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Pharmacovigilance

Critique and Ways Forward

  • Thought provoking views of experienced experts looking forward provide compelling arguments for changes in pharmacovigilance

  • Proposals for a more comprehensive approach to vigilance in health care give readers a framework for linking pharmacovigilance to outcomes research in health care

  • Argues the need to cut out unnecessary bureaucracy, encouraging the reader to consider the needs of individual patients, as well as broader public health matters

  • Includes supplementary material: sn.pub/extras

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Table of contents (18 chapters)

  1. Front Matter

    Pages i-xxxi
  2. Teaching Pharmacovigilance in University

    • Raquel Herrera Comoglio, Luis Alesso
    Pages 1-8
  3. Lost in Regulation

    • Pia Caduff-Janosa
    Pages 9-19
  4. Some Other Ideas About the Future of Pharmacovigilance

    • Alfonso Carvajal, Teresa Falomir, Carmelo Aguirre
    Pages 31-33
  5. The Unified Drug Safety-Clinical Database

    • Giovanni Furlan, Barry Burnstead
    Pages 55-66
  6. Pharmacovigilance Indicators: Desiderata for the Future of Medicine Safety

    • Ambrose O. Isah, Ivor Ralph Edwards
    Pages 99-114
  7. Thoughts on Pharmacovigilance in the Future: There Are More Weber-Effects

    • Ronald H. B. Meyboom, Hubert G. M. Leufkens, Eugène P. van Puijenbroek
    Pages 115-120
  8. Broadening the Scope of Pharmacovigilance

    • Eugène P. van Puijenbroek, Linda Harmark
    Pages 131-144
  9. Herbal and Traditional Medicines, Now and Future

    • Souad Skalli, Scott A. Jordan
    Pages 145-159
  10. The Concept of ‘Health’

    • Shirley-Ann van der Spuy
    Pages 161-172
  11. Ecopharmacovigilance

    • Giampaolo Velo
    Pages 195-205

About this book

Written by experienced authors, this book offers expert personal views on what the current problems in pharmacovigilance are and how they should be solved. This book stems from thoughts and ideas discussed in a series of meetings of the International Society of Pharmacovigilance (ISoP), where concerns were raised that the current pharmacovigilance system is not delivering optimally to improve therapeutics in clinical practice.

Pharmacovigilance of the future must be an active and integral part of health care delivery, and focus more on science and practices that support health professionals and patients in day-to-day care situations. To achieve this, a dynamic and sustainable development of vigilance must take precedence over the current excessive preoccupations with data processing and regulations; all aspects of medicines use and their effects need to be considered; and all stakeholders must be involved and engaged in an open and constructive debate.

The work is essential reading for anyone who has an interest in safer use of medicines. It is intended to be equally challenging and rewarding, and sets out to stimulate a continuous debate on how pharmacovigilance can better meet the needs of health professionals and patients to achieve the aim of wise therapeutic decision making.

Editors and Affiliations

  • Uppsala Monitoring Centre, Uppsala, Sweden

    I. Ralph Edwards, Marie Lindquist

About the editors

Ivor Ralph Edwards is a Professor in Medicine, Senior Advisor, WHO and Uppsala Monitoring Centre.  He was the first Director of the UMC and the inaugural President of the International Society of Pharmacovigilance. He has been Professor of Medicine in Zimbabwe and Director of the National Toxicology Group in New Zealand. Research interests lie in the area of clinical toxicology and pharmacovigilance with a main interest in knowledge finding in drug safety, and  the risk and benefit analysis of drugs.  He has been a consultant to WHO, the UN and UNITAID, and acted in the capacity of expert witness in cases concerning drug and chemical injury in the UK, USA, New Zealand and Sweden. He has published over 300 peer reviewed scientific publications and completed work in 4 books, and serves as a member of the editorial board of Drug Safety and the International Journal of Risk and Safety in Medicine. He is a Fellow of the Colleges of Physicians of London, Edinburgh and Australasia.

Marie Lindquist is Director and CEO of the Uppsala Monitoring Centre and heads the Foundation WHO Collaborating Centre for International Drug Monitoring. She has served as Vice President of the International Society of Pharmacovigilance and is a Board Member of the International Society of Pharmacoepidemiology. Her research interests are in clinical epistemiology and ontology with data quality management and analysis of big data, as well as development of problem solving methodology. She has published 57 peer reviewed papers and completed work on 4 books. She has been an expert member of WHO, ISO, CIOMS and ICH working groups, and serves as a member of the editorial board of Drug Safety and the International Journal of Risk and Safety in Medicine. She is a PhD (cum laude) in Medical Science, University of Nijmegen and Honorary Fellow of the Royal College of Physicians (London).

Bibliographic Information

  • Book Title: Pharmacovigilance

  • Book Subtitle: Critique and Ways Forward

  • Editors: I. Ralph Edwards, Marie Lindquist

  • DOI: https://doi.org/10.1007/978-3-319-40400-4

  • Publisher: Adis Cham

  • eBook Packages: Medicine, Medicine (R0)

  • Copyright Information: Springer International Publishing Switzerland 2017

  • Hardcover ISBN: 978-3-319-40399-1Published: 10 November 2016

  • Softcover ISBN: 978-3-319-82093-4Published: 27 June 2018

  • eBook ISBN: 978-3-319-40400-4Published: 27 October 2016

  • Edition Number: 1

  • Number of Pages: XXXI, 205

  • Number of Illustrations: 13 b/w illustrations, 3 illustrations in colour

  • Topics: Drug Safety and Pharmacovigilance

Buy it now

Buying options

eBook USD 84.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book USD 119.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book USD 109.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Other ways to access