Textbook of Pharmacoepidemiology (eBook)

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 Studies17
Brian L. Strom

3 Sample Size Considerations for Pharmacoepidemiologic Studies30
Brian L. Strom

4 Basic Principles of Clinical Pharmacology Relevant toPharmacoepidemiologic 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 theLegal 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 Systems101
Gerald J. Dal Pan, Marie Lindquist, and Kate Gelperin

8 Overview of Automated Databases in Pharmacoepidemiology118
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, RonM.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 PharmacoepidemiologyMethodology203

12 Validity of Pharmacoepidemiologic Drug and Diagnosis Data205
Suzanne L. West, Mary Elizabeth Ritchey, and CharlesPoole

13 Assessing Causality of Case Reports of Suspected AdverseEvents 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 forPharmacoepidemiologic Studies 269
Samuel M. Lesko and Allen A. Mitchell

17 Pharmacoeconomics: Economic Evaluation of Pharmaceuticals280
Kevin A. Schulman, Henry A. Glick, Daniel Polsky, and Shelby D.Reed

18 Using Quality-of-Life Measurements in PharmacoepidemiologicResearch 291
Holger J. SchEURunemann, Bradley C. Johnston, RomanJaeschke, 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 inPharmacoepidemiologic 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, DanicaMarinac-Dabic, Sharon-Lise T. Normand, Art Sedrakyan, Allen A.Mitchell, Gerald J. Dal Pan, Stella Blackburn, Claudia Manzo, HannaM. 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