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<p>Contributors x</p> <p>Preface xix</p> <p>Acknowledgments xxiii</p> <p><b>Part I Introduction 1</b></p> <p>1 What is Pharmacoepidemiology? 3<br /> <i>Brian L. Strom</i></p> <p>2 Basic Principles of Clinical Pharmacology Relevant to Pharmacoepidemiologic Studies 27<br /> <i>Jeffrey S. Barrett</i></p> <p>3 Basic Principles of Clinical Epidemiology Relevant to Pharmacoepidemiologic Studies 44<br /> <i>Brian L. Strom</i></p> <p>4 Sample Size Considerations for Pharmacoepidemiologic Studies 60<br /> <i>Brian L. Strom</i></p> <p>5 When Should One Perform Pharmacoepidemiologic Studies? 71<br /> <i>Brian L. Strom</i></p> <p><b>Part II The Role of Pharmacoepidemiology in Different Sectors 81</b></p> <p>6 The Role of Pharmacoepidemiology in the Healthcare System and Academia 83<br /> <i>Joshua J. Gagne and Jerry Avorn</i></p> <p>7 The Role of Pharmacoepidemiology in Industry 98<br /> <i>Nicolle M. Gatto, Rachel E. Sobel, Jamie Geier, Jingping Mo, Andrew Bate, and Robert F. Reynolds</i></p> <p>8 The Role of Pharmacoepidemiology in Regulatory Agencies 126<br /> <i>Gerald J. Dal Pan, June Raine, and Shinobu Uzu</i></p> <p>9 Pharmacoepidemiology and the Law 140<br /> <i>Aaron S. Kesselheim and Kerstin N. Vokinger</i></p> <p><b>Part III Sources of Data for Pharmacoepidemiology Research 165</b></p> <p><b>Part IIIa Spontaneous Reporting 167</b></p> <p>10 Postmarketing Spontaneous Pharmacovigilance Reporting Systems 169<br /> <i>Gerald J. Dal Pan, Marie Lindquist, and Kate Gelperin</i></p> <p><b>Part IIIb Electronic Data Systems 203</b></p> <p>11 Overview of Electronic Databases in Pharmacoepidemiology 205<br /> <i>Brian L. Strom</i></p> <p>12 Encounter Databases 211<br /><i>Tobias Gerhard, Yola Moride, Anton Pottegård , and Nicole Pratt</i></p> <p>13 Electronic Health Record Databases 241<br /> Daniel B. Horton, Harshvinder Bhullar, Lucy Carty, Francesca Cunningham, Alexis Ogdie, Janet <i>Sultana, and Gianluca Trifiro</i></p> <p>14 Inpatient Databases 290<br /> <i>James A. Feinstein, Peter K. Lindenauer, Chris Feudtner, and Brian T. Fisher</i></p> <p><b>Part IIIc Studies Involving Ad Hoc Data Collection 305</b></p> <p>15 Event Monitoring in the UK 307<br /> <i>Vicki Osborne and Saad A.W. Shakir</i></p> <p>16 Primary Data Collection for Pharmacoepidemiology 342<br /> <i>Nancy A. Dreyer, Ana Filipa Macedo, and Priscilla Velentgas</i></p> <p><b>Part IIId Choosing a Data Source 355</b></p> <p>17 Choosing among the Available Data Sources for Pharmacoepidemiology Research 357<br /> <i>Brian L. Strom</i></p> <p><b>Part IV Selected Applications of Pharmacoepidemiology 373</b></p> <p>18 Studies of Drug Utilization 375<br /> <i>Bj</i><i>örn Wettermark, Vera Vlahović-Palčevski, David Lee, and Ulf Bergman</i></p> <p>19 Evaluating and Improving Physician Prescribing 411<br /> <i>Christine Y. Lu, the late Sumit R. Majumdar, Helene Lipton, and Stephen B. Soumerai</i></p> <p>20 Pharmacoepidemiologic Studies of Vaccine Safety 437<br /> <i>Robert T. Chen, Jason M. Glanz, and Tom T. Shimabukuro</i></p> <p>21 Epidemiologic Studies of Medical Devices: Methodologic Considerations for Implantable Devices 496<br /> <i>Danica Marinac‐Dabic, Sharon‐Lise Normand, Art Sedrakyan, and Thomas P. Gross</i></p> <p>22 Research on the Effects of Medications in Pregnancy and in Children 524<br /> <i>Daniel B. Horton, Sonia Hernandez‐Diaz, Tamar Lasky, and Krista F. Huybrechts</i></p> <p>23 Study of Biologics and Biosimilars 561<br /> <i>Jeffrey R. Curtis and James D. Lewis</i></p> <p>24 Risk Management 581<br /> <i>Claudia Manzo, Emil Cochino, Lubna Merchant, and Giampiero Mazzaglia</i></p> <p>25 Distributed Networks of Databases Analyzed Using Common Protocols and/or Common Data Models 617<br /> <i>Sengwee Toh, Nicole Pratt, Olaf Klungel, Joshua J. Gagne, and Robert W. Platt</i></p> <p>26 Comparative Effectiveness Research 639<br /> <i>Soko Setoguchi and Ian Chi Kei