Title Details

List of Contributors. Preface. Acknowledgments. PART I. INTRODUCTION. 1. What is Pharmacoepidemiology (Brian L. Strom)? 2. Study Design 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 (David A. Henry, Patricia McGettigan, Anne Tonkin and Sean Hennessy). 5. When Should One Perform Pharmacoepidemiology Studies (Brian L. Strom)? PART II. PERSPECTIVES ON PHARMACOEPIDEMIOLOGY. 6. A View from Academia (Robert M. Califf and Leanne K. Madre). 7. A View from Industry (Robert F. Reynolds, Dale B. Glasser and Gretchen S. Dieck). 8. A View from Regulatory Agencies (Peter Arlett, Jane Moseley and Paul J. Sedigman). PART III. SOURCES OF DATA FOR PHARMACOEPIDEMIOLOGY STUDIES.PART IIIa. Ad Hoc Data Sources Available for Pharmacoepidemiology Studies. 9. Spontaneous Reporting in the United States (Syed Rizwanuddin Ahmad, Roger A. Goetsch and Norman S. Marks). 10. Global Drug Surveillance: The WHO Programme for International Drug Monitoring (I. Ralph Edwards, Sten Olsson, Marie Lindquist and Bruce Hugman). 11. Case-Control Surveillance (Lynn Rosenberg, Patricia F. Coogan and Juliet R. Palmer). 12. Prescription-Event Monitoring (Saad A. W. Shakir). PART IIIb Automated Data Systems Available for Pharmacoepidemiology Studies. 13. Overview of Automated Databases in Pharmacoepidemiology (Brian L. Strom). 14. Group-Health Cooperative (Kathleen W. Saunders, Robert L. Davis and Andy Stergachis). 15. Kaiser Permanente Medical Care Program (Joe V. Selby, David H. Smith, Eric S. Johnson, Marsha A. Raebel, Gary D. Friedman and Bentson H. McFarland). 16. The HMO Research Network (K.nold Chan, Robert L.el, Douglas W. Roblin, David H. Smith and Richard Platt). 17. UnitedHealth Group (Deborah Shatin, Nigel S. B. Rawson and Andy Stergachis). 18. Medicaid Databases (Sean Hennessy, Jeffrey L. Carson, Wayne A. Ray and Brian L. Strom). 19. Health Services Databases in Saskatchewan (Winanne Downey, MaryRose Stang, Patricia Beck, William Osei and James L. Nichol). 20. Automated Pharmacy Record Linkage in the Netherlands (Hubert G. Leufkens and John Urquhart). 21. The Tayside Medicines Monitoring Unit (MEMO) (Li Wei, John Parkinson and Thomas M. MacDonald). 22. The UK General Practice Research Database (Joel M. Gelfand, David J. Margolis and Hassy Dattani). PART IIIc. Other Approaches to Pharmacoepidemiology Studies. 23. Other Approaches to Pharmacoepidemiology Studies (Brian L. Strom). 24. How Should One Perform Pharmacoepidemiology Studies? Choosing Among the Available Alternatives (Brian L. Strom). PART IV. SELECTED SPECIAL APPLICATIONS OF PHARMACOEPIDEMIOLOGY. 25. National Medicinal Drug Policies: Their Relationship to Pharmacoepidemiology (Suzanne Hill and David A. Henry). 26. Premarketing Applications of Pharmacoepidemiology (Harry A. Guess). 27. Studies of Drug Utilization (David Lee and Ulf Bergman). 28. Evaluating and Improving Physician Prescribing (Sumit R. Majumdar, Helene Levens Lipton and Stephen B. Soumerai). 29. Drug Utilization Review (Sean Hennessey, Stephen B. Soumerai, Helene Levens Lipton and Brian L. Strom). 30. Special Methodological Issues in Pharmacoepidemiology Studies of Vaccine Safety (Robert T. Chen, Robert L. Davis and Philip H. Rhodes). 31. Pharmacoepidemiologic Studies of Devices (Roselie A. Bright). 32. Studies of Drug-Induced Birth Defects (Allen A. Mitchell). 33. Pharmacoepidemiology and Risk Management (David J. Graham, Andrew D. Mosholder, Kate Gelperin and Mark I. Avigan). 34. The Use of Pharmacoepidemiology to Study Medication Errors (Rainu Kaushal and David W. Bates). 35.Hospital Pharmacoepidemiology (Brian L. Strom and Rita Schinnar). PART V. SELECTED SPECIAL METHODOLOGIC ISSUES IN PHARMACOEPIDEMIOLOGY. 36. Determining Causation from Case Report (Judith K. Jones). 37. Molecular Pharmacoepidemiology (Stephen E. Kimmel, Hubert G. Leufkens and Timothy R. Rebbeck). 38. Bioethical Issues in Pharmacoepidemiology Research (David Casarett, Jason Karlawish, Elizabeth Andrews and Arthur Caplan). 39. The Use of Randomized Controlled Trials for Pharmacoepidemiology Studies (Samuel M. Lesko and Allen A. Mitchell). 40. The Use of Pharmacoepidemiology to Study Beneficial Drug Effects (Brian L. Strom and the late Kenneth L. Melmon). 41. Pharmacoeconomics: Economic Evaluation of Pharmaceuticals (Kevin A. Schulman, Henry A. Glick and Daniel Polsky). 42. Using Quality-of-Life Measurements in Pharmacoepidemiologic Research (Holger Schünemann, Gordon H. Guyatt and Roman Jaeschke). 43. N-of-1 Randomized Clinical Trials in Pharmacoepidemiology (Gordon H. Guyatt, Roman Jaeschke and Robin Roberts). 44. The Use of Meta-Analysis in Pharmacoepidemiology (Jesse A. Berlin and Carin J. Kim). 45. Validity of Pharmacoepidemiologic Drug and Diagnosis Data (Suzanne L. West, Brian L. Strom and Charles Poole). 46. Variable Compliance and Persistence with Prescribed Drug Doing Regimens: Implications for Benefits, Risks, and Economics of Pharmacotherapy (John Urquhart). 47. Bias and Confounding in Pharmacoepidemiology (Ilona Csizmadi, Jean-Paul Collet and Jean-François Boivin). 48. Novel Approaches to Pharmacoepidemiology Study Design and Statistical Analysis (Samy Suissa). PART IV. CONCLUSION. 49. The Future of Pharmacoepidemiology (Brian L. Strom and Sean Hennessy). Appendix A: Sample Size Tables. Appendix B: Glossary. Index.

"…a useful text that should be considered a standard in this specialty area." (The Annals of Pharmacotherapy, May 2006)

"…a highly useful introduction to pharmacoepidemiology. It also serves as a key reference for people interested in this new field." (Doody's Health Services)