Improving Prescription Drug Warning Labels
Prior studies have documented a high prevalence of patients misunderstanding prescription drug warning labels, placing them at risk for medication error.
We sought to evaluate the effectiveness of 'enhanced print' drug warnings to improve patient comprehension beyond a current standard.A three-arm, controlled clinical trial was conducted. Patients were assigned to receive 1) current standard drug warning labels on prescription containers (standard), 2) 'enhanced' drug warnings with text rewritten in plain language (enhanced text), or 3) enhanced language and icons developed with patient feedback (enhanced text + icon).
Setting: Two academic and two community health primary care clinics in Chicago, IL and Shreveport, LA.
Patients: 500 adult patients consecutively recruited at each clinic. Main Outcome Measure: Rates of correct interpretation of nine drug warning labels as determined by a blinded panel review of patients' verbatim responses.
|Enhanced Text Enhanced Text + Icon||Other: Enhanced drug labeling||Phase 4|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
|Study Start Date:||June 2007|
|Study Completion Date:||February 2009|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
Other: Enhanced drug labeling
Please refer to this study by its ClinicalTrials.gov identifier: NCT00846209
|United States, Illinois|
|Northwestern Memorial Faculty Foundation|
|Chicago, Illinois, United States, 60611|