Pharmacoepidemiology, Fourth Edition 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 in this new edition, and the topics have been thoroughly revised to document the latest developments in the field.

Contents

Introduction

1. What is Pharmacoepidemiology?
2. Study Design Available for Pharmacoepidemiology Studies
3. Sample Size Considerations for Pharmacoepidemiology Studies
4. Basic Principles of Clinical Pharmacology Relevant to Pharmacoepidemiology Studies
5. When Should One Perform Pharmacoepidemiology Studies?

Perspectives on Pharmacoepidemiology

6. A View from Academia
7. A View from Industry
8. A View from Regulatory Agencies

Sources of Data for Pharmacoepidemiology Studies: Ad Hoc Data Sources Available for Pharmacoepidemiology Studies

9. Spontaneous Reporting in the United States
10. Global Drug Surveillance: The WHO Programme for International Drug Monitoring
11. Case-Control Surveillance
12. Prescription-Event Monitoring

Sources of Data for Pharmacoepidemiology Studies: Automated Data Systems Available for Pharmacoepidemiology Studies

13. Overview of Automated Databases in Pharmacoepidemiology
14. Group-Health Cooperative
15. Kaiser Permanente Medical Care Program
16. The HMO Research Network
17. UnitedHealth Group
18. Medicaid Databases
19. Health Services Databases in Saskatchewan
20. Automated Pharmacy Record Linkage in the Netherlands
21. The Tayside Medicines Monitoring Unit (MEMO)
22. The UK General Practice Research Database

Sources of Data for Pharmacoepidemiology Studies: Other Approaches to Pharmacoepidemiology Studies

23. Other Approaches to Pharmacoepidemiology Studies
24. How Should One Perform Pharmacoepidemiology Studies? Choosing Among the Available Alternatives

Selected Special Applications of Pharmacoepidemiology

25. National Medicinal Drug Policies: Their Relationship to Pharmacoepidemiology
26. Premarketing Applications of Pharmacoepidemiology
27. Studies of Drug Utilization
28. Evaluating and Improving Physician Prescribing
29. Drug Utilization Review
30. Special Methodological Issues in Pharmacoepidemiology Studies of Vaccine Safety
31. Pharmacoepidemiologic Studies of Devices
32. Studies of Drug-Induced Birth Defects
33. Pharmacoepidemiology and Risk Management
34. The Use of Pharmacoepidemiology to Study Medication Errors
35. Hospital Pharmacoepidemiology

Selected Special Methodologic Issues in Pharmacoepidemiology

36. Determining Causation from Case Report
37. Molecular Pharmacoepidemiology
38. Bioethical Issues in Pharmacoepidemiology Research
39. The Use of Randomized Controlled Trials for Pharmacoepidemiology Studies
40. The Use of Pharmacoepidemiology to Study Beneficial Drug Effects
41. Pharmacoeconomics: Economic Evaluation of Pharmaceuticals
42. Using Quality-of-Life Measurements in Pharmacoepidemiologic Research
43. N-of-1 Randomized Clinical Trials in Pharmacoepidemiology
44. The Use of Meta-Analysis in Pharmacoepidemiology
45. Validity of Pharmacoepidemiologic Drug and Diagnosis Data
46. Variable Compliance and Persistence with Prescribed Drug Doing Regimens: Implications
47. Benefits, Risks, and Economics of Pharmacotherapy
48. Bias and Confounding in Pharmacoepidemiology
49. Novel Approaches to Pharmacoepidemiology Study Design and Statistical Analysis

Conclusion

49. The Future of Pharmacoepidemiology

Appendices

• Sample Size Tables
• Glossary

Index

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