The Editors Brian L. Strom is Chancellor, Rutgers Biomedical and Health Sciences and Executive Vice President for Health Affairs, Rutgers University, Newark, NJ, USA. Stephen E. Kimmel is Professor of Medicine and Director of the Division of Epidemiology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA. Sean Hennessy is Professor of Epidemiology and Director of the Center for Pharmacoepidemiology Research and Training, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.

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• Contributors xPreface xixAcknowledgments xxiiiPart I Introduction 11 What is Pharmacoepidemiology? 3Brian L. Strom2 Basic Principles of Clinical Pharmacology Relevant to Pharmacoepidemiologic Studies 27Jeffrey S. Barrett3 Basic Principles of Clinical Epidemiology Relevant to Pharmacoepidemiologic Studies 44Brian L. Strom4 Sample Size Considerations for Pharmacoepidemiologic Studies 60Brian L. Strom5 When Should One Perform Pharmacoepidemiologic Studies? 71Brian L. StromPart II The Role of Pharmacoepidemiology in Different Sectors 816 The Role of Pharmacoepidemiology in the Healthcare System and Academia 83Joshua J. Gagne and Jerry Avorn7 The Role of Pharmacoepidemiology in Industry 98Nicolle M. Gatto, Rachel E. Sobel, Jamie Geier, Jingping Mo, Andrew Bate, and Robert F. Reynolds8 The Role of Pharmacoepidemiology in Regulatory Agencies 126Gerald J. Dal Pan, June Raine, and Shinobu Uzu9 Pharmacoepidemiology and the Law 140Aaron S. Kesselheim and Kerstin N. VokingerPart III Sources of Data for Pharmacoepidemiology Research 165Part IIIa Spontaneous Reporting 16710 Postmarketing Spontaneous Pharmacovigilance Reporting Systems 169Gerald J. Dal Pan, Marie Lindquist, and Kate GelperinPart IIIb Electronic Data Systems 20311 Overview of Electronic Databases in Pharmacoepidemiology 205Brian L. Strom12 Encounter Databases 211Tobias Gerhard, Yola Moride, Anton Pottegård , and Nicole Pratt13 Electronic Health Record Databases 241Daniel B. Horton, Harshvinder Bhullar, Lucy Carty, Francesca Cunningham, Alexis Ogdie, Janet Sultana, and Gianluca Trifiro14 Inpatient Databases 290James A. Feinstein, Peter K. Lindenauer, Chris Feudtner, and Brian T. FisherPart IIIc Studies Involving Ad Hoc Data Collection 30515 Event Monitoring in the UK 307Vicki Osborne and Saad A.W. Shakir16 Primary Data Collection for Pharmacoepidemiology 342Nancy A. Dreyer, Ana Filipa Macedo, and Priscilla VelentgasPart IIId Choosing a Data Source 35517 Choosing among the Available Data Sources for Pharmacoepidemiology Research 357Brian L. StromPart IV Selected Applications of Pharmacoepidemiology 37318 Studies of Drug Utilization 375Björn Wettermark, Vera Vlahović-Palčevski, David Lee, and Ulf Bergman19 Evaluating and Improving Physician Prescribing 411Christine Y. Lu, the late Sumit R. Majumdar, Helene Lipton, and Stephen B. Soumerai20 Pharmacoepidemiologic Studies of Vaccine Safety 437Robert T. Chen, Jason M. Glanz, and Tom T. Shimabukuro21 Epidemiologic Studies of Medical Devices: Methodologic Considerations for Implantable Devices 496Danica Marinac‐Dabic, Sharon‐Lise Normand, Art Sedrakyan, and Thomas P. Gross22 Research on the Effects of Medications in Pregnancy and in Children 524Daniel B. Horton, Sonia Hernandez‐Diaz, Tamar Lasky, and Krista F. Huybrechts23 Study of Biologics and Biosimilars 561Jeffrey R. Curtis and James D. Lewis24 Risk Management 581Claudia Manzo, Emil Cochino, Lubna Merchant, and Giampiero Mazzaglia25 Distributed Networks of Databases Analyzed Using Common Protocols and/or Common Data Models 617Sengwee Toh, Nicole Pratt, Olaf Klungel, Joshua J. Gagne, and Robert W. Platt26 Comparative Effectiveness Research 639Soko Setoguchi and Ian Chi Kei Wong27 Data Mining and Other Informatics Approaches to Pharmacoepidemiology 675Andrew Bate, Gianluca Trifirò, Paul Avillach, and Stephen J.W. Evans28 Pharmacoepidemiologic Research on Drugs of Abuse 701Jana McAninch, Alex Secora, Cynthia Kornegay, and Judy StaffaPart V Selected Special Methodologic Issues in Pharmacoepidemiology 72329 Assessing Causation from Case Reports 725Judith K. Jones, Bernard Bégaud, and Elyse Kingery30 Molecular Pharmacoepidemiology 746Christine Y. Lu and Stephen E. Kimmel31 Bioethical Issues in Pharmacoepidemiologic Research 772Laura E. Bothwell, Annika Richterich, and Jeremy Greene32 The Use of Randomized Controlled Trials in Pharmacoepidemiology 792Robert F. Reynolds, Samuel M. Lesko, Nicolle M. Gatto, Tjeerd P. van Staa, and Allen A. Mitchell33 The Use of Pharmacoepidemiology to Study Beneficial Drug Effects 813Brian L. Strom and the late Kenneth L. Melmon34 Pharmacoeconomics: The Economics of Pharmaceuticals 837Kevin A. Schulman35 Benefit–Risk Assessments of Medical Treatments 867Bennett Levitan, Rachael DiSantostefano, and Scott Evans36 The Use of Metaanalysis in Pharmacoepidemiology 897Jesse A. Berlin, Brenda J. Crowe, H. Amy Xia, and Stephen J.W. Evans37 Validity of Drug and Diagnosis Data in Pharmacoepidemiology 948Mary Elizabeth Ritchey, Suzanne L. West, and George Maldonado38 Studies of Medication Adherence 991Julie Lauffenburger, Trisha Acri, and Robert Gross39 Risk Evaluation and Communication 1010Susan J. Blalock, Rebecca Dickinson, and Peter Knapp40 Methods for Studying the Health Effects of Drug–Drug Interactions 1030Sean Hennessy, Charles E. Leonard, Joshua J. Gagne, James H. Flory, Colleen M. Brensinger, and Warren B. Bilker41 The Pharmacoepidemiology of Medication Errors 1046Hanna M. Seidling and David W. Bates42 Patient Engagement and Patient‐Reported Outcomes 1061Esi M. Morgan43 Advanced Approaches to Controlling Confounding in Pharmacoepidemiologic Studies 1078Sebastian Schneeweiss and Samy SuissaPart VI Conclusion 110944 The Future of Pharmacoepidemiology 1111Brian L. Strom, Stephen E. Kimmel, and Sean HennessyAppendix A Sample Size Tables 1123Appendix B Glossary 1141Index 1155