Veterinary Pharmacovigilance

Adverse Reactions to Veterinary Medicinal Products

Kevin Woodward (Intervet/Schering-Plough Animal Health, UK.)

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English

Wiley-Blackwell
05 June 2009

Veterinary medicine; Veterinary pharmacology

Veterinary Pharmacovigilance: Adverse Reactions to Veterinary Medicinal Products is an in-depth examination of veterinary pharmacovigilance, looking at the scientific methodologies involved, the role of regulatory agencies and legislation, and the underpinning science. Edited by a renowned expert, with over 20 years experience in the field, it draws together the expertise of authors from around the world.

Adverse drug reactions may become apparent in treated animal patients, in exposed users or as adverse effects on the environment. They may also manifest as excess drug residues in food of animal origin. As a consequence, legislation and regulatory approaches have developed to address these issues and to ensure monitoring of continued product safety and, where necessary, the use of regulatory actions. All of these aspects are covered by the term “pharmacovigilance”.

Veterinary pharmacovigilance is a rapidly growing discipline in both regulatory and scientific terms, and its importance can only increase as regulatory agencies across the globe seek to improve their hazard and risk assessment of marketed veterinary medicines by applying the techniques of post-marketing surveillance. Its roots include veterinary medicine, medicine, pharmacology, toxicology, pathology and, increasingly, ecotoxicity and environmental safety.

This book will be fundamentally important reading for all involved in the field of veterinary pharmacovigilance including veterinarians, physicians, environmental scientists, regulators and those involved in drug development and market maintenance.

Edited by: Kevin Woodward (Intervet/Schering-Plough Animal Health UK.)
Imprint: Wiley-Blackwell
Country of Publication: United Kingdom
Dimensions: Height: 279mm, Width: 221mm, Spine: 41mm
Weight: 2.291kg
ISBN: 9781405169684
ISBN 10: 1405169680
Pages: 776
Publication Date: 05 June 2009
Audience: College/higher education , Professional and scholarly , Postgraduate, Research & Scholarly , A / AS level , Undergraduate
Format: Hardback
Publisher's Status: Active

List of contributors ix Preface xi Acknowledgements xiii Introduction 1 D. Skilton 1 Elements of veterinary pharmacovigilance 9 K.N. Woodward 2 Veterinary pharmacovigilance in the European Union 19 K.N. Woodward 3 Pharmacovigilance and the European Medicines Agency: conduct of pharmacovigilance activities 47 K. Grein 4 Veterinary pharmacovigilance in France 55 G. Keck and X. Pineau 5 Pharmacovigilance in Germany 65 C. Ibrahim and A. Wilke 6 Veterinary pharmacovigilance – the UK experience 91 K.N. Woodward 14 Preclinical safety testing and assessment of veterinary pharmaceuticals and pharmacovigilance 297 K.N. Woodward 15 Safety assessment of veterinary vaccines 347 M.J. Francis 16 Microbiological assessment of veterinary medicinal products and potential adverse effects 355 P. Silley 17 Adverse effects of veterinary pharmaceutical products in animals 393 K.N. Woodward 18 Adverse drug reactions in dogs – toxic hepatic responses 423 K.N. Woodward 19 Adverse reactions to vaccines 453 K.N. Woodward and L.A. Toon 20 Adverse reactions in humans following exposure to veterinary drugs 475 K.N. Woodward 21 Medicines used to control and treat external parasites of sheep – toxicology and the phenomenon of reported adverse human responses to organophosphorus sheep dips 517 T.C. Marrs and P. Edwards 22 User safety assessment of veterinary medicinal products 529 K.N. Woodward 23 Maximum residue limits 547 K.N. Woodward 24 Determination of withdrawal periods for pharmaceutical products used in food animals 569 R.C. Parker 25 Surveillance for veterinary residues 587 K.N. Woodward 26 Adverse environmental effects and veterinary medicinal products 605 A. Tait 27 Causality in pharmacovigilance and expectedness of adverse reactions 639 K.N. Woodward 28 Quantitative aspects of veterinary pharmacovigilance 659 K.N. Woodward 29 Veterinary adverse reactions and crisis management 673 K.N. Woodward 30 The role of veterinary pharmacovigilance in risk analysis and the influence of risk perception on veterinary pharmacovigilance 691 H.P.A. Illing 31 The role of quality assurance in veterinary pharmacovigilance 709 R. Visanji and H. Politis-Norton 32 Concordance between results from animal toxicology studies and adverse reactions in animals 715 K.N. Woodward Index 751

Dr K.N. Woodward is Director of International Regulatory Affairs at Intervet/Schering-Plough Animal Health in the UK and has been involved in veterinary pharmacovigilance for over 20 years. He was formerly the Director of Licensing at the Veterinary Medicines Directorate (VMD) in the UK. He has also worked for the Health and Safety Executive on the regulation of industrial chemicals and non-agricultural pesticides and for the Department of Health where he was Scientific Secretary to the Committee on Carcinogenicity and held responsibilities for the safety of veterinary drugs. A toxicologist, he was Chairman of the Working Group on the Safety of Residues of the Committee for Veterinary Medicinal Products (CVMP, now the Committee for Medicinal Products for Veterinary Use) for over 5 years and a member of the CVMP. He was the leader of the UK delegation to the Codex Committee on Residues of Veterinary Drugs in Food in Washington for 3 years and a member of the Joint FAO/WHO Expert Committee on Food Additives (JECFA).

Reviews for Veterinary Pharmacovigilance: Adverse Reactions to Veterinary Medicinal Products

In terms of utility to the practical toxicologist, the book is excellent and I am very pleased to have it on my shelf - well away from the door. (British Toxicology Society, Winter 2010) <p>  