Caitlin A. Knox|Christian Hampp|Mary E. Willy|Almut G. Winterstein|Gerald J. Dal Pan
Patient understanding of drug risks: an evaluation of medication guide assessments
University of Florida|Center for Drug Evaluation and Research|United States Food and Drug Administration|Center for Drug Evaluation and Research|United States Food and Drug Administration|University of Florida|Florida College|Center for Drug Evaluation and Research|United States Food and Drug Administration
purpose medication guide mg part risk evaluation mitigation strategy rems manufacturers assess effectiveness mgs patient surveys undergone systematic evaluation aimed characterize knowledge rates patient surveys describe design respondent characteristics explore predictors acceptable knowledge rates methods analyzed mg assessments submitted food drug administration september 2008 june 2012 evaluated prevalence specific characteristics calculated knowledge rates whereby defined acceptable knowledge 80 respondents correctly answered questions primary drug risk univariate logistic models used investigate predictors acceptable knowledge rates results analyzed first completed mg assessment drug patient survey resulting 66 unique mg assessments mean knowledge rate 638 20 mg assessments 303 achieving 80 threshold compared assessments reach acceptable knowledge rates likely associated additional rems elements eg elements assure safe use communication plans factors including mean age reading understanding mg offered accepting counseling associated knowledge rates considerable variation design mg assessments conclusions mg assessments reach 80 knowledge threshold associated additional interventions likely achieve study highlights need improve patientdirected information methods assessing copyright 2015 john wiley sons ltd