Pharmacoepidemiology, 4th edition

Content: Chapter 1 What is Pharmacoepidemiology? (pages 1–15): Brian L. StromChapter 2 Study Designs Available for Pharmacoepidemiology Studies (pages 17–28): Brian L. StromChapter 3 Sample Size Considerations for Pharmacoepidemiology Studies (pages 29–36): Brian L. StromChapter 4 Basic Principles of Clinical Pharmacology Relevant to Pharmacoepidemiology Studies (pages 37–57): David A. Henry, Patricia McGettigan, Anne Tonkin and Sean HennessyChapter 5 When Should One Perform Pharmacoepidemiology Studies? (pages 59–66): Brian L. StromChapter 6 A View from Academia (pages 67–76): Robert M. Califf and Leanne K. MadreChapter 7 A View from Industry (pages 77–101): Robert F. Reynolds, Dale B. Glasser and Gretchen S. DieckChapter 8 A View from Regulatory Agencies (pages 103–130): Peter Arlett, Jane Moseley and Paul J. SeligmanChapter 9 Spontaneous Reporting in the United States (pages 131–159): Syed Rizwanuddin Ahmad, Roger A. Goetsch and Norman S. MarksChapter 10 Global Drug Surveillance: The WHO Programme for International Drug Monitoring (pages 161–183): I. Ralph Edwards, Sten Olsson, Marie Lindquist and Bruce HugmanChapter 11 Case–Control Surveillance (pages 185–202): Lynn Rosenberg, Patricia F. Coogan and Julie R. PalmerChapter 12 Prescription?Event Monitoring (pages 203–216): Saad A. W. ShakirChapter 13 Overview of Automated Databases in Pharmacoepidemiology (pages 217–222): Brian L. StromChapter 14 Group Health Cooperative (pages 223–239): Kathleen W. Saunders, Robert L. Davis and Andy StergachisChapter 15 Kaiser Permanente Medical Care Program (pages 241–259): Joe V. Selby, David H. Smith, Eric S. Johnson, Marsha A. Raebel, Gary D. Friedman and Bentson H. McFarlandChapter 16 The HMO Research Network (pages 261–269): K. Arnold Chan, Robert L. Davis, Margaret J. Gunter, Jerry H. Gurwitz, Lisa J. Herrinton, Winnie W. Nelson, Marsha A. Raebel, Douglas W. Roblin, David H. Smith and Richard PlattChapter 17 UnitedHealth Group (pages 271–280): Deborah Shatin, Nigel S. B. Rawson and Andy StergachisChapter 18 Medicaid Databases (pages 281–294): Sean Hennessy, Jeffrey L. Carson, Wayne A. Ray and Brian L. StromChapter 19 Health Services Databases in Saskatchewan (pages 295–310): Winanne Downey, Maryrose Stang, Patricia Beck, William Osei and James L. NicholChapter 20 Automated Pharmacy Record Linkage in The Netherlands (pages 311–322): Hubert G. Leufkens and John UrquhartChapter 21 The Tayside Medicines Monitoring Unit (MEMO) (pages 323–336): Li Wei, John Parkinson and Thomas M. MacDonaldChapter 22 The UK General Practice Research Database (pages 337–346): Joel M. Gelfand, David J. Margolis and Hassy DattaniChapter 23 Other Approaches to Pharmacoepidemiology Studies (pages 347–362): Brian L. StromChapter 24 How Should One Perform Pharmacoepidemiology Studies? Choosing Among the Available Alternatives (pages 363–374): Brian L. StromChapter 25 National Medicinal Drug Policies: Their Relationship to Pharmacoepidemiology (pages 375–390): Suzanne Hill and David A. HenryChapter 26 Premarketing Applications of Pharmacoepidemiology (pages 391–400): Harry A. GuessChapter 27 Studies of Drug Utilization (pages 401–417): David Lee and Ulf BergmanChapter 28 Evaluating and Improving Physician Prescribing (pages 419–437): Sumit R. Majumdar, Helene Levens Lipton and Stephen B. SoumeraiChapter 29 Drug Utilization Review (pages 439–453): Sean Hennessy, Stephen B. Soumerai, Helene Levens Lipton and Brian L. StromChapter 30 Special Methodological Issues in Pharmacoepidemiology Studies of Vaccine Safety (pages 455–485): Robert T. Chen, Robert L. Davis and Philip H. RhodesChapter 31 Pharmacoepidemiologic Studies of Devices (pages 487–500): Roselie A. BrightChapter 32 Studies of Drug?Induced Birth Defects (pages 501–514): Allen A. MitchellChapter 33 Pharmacoepidemiology and Risk Management (pages 515–530): David J. Graham, Andrew D. Mosholder, Kate Gelperin and Mark I. AviganChapter 34 The Use of Pharmacoepidemiology to Study Medication Errors (pages 531–538): Rainu Kaushal and David W. BatesChapter 35 Hospital Pharmacoepidemiology (pages 539–553): Brian L. Strom and Rita SchinnarChapter 36 Determining Causation from Case Reports (pages 555–570): Judith K. JonesChapter 37 Molecular Pharmacoepidemiology (pages 571–586): Stephen E. Kimmel, Hubert G. Leufkens and Timothy R. RebbeckChapter 38 Bioethical Issues in Pharmacoepidemiologic Research (pages 587–598): David Casarett, Jason Karlawish, Elizabeth Andrews and Arthur CaplanChapter 39 The Use of Randomized Controlled Trials for Pharmacoepidemiology Studies (pages 599–610): Samuel M. Lesko and Allen A. MitchellChapter 40 The Use of Pharmacoepidemiology to Study Beneficial Drug Effects (pages 611–628): Brian L. Strom and Kenneth L. Melmon (the late)Chapter 41 Pharmacoeconomics: Economic Evaluation of Pharmaceuticals (pages 629–652): Kevin A. Schulman, Henry A. Glick and Daniel PolskyChapter 42 Using Quality?of?Life Measurements in Pharmacoepidemiologic Research (pages 653–663): Holger Schunemann, Gordon H. Guyatt