Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems.
This introductory guide is designed to aid the rapid understanding of the key principles of pharmacovigilance. Packed full of examples illustrating drug safety issues it not only covers the processes involved, but the regulatory aspects and ethical and societal considerations of pharmacovigilance.
Covering the basics step-by-step, this book is perfect for beginners and is essential reading for those new to drug safety departments and pharmaceutical medicine students. The second edition is thoroughly revised and updated throughout and includes a new chapter on clinical aspects of pharmacovigilance.
Preface to the Second Edition xi
Preface to the First Edition xiii
List of Abbreviations xvii
1 What is Pharmacovigilance and How Has it Developed? 1
2 Basic Concepts 19
3 Types and Sources of Data 37
4 The Process of Pharmacovigilance 55
5 Regulatory Aspects of Pharmacovigilance 75
6 International Collaboration 95
7 Clinical Aspects of Adverse Drug Reactions 109
8 Ethical and Societal Considerations 123
9 Future Directions 135
10 Learning More About Pharmacovigilance 145
Patrick Waller was an Honorary Professor at the London School of Hygiene and Tropical Medicine from 2011-16 and Chair of the Independent Scientific Advisory Committee for MHRA database research (ISAC) from 2012-16. He graduated in medicine in Sheffield, and then trained in clinical pharmacology and public health. Subsequently he worked at the Drug Safety Research Unit in Southampton and the Medicines Control Agency in London. From 1998-2000 he was Chairman of the EU Pharmacovigilance Working Party. From 2002-2011 he was an independent consultant in pharmacovigilance and pharmacoepidemiology.
Mira Harrison-Woolrych is an Honorary Research Associate Professor at the Dunedin School of Medicine, University of Otago. With a background in clinical obstetrics and gynaecology, she has over twenty years of experience in pharmacovigilance in both the UK and New Zealand. She is currently Secretary General of the International Society of Pharmacovigilance (ISoP). As a Senior Medical Assessor at the UK Medicines and Healthcare products Regulatory Agency, Mira specialises in women’s medicines and in 2015 edited the textbook “Medicines for Women”. Between 2003 and 2013, she was the Director of the NZ Intensive Medicines Monitoring Programme (IMMP) and has an extensive list of pharmacoepidemiology research publications. She has also served on several national and international pharmacovigilance committees.