Pharmacoepidemiology

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.Dieses Lehrbuch, ein wegweisender Klassiker, bietet in der 6. Auflage noch mehr Inhalte für Leser, die aktuelle Informationen zur Pharmakoepidemiologie benötigen. Die vorliegende Auflage wurde vollständig überarbeitet und aktualisiert. Sie bietet einen Überblick über sämtliche Facetten des Fachgebiets, aus Sicht von Lehre und Forschung, aus Sicht der Industrie und von Regulierungsbehörden. Datenquellen, Anwendungen und Methodiken werden verständlich erläutert.

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
Björn 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

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.

Pharmacoepidemiology SIXTH EDITION

Still the premiere reference text in the field, the sixth edition of Pharmacoepidemiology 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.

• Presents new and extensively revised, expanded, and updated material throughout
• Offers an increased global outlook and prominent international contributors
• Provides the most wide-ranging coverage of pharmacoepidemiology available
• Describes various automated data systems and their respective advantages and shortcomings
• Written and edited by world-renowned experts in the field

Pharmacoepidemiology 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.