Textbook of Pharmacoepidemiology

Edited byBrian L. Strom, MD, MPHExecutive Vice Dean for Institutional Affairs, George S. Pepper Professor of Public Healthand Preventive Medicine, Professor of Biostatistics and Epidemiology, of Medicine, andof Pharmacology, Center for Clinical Epidemiology and Biostatistics, Center forPharmacoepidemiology Research and Training, Perelman School of Medicine at theUniversity of Pennsylvania, Philadelphia, PA, USAStephen E. Kimmel, MD, MSCEProfessor of Medicine and of Epidemiology, Center for Clinical Epidemiology andBiostatistics, Center for Pharmacoepidemiology Research and Training, Perelman Schoolof Medicine at the University of Pennsylvania, Philadelphia, PA, USASean Hennessy, PharmD, PhDAssociate Professor of Epidemiology and of Pharmacology, Center for Clinical Epidemiologyand Biostatistics, Center for Pharmacoepidemiology Research and Training, Perelman Schoolof Medicine at the University of Pennsylvania, Philadelphia, PA, USA

• Preface, xiiiAcknowledgements, xviiPart I Introduction to Pharmacoepidemiology 11 What is Pharmacoepidemiology? 3Brian L. Strom2 Study Designs Available for Pharmacoepidemiologic Studies 17Brian L. Strom3 Sample Size Considerations for Pharmacoepidemiologic Studies 30Brian L. Strom4 Basic Principles of Clinical Pharmacology Relevant to Pharmacoepidemiologic Studies 40Jeffrey S. Barrett and Athena F. Zuppa5 When Should One Perform Pharmacoepidemiologic Studies? 54Brian L. Strom6 Views from Academia, Industry, Regulatory Agencies, and the Legal System 63Jerry Avorn, Jingping Mo, Robert F. Reynolds, Gerald J. Dal Pan, Peter Arlett, and Aaron S. KesselheimPart II Sources of Pharmacoepidemiology Data 997 Postmarketing Spontaneous Pharmacovigilance Reporting Systems 101Gerald J. Dal Pan, Marie Lindquist, and Kate Gelperin8 Overview of Automated Databases in Pharmacoepidemiology 118Brian L. Strom9 Examples of Existing Automated Databases 123Sengwee 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 Pedersen10 Field Studies 178David W. Kaufman11 How Should One Perform Pharmacoepidemiologic Studies? Choosing Among the Available Alternatives 190Brian L. StromPart III Special Issues in PharmacoepidemiologyMethodology 20312 Validity of Pharmacoepidemiologic Drug and Diagnosis Data 205Suzanne L. West, Mary Elizabeth Ritchey, and Charles Poole13 Assessing Causality of Case Reports of Suspected Adverse Events 228Judith K. Jones14 Molecular Pharmacoepidemiology 239Stephen E. Kimmel, Hubert G. Leufkens, and Timothy R. Rebbeck15 Bioethical Issues in Pharmacoepidemiologic Research 256Antoine C. El Khoury16 The Use of Randomized Controlled Trials for Pharmacoepidemiologic Studies 269Samuel M. Lesko and Allen A. Mitchell17 Pharmacoeconomics: Economic Evaluation of Pharmaceuticals 280Kevin A. Schulman, Henry A. Glick, Daniel Polsky, and Shelby D. Reed18 Using Quality-of-Life Measurements in Pharmacoepidemiologic Research 291Holger J. Sch€unemann, Bradley C. Johnston, Roman Jaeschke, and Gordon H. Guyatt19 The Use of Meta-analysis in Pharmacoepidemiology 300Jesse A. Berlin and M. Soledad Cepeda20 Studies of Medication Adherence 314Trisha Acri and Robert Gross21 Advanced Approaches to Controlling Confounding in Pharmacoepidemiologic Studies 324Sebastian Schneeweiss and Samy SuissaPart IV Special Applications 33722 Special Applications of Pharmacoepidemiology 339David 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 Hennessy23 The Future of Pharmacoepidemiology 407Brian L. Strom, Stephen E. Kimmel, and Sean HennessyAppendix A—Sample Size Tables 417Appendix B—Glossary 435Index 445