Patient understanding of drug risks: an evaluation of medication guide assessments

Author:

Knox Caitlin A.1,Hampp Christian2,Willy Mary2,Winterstein Almut G.13,Dal Pan Gerald2

Affiliation:

1. Pharmaceutical Outcomes and Policy; College of Pharmacy, University of Florida; Gainesville FL USA

2. Office of Surveillance and Epidemiology; Center for Drug Evaluation and Research, U.S. Food and Drug Administration; Silver Spring MD USA

3. Epidemiology, College of Public Health and Health Professions and College of Medicine; University of Florida; Gainesville FL USA

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Reference22 articles.

1. Medication guides-distribution requirements and inclusion in Risk Evaluation and Mitigation Strategies (REMS) 2011

2. Risk Evaluation and Mitigation Strategy (REMS) assessments: social science methodologies to assess goals related to knowledge 2012

3. Standardizing and evaluating risk evaluation and mitigation strategies; notice of public meeting; request for comments 2013

4. Strengthening Risk Evaluation and Mitigation Strategies (REMS) Through Systematic Analysis, Standardized Design, and Evidence-Based Assessment 2013

5. Usability of FDA-approved medication guides;Wolf;J Gen Intern Med,2012

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