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FDA Study Finds Consumer Medication Information Not Consistently Useful

By January 19, 2009


Monday Morning Medication Safety Tip
Each week, Dr. Mike shares information on how to take your medications safely.

Last month, the U.S. Food and Drug Administration (FDA) released a study that found that the printed consumer medication information provided with new prescriptions by retail pharmacies does not consistently provide easy-to-read, understandable information about the use and safety of medications.

The FDA-sponsored study, Expert and Consumer Evaluation of Consumer Medication Information, was carried out using shoppers who were trained to simulate patients. These shoppers visited drugstores around the U.S. and gave the pharmacists prescriptions for two commonly prescribed generic medications – metformin (commonly used to treat type 2 diabetes) and lisinopril (commonly used to treat high blood pressure). The shoppers collected the consumer medication leaflets provided with their prescriptions. Medical experts and consumers evaluated the quantity and quality of this information.

In 1996, Congress called for 95 percent of all new prescriptions to be accompanied by useful consumer medical information by 2006. The FDA study showed that:

  • six percent of the time, the shopper was not given a leaflet
  • 25 percent of the information failed to meet minimum standards for usefulness
  • 97 percent of the lisinopril leaflets and 82 percent of the metformin leaflets failed to adequately warn consumers about stopping the medication if side effects occurred

According to the FDA, the consumer leaflets should include the name of the medication you’re taking and how to use it, how to know if you are improving for the condition being treated, situations when you should not use the medication, symptoms of serious or frequent side effects and what to do, and encouraging you to talk to your health care professional about your medication.

What do you think? Leave a comment below or in the Medication Forum.

To ask me a question about medication, email me at drugs.guide@about.com.

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