Pharmacoepidemiology /

Includes bibliographical references and index

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

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"This classic, field-defining textbook, now in its sixth edition, provides the most comprehensive guidance available for anyone needing up-to-date information in pharmacoepidemiology. This edition has been fully revised and updated throughout and continues to provide a rounded view on all perspectives from academia, industry and regulatory bodies, addressing data sources, applications and methodologies with great clarity"-- Provided by publisher