Extending FDA guidance to include consumer medication information (CMI) delivery on mobile devices

Adam Sage, Susan J. Blalock, Delesha Carpenter

Research output: Research - peer-reviewComment/debate

Abstract

This paper describes the current state of consumer-focused mobile health application use and the current U.S. Food and Drug Administration (FDA) guidance on the distribution of consumer medication information (CMI), and discusses recommendations and considerations for the FDA to expand CMI guidance to include CMI in mobile applications. Smartphone-based health interventions have been linked to increased medication adherence and improved health outcomes. Trends in smartphone ownership present opportunities to more effectively communicate and disseminate medication information; however, current FDA guidance for CMI does not outline how to effectively communicate CMI on a mobile platform, particularly in regards to user-centered design and information sourcing. As evidence supporting the potential effectiveness of mobile communication in health care continues to increase, CMI developers, regulating entities, and researchers should take note. Although mobile-based CMI offers an innovative mechanism to deliver medication information, caution should be exercised. Specifically, considerations for developing mobile CMI include consumers' digital literacy, user experience (e.g., usability), and the quality and accuracy of new widely used sources of information (e.g., crowd-sourced reviews and ratings). Recommended changes to FDA guidance for CMI include altering the language about scientific accuracy to address more novel methods of information gathering (e.g., anecdotal experiences and Google Consumer Surveys) and including guidance for usability testing of mobile health applications.

LanguageEnglish (US)
Pages209-213
Number of pages5
JournalResearch in Social and Administrative Pharmacy
Volume13
Issue number1
DOIs
StatePublished - Jan 1 2017

Fingerprint

United States Food and Drug Administration
Equipment and Supplies
Mobile devices
Mobile Applications
Smartphones
Health
mHealth
Telemedicine
Smartphone
Bioelectric potentials
Health care
Communication
Testing
User centered design
Medication Adherence
Ownership
Language
Research Personnel
Delivery of Health Care
Surveys and Questionnaires

Keywords

  • Consumer medication information
  • Mobile
  • Policy
  • Usability

ASJC Scopus subject areas

  • Pharmacy
  • Pharmaceutical Science

Cite this

Extending FDA guidance to include consumer medication information (CMI) delivery on mobile devices. / Sage, Adam; Blalock, Susan J.; Carpenter, Delesha.

In: Research in Social and Administrative Pharmacy, Vol. 13, No. 1, 01.01.2017, p. 209-213.

Research output: Research - peer-reviewComment/debate

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