Identifying Best Practices for the Safe Use of Pediatric Cough and Cold Medications

Performer: New York University
Principal Investigator:
Shonna Yin MD, MS

Project Duration: 9/30/15-9/29/18

Regulatory Science Challenge

One in ten U.S. children are exposed to cough and cold medications in a given week. Parent confusion about the appropriate use of cough and cold medications is one contributor to the >20,000 U.S. poison control center calls per year attributed to therapeutic errors, or errors in management, involving cough and cold medications. Approximately 7000 annual pediatric emergency department visits involve cough and cold medications in young children. Children less than 6 years old, who use liquid formulations, are at a particularly high risk. Suboptimally designed product containers or carton labeling and packaging have been specifically cited as important factors in medication errors and adverse events. The ability to understand instructions for proper administration of pediatric cough and cold medications is an important health literacy and patient safety concern. As the majority of cough and cold medications used are over-the-counter (OTC), parents often do not consult with health care providers prior to giving medications, relying on their health literacy skills to determine how to administer medications to their children.

Project Description

A multi-part experiment to fill gaps in knowledge pertaining to the optimal labeling and dosing of OTC pediatric cough and cold medications will be conducted. Findings will be merged with known evidence around health literacy best practices to develop a comprehensive, consumer-centered strategy for English and Spanish-speaking parents. The comprehensive strategy will be pilot tested in comparison to existing labels. A white paper summarizing the findings will be produced and shared with federal and national groups, including the FDA and AAP. The findings will extend the body of literature on health literacy and pediatric cough and cold medication use, promoting safe use.

Project Goals

  • Test the efficacy of specific labeling and dosing strategies for improving parent understanding and demonstrated use of pediatric cough and cold medications
  • Explore differences in efficacy of specific labeling and dosing strategies by parent health literacy, English proficiency, and language
  • Explore the efficacy of a comprehensive consumer-centered labeling and dosing strategy for pediatrics in improving parent understanding and use of pediatric cough and cold medications


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