Introduction to Pharmacovigilance (eBook)

Dr Patrick Waller has been an independent consultant in pharmacovigilance and pharmacoepidemiology based in Southampton since 2002. He also holds honorary academic appointments at the London School of Hygiene and Tropical Medicine and the University of Dundee. From 1998-2004 he was Visiting Professor in the Department of Pharmacological Sciences at the University of Newcastle-upon-Tyne. From 1990-2002 he worked in the field of pharmacovigilance for the Medicines Control Agency in London. From 1998-2000 he was one of the UK delegates to the Committee for Proprietary Medicinal Products and Chairman of its Pharmacovigilance Working Party.

Acknowledgements ix

Foreword x

Preface xii

Chapter 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