Wong</i></p> <p>27 Data Mining and Other Informatics Approaches to Pharmacoepidemiology 675<br /><i>Andrew Bate, Gianluca Trifirò, Paul Avillach, and Stephen J.W. Evans</i></p> <p>28 Pharmacoepidemiologic Research on Drugs of Abuse 701<br /> <i>Jana McAninch, Alex Secora, Cynthia Kornegay, and Judy Staffa</i></p> <p><b>Part V Selected Special Methodologic Issues in Pharmacoepidemiology 723</b></p> <p>29 Assessing Causation from Case Reports 725<br /><i>Judith K. Jones, Bernard Bégaud, and Elyse Kingery</i></p> <p>30 Molecular Pharmacoepidemiology 746<br /> <i>Christine Y. Lu and Stephen E. Kimmel</i></p> <p>31 Bioethical Issues in Pharmacoepidemiologic Research 772<br /> <i>Laura E. Bothwell, Annika Richterich, and Jeremy Greene</i></p> <p>32 The Use of Randomized Controlled Trials in Pharmacoepidemiology 792<br /> <i>Robert F. Reynolds, Samuel M. Lesko, Nicolle M. Gatto, Tjeerd P. van Staa, and Allen A. Mitchell</i></p> <p>33 The Use of Pharmacoepidemiology to Study Beneficial Drug Effects 813<br /> <i>Brian L. Strom and the late Kenneth L. Melmon</i></p> <p>34 Pharmacoeconomics: The Economics of Pharmaceuticals 837<br /> <i>Kevin A. Schulman</i></p> <p>35 Benefit–Risk Assessments of Medical Treatments 867<br /> <i>Bennett Levitan, Rachael DiSantostefano, and Scott Evans</i></p> <p>36 The Use of Metaanalysis in Pharmacoepidemiology 897<br /> <i>Jesse A. Berlin, Brenda J. Crowe, H. Amy Xia, and Stephen J.W. Evans</i></p> <p>37 Validity of Drug and Diagnosis Data in Pharmacoepidemiology 948<br /> <i>Mary Elizabeth Ritchey, Suzanne L. West, and George Maldonado</i></p> <p>38 Studies of Medication Adherence 991<br /> <i>Julie Lauffenburger, Trisha Acri, and Robert Gross</i></p> <p>39 Risk Evaluation and Communication 1010<br /> <i>Susan J. Blalock, Rebecca Dickinson, and Peter Knapp</i></p> <p>40 Methods for Studying the Health Effects of Drug–Drug Interactions 1030<br /> <i>Sean Hennessy, Charles E. Leonard, Joshua J. Gagne, James H. Flory, Colleen M. Brensinger, and Warren B. Bilker</i></p> <p>41 The Pharmacoepidemiology of Medication Errors 1046<br /> <i>Hanna M. Seidling and David W. Bates</i></p> <p>42 Patient Engagement and Patient‐Reported Outcomes 1061<br /> <i>Esi M. Morgan</i></p> <p>43 Advanced Approaches to Controlling Confounding in Pharmacoepidemiologic Studies 1078<br /> <i>Sebastian Schneeweiss and Samy Suissa</i></p> <p><b>Part VI Conclusion 1109</b></p> <p>44 The Future of Pharmacoepidemiology 1111<br /> <i>Brian L. Strom, Stephen E. Kimmel, and Sean Hennessy</i></p> <p>Appendix A Sample Size Tables 1123</p> <p>Appendix B Glossary 1141</p> <p>Index 1155</p>

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

<p><b>Pharmacoepidemiology</b></br> SIXTH EDITION <p>Still the premiere reference text in the field, the sixthedition of <i>Pharmacoepidemiology</i> presents all of the latest information using a balanced survey of current research, data sources, applications, methods, and systems. Integrating multiple perspectives from academia, industry, and regulatory agencies, this comprehensive volume has been fully revised and updated to provide first-class guidance for anyone in need of up-to-date information on all aspects of pharmacoepidemiology. <ul> <li>Presents new and extensively revised, expanded, and updated material throughout</li> <li>Offers an increased global outlook and prominent international contributors</li> <li>Provides the most wide-ranging coverage of pharmacoepidemiology available</li> <li>Describes various automated data systems and their respective advantages and shortcomings</li> <li>Written and edited by world-renowned experts in the field</li> </ul> <p><i>Pharmacoepidemiology</i> is the classic text on the subject and a must-have for pharmaceutical scientists and researchers, academics, educators, regulatory agencies, and related areas of drug safety and drug utilization research.

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