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System of simplified, standardized dosing instructions for prescription drug labels proposed
Date:11/28/2007

e ACPFs Medication Labeling Technical Advisory Board, a randomized trial of 500 patients found that understanding of the UMS label was five times greater compared to a typical label.

Prescription medication container labels need a radical change, said Ruth Parker, MD, FACP, co-chair of the ACPFs Medication Labeling Technical Advisory Board. Improving drug labels is an issue that sits at the intersection of health literacy and patient safety. The variability of dosing instructions on labels is a source of confusion among patients, which could lead to adverse drug events.

The UMS idea comes in response to a recently released evidence-based ACPF white paper, Improving Prescription Drug Container Labeling in the United States: A Health Literacy and Medication Safety Initiative, that describes problems with current medication labels and notes that poor patient understanding of labels is prevalent and a significant safety concern.

The white paper, presented to the IOM Roundtable on Health Literacy on October 12, 2007, recommends the following standards for improving patient understanding of prescription medication container labels:

  • Use a UMS to convey and simplify dosage/use instructions.
  • Use explicit text to describe dosage/interval in instructions.
  • Organize label in a patient-centered manner.
  • Include distinguishable front and back sides to the label.
  • When possible, include indication for use.
  • Simplify language, avoiding unfamiliar words/medical jargon.
  • Improve typography, use larger, sans serif font.
  • When applicable, use numeric vs. alphabet characters.
  • Use typographic cues (bolding and highlighting) for patient content only.
  • Use horizontal text only.
  • Use a standard icon system for signaling and organizing auxiliary warnings and instructions.

As the ACP Foundation white paper notes, the lack of universal standards and regulations for drug labels is a root cause
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Contact: Steve Majewski
smajewski@acponline.org
215-351-2514
American College of Physicians
Source:Eurekalert

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