Textbook of Pharmacoepidemiology

  • ID: 2325353
  • Book
  • 518 Pages
  • John Wiley and Sons Ltd
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In recent years the public has clearly become markedly more interested in assuring the safety and effectiveness of its medicines. It is also critical that available medicines are used optimally, by both health care practitioners and patients. We need to know the extent to which an intervention does what it is really intended to do, under routine circumstances rather than ideal conditions, for those who receive it. Appropriate and valid pharmacoepidemiology methods are central to evaluating the safety and effectiveness of medicines and their use. This textbook is the abridged version of Brian Strom′s Pharmacoepidemiology Fourth Edition, and presents the essential material for such evaluations.

It provides methods, details of potential data sources, and information about evaluating the results and drawing conclusions. The layout and easy to read style will provide an accessible introduction to pharmacoepidemiology as well as a reference source for academics, public health practitioners, regulatory agencies, the pharmaceutical industry and the law.

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List of Contributors.

Preface.

Acknowledgments.

Acknowledgments from Pharmacoepidemiology, Fourth Edition.

SECTION I INTRODUCTION TO PHARMACOEPIDEMIOLOGY.

1. What is Pharmacoepidemiology? (Brian L. Strom).

2. Study Designs Available for Pharmacoepidemiology Studies (Brian L. Strom).

3. Sample Size Considerations for Pharmacoepidemiology Studies (Brian L. Strom).

4. Basic Principles of Clinical Pharmacology Relevant to Pharmacoepidemiology Studies (Sean Hennessy).

5. When Should One Perform Pharmacoepidemiology Studies? (Brian L. Strom).

6. Views from Academia, Industry, and Regulatory Agencies (Leanne K. Madre, Robert M. Califf, Robert F. Reynolds, Peter Arlett, and Jane Moseley).

SECTION II SOURCES OF PHARMACOEPIDEMIOLOGY DATA.

7. Spontaneous Reporting in the United States (Syed Rizwanuddin Ahmad, Norman S. Marks, and Roger A. Goetsch).

8. Global Drug Surveillance: The WHO Programme for International Drug Monitoring (I. Ralph Edwards, Sten Olsson, Marie Lindquist, and Bruce Hugman).

9. Case Control Surveillance (Lynn Rosenberg, Patricia F. Coogan, and Julie R. Palmer).

10. Prescription–Event Monitoring (Saad A.W. Shakir).

11. Overview of Automated Databases in Pharmacoepidemiology (Brian L. Strom).

12. Examples of Automated Databases (Andy Stergachis, Kathleen W. Saunders, Robert L. Davis, Stephen E. Kimmel, Rita Schinnar, K. Arnold Chan, Deborah Shatin, Nigel S.B. Rawson, Sean Hennessy, Winanne Downey, MaryRose Stang, Patricia Beck, William Osei, Hubert G. Leufkens, Thomas M. MacDonald, and Joel M. Gelfand).

13. Other Approaches to Pharmacoepidemiology Studies (Brian L. Strom).

14. How Should One Perform Pharmacoepidemiology Studies? Choosing Among the Available Alternatives (Brian L. Strom).

15. Validity of Pharmacoepidemiologic Drug and Diagnosis Data (Suzanne L. West, Brian L. Strom, and Charles Poole).

SECTION III SPECIAL ISSUES IN PHARMACOEPIDEMIOLOGY METHODOLOGY.

16. Bias and Confounding in Pharmacoepidemiology (Ilona Csizmadi and Jean–Paul Collet).

17. Determining Causation from Case Reports (Judith K. Jones).

18. Molecular Pharmacoepidemiology (Stephen E. Kimmel).

19. Bioethical Issues in Pharmacoepidemiologic Research (Kevin Haynes, Jason Karlawish, and Elizabeth B. Andrews).

20. The Use of Randomized Controlled Trials for Pharmacoepidemiology Studies (Samuel M. Lesko and Allen A. Mitchell).

21. The Use of Pharmacoepidemiology to Study Beneficial Drug Effects (Brian L. Strom).

22. Pharmacoeconomics: Economic Evaluation of Pharmaceuticals (Kevin A. Schulman, Henry A. Glick, and Daniel Polsky).

23. Using Quality–of–Life Measurements in Pharmacoepidemiologic Research (Holger Schünemann, Gordon H. Guyatt, and Roman Jaeschke).

24. The Use of Meta–analysis in Pharmacoepidemiology (Carin J. Kim and Jesse A. Berlin).

25. Patient Adherence to Prescribed Drug Dosing Regimens in Ambulatory Pharmacotherapy (John Urquhart and Bernard Vrijens).

26. Novel Approaches to Pharmacoepidemiology Study Design and Statistical Analysis (Samy Suissa).

SECTION IV SPECIAL APPLICATIONS OF PHARMACOEPIDEMIOLOGY.

27. Special Applications of Pharmacoepidemiology (David Lee, Sumit R. Majumdar, Helene Levens Lipton, Stephen B. Soumerai, Sean Hennessy, Robert L. Davis, Robert T. Chen, Roselie A. Bright, Allen A. Mitchell, David J. Graham, David W. Bates, and Brian L. Strom).

28. The Future of Pharmacoepidemiology (Brian L. Strom and Stephen E. Kimmel).

Appendix A Sample Size Tables.

Appendix B Glossary.

Index.

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Brian L. Strom
Stephen E. Kimmel
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