Study Finds Much of Private-Sector Consumer Medication Information Not Consistently Useful

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A study released in December by the US Food and Drug Administration (FDA) 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, Expert and Consumer Evaluation of Consumer Medication Information, showed that, although 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, 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. “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.”

According to the FDA, CMI is defined as useful “if it includes scientifically accurate, unbiased information that is presented in an understandable and legible format. Specifically, CMI 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 certain general information, including statements encouraging patients to talk to their health care professional.”

“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 Woodcock. In early 2009, the FDA's Risk Communication Advisory Committee will hold a public meeting to discuss the study's findings. Although the FDA regulates prescription drug labeling written for health care professionals and Medication Guides and Patient Package Inserts written for consumers, it does not review or approve CMI leaflets. The agency's role, as set forth by Congress, has been to encourage the private sector to provide this information, to supply the companies with the necessary guidance and to evaluate the private sector's progress.

The FDA-sponsored study was conducted by the National Association of Boards of Pharmacy through a subcontract with researchers at the University of Florida, College of Pharmacy. Shoppers trained to simulate patients visited randomly selected pharmacies throughout the United States. The shoppers gave the pharmacists prescriptions for 2 commonly prescribed drugs, metformin and lisinopril, and collected the CMI provided with the prescriptions. Expert and consumer panels evaluated the quantity and quality of this information.

According to the agency, some improvements were shown by the new study when compared with a similar evaluation of CMI in 2001, Evaluation of Written Prescription Information Provided in Community Pharmacies, 2001. That study revealed that 89% of patients received written information when their new prescriptions were filled, but only 50% of the CMI met minimal criteria for usefulness.