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FDA Says Consumer Drug Info Not Helpful

Dec 17, 2008 | Parker Waichman LLP The U.S. Food and Drug Administration (FDA) just released a study revealing that the printed consumer medication information (CMI)—the hand-outs consumers receive when they pick up prescription drugs— do not always provide easy-to-read, understandable information about a medications’ uses and risks.

The agency’s study entitled, “Expert and Consumer Evaluation of Consumer Medication Information,” indicated that while the vast majority of consumers—94 percent—did receive a CMI with their new prescriptions, only about 75 percent of these documents actually met the minimum criteria for usefulness as defined by a panel of stakeholders.  Of note, in 1996, Congress called for 95 percent of all new prescriptions to be accompanied by useful CMI by 2006, two years ago.

"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, M.D., director of the FDA's Center for Drug Evaluation and Research in the FDA release. "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," Woodcock said, adding, "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."

According to the FDA, a CMI is considered of use if, “it includes scientifically accurate, unbiased information that is presented in an understandable and legible format.”  The FDA notes that the CMI must include the drug name and uses; how to monitor for improvement in the condition for which the drug is treating; contraindications; symptoms of serious or frequent adverse reactions and what to do in the event of such reactions; and some general information, including statements advising patients to speak to their health care professional.  A contraindication is a situation in which a medicine should not be used, notes the FDA.

Early 2009, the FDA Risk Communication Advisory Committee will hold a public meeting to discuss the study's findings; the FDA has created a Website ( to receive public comment and obtain feedback on the best ways to provide useful CMI to consumers, it said.  While the FDA regulates prescription drug labeling developed for health care professionals and Medication Guides and Patient Package Inserts written for consumers, it does not review or approve CMIs, it points out  The FDA notes that its role—as set forth by Congress—is to encourage the private sector to provide this information and evaluate its progress and to supply companies with necessary guidance.

The FDA noted that the study, which it sponsored, was conducted by the National Association of Boards of Pharmacy through a sub-contract with researchers at the University of Florida, College of Pharmacy.  The study involved shoppers trained to simulate patients visiting randomly-selected nationwide pharmacies and who provided pharmacists with prescriptions for two common prescription drugs—metformin and lisinopril—collecting CMIs. Expert and consumer panels evaluated the quantity and quality of the CMIs.

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