Textbook of Pharmacoepidemiology

Pharmacoepidemiology originally arose from the union of the fields of clinical pharmacology and epidemiology. Pharmacoepidemiology studies the use of and the effects of medical products in large numbers of people and applies the methods of epidemiology to the content area of clinical pharmacology. This field represents the science underlying studies of the effects of medical products (such as drugs, biologicals, and devices) in real world use.  

Strom’s Textbook of Pharmacoepidemiology meets the increasing need for people to be trained in the field. Designed to meet the need of students, this textbook offers an approach that focuses on the core of the discipline, providing a focused educational resource for students. The book is designed for students at all levels: upper-level undergraduates, graduate students, post-doctoral fellows, and others who are learning the field. Case examples feature in most chapters, and all chapters include key points and a list of further reading. 

Fully revised and updated throughout, Textbook of Pharmacoepidemiology, 3rd edition is a useful introduction and resource for students of pharmacoepidemiology, both those enrolled in formal classes and those learning in “the real world,” who will respond to the challenges that they encounter.  

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 of Epidemiology and Chair, Department of Epidemiology, University of Florida College of Public Health and Health Professions and College of Medicine, 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

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