Textbook of Pharmacoepidemiology

Edited by
Brian L. Strom, MD, MPH
Executive Vice Dean for Institutional Affairs, George S. Pepper Professor of Public Health
and Preventive Medicine, Professor of Biostatistics and Epidemiology, of Medicine, and
of Pharmacology, Center for Clinical Epidemiology and Biostatistics, Center for
Pharmacoepidemiology Research and Training, Perelman School of Medicine at the
University of Pennsylvania, Philadelphia, PA, USA

Stephen E. Kimmel, MD, MSCE
Professor of Medicine and of Epidemiology, Center for Clinical Epidemiology and
Biostatistics, Center for Pharmacoepidemiology Research and Training, Perelman School
of Medicine at the University of Pennsylvania, Philadelphia, PA, USA

Sean Hennessy, PharmD, PhD
Associate Professor of Epidemiology and of Pharmacology, Center for Clinical Epidemiology
and Biostatistics, Center for Pharmacoepidemiology Research and Training, Perelman School
of Medicine at the University of Pennsylvania, Philadelphia, PA, USA

List of Contributors

Preface to Second Edition

Acknowledgements

I. INTRODUCTION TO PHARMACOEPIDEMIOLOGY

1. What is Pharmacoepidemiology?
Brian L. Strom

2. Study Designs Available for Pharmacoepidemiology Studies
Brian L. Strom

3. Sample Size Considerations for Pharmacoepidemiology Studies
Brian L. Strom

4. Basic Principles of Clinical Pharmacology Relevant to Pharmacoepidemiology Studies
Jeffrey Barrett and Athena F. Zuppa

5. When Should One Perform Pharmacoepidemiology Studies?
Brian L. Strom

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

The View from Academia
Jerry Avorn

The View from Industry
Jingping Mo and Robert F. Reynolds

The View from Regulatory Agencies
Gerald J. Dal Pan and Peter Arlett

The View from the Legal System
Aaron S. Kesselheim

II. SOURCES OF PHARMACOEPIDEMIOLOGY DATA

7. Postmarketing Spontaneous Pharmacovigilance Reporting Systems
Gerald J. Dal Pan, Marie Lindquist, and Kate Gelperin

8. Overview of Automated Databases in Pharmacoepidemiology
Brian L. Strom

9. Examples of Existing Databases:

Health Maintenance Organizations / Health Plans
Sengwee Toh, Susan E. Andrade, Marsha A. Raebel, Denise Boudreau, Robert L. Davis,
Katherine Haffenreffer, Pamala A. Pawloski, Richard Platt is

US Government Claims Databases
Sean Hennessy, Cristin Palumbo Freeman, Francesca Cunningham

Medical Record Databases
Alexis Ogdie, Sinéad M Langan, John Parkinson, Hassy Dattani, Karel Kostev and Joel M Gelfand

Canadian provincial databases
Yola Moride

Pharmacy-based Medical Record Linkage Systems
Ron MC Herings and Lars Pedersen

10. Field Studies
David F Kaufman

11. How Should One Perform Pharmacoepidemiology Studies? Choosing Among the Available Alternatives
Brian L. Strom

III. SPECIAL ISSUES IN PHARMACOEPIDEMIOLOGY METHODOLOGY

12. Validity of Pharmacoepidemiologic Drug and Diagnosis Data
Suzanne L. West, Mary Elizabeth Ritchey, and Charles Poole

13. Inferring Causation from Case Reports
Judith K. Jones

14. Molecular Pharmacoepidemiology
Stephen E. Kimmel, Hubert G. Leufkens, and Timothy R. Rebbeck

15. Bioethical Issues in Pharmacoepidemiologic Research
Antoine C El Khoury

16. The Use of Randomized Controlled Trials for Pharmacoepidemiologic Studies
Samuel M. Lesko and Allen A. Mitchell

17. Pharmacoeconomics: Economic Evaluation of Pharmaceuticals
Kevin A. Schulman, Henry A. Glick, Daniel Polsky, and Shelby D. Reed

18. Using Quality-of-Life Measurements in Pharmacoepidemiologic Research
Holger J. Schünemann, Bradley C. Johnston, Roman Jaeschke, Gordon H. Guyatt

19. The Use of Meta-analysis in Pharmacoepidemiology
Jesse A. Berlin and M. Soledad Cepeda

20. Studies of Medication Adherence
Trisha Acri and Robert Gross

21. Advanced Approaches to Controlling Confounding in Pharmacoepidemiologic Research
Sebastian Schneeweiss and Samy Suissa

IV. SPECIAL APPLICATIONS

22. Special Applications of Pharmacoepidemiology

Studies of Drug Utilization
David Lee

Evaluating and Improving Physician Prescribing
Sumit R. Majumdar, Helene L. Lipton, and Stephen B. Soumerai

Special Methodological Issues in Pharmacoepidemiology Studies of Vaccine Safety
Claudia Vellozzi, Robert T. Chen, and Jason Glanz

Pharmacoepidemiologic Studies of Devices
Danica Marinac-Dabic, Sharon-Lise T. Normand, and Art Sedrakyan

Studies of Drug-Induced Birth Defects
Allen A. Mitchell

Risk Management
Gerald J. Dal Pan, Stella Blackburn, and Claudia Karwoski

The Use of Pharmacoepidemiology to Study Medication Errors
David W. Bates

FDA Sentinel
Melissa A. Robb and Rachel E. Sherman

Comparative Effectiveness Research
Brian L. Strom, Rita Schinnar, and Sean Hennessy

23. The Future of Pharmacoepidemiology
Brian L. Strom, Stephen E. Kimmel, and Sean Hennessy

Appendix A – Sample size tables

Appendix B – Glossary

Index

The New copy of this book will include any supplemental materials advertised. Please check the title of the book to determine if it should include any access cards, study guides, lab manuals, CDs, etc.

The Used, Rental and eBook copies of this book are not guaranteed to include any supplemental materials. Typically, only the book itself is included. This is true even if the title states it includes any access cards, study guides, lab manuals, CDs, etc.