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

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