The panel made its recommendations in November 2009 (USP, 2010). These recommendations are presented in Box 4-1.

The recommendations have been adopted by the Safe Medication Use Committee. USP is preparing a General Chapter for the USP-National Formulary. The patient-centered prescription label standards are for the format, appearance, content, and language of prescription medication containers to promote patient understanding. These recommendations are evidence based and address optimal understanding, adherence, and safe and effective use of medications by patients, Schwartzberg said.

BOX 4-1

Recommendations of the U.S. Pharmacopeia Health Literacy and Prescription Container Labeling Advisory Panel

Recommendations


Organize the Prescription Label in a Patient-Centered Manner


Patient-directed 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.


Patient-directed instructional content will be at the top of the label, and other less critical content (e.g., pharmacy name and phone number, prescriber name, fill date, refill information, expiration date, prescription number, drug quantity, product description, and evidence-based auxiliary information) should not supersede critical patient information. Such less critical information can be placed, e.g., at the bottom of the label or another less prominent location. Drug name and directions for use (e.g., specific dosage/usage/administration instructions) should be displayed with greatest prominence.


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; see below) and unclear medical jargon should be avoided.


Whenever available and appropriate to the patient context, standardized patient-centered translations of common prescribing directions to patients (SIG) should be used. Ambiguous directions such as “take as directed” should be avoided unless clear and unambiguous supplemental instructions and counseling are provided (e.g., directions for use that will not fit on the prescription container label). A clear statement referring the patient to such supplemental materials should be stated on the container label.



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