and Roman JaeschkeChapter 43 N?of?1 Randomized Clinical Trials in Pharmacoepidemiology (pages 665–680): Gordon H. Guyatt, Roman Jaeschke and Robin RobertsChapter 44 The Use of Meta?analysis in Pharmacoepidemiology (pages 681–707): Jesse A. Berlin and Carin J. KimChapter 45 Validity of Pharmacoepidemiologic Drug and Diagnosis Data (pages 709–765): Suzanne L. West, Brian L. Strom and Charles PooleChapter 46 Variable Compliance and Persistence with Prescribed Drug Dosing Regimens: Implications for Benefits, Risks, and Economics of Pharmacotherapy (pages 767–789): John UrquhartChapter 47 Bias and Confounding in Pharmacoepidemiology (pages 791–809): Ilona Csizmadi, Jean?Paul Collet and Jean?Francois BoivinChapter 48 Novel Approaches to Pharmacoepidemiology Study Design and Statistical Analysis (pages 811–829): Samy SuissaChapter 49 The Future of Pharmacoepidemiology (pages 831–839): Brian L. Strom and Sean Hennessy PHARMACOEPIDEMIOLOGY Fourth Edition......Page 3 Contents......Page 7 List of Contributors......Page 11 Preface......Page 17 Acknowledgments......Page 21 PART I INTRODUCTION......Page 23 1. What is Pharmacoepidemiology?......Page 25 2. Study Designs Available for Pharmacoepidemiology Studies......Page 39 3. Sample Size Considerations for Pharmacoepidemiology Studies......Page 51 4. Basic Principles of Clinical Pharmacology Relevant to Pharmacoepidemiology Studies......Page 59 5. When Should One Perform Pharmacoepidemiology Studies?......Page 81 PART II PERSPECTIVES ON PHARMACOEPIDEMIOLOGY......Page 89 6. A View from Academia......Page 91 7. A View from Industry......Page 99 8. A View from Regulatory Agencies......Page 125 PART III SOURCES OF DATA FOR PHARMACOEPIDEMIOLOGY STUDIES......Page 153 PART IIIa Ad Hoc Data Sources Available for Pharmacoepidemiology Studies......Page 155 9. Spontaneous Reporting in the United States......Page 157 10. Global Drug Surveillance: The WHO Programme for International Drug Monitoring......Page 183 11. Case–Control Surveillance......Page 207 12. Prescription-Event Monitoring......Page 225 PART IIIb Automated Data Systems Available for Pharmacoepidemiology Studies......Page 239 13. Overview of Automated Databases in Pharmacoepidemiology......Page 241 14. Group Health Cooperative......Page 245 15. Kaiser Permanente Medical Care Program......Page 263 16. The HMO Research Network......Page 283 17. UnitedHealth Group......Page 293 18. Medicaid Databases......Page 303 19. Health Services Databases in Saskatchewan......Page 317 20. Automated Pharmacy Record Linkage in The Netherlands......Page 333 21. The Tayside Medicines Monitoring Unit (MEMO)......Page 345 22. The UK General Practice Research Database......Page 359 PART IIIc Other Approaches to Pharmacoepidemiology Studies......Page 369 23. Other Approaches to Pharmacoepidemiology Studies......Page 371 24. How Should One Perform Pharmacoepidemiology Studies? Choosing Among the Available Alternatives......Page 385 PART IV SELECTED SPECIAL APPLICATIONS OF PHARMACOEPIDEMIOLOGY......Page 397 25. National Medicinal Drug Policies: Their Relationship to Pharmacoepidemiology......Page 399 26. Premarketing Applications of Pharmacoepidemiology......Page 413 27. Studies of Drug Utilization......Page 423 28. Evaluating and Improving Physician Prescribing......Page 441 29. Drug Utilization Review......Page 461 30. Special Methodological Issues in Pharmacoepidemiology Studies of Vaccine Safety......Page 477 31. Pharmacoepidemiologic Studies of Devices......Page 509 32. Studies of Drug-Induced Birth Defects......Page 523 33. Pharmacoepidemiology and Risk Management......Page 537 34. The Use of Pharmacoepidemiology to Study Medication Errors......Page 553 35. Hospital Pharmacoepidemiology......Page 561 PART V SELECTED SPECIAL METHODOLOGIC ISSUES IN PHARMACOEPIDEMIOLOGY......Page 577 36. Determining Causation from Case Reports......Page 579 37. Molecular Pharmacoepidemiology......Page 593 38. Bioethical Issues in Pharmacoepidemiologic Research......Page 609 39. The Use of Randomized Controlled Trials for Pharmacoepidemiology Studies......Page 621 40. The Use of Pharmacoepidemiology to Study Beneficial Drug Effects......Page 633 41. Pharmacoeconomics: Economic Evaluation of Pharmaceuticals......Page 651 42. Using Quality-of-Life Measurements in Pharmacoepidemiologic Research......Page 675 43. N-of-1 Randomized Clinical Trials in Pharmacoepidemiology......Page 687 44. The Use of Meta-analysis in Pharmacoepidemiology......Page 703 45. Validity of Pharmacoepidemiologic Drug and Diagnosis Data......Page 731 46. Variable Compliance and Persistence with Prescribed Drug Dosing Regimens: Implications for Benefits, Risks, and Economics of Pharmacotherapy......Page 789 47. Bias and Confounding in Pharmacoepidemiology......Page 813 48. Novel Approaches to Pharmacoepidemiology Study Design and Statistical Analysis......Page 833 PART VI CONCLUSION......Page 853 49. The Future of Pharmacoepidemiology......Page 855 Appendix A Sample Size Tables......Page 863 Appendix B Glossary......Page 881 Index......Page 889

