FDA: Too Much Consumer Drug Information is Unclear, Hard to Read
Not all the printed information handed out by retail pharmacies to consumers picking up new prescriptions provides clear, easy-to-understand language about the risks of the medication and other helpful details, according to the Food and Drug Administration.
In a study released December 16, 2008, the agency found that while 94 percent of people receive some sort of printed consumer medical information when picking up a new prescription, just 75 percent of that information currently meets the agency’s standards for usefulness. That means that one in four consumers get information that is hard to understand or gives incomplete details about the prescription.
The mark falls well short of the goal set by Congress in 1996, when leaders said that 95 percent of all new prescriptions should come with useful consumer medication information by 2006.
The study was conducted by the National Association of Boards of Pharmacy in conjunction with researchers at the University of Florida, College of Pharmacy. Shoppers visited pharmacies throughout the United States, gave the pharmacists prescriptions for two commonly prescribed drugs, metformin and lisinopril, and gathered the printed consumer medical information provided with the prescriptions. Expert and consumer panels then evaluated the quantity and quality of the information.
The FDA regulates prescription drug labeling and medication guides in the packaging written for consumers, but the agency does not review or approve of the content of leaflets given to consumers directly by retail pharmacies. However, the agency does strive to encourage pharmacies to provide accurate and easy-to-understand consumer literature with new drug prescriptions.
According to the FDA, useful consumer medical information should provide scientifically accurate, unbiased information that is presented in an understandable and legible format. It should include the drug’s name, how the drug is to be used, situations where the drug should not be taken, symptoms of adverse reactions and what to do if an adverse reaction occurs, and other general information. For instance, the printed information should encourage the consumer to contact their health-care provider if they have questions.
While the percentage of useful consumer medical information failed to live up to Congressional goals, there has been improvement in the area in recent years, the FDA said. In 2001, a similar agency study found that only 89 percent of patients received printed information with their new prescriptions and that only half of that material met the agency’s standards for usefulness.
The FDA also announced that in early 2009, an advisory committee will hold a public meeting to discuss the study’s findings in an effort to find the best ways to provide better, more reliable and useful drug information to consumers.
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