Does anyone really read Rx information?
WASHINGTON, D.C.; December 17, 2008 But a new study by the Food and Drug Administration shows most are hard to understand, and don't explain the risks very well. The study showed that only about three-quarters meet minimum requirements for usefulness, well below the mark set by Congress. It said that by 2006, 95 per cent had to meet the standard. While the FDA regulates prescription drug labelling, and the package inserts within medications, it does not review or approve the consumer information leaflets. The format and language of those is created by drug retailers, and pharmaceutical companies. "The current voluntary system has failed to provide consumers with the quality information they need in order to use medicines effectively and safely," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. Dr. Woodcock says the FDA will now ask for the public's input on making the information easier to understand. "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. 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 pharmacies randomly selected throughout the United States. The shoppers gave the pharmacists prescriptions for two 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. The FDA has created a Web site to receive comment on the study and get feedback on the best ways to provide useful information. Give the FDA your thoughts by clicking on this link<\a>.
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