43. Risk Evaluation and Communication

  1. Brian L. Strom MD, MPH2,3,4,5,
  2. Stephen E. Kimmel MD, MSCE4,5 and
  3. Sean Hennessy PHARMD, PHD4,5
  1. Susan J. Blalock and
  2. Betsy L. Sleath

Published Online: 3 JAN 2012

DOI: 10.1002/9781119959946.ch43

Pharmacoepidemiology, Fifth Edition

Pharmacoepidemiology, Fifth Edition

How to Cite

Blalock, S. J. and Sleath, B. L. (2012) Risk Evaluation and Communication, in Pharmacoepidemiology, Fifth Edition (eds B. L. Strom, S. E. Kimmel and S. Hennessy), Wiley-Blackwell, Oxford, UK. doi: 10.1002/9781119959946.ch43

Editor Information

  1. 2

    George S. Pepper Professor of Public Health and Preventive Medicine, Philadelphia, PA, USA

  2. 3

    Department of Biostatistics and Epidemiology, Philadelphia, PA, USA

  3. 4

    Center for Clinical Epidemiology and Biostatistics, Philadelphia, PA, USA

  4. 5

    Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA

Author Information

  1. Division of Pharmaceutical Outcomes and Policy, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA

Publication History

  1. Published Online: 3 JAN 2012
  2. Published Print: 17 FEB 2012

ISBN Information

Print ISBN: 9780470654750

Online ISBN: 9781119959946



  • pharmacoepidemiology;
  • medications;
  • risk;
  • communication;
  • REMS;
  • safety


All medications have risks. A drug is considered “safe” if the risks associated with it are deemed acceptable. In some cases, medications with serious risks are judged as meeting safety standards because the benefits of the medication outweigh the risks. To minimize medication risks following market approval, all parties involved in the medication-use process must have access to up-to-date information concerning potential risks, including measures that can be used to prevent or control these risks. Moreover, this information must be provided in a timely manner and in a way that is understood by the target audience and that facilitates informed decision-making. In this chapter, we discuss some of the clinical and methodologic challenges that must be addressed to meet these goals. We also discuss approaches that are currently used to enhance the dissemination and usability of medication risk information. We conclude by suggesting directions for future research in this area.