Pharmacovigilance, 2nd Edition

Cover......Page 1
Book......Page 2
Pharmacovigilance......Page 4
Contents......Page 8
Contributors......Page 12
Preface......Page 18
Foreword......Page 20
Part I. The Basis of Pharmacovigilance......Page 22
1. Introduction......Page 24
2. Legal Basis – EU......Page 34
3. Legal Basis – United States......Page 46
4. Ethical Oversight, Consent and Confidentiality......Page 56
5. Pharmacovigilance-Related Topics at the Level of the International Conference on Harmonisation......Page 72
6. Periodic Safety Update Reports......Page 84
7. Non-Clinical Safety Evaluation and Adverse Events in Phase I Trials......Page 96
8. Mechanisms of Adverse Drug Reactions......Page 106
9. Micturin and Torsades de Pointes......Page 126
10. Withdrawal of Terodiline: A Tale of Two Toxicities......Page 130
11. Nomifensine and Haemolytic Anaemia......Page 158
Part II. Signal Generation......Page 170
12. WHO Programme – Global Monitoring......Page 172
13. Medical Dictionary for Regulatory Activities (MedDRA®)......Page 188
14. Regulatory Pharmacovigilance in the EU......Page 206
15. Spontaneous Reporting – UK......Page 220
16. Spontaneous Reporting – France......Page 238
17. Spontaneous Reporting in Germany......Page 248
18. Spontaneous Reporting – United States......Page 258
19. Statistical Methods of Signal Detection......Page 270
20. Statistical Methods of Evaluating Pharmacovigilance Data......Page 278
21. Data Mining in Pharmacovigilance: A View from the Uppsala Monitoring Centre......Page 286
22. Pharmacovigilance in the Netherlands......Page 298
23. CIOMS Working Groups and their Contribution to Pharmacovigilance......Page 308
24. PEM in the UK......Page 328
25. PEM in New Zealand......Page 338
26. MEMO in the United Kingdom......Page 354
27. The General Practice Research Database: Now and the Future......Page 362
28. Overview of North American Databases......Page 370
29. Other Databases in Europe for the Analytic Evaluation of Drug Effects......Page 382
30. Surveillance for Medical Devices – USA......Page 396
31. Pharmacovigilance and Risk Management in Japan......Page 408
Part III. Pharmacovigilance and Selected System Organ Classes......Page 416
32. Dermatological ADRs......Page 418
33. Gastrointestinal ADRs......Page 428
34. Haematological ADRs......Page 440
35. Hepatic ADRs......Page 450
36. Ocular Side Effects of Prescription Medications......Page 466
37. Drug Safety in Pregnancy......Page 476
38. Renal Adverse Drug Reactions......Page 488
39. Anaesthetic Adverse Drug Reactions......Page 496
40. Pharmacovigilance in Pediatrics......Page 518
41. The Cardiovascular Spectrum of Adverse Drug Reactions......Page 528
42. Drugs and the Elderly......Page 536
Part IV. Key Current Topics......Page 554
43. US Activities in Risk Management of Pharmaceutical Products......Page 556
44. Risk Management – a European Regulatory View......Page 574
45. The Efficacy and Safety of Selective Serotonin Reuptake Inhibitors for the Treatment of Depression in Children and Adolescents......Page 580
46. Pharmacoepidemiology of Hormone Therapy: An Evolving Picture......Page 592
47. NSAIDs – COX-2 Inhibitors – Risks and Benefits......Page 604
48. Introduction to Pharmionics: The Vagaries in Ambulatory Patients’ Adherence to Prescribed Drug Dosing Regimens, and Some of Their Clinical and Economic Consequences......Page 624
Part V. Lessons and Directions......Page 640
49. Teaching and Learning Pharmacovigilance......Page 642
49b. Practical Experience in Teaching Pharmacovigilance......Page 654
50. Fatal Medication Errors and Adverse Drug Reactions – Coroners’ Inquests and Other Sources......Page 656
51. Pharmacogenetics and the Genetic Basis of ADRs......Page 668
52. Keynote Clinical Lessons from Pharmacovigilance......Page 688
Index......Page 698
Plates......Page 708