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Have you ever tried to read the patient information booklet enclosed with your medication? The print type is small, the letters are crammed in each line, and the medical information is like reading another language.
Just recently, I had to sit down with my mother to explain the dosing information regarding her heart medications. She couldn't read the patient information booklet or what was printed on the pill bottle. Not very comforting if English isn't your first language or if your eyesight isn't the sharpest.
Drug labeling should consist of large letters, easy-to-read language (in different languages), comprehensive graphics, and simple layout and design. But is that what we see? Have we really made significant changes to drug labels and packages? And who exactly is policing this? If it's the FDA, has there been a recent report on the progress of drug labeling? Has there been progress with pharmacies and pharmaceutical agencies?
As an average consumer and a concerned daughter, it would give me great comfort to see my mother read from her pill bottle, so that she knows how many times a day she should take her heart medication.
Linda Thrasybule
Bronx, N.Y.
The FDA's Office of Drug Safety responds:
Thank you for sharing your concerns with the FDA. Understanding why a medicine has been prescribed and how to use it is essential to gaining the greatest benefit from the medicine while keeping any harmful or annoying side effects to a minimum. Information on how to use any medical product should be written clearly and in a format that is understandable to the consumer.
Recognizing the importance of useful written information for consumers who receive prescription medicines, Congress passed a law in 1996 requiring that by 2006, 95 percent of all U.S. prescriptions be accompanied by information that is useful to the consumer. The FDA has the responsibility of monitoring how well pharmacies are progressing in meeting this goal.
A nationwide study done by the FDA in 2001 showed that, while 90 percent of all prescriptions are accompanied by some form of written information for consumers, the majority of this information does not meet the "useful" criterion. In many cases, as you point out, the letters are too small to read and the information is incomplete. The research report is available on the FDA Web site at www.fda.gov/cder/reports/prescriptioninfo/. The FDA is currently working with a broad coalition of pharmacy and consumer groups to improve this situation and meet the 2006 goal specified in the 1996 law.
However, the information that pharmacists put on the "amber bottle" that contains the medicine given to the patient is not regulated by the FDA.
We encourage you and other consumers to tell your pharmacist: "Please give me a label that I can read and written information about my medicine that I can understand."