Veterinary Pharmacovigilance: Adverse Reactions to Veterinary Medicinal Products

754 Pages·2009·14.95 MB·English

Veterinary Pharmacovigilance
Veterinary Pharmacovigilance: Adverse Reactions to Veterinary Medicinal Products Edited by K.N. Woodward
© 2009 Blackwell Publishing Ltd. ISBN: 978-1-405-16968-4
Veterinary Pharmacovigilance
Adverse Reactions to Veterinary
Medicinal Products
Edited by
K.N. Woodward
A John Wiley & Sons, Ltd., Publication
This edition fi rst published 2009
© 2009 Blackwell Publishing Ltd.
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Library of Congress Cataloging-in-Publication Data
Veterinary pharmacovigilance : adverse reactions to veterinary medicinal products / Kevin N. Woodward, editor.
p. cm.
Includes bibliographical references and index.
ISBN 978-1-4051-6968-4 (alk. paper)
1. Veterinary drugs--Side effects. I. Woodward, Kevin N.
SF917.V495 2009
636.089’57042–dc22
2008044761
A catalogue record for this book is available from the British Library.
Set in 10.5 on 14 pt Palatino by SNP Best-set Typesetter Ltd., Hong Kong
Printed and bound in Singapore by Markono Print Media Pte Ltd
1 2009
To Diana, Alastair, Frances and Felicity
And to Jenny, Sally and Patsy, to Alfi e and Molly,
and to Jack Russell Terriers everywhere.
Contents
List of contributors ix 7 Veterinary adverse drug event
Preface xi reporting in the United States,
Acknowledgements xiii Australia and Canada 119
K.N. Woodward
Introduction 1
8 Veterinary pharmacovigilance:
D. Skilton
a South African perspective 151
1 Elements of veterinary V. Naidoo
pharmacovigilance 9
9 Pharmacovigilance inspections in the
K.N. Woodward
European Union 163
2 Veterinary pharmacovigilance in the K.N. Woodward and C.W. Evans
European Union 19
10 Essential elements of veterinary
K.N. Woodward
pharmacovigilance and the role and
3 Pharmacovigilance and the European duties of the Qualifi ed Person 177
Medicines Agency: conduct of B. Cornez
pharmacovigilance activities 47
11 Veterinary pharmacovigilance in an
K. Grein
industry setting – the European
4 Veterinary pharmacovigilance in Union 209
France 55 M. O’Gorman
G. Keck and X. Pineau
12 Pharmacovigilance in the US – an
5 Pharmacovigilance in Germany 65 industry perspective 231
C. Ibrahim and A. Wilke T.M. Hodge
6 Veterinary pharmacovigilance – 13 Practical veterinary
the UK experience 91 pharmacovigilance 287
K.N. Woodward D. O’Rourke
viii Contents
14 Preclinical safety testing and assessment 24 Determination of withdrawal periods
of veterinary pharmaceuticals and for pharmaceutical products used in
pharmacovigilance 297 food animals 569
K.N. Woodward R.C. Parker
15 Safety assessment of veterinary 25 Surveillance for veterinary residues 587
vaccines 347 K.N. Woodward
M.J. Francis
26 Adverse environmental effects and
16 Microbiological assessment of veterinary medicinal products 605
veterinary medicinal products and A. Tait
potential adverse effects 355
27 Causality in pharmacovigilance and
P. Silley
expectedness of adverse reactions 639
17 Adverse effects of veterinary K.N. Woodward
pharmaceutical products in animals 393
28 Quantitative aspects of veterinary
K.N. Woodward
pharmacovigilance 659
18 Adverse drug reactions in dogs – toxic K.N. Woodward
hepatic responses 423
29 Veterinary adverse reactions and crisis
K.N. Woodward
management 673
19 Adverse reactions to vaccines 453 K.N. Woodward
K.N. Woodward and L.A. Toon
30 The role of veterinary
20 Adverse reactions in humans following pharmacovigilance in risk analysis
exposure to veterinary drugs 475 and the infl uence of risk
K.N. Woodward perception on veterinary
pharmacovigilance 691
21 Medicines used to control and treat
H.P.A. Illing
external parasites of sheep – toxicology
and the phenomenon of reported adverse 31 The role of quality assurance in
human responses to organophosphorus veterinary pharmacovigilance 709
sheep dips 517 R. Visanji and H. Politis-Norton
T.C. Marrs and P. Edwards
32 Concordance between results from
22 User safety assessment of veterinary animal toxicology studies and adverse
medicinal products 529 reactions in animals 715
K.N. Woodward K.N. Woodward
23 Maximum residue limits 547
K.N. Woodward Index 751
List of contributors
Bob Cornez DVM H. Paul A. Illing MSc PhD CSci CChem FRSC
Huvepharma NV, Antwerp, Belgium CBiol FIBiol FRIPH FIOSH ERT
Paul Illing Consultancy Services Ltd, Sherwood,
Philippa Edwards PhD
Heswall, Wirral, United Kingdom, and Centre
Chemical Hazard and Poisons Division, Health
for Occupational and Environmental Health,
Protection Agency, Chilton, Didcot,
University of Manchester, Manchester, United
Oxfordshire, United Kingdom
Kingdom
Caroline W. Evans HNC LiBiol
Gérard Keck DVM MSc Pr Ag
Veterinary Medicines Directorate, New Haw,
National Veterinary School of Lyon, University
Addlestone, Surrey, United Kingdom
of Lyon, Marcy l’Étoile, Lyon, France
Mike J. Francis BSc PhD CBiol FIBiol
Timothy C. Marrs OBE MD DSc FRCP
Intervet/Schering-Plough Animal Health,
FRCPath FATS FBTS
Milton Keynes, Buckinghamshire, United
Edentox Associates, Pinehurst, Edenbridge,
Kingdom
Kent, United Kingdom
Kornelia Grein PhD
