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Universal standards proposed for prescription container labels to help reduce medication misuse
Date:1/3/2011

SP across the fields of pharmacy, medicine, health literacy, patient safety, human factors research, drug database software and chain drug retail operations, the standards could be adopted by state boards of pharmacy, other governmental authorities, or conformity assessment bodies into state laws, regulations, guidelines or other documents. Adoption of USP's standards at the state level is common, such as in the cases of USP's widely recognized standards for sterile and nonsterile pharmaceutical compounding to help ensure safe preparation of these customized medications. A few states, including California and New York, recently developed their own regulations for prescription container labeling.

Generally, the new standards propose that prescription container labels generated by pharmacies:

  • Are organized in a patient-centered mannerOrganized in a way that best reflects how most patients understand medication instructions, featuring the most important information for safe and effective understanding and use.
  • Emphasize instructions and other important information to patientsProminently display information that is critical to patient's safe and effective use of the medicine, such as, patient's name, drug name and strength, and clear directions for use. Less critical but important content (e.g., pharmacy name and number) should not supersede critical patient information.
  • Give explicit instructionsInstructions should clearly separate the dose itself from the timing of each dose and use numeric characters (e.g., "Take 2 tablets in the morning and 2 tablets in the evening" rather than "Take two tablets twice daily").
  • Include purpose for useThe medication's purpose should be included on the label unless the patient prefers that it not appear. When included, use clear, simple terms (e.g., "for high blood pressure" rather than "for hypertension").
  • Improve readabilityThe label type should use high-contrast print (e.g. black print
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Contact: Theresa Laranang-Mutlu
trl@usp.org
301-816-8167
US Pharmacopeia
Source:Eurekalert

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