Pharmacovigilance
Second edition edited by Ron Mann

Written by an international team of outstanding editors and contributors, Pharmacovigilance, 2nd edition is the definitive text on this important subject.

This new edition has been completely revised and updated to include:

• legal aspects
• drug regulatory requirements
• methods of signal generation
• reporting schemes
• pharmacovigilance in selected system-organ classes

Contents:

Basis of Pharmacovigilance

1. Introduction
2. Legal Basis - EU
3. Legal Basis - United States
4. Ethical Oversight, Consent and Confidentiality
5. Pharmacovigilance-Related Topics at the Level of the International Conference on
6. Harmonisation (Priya Bahri and Panos Tsintis).
7. Periodic Safety Update Reports
8. Non-Clinical Safety Evaluation and Adverse Events in Phase I Trials
9. Mechanisms of Adverse Drug Reactions
10. Micturin and Torsades de Pointes
11. Withdrawal of Terodiline: A Tale of Two Toxicities
12. Nomifensine and Haemolytic Anaemia

Signal Generation

12. WHO Programme – Global Monitoring
13. Medical Dictionary for Regulatory Activities (MedDRA®)
14. Regulatory Pharmacovigilance in the EU
15. Spontaneous Reporting – UK
16. Spontaneous Reporting – France
17. Spontaneous Reporting in Germany
18. Spontaneous Reporting – United States
19. Statistical Methods of Signal Detection
20. Statistical Methods of Evaluating Pharmacovigilance Data
21. Data Mining in Pharmacovigilance: A View from the Uppsala Monitoring Centre
22. Pharmacovigilance in the Netherlands
23. CIOMS Working Groups and their Contribution to Pharmacovigilance
24. PEM in the UK
25. PEM in New Zealand
26. MEMO in the United Kingdom
27. The General Practice Research Database: Now and the Future
28. Overview of North American Databases
29. Other Databases in Europe for the Analytic Evaluation of Drug Effects
30. Surveillance for Medical Devices – USA
31. Pharmacovigilance and Risk Management in Japan

Pharmacovigilance and Selected System Organ Classes

32. Dermatological ADRs
33. Gastrointestinal ADRs
34. Haematological ADRs
35. Hepatic ADRs
36. Ocular Side Effects of Prescription Medications
37. Drug Safety in Pregnancy
38. Renal Adverse Drug Reactions
39. Anaesthetic Adverse Drug Reactions
40. Pharmacovigilance in Pediatrics
41. The Cardiovascular Spectrum of Adverse Drug Reactions
42. Drugs and the Elderly

Key Current Topics

43. US Activities in Risk Management of Pharmaceutical Products
44. Risk Management – a European Regulatory View
45. The Efficacy and Safety of Selective Serotonin Reuptake Inhibitors for the Treatment of Depression in Children and Adolescents
46. Pharmacoepidemiology of Hormone Therapy: An Evolving Picture
47. NSAIDs – COX-2 Inhibitors – Risks and Benefits
48. Introduction to Pharmionics: The Vagaries in Ambulatory Patients’ Adherence to Prescribed Drug Dosing Regimens, and Some of Their Clinical and Economic Consequences

Lessons and Directions

49. a. Teaching and Learning Pharmacovigilance
    b. Practical Experience in Teaching Pharmacovigilance
50. Fatal Medication Errors and Adverse Drug Reactions – Coroners’ Inquests and Other Sources
51. Pharmacogenetics and the Genetic Basis of ADRs
52. Keynote Clinical Lessons from Pharmacovigilance

Index

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