Special Applications of Pharmacoepidemiology

David Lee, Bjorn Wettermark, Christine Y. Lu, Stephen B. Soumerai, Robert T. Chen, Sharon Lise T. Normand, Art Sedrakyan, Danica Marinac-Dabic, Daniel B. Horton, Sonia Hernandez-Diaz, Tamar Lasky, Krista F. Huybrechts, Claudia Manzo, Emil Cochino, Hanna M. Seidling, David W. Bates, Bennett Levitan, Rachael L. Disantostefano, Scott Evans

Research output: Chapter in Book/Report/Conference proceedingChapter


This chapter presents selected special applications of pharamcoepidemiology, which include studies of drug utilization; evaluating and improving prescribing; special methodological issues in pharmacoepidemiologic studies of vaccine safety; epidemiologic studies of implantable medical devices; research on the effects of medications in pregnancy and in children; risk management; the pharmacoepidemiology of medication errors; and benefit-risk (B‐R) assessments of medical treatments. It also presents this information using a standard format, focusing on clinical and methodological problems, examples of solutions, and perspectives on the future. Each application ends with a case example and key points. Methodology for B‐R has advanced considerably, and health authorities worldwide have developed much more rigorous B‐R regulatory policies relating to regulatory approval and post‐approval decisions. These advances have led to transparent and rigorous systematic approaches to B‐R which incorporate the patient perspective and can be communicated clearly and succinctly to clinical and patient audiences.

Original languageEnglish (US)
Title of host publicationTextbook of Pharmacoepidemiology, Third Edition
Number of pages75
ISBN (Electronic)9781119701101
ISBN (Print)9781119701088
StatePublished - Jan 1 2021
Externally publishedYes

All Science Journal Classification (ASJC) codes

  • Medicine(all)
  • Pharmacology, Toxicology and Pharmaceutics(all)


  • benefit-risk assessments
  • drug utilization
  • implantable medical devices
  • medical treatments
  • medication errors
  • pharmacoepidemiologic studies
  • risk management
  • vaccine safety


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