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Panel recommends standardizing prescription container labeling
Date:5/10/2010

g, M.D., co-chair of the USP Health Literacy and Prescription Container Labeling Advisory Panel. "Confusing medication labels is one area that can be improved considerably. As most of us who have ever received a prescription drug know, the content and appearance of medication labels can vary widely. Sometimes, there is so much information included that it can be difficult to find the most essential informationthe directions for use. By standardizing labels of medications so that they provide reliable, simple and concise information, I think we can significantly advance patient health and safety."

The recommendations by the advisory panel include:

  • Organize the Prescription Label in a Patient-Centered Manner. Information must be organized in a way that best reflects how most patients seek out and understand medication instructions. Prescription container labeling should feature only the most critical patient information needed for safe and effective understanding and use.

  • Simplify Language. To improve patient understanding and safe and effective prescription medication use, language on the label should be clear, simplified, concise and standardized. Only common terms and sentences should be used. Use of unfamiliar words (including Latin terms) and unclear medical jargon should be avoided. Ambiguous directions such as "take as directed" should be avoided unless clear and unambiguous supplemental instructions and counseling are provided.

  • Use Explicit Text to Describe Dosage/Interval Instructions. Dosage, usage and administration instructions must clearly separate dose from interval and must provide the explicit frequency of drug administration (e.g., "Take 4 tablets each day. Take 2 tablets in the morning and 2 tablets in the evening" is better than "Take two tablets by mouth twice daily"). Use numeric rather than alphabetic characters for numbers.

  • Include Purpose for Use. Confidentiality and FDA approval for
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Contact: Francine Pierson
fp@usp.org
301-816-8588
US Pharmacopeia
Source:Eurekalert

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