Pharmacoepidemiology

Contributors

Preface

Acknowledgments

Part I Introduction

1. What Is Pharmacoepidemiology?
Brian L. Strom

2. Basic Principles of Clinical Pharmacology Relevant to Pharmacoepidemiologic Studies
Jeffrey S. Barrett

3. Basic Principles of Clinical Epidemiology Relevant to Pharmacoepidemiologic Studies
Brian L. Strom

4. Sample Size Considerations for Pharmacoepidemiologic Studies
Brian L. Strom

5. When Should One Perform Pharmacoepidemiologic Studies?
Brian L. Strom

Part II The Role of Pharmacoepidemiology in Different Sectors

6. The Role of Pharmacoepidemiology in the Healthcare System and Academia
Joshua J. Gagne and Jerome Avorn

7. The Role of Pharmacoepidemiology in Industry
Nicolle M. Gatto, Rachel E. Sobel, Jamie Geier, Jingping Mo, Andrew Bate, and Robert F. Reynolds

8. The Role of Pharmacoepidemiology in Regulatory Agencies
Gerald J. Dal Pan, June Raine, and Shinobu Uzu

9. Pharmacoepidemiology and the Law
Aaron S. Kesselheim and Kerstin N. Vokinger

Part III Sources of Data for Pharmacoepidemiology Research [editor SH]

Part IIIa Spontaneous Reporting

10. Postmarketing Spontaneous Pharmacovigilance Reporting Systems
Gerald J. Dal Pan, Marie Lindquist, and Kate Gelperin

Part IIIb Electronic Data Systems

11. Overview of Electronic Databases in Pharmacoepidemiology
Brian L. Strom

12. Encounter Databases
Tobias Gerhard, Yola Moride, Anton Pottegård, and Nicole Pratt

13. Electronic Health Record Databases
Daniel B. Horton, Harshvinder Bhullar, Lucy Carty, Francesca Cunningham, Alexis Ogdie-Beatty, Janet Sultana, and Gianluca Trifirò

14. Inpatient Databases
James A. Feinstein, Peter K. Lindenauer, Chris Feudtner, and Brian T. Fisher

Part IIIc Studies Involving Ad Hoc Data Collection

15. Event Monitoring in the UK
Vicki Osborne and Saad A.W. Shakir

16. Primary Data Collection for Pharmacoepidemiology
Nancy A. Dreyer, Ana Filipa Macedo, and Priscilla Velentgas

Part IIId Choosing a Data Source

17. Choosing among the Available Data Sources for Pharmacoepidemiology Research

Brian L. Strom

Part IV Selected Applications of Pharmacoepidemiology

18. Studies of Drug Utilization
Björn Wettermark, Vera Vlahovic-Palcevski, David Lee, and Ulf Bergman

19. Evaluating and Improving Physician Prescribing
Christine Y. Lu, Sumit R. Majumdar, Helene Lipton, and Stephen B. Soumerai

20. Pharmacoepidemiologic Studies of Vaccine Safety
Robert T. Chen, Jason M. Glanz, and Tom T. Shimabukuro

21. Epidemiologic Studies of Medical Devices: Methodologic Considerations for Implantable Devices
Danica Marinac-Dabic, Sharon-Lise Normand, Art Sedrakyan, and Thomas P. Gross

22. Research on the Effects of Medications in Pregnancy and in Children
Daniel B. Horton, Sonia Hernandez-Diaz, Tamar Lasky, and Krista F. Huybrechts

23. Study of Biologics
Jeffrey R. Curtis and James D. Lewis

24. Risk Management
Claudia Manzo, Emil Cochino, Lubna Merchant, and Giampiero Mazzaglia

25. Distributed Networks of Databases Analyzed Using Common Protocols and/or Common Data Models
Sengwee Toh, Nicole Pratt, Olaf Hendrik Klungel, Joshua J. Gagne, and Robert W. Platt

26. Comparative Effectiveness Research
Soko Setoguchi and Ian Chi Kei Wong

27. Data Mining and Other Informatics Approaches to Pharmacoepidemiology
Andrew Bate, Gianluca Trifirò, Paul Avillach, and Stephen J.W. Evans

28. Pharmacoepidemiology Research on Drugs of Abuse
Jana McAninch, Alex Secora, Cyndy Kornegay, and Judy Staffa

Part V Selected Special Methodologic Issues in Pharmacoepidemiology

29. Assessing Causation from Case Reports
Judith K. Jones, Bernard Bégaud, and Elyse Kingery

30. Molecular Pharmacoepidemiology
Christine Y. Lu and Stephen E. Kimmel

31. Bioethical Issues in Pharmacoepidemiologic Research
Laura E. Bothwell, Annika Richterich, and Jeremy Greene

32. The Use of Randomized Controlled Trials in Pharmacoepidemiology
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
Brian L. Strom and Kenneth L. Melmon

34. Pharmacoeconomics: The Economics of Pharmaceuticals
Kevin A. Schulman

35. Benefit–Risk Assessments of Medical Treatments
Bennett Levitan, Rachael L. DiSantostefano, and Scott Evans

36. The Use of Metaanalysis in Pharmacoepidemiology
Jesse A. Berlin, Brenda J. Crowe, H. Amy Xia, and Stephen J.W. Evans

37. Validity of Drug and Diagnosis Data in Pharmacoepidemiology
Mary Elizabeth Ritchey, Suzanne L. West, and George Maldonado

38. Studies of Medication Adherence
Julie Lauffenburger, Trisha Acri, and Robert Gross

39. Risk Evaluation and Communication
Susan J. Blalock, Rebecca Dickinson, and Peter Knapp

40. Methods for Studying the Health Effects of Drug–Drug Interactions
Sean Hennessy, Charles E. Leonard, Joshua J. Gagne, James H. Flory, Colleen M. Brensinger, and Warren B. Bilker

41. The Pharmacoepidemiology of Medication Errors
Hanna M. Seidling and David W. Bates

42. Patient Engagement and Patient-Reported Outcomes
Esi M. Morgan

43. Advanced Approaches to Controlling Confounding in Pharmacoepidemiologic Studies
Sebastian Schneeweiss and Samy Suissa

Part VI Conclusion

44. The Future of Pharmacoepidemiology
Brian L. Strom, Stephen E. Kimmel, and Sean Hennessy

Appendix A Sample Size Tables

Appendix B Glossary

Index

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.

Brian L. Strom is Chancellor, Rutgers Biomedical and Health Sciences and Executive Vice President for Health Affairs, Rutgers University.

Stephen E. Kimmel is Professor of Medicine and Director of the Division of Epidemiology, University of Pennsylvania Perelman School of Medicine.

Sean Hennessy is Professor of Epidemiology and Director of the Center for Pharmacoepidemiology Research and Training, University of Pennsylvania Perelman School of Medicine.