What is included with this book?
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
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