Title Details

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

Preface, xiii

Acknowledgements, xvii

Part I Introduction to Pharmacoepidemiology 1

1 What is Pharmacoepidemiology? 3
Brian L. Strom

2 Study Designs Available for Pharmacoepidemiologic Studies 17
Brian L. Strom

3 Sample Size Considerations for Pharmacoepidemiologic Studies 30
Brian L. Strom

4 Basic Principles of Clinical Pharmacology Relevant to Pharmacoepidemiologic Studies 40
Jeffrey S. Barrett and Athena F. Zuppa

5 When Should One Perform Pharmacoepidemiologic Studies? 54
Brian L. Strom

6 Views from Academia, Industry, Regulatory Agencies, and the Legal System 63
Jerry Avorn, Jingping Mo, Robert F. Reynolds, Gerald J. Dal Pan, Peter Arlett, and Aaron S. Kesselheim

Part II Sources of Pharmacoepidemiology Data 99

7 Postmarketing Spontaneous Pharmacovigilance Reporting Systems 101
Gerald J. Dal Pan, Marie Lindquist, and Kate Gelperin

8 Overview of Automated Databases in Pharmacoepidemiology 118
Brian L. Strom

9 Examples of Existing Automated Databases 123
Sengwee Toh, Susan E. Andrade, Marsha A. Raebel, Denise M. Boudreau, Robert L. Davis, Katherine Haffenreffer, Pamala A. Pawloski, Richard Platt, Sean Hennessy, Cristin Palumbo Freeman, Francesca Cunningham, Yola Moride, Alexis Ogdie, Sinead M. Langan, John Parkinson, Hassy Dattani, Karel Kostev, Joel M. Gelfand, Ron M.C. Herings, and Lars Pedersen

10 Field Studies 178
David W. Kaufman

11 How Should One Perform Pharmacoepidemiologic Studies? Choosing Among the Available Alternatives 190
Brian L. Strom

Part III Special Issues in PharmacoepidemiologyMethodology 203

12 Validity of Pharmacoepidemiologic Drug and Diagnosis Data 205
Suzanne L. West, Mary Elizabeth Ritchey, and Charles Poole

13 Assessing Causality of Case Reports of Suspected Adverse Events 228
Judith K. Jones

14 Molecular Pharmacoepidemiology 239
Stephen E. Kimmel, Hubert G. Leufkens, and Timothy R. Rebbeck

15 Bioethical Issues in Pharmacoepidemiologic Research 256
Antoine C. El Khoury

16 The Use of Randomized Controlled Trials for Pharmacoepidemiologic Studies 269
Samuel M. Lesko and Allen A. Mitchell

17 Pharmacoeconomics: Economic Evaluation of Pharmaceuticals 280
Kevin A. Schulman, Henry A. Glick, Daniel Polsky, and Shelby D. Reed

18 Using Quality-of-Life Measurements in Pharmacoepidemiologic Research 291
Holger J. Sch€unemann, Bradley C. Johnston, Roman Jaeschke, and Gordon H. Guyatt

19 The Use of Meta-analysis in Pharmacoepidemiology 300
Jesse A. Berlin and M. Soledad Cepeda

20 Studies of Medication Adherence 314
Trisha Acri and Robert Gross

21 Advanced Approaches to Controlling Confounding in Pharmacoepidemiologic Studies 324
Sebastian Schneeweiss and Samy Suissa

Part IV Special Applications 337

22 Special Applications of Pharmacoepidemiology 339
David Lee, Sumit R. Majumdar, Helene L. Lipton, Stephen B. Soumerai, Claudia Vellozzi, Robert T. Chen, Jason Glanz, Danica Marinac-Dabic, Sharon-Lise T. Normand, Art Sedrakyan, Allen A. Mitchell, Gerald J. Dal Pan, Stella Blackburn, Claudia Manzo, Hanna M. Seidling, David W. Bates, Melissa A. Robb, Rachel E. Sherman, Brian L. Strom, Rita Schinnar, and Sean Hennessy

23 The Future of Pharmacoepidemiology 407
Brian L. Strom, Stephen E. Kimmel, and Sean Hennessy

Appendix A—Sample Size Tables 417

Appendix B—Glossary 435

Index 445