USP Health Literacy

Promoting Safe Medication Use

Doctor with patient

The USP Healthcare Quality and Safety (HQS) Center of Excellence works with experts and stakeholders to develop health literacy tools and solutions for healthcare professionals that promote patient understanding and mitigate medication errors, reinforcing our commitment to improved global health. Approximately 90 million American adults (47%) have limited health literacy, putting them at a higher risk for adverse medication use.1 Limited understanding of how to use medications can worsen health outcomes and increase costs for patients, as well as the healthcare system. Healthcare professionals play a pivotal role in providing individuals with clear, understandable, and accessible health information.

USP Health Literacy Initiatives

The USP Healthcare Quality and Safety (HQS) Center of Excellence is focused on providing standards and solutions that address the multidimensional challenges related to health literacy, supporting social determinants of health through different learning styles. HQS works to ensure that health literacy and health equity are both incorporated into our work to promote improved health outcomes for all patients.

Important Updates

  • September 30, 2024 - The public comment period for USP General Chapter <1265> Prescription Drug Information – Guidelines was open for 90 days from July 1, 2024, to September 30, 2024.
    • The purpose of this chapter is to ensure that patients receive useful information about their medications, helping maximize adherence benefit while reducing medication misuse. Proposed revisions to this chapter include removing “written” from the chapter title to better address the other ways to deliver medication information to patients and/or caregivers and updated the principles for developing a medication guide, and more 
  • June 27, 2024 - How to create medication guide published
    • Based on the principles of <1265> Written Prescription Drug Information Guidelines provides best strategies for healthcare practitioners who design medication guides. 
  • June 27, 2024 - How to read an OTC label guide published
    • Provides step-by-step instructions on reading label information of over-the-counter drugs for healthcare practitioners to share with patients.
Standards

USP health literacy standards provide information for the optimal formatting of medication guides and prescription containers that are directly dispensed to the patients. These standards support patient understanding about essential medication information, which can help improve safe and appropriate medication use.

Our standards include:

USP <17> Prescription Container Labeling

USP <1265> Written Prescription Drug Information – Guidelines

To view either USP General Chapter, please visit the USP-NF or USP Compounding Compendium

Guides

USP creates informational resources that healthcare professionals can use to help improve patient health literacy. Health literacy infographics provide guidance to aid in patient and caregiver comprehension of medication use.

How to create a medication guide

Based on the principles of <1265> Written Prescription Drug Information Guidelines provides best strategies for healthcare practitioners who design medication guides. 

How to read an OTC label

Provides step-by-step instructions on reading label information of over-the-counter drugs for healthcare practitioners to share with patients.

Pictograms
Pictograms

USP Pictograms, in the form of graphic symbols and instructional diagrams, increase the likelihood of a patient understanding important medication instructions.

The USP Pictogram Library contains over 80 standardized images that convey medication instructions, purpose for use, precautions, and/or warnings to patients and consumers for healthcare professionals to reinforce printed or oral instructions.

USP Pictogram Library

USP Health Literacy History

USP’s history of setting health literacy related standards and providing solutions began over thirty years ago.

  • 1987 – USP Pictograms were developed to assist in proper medication use across literacy and language barriers.
  • 1997 – USP Pictograms were revised to improve comprehension.
  • 2007 – USP participated in the National Academy of Medicine’s initiative to improve health literacy.
    • USP established the Safe Medication Use Expert Committee to develop standards for patient-centered prescription labeling.
  • 2008 – USP established a Health Literacy and Prescription Container Labeling Advisory Panel to identify optimal prescription label content and format for a universal prescription label that promotes safe medication use.
  • 2012 – USP Health Literacy Expert Panel was formed under the Nomenclature, Safety & Labeling Expert Committee to develop patient-centered standards and resources.
  • 2021 – Additions to General Chapter <17> that include the use of oral liquid medication dosing tools with metric measurements.
  • 2023 – Requirements for expiration date formats on drug products changed to use 4-digit year (example: 2028-05).
  • 2024 – Pictogram redesign is currently in process.

HQS Health Literacy Related Standards

  • USP General Chapter <17> Prescription Container Labeling was published, focusing on patient-centered labeling, including style, format, content, and language. It incorporates principles of patient safety, public health messaging, and patient experience to simplify comprehension of important medication information and instructions.
  • USP General Chapter <1265> Written Prescription Drug Information – Guidelines provides guidelines on prescription drug leaflet format, content, and accessibility to help providers who counsel patients about their medicines. The guidelines provide ways to ensure understanding of medicine information to maximize benefit and minimize harm.

HQS Health Literacy Collaborators

HQS partners with external organizations on opportunities to advocate for health literacy, including:

  • Wisconsin Health Literacy
  • Centers for Disease Control (CDC) - PRevention of Overdoses and Treatment Errors in Children Taskforce (PROTECT) Initiative
  • International Pharmaceutical Federation (FIP)

Questions? Any questions related to USP’s work in health literacy can be directed to NomenclatureSL@usp.org.

 

1. Medication Competence, Numeracy, and Health Literacy