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

intended use (e.g., labeled versus off-label use) may limit inclusion of indications on drug product labels. Current evidence supports inclusion of purpose-for-use language in clear, simple terms. Therefore, the prescriber's intended purpose of use/indication should be included on the prescription whenever possible and should be stated in clear, simple language (e.g., for high blood pressure, for rash or for stomach cramps).

  • Improve Readability. Critical information for patients must appear on the prescription label in an uncondensed, simple, familiar, minimum 12-point, sans serif font (e.g., Arial) that is in sentence case (i.e., punctuated like a normal sentence in English: initial capital followed by lower-case letters except for proper nouns, acronyms, etc.). Field size (examples of "fields" include patient name and directions for use) and font size may be increased in the best interest of patient care. Critical information should never be truncated.

  • Provide Labeling in Patient's Preferred Language. Whenever possible, prescription container labeling should be provided in a patient's preferred language. Translations of labels should be produced using a high-quality translation process.

  • Include Supplemental Information. Auxiliary information on the prescription container should be minimized and should be limited to evidence-based critical information. The information should be presented in a standardized manner and should be necessary for patient understanding. This is important because of the extensive variability in the content and application of supplemental information, the lack of scientific evidence for these labels, and the potential ambiguity and failure to address specific patient needs.

  • Standardize Directions to Patients. In recognition of the nation's move toward e-prescribing, standards should be developed for prescribing directions to patients. This would lead to consistency of language and use across all healt
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  • Contact: Francine Pierson
    fp@usp.org
    301-816-8588
    US Pharmacopeia
    Source:Eurekalert

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