Textbook of Pharmacoepidemiology (eBook)

About the Editors Brian L. Strom is Chancellor, Rutgers Biomedical and Health Sciences, University Professor, and Executive Vice President for Health Affairs, Rutgers University, Newark, NJ, USA. Stephen E. Kimmel is Dean's Professor and Chair of Epidemiology, College of Public Health and Health Professions and College of Medicine, University of Florida, Gainesville, FL, USA. Sean Hennessy is Professor of Epidemiology and Director of the Center for Pharmacoepidemiology Research and Training, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.

Contributors

Preface

Acknowledgements

Part I Introduction to Pharmacoepidemiology

1 What is Pharmacoepidemiology?

Brian L. Strom

2 Study Designs Available for Pharmacoepidemiologic Studies

Brian L. Strom

3 Sample Size Considerations for Pharmacoepidemiologic Studies

Brian L. Strom

4 Basic Principles of Clinical Pharmacology Relevant to Pharmacoepidemiologic Studies

Jeffrey S. Barrett

5 When Should One Perform Pharmacoepidemiologic Studies?

Brian L. Strom

6 Views from Academia, Industry, Regulatory Agencies, and the Legal System

Joshua J Gagne, Jerry Avorn, Nicolle M Gatto,Jingping Mo, Gerald J. Dal Pan, June Raine, Shinobu Uzu, Aaron S. Kesselheim, Kerstin N. Vokinger



Part II Sources of Pharmacoepidemiology Data

7 Postmarketing Spontaneous Pharmacovigilance Reporting Systems

Gerald J. Dal Pan, Marie Lindquist, and Kate Gelperin

8 Overview of Electronic Databases in Pharmacoepidemiology

Brian L. Strom

9 Encounter Databases

Tobi Gerhard, Yola Moride, Anton Pottegard, Nicole Pratt

10 Electronic Health Record Databases

Daniel Horton, Harshvinder Bhullar, Francesca Cunningham, Janet Sultana B. Pharm (Hons.), and Gialuca Trifiro

11 Primary Data Collection for Pharmacoepidemiology

Priscilla Velentgas









12 How Should One Perform Pharmacoepidemiologic Studies? Choosing Among the Available Alternatives

Brian L. Strom



Part III Special Issues in Pharmacoepidemiology Methodology

13 Validity of Drug and Diagnosis Data in Pharmacoepidemiology

Mary Elizabeth Ritchey, Suzanne L West, and George Maldonado

14 Assessing Causality from Case Reports

Bernard Begaud, and the late Judith K. Jones

15 Molecular Pharmacoepidemiology

Christine Y Lu and Stephen E. Kimmel

16 Bioethical Issues in Pharmacoepidemiologic Research

Laura E Bothwell, Annika Richterich, and Jeremy Greene

17 The Use of Randomized Controlled Trials in Pharmacoepidemiology

Robert Reynolds, Samuel M. Lesko, Allen A. Mitchell

18 Pharmacoeconomics: Economic Evaluation of Pharmaceuticals

Kevin A. Schulman

19 Patient Engagement and Patient Reported Outcomes

Esi Morgan

20 The Use of Meta-analysis in Pharmacoepidemiology

Jesse A. Berlin, Vrenda J Crowe, H Amy Xia, and Stephen JW Evans

21 Studies of Medication Adherence

Julie Lauffenburger, Trisha Acri, and Robert Gross

22 Advanced Approaches to Controlling Confounding in Pharmacoepidemiologic Studies

Sebastian Schneeweiss and Samy Suissa



Part IV Special Applications and The Future of Pharmacoepidemiology

23 Special Applications of Pharmacoepidemiology, 339

David Lee, Björn 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, Rachel DiSantostefano, Scott Evans



Studies of Drug Utilization

Evaluating and Improving Prescribing

Special Methodological Issues in Pharmacoepidemiologic Studies of Vaccine Safety

Epidemiologic Studies of Implantable Devices

Research on the Effects of Medications in Pregnancy and in Children

Risk Management

The Pharmacoepidemiology of Medication Errors

Benefit-Risk Assessments of Medical Treatments.



24 The Future of Pharmacoepidemiology

Brian L. Strom, Stephen E. Kimmel, and Sean Hennessy



Appendix A -- Sample Size Tables

Appendix B -- Glossary

Index