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FDA Faults Drug Information for Consumers

Pamphlets given out by pharmacies aren't always easy to understand

TUESDAY, Dec. 16 (HealthDay News) -- The printed consumer information that accompanies new prescription drugs is often difficult to read or understand, the U.S. Food and Drug Administration said Tuesday.

In a new report, the FDA said the "consumer medication information" -- intended to spell out the proper use and risks of drugs -- failed to meet a Congressionally mandated goal that 95 percent of all new prescriptions be accompanied by useful guidance.

"The study reveals that consumers are not consistently getting the information they need to promote the safe and effective use of prescription medicines," Dr. Paul Seligman, associate director of safety policy and communication at the FDA's Center for Drug Evaluation and Research, said during a Tuesday teleconference.

"The current system has had more than a decade to get it right," Seligman said. "It's time to try a different approach with a greater chance of success."

Back in 1996, Congress stipulated that 95 percent of all new prescriptions coming from pharmacies be accompanied by useful consumer medication information by 2006.

The new report, Expert and Consumer Evaluation of Consumer Medication Information, said most consumers -- 94 percent -- received leaflets either stapled to the prescription or inside the bag. But only about three-quarters of this information met the minimum criteria for usefulness, the report said.

The FDA considers the information useful if it is scientifically accurate, unbiased and presented in a legible and easy-to-understand format. The information should include the drug's name, how it should be used, potential adverse reactions, and a reminder urging patients to talk to their health-care professional. It should also tell consumers how to know if the drug is effective and situations when it shouldn't be used.

The study found less than one in 10 leaflets met the criteria set for legibility and comprehensibility, Seligman said. "Leaflets for the same drug ranged from as few as 33 words to as many as 2,400 words, depending on the pharmacy where the information was distributed," he said.

The researchers evaluated the consumer information provided by 284 pharmacies for two drugs -- metformin, a diabetes drug used to lower blood sugar, and lisinopril (Prinivil), a medication for high blood pressure.

Seligman said there has been some improvement since the last FDA study, done in 2001, which found that 89 percent of patients received written information with their new prescriptions. But only about 50 percent of the information met the minimum standards for consumer usefulness.

To solve these problems, the FDA's Risk Communication Advisory Committee will hold a public meeting early in 2009 to discuss the study's findings. Also, the agency has created a Web site where the public can comment on the study and offer suggestions on ways to provide better prescription information.

The study was conducted by the University of Florida College of Pharmacy under a $350,000 FDA contract.

More information

To learn more about the new study and to offer comments, visit this FDA Web page.

SOURCES: Dec. 16, 2008, teleconference with Paul Seligman, M.D., M.P.H., associate director of safety policy and communication, U.S. Food and Drug Administration Center for Drug Evaluation and Research

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