-available CMI is “not consistently useful.”

CMI is provision is currently conducted under a voluntary system, but a survey by the FDA shows that, while 94% of consumers receive CMI with new prescriptions, only about 75% of this information meets the minimum criteria for usefulness as defined by a panel of stakeholders.

The new study shows some improvements on the findings of a similar survey, conducted in 2001, which reported that while 89% of prescriptions received written information when their new prescriptions were filled, only about 50% of it met minimal criteria for usefulness.

Nevertheless, commenting on the latest findings, Dr Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research (CDER) said they show that the current voluntary system has failed to provide consumers with the quality information they need in order to use medicines effectively and safely. In 1996, Congress had called for 95% of all new prescriptions to be accompanied by “useful” CMI by 2006 and, because these goals have not been met, the FDA intends to seek public comment on initiatives that can be used to meet the goals, she added.

"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," said Dr Woodcock.

On February 26-27, the FDA Risk Communication Advisory Committee will hold a meeting, which will be open to the public, to discuss the study's findings and examine the different types of prescription drug information currently available to patients, in the form of medication guides and package inserts as well as CMI. In addition, the FDA has created a website to receive public comment on the study and solicit feedback on the best ways to provide useful prescription information to consumers.

- CMI is defined as “useful” if it includes scientifically accurate, unbiased information that is presented in an understandable and legible format. Specifically, this information should include the drug's name and its uses, how to monitor for improvement in the condition being treated, contraindications, symptoms of serious or frequent adverse reactions and what to do, plus certain general information, including statements encouraging patients to talk to their health care professional.