The fourth edition of Pharmacoepidemiology is an outstanding and fully comprehensive textbook, which will be an essential resource for all interested in the field—in academia, in regulatory agencies, in industry and in the law. Brian Strom's classic textbook continues both to reflect the increased maturation of pharmacoepedemiology and to help shape it's direction.

Reviews of previous editions of his celebrated textbook include:

"The book is essential reading for anyone interested in pharmacoepidemiology."

INTERNATIONAL JOURNAL OF EPIDEMIOLOGY

"...an excellent textbook and a comprehensive reference which belongs in the library of every pharmaceutical manufacturer and regulator."

EUROPEAN JOURNAL OF PUBLIC HEALTH

The fourth edition of Pharmacoepidemiology is an outstanding and fully comprehensive textbook, which will be an essential resource for all interested in the field--in academia, in regulatory agencies, in industry and in the law. Brian Strom's classic textbook continues both to reflect the increased maturation of pharmacoepedemiology and to help shape it's direction. Reviews of previous editions of his celebrated textbook include: "The book is essential reading for anyone interested in pharmacoepidemiology." INTERNATIONAL JOURNAL OF EPIDEMIOLOGY "...an excellent textbook and a comprehensive reference which belongs in the library of every pharmaceutical manufacturer and regulator." EUROPEAN JOURNAL OF PUBLIC HEALTH "Appropriate and valid pharmacoepidemiology methods are central to evaluating the safety and effectiveness of medicines and their use. Brian Strom's book, now in its fourth edition, is the comprehensive text for such evaluations. It provides methods, details of potential data sources, and information about evaluating the results and drawing conclusions. The successful layout and easy to read style is retained while the topics have been thoroughly revised to document the developments in the field."--BOOK JACKET