title: An Interactive User Interface for Drug Labeling to Improve Readability and Decision-Making.
abstract: FDA-approved prescribing information (also known as product labeling or labels) contain critical safety information for health care professionals. Drug labels have often been criticized, however, for being overly complex, difficult to read, and rife with overwarning, leading to high cognitive load. In this project, we aimed to improve the usability of drug labels by increasing the 'signal-to-noise ratio' and providing meaningful information to care providers based on patient-specific comorbidities and concomitant medications. In the current paper, we describe the design process and resulting web application, known as myDrugLabel. Using the Structured Product Label documents as a base, we describe the process of label personalization, readability improvements, and integration of diverse evidence sources, including the medical literature from PubMed, pharmacovigilance reports from FDA adverse event reporting system (FAERS), and social media signals directly into the label.
authors.affiliation: School of Informatics and Computing, Indiana University, Indianapolis, IN.
authors.forename: Hamed
authors.initials: H
authors.lastname: Abedtash
authors.affiliation: Regenstrief Institute, Indianapolis, IN.
authors.forename: Jon D
authors.initials: JD
authors.lastname: Duke
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D032882:Comprehension; D003657:Decision Making; D004348:Drug Labeling / Q000379:methods / Q000592:standards*; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D020407:Internet; D061214:Patient Safety; D060735:Pharmacovigilance; D039781:PubMed; D059629:Signal-To-Noise Ratio; D061108:Social Media; D012985:Software Design; D014481:United States; D014486:United States Food and Drug Administration; D014584:User-Computer Interface