Discover Pharmacoepidemiology: Expert Insights

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Description

Now in its fifth iteration, Pharmacoepidemiology delineates the discipline and offers the most extensive guidance found in any publication on this subject. Crafted by globally recognized authorities in the area, this essential text examines the varied research designs and data sources accessible for pharmacoepidemiologic investigation, detailing an array of automated data systems and their respective benefits and drawbacks. By integrating insights from academia, industry, and regulatory authorities, this publication delivers thorough observations into every facet of pharmacoepidemiology.

List of Contributors
Preface
Acknowledgements

Part I: Introduction

1. What is Pharmacoepidemiology?, (Brian L. Strom)
2. Fundamental Principles of Clinical Pharmacology Relevant to Pharmacoepidemiologic Studies, (Jeffrey S. Barrett and Athena F. Zuppa)
3. Essential Principles of Clinical Epidemiology Applicable to Pharmacoepidemiologic Studies, (Brian L. Strom)
4. Sample Size Considerations for Pharmacoepidemiologic Research, (Brian L. Strom)
5. When to Conduct Pharmacoepidemiologic Studies?, (Brian L. Strom)

Part II: The Role of Pharmacoepidemiology in Various Sectors

6. The Contribution of Pharmacoepidemiology in Health-Care Systems and Academia, (Jerry Avorn)
7. The Influence of Pharmacoepidemiology in the Pharmaceutical Industry, (Jingping Mo, Nicolle M. Gatto, Rachel E. Sobel, and Robert F. Reynolds)
8. The Role of Pharmacoepidemiology within Regulatory Agencies, (Gerald J. Dal Pan and Peter Arlett)
9. The Intersection of Pharmacoepidemiology and Legal Matters, (Aaron S. Kesselheim)

Part III: Data Sources for Pharmacoepidemiologic Studies

A. Spontaneous Reporting
10. Postmarketing Spontaneous Pharmacovigilance Reporting Systems, (Gerald J. Dal Pan, Marie Lindquist, and Kate Gelperin)
B. Automated Data Systems
11. Overview of Automated Databases in Pharmacoepidemiology, (Brian L. Strom)
12. Health Maintenance Organizations/Health Plans, (Susan E. Andrade, Marsha A. Raebel, Denise Boudreau, Robert L. Davis, Katherine Haffenreffer, Pamala A. Pawloski, Sengwee Toh, and Richard Platt)
13. Commercial Insurance Databases, (John Seeger and Gregory W. Daniel)
14. U.S. Government Claims Databases, (Sean Hennessy, Cristin Palumbo Freeman, and Francesca Cunningham)
15. Medical Record Databases, (Alexis Ogdie, Sinéad M. Langan, John Parkinson, Hassy Dattani, Karel Kostev, and Joel M. Gelfand)
16. In-Hospital Databases, (Brian T. Fisher, Peter K. Lindenauer, and Chris Feudtner)
17. Canadian Provincial Databases, (Yola Moride and Colleen J. Metge)
18. Pharmacy-Based Medical Record Linkage Systems, (Ron M.C. Herings and Lars Pedersen)
C. Ongoing Studies for Pharmacoepidemiologic Research
19. Case-Control Surveillance, (Lynn Rosenberg, Patricia F. Coogan, and Julie R. Palmer)
20. Prescription-Event Monitoring, (Deborah Layton and Saad A.W. Shakir)
21. Registries, (Nancy A. Dreyer and Priscilla Velentgas)
D. Ad Hoc Studies–De Novo Research
22. Field Studies, (David W. Kaufman)
E. Selecting Among Available Alternatives
23. Conducting Pharmacoepidemiologic Studies: Choosing the Best Approaches, (Brian L. Strom)

Part IV: Special Applications of Pharmacoepidemiology

24. Investigating Drug Utilization, (David Lee and Ulf Bergman)
25. Enhancing and Evaluating Physician Prescribing, (Sumit R. Majumdar, Helene Levens Lipton, and Stephen B. Soumerai)
26. Safety Studies of Vaccines, (Robert T. Chen, Jason M. Glanz, and Claudia Vellozzi)
27. Epidemiological Research on Medical Devices: Methodological Issues Regarding Implantable Devices, (Danica Marinac-Dabic, Sharon-Lise Normand, Art Sedrakyan, and Thomas Gross)
28. Studies on Drug-Induced Congenital Anomalies, (Allen A. Mitchell)
29. Risk Management Strategies, (Gerald J. Dal Pan, Stella Blackburn, and Claudia Karwoski)
30. FDA Sentinel Initiative: Proactive Surveillance to Detect Safety Issues, (Judith A. Racoosin, Melissa A. Robb, Rachel E. Sherman, and Janet Woodcock)
31. Pharmacoepidemiology and Pharmaceutical Reimbursement Policies, (Mitchell Levine and Jacques LeLorier)
32. Research on Comparative Effectiveness, (Brian L. Strom, Rita Schinnar, and Sean Hennessy)

Part V: Specialized Methodological Topics in Pharmacoepidemiology

33. Evaluating Causality in Reports of Suspected Adverse Effects, (Judith K. Jones)
34. Molecular Pharmacoepidemiology, (Stephen E. Kimmel, Hubert G. Leufkens, and Timothy R. Rebbeck)
35. Ethical Dimensions in Pharmacoepidemiological Research, (Antoine C. El Khoury, Jason Karlawish, Elizabeth Andrews, and Arthur Caplan)
36. Utilizing Randomized Controlled Trials for Pharmacoepidemiologic Research, (Samuel M. Lesko and Allen A. Mitchell)
37. Using Pharmacoepidemiology to Investigate Positive Drug Effects, (Brian L. Strom and Kenneth L. Melmon)
38. Pharmacoeconomics: Evaluating Pharmaceutical Costs, (Kevin A. Schulman, Henry A. Glick, Daniel Polsky, and Shelby D. Reed)
39. Quality of Life Assessments in Pharmacoepidemiology, (Holger Schünemann, Bradley C. Johnston, Roman Jaeschke, and Gordon H. Guyatt)
40. Applying Meta-Analysis in Pharmacoepidemiology, (Jesse A. Berlin, M. Soledad Cepeda, and Carin J. Kim)
41. Validity of Drug and Diagnosis Data in Pharmacoepidemiology, (Suzanne L. West, Mary Elizabeth Ritchey, and Charles Poole)
42. Research on Medication Adherence, (Trisha Acri and Robert Gross)
43. Risk Assessment and Communication, (Susan J. Blalock and Betsy L. Sleath)
44. Analyzing the Effects of Antibiotics, (Darren R. Linkin and Ebbing Lautenbach)
45. The Pharmacoepidemiology of Medication Errors, (Hanna M. Seidling and David W. Bates)
46. Advanced Statistical Methods for Prospective Postmarketing Safety Surveillance, (Martin Kulldorff)
47. Sophisticated Techniques for Managing Confounding in Pharmacoepidemiological Studies, (Sebastian Schneeweiss and Samy Suissa)

Part VI: Conclusion

48. The Future of Pharmacoepidemiology, (Brian L. Strom, Stephen E. Kimmel, and Sean Hennessy)
Appendix A: Sample Size Tables
Appendix B: Glossary
Index

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