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.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 Pottegard , 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
Bjoern Wettermark, Vera Vlahovi?-Pal?evski, 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 Trifiro, 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 Begaud, 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 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.
