Table of Contents
Acknowledgements ix
Foreword x
Preface xiiChapter 1 What is pharmacovigilance and how has it developed? 1
Origins and definition of pharmacovigilance 1
Scope and purposes of pharmacovigilance 3
Development of pharmacovigilance since the 1960s 5
Conclusion 14
Chapter 2 Basic concepts 15
Introduction 15
Adverse drug reactions 15
The concept of safety 21
Causation – was the drug responsible? 25
Conclusion 29
Chapter 3 Types and sources of data 30
Introduction 30
Pre-clinical studies 30
Human volunteer studies 31
Clinical trials 31
Post-marketing surveillance 33
Systematic reviews and meta-analysis 42
Conclusion 43
Chapter 4 The process of pharmacovigilance 44
Overview – a risk management process 44
Signal detection 44
Evaluation and investigation 50
Taking action 52
Communication 56
Crisis management 59
Conclusion 60
Chapter 5 Regulatory aspects of pharmacovigilance 61
Introduction 61
Legislation and guidelines 62
Regulatory pharmacovigilance systems 64
Obligations of pharmaceutical companies 65
Risk management planning 69
Conclusion 73
Chapter 6 International collaboration 74
Introduction 74
World Health Organisation 75
Council for the Organisation of Medical Sciences 75
International Conference on Harmonisation 78
Conclusion 79
Chapter 7 Ethical and societal considerations 80
Introduction 80
Stakeholders and their perspectives 80
Ethical principles 83
Ethical safeguards in relation to safety 84
Transparency 85
Conflicts of interest 86
Conclusion 87
Chapter 8 Future directions 89
Introduction—current limitations 89
Meeting the challenges 90
Conclusion 93
Chapter 9 Learning more about pharmacovigilance 94
Books 94
Journals 95
Useful websites 95
Courses 96
International societies 96
Conclusion 96
Glossary 98
Index 101