Vinny Naidoo BVMCh (MEDUNSA) MSc (Vet)
European Medicines Agency (EMEA), Canary
(Pretoria) PhD
Wharf, London, United Kingdom
Section of Pharmacology and Toxicology,
Tatty M. Hodge MS DVM MPH DACVPM Department of Paraclinical Sciences, Faculty
VMRA Pharmacovigilance, Pfi zer Animal of Veterinary Science, University of Pretoria,
Health, Kalamazoo, Michigan, USA Onderstepoort, South Africa
Cornelia Ibrahim DVM PhD Mike O’Gorman BVetMed MBA LLM MRCVS
Bundesamt für Verbraucherschutz und Intervet/Schering-Plough Animal Health,
Lebensmittelsicherheit, Harefi eld, Uxbridge, Middlesex, United
Berlin, Germany Kingdom
x List of contributors
Declan O’Rourke MVB DipM MBA FRCVS Alex Tait BSc PhD
Ortec Consultancy, Canterbury, Kent, United Veterinary Medicines Directorate, New Haw,
Kingdom Addlestone, Surrey, United Kingdom
Roger C. Parker BSc PhD EurChem CChem Lindsey A. Toon BSc PhD
FRSC MTOPRA Intervet/Schering-Plough Animal Health,
Winsford Associates, Berkhamsted, Harefi eld, Uxbridge, Middlesex, United
Hertfordshire, United Kingdom Kingdom
Xavier Pineau DVM Ramzan Visanji MSc FRQA CBiol FIBiol
CPVL (Veterinary Pharmacovigilance Centre of Intervet/Schering-Plough Animal Health,
Lyon), National Veterinary School of Lyon, Harefi eld, Uxbridge, Middlesex, United
University of Lyon, Marcy l’Étoile, Lyon, Kingdom
France
Annette Wilke DVM PhD
Helen Politis-Norton BPharm MSc PgD Bundesamt für Verbraucherschutz und
(Pharmacovigilance) Lebensmittelsicherheit, Berlin, Germany
Global Quality Audits and Compliance;
Kevin N. Woodward BA BSc (Jt Hons) MSc
Global Compliance and Business Practices,
(Exp Pathol/Toxicol) MSc
Schering-Plough Ltd, Welwyn Garden City,
(Pharmacovigilance), PhD, CBiol, FIBiol,
Hertfordshire, United Kingdom
EurProBiol, CChem, FRSC, DipRCPath (Tox),
Peter Silley BSc PhD CBiol FIBiol FIFST FRSM MTOPRA, FBTS
MB Consult Ltd, Lymington, Hampshire, International Regulatory Affairs, Intervet/
United Kingdom, and Department of Schering-Plough Animal Health, Harefi eld,
Biomedical Sciences, University of Bradford, Uxbridge, Middlesex, United Kingdom
Bradford, United Kingdom
David Skilton BVSc MRCVS
Veterinary Products Committee, c/o Veterinary
Medicines Directorate, New Haw,
Addlestone, Surrey, United Kingdom
Preface
When a new veterinary medicinal product is may be seen and to examine some of the scientifi c
launched into widespread use, adverse drug reac- principles involved. I hope it will prove useful
tions may become apparent. These may be seen in in academia, in the regulatory environment and
the treated animal patients, in exposed users or as within the animal health industry.
adverse effects on the environment. Additionally, Finally, I should like to pay tribute to one of
they may manifest as excess residues of the drug my contributors, Ramzan Visanji, who died in
in food of animal origin. As a consequence, legis- October 2008. Ramzan, a person of tremendous
lation and regulatory approaches have developed courage, was a great colleague and a good friend.
across the globe to address these issues and to His advice and views will be sorely missed, as
ensure that the continued safety of these pro- will his fi ne sense of humour.
ducts can be monitored and, where necessary, Readers should note that the views expressed
that regulatory actions can be pursued to assuage by the editor herein are solely the editor’s views
any concerns. All of these can be covered by the and they do not necessarily refl ect the views of
single term ‘pharmacovigilance’. Intervet/Schering-Plough Animal Health.
This book is an attempt to survey and sum-
marise current approaches to veterinary pharma- K.N. Woodward
covigilance, to review the types of effects that 2008
Acknowledgements
I am most grateful to the help and support given help, and to Julie Musk whose copy-editing skills
to me by my family during the duration of this have contributed signifi cantly to the readability
project. I appreciate their forbearance during and accuracy of this book. I would like to thank
long winter evenings, weekends and holidays Professor Peter Lees for his helpful comments
and in my prolonged disappearances into my prior to embarking on this enterprise. Thanks are
offi ce when I am sure that something more inter- due to Dr Peter Jones and Dr Steve Sundloff
esting (to them) would have been welcomed. whose editorial in an issue of the Journal of
I am also grateful to all of the contributors for Veterinary Pharmacology and Therapeutics (2005)
their help and assistance. I would like to express (Volume 28, pp. 127–128) convinced me that this
my gratitude to colleagues in Intervet/Schering- exercise was well worth all that was likely to be
Plough Animal Health for their help and support, involved. Finally, I must thank those with whom
especially to Drs K.J. Varma and John Rogers, I have had numerous discussions, debates and
and Mr Jim Gould. I am also grateful to those occasionally disagreements during the prepara-
at my publisher, Wiley Blackwell, especially to tion of this work. To all, your contributions have
Sophie Gillanders and Amy Brown, for their been most gratefully received.