FDA Faults Drug Information for Consumers
Dec. 17 -- 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.
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