Veterinary Pharmacovigilance: Adverse Reactions to Veterinary Medicinal Products

Front Cover
Kevin Woodward
John Wiley & Sons, Nov 24, 2009 - Medical - 776 pages
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.

 

Contents

Adverse Reactions to Veterinary Medicinal Products Introduction
1
Adverse Reactions to Veterinary Medicinal Products 1 Elements of veterinary pharmacovigilance
9
Adverse Reactions to Veterinary Medicinal Products 2Veterinary pharmacovigilance in the European Union
19
Adverse Reactions to Veterinary Medicinal Products 3 Pharmacovigilance and the European Medicines Agency conduct of pharmacovigilance activit...
47
Adverse Reactions to Veterinary Medicinal Products 4 Veterinary pharmacovigilance in France
55
Adverse Reactions to Veterinary Medicinal Products 5 Pharmacovigilance in Germany
65
Adverse Reactions to Veterinary Medicinal Products 6 Veterinary pharmacovigilance the UK experience
91
Adverse Reactions to Veterinary Medicinal Products 7 Veterinary adverse drug event reporting in the United States Australia and Canada
119
Adverse Reactions to Veterinary Medicinal Products 18 Adverse drug reactions in dogs toxic hepatic responses
423
Adverse Reactions to Veterinary Medicinal Products 19 Adverse reactions to vaccines
453
Adverse Reactions to Veterinary Medicinal Products 20 Adverse reactions in humans following exposure to veterinary drugs
475
Adverse Reactions to Veterinary Medicinal Products 21 Medicines used to control and treat external parasites of sheep toxicology and the phenomen...
517
Adverse Reactions to Veterinary Medicinal Products 22 User safety assessment of veterinary medicinal products
529
Adverse Reactions to Veterinary Medicinal Products 23 Maximum residue limits
547
Adverse Reactions to Veterinary Medicinal Products 24 Determination of withdrawal periods for pharmaceutical products used in food animals
569
Adverse Reactions to Veterinary Medicinal Products 25 Surveillance for veterinary residues
587

Adverse Reactions to Veterinary Medicinal Products 8 Veterinary pharmacovigilance a South African perspective
151
Adverse Reactions to Veterinary Medicinal Products 9 Pharmacovigilance inspections in the European Union
163
Adverse Reactions to Veterinary Medicinal Products 10 Essential elements of veterinary pharmacovigilance and the role and duties of the Qualified P...
177
Adverse Reactions to Veterinary Medicinal Products 11 Veterinary pharmacovigilance in an industry setting the European Union
209
Adverse Reactions to Veterinary Medicinal Products 12 Pharmacovigilance in the US an industry perspective
231
Adverse Reactions to Veterinary Medicinal Products 13 Practical veterinary pharmacovigilance
287
Adverse Reactions to Veterinary Medicinal Products 14 Preclinical safety testing and assessment of veterinary pharmaceuticals and pharmacovigilance
297
Adverse Reactions to Veterinary Medicinal Products 15 Safety assessment of veterinary vaccines
347
Adverse Reactions to Veterinary Medicinal Products 16 Microbiological assessment of veterinary medicinal products and potential adverse effects
355
Adverse Reactions to Veterinary Medicinal Products 17 Adverse effects of veterinary pharmaceutical products in animals
393
Adverse Reactions to Veterinary Medicinal Products 26 Adverse environmental effects and veterinary medicinal products
605
Adverse Reactions to Veterinary Medicinal Products 27 Causality in pharmacovigilance and expectedness of adverse reactions
639
Adverse Reactions to Veterinary Medicinal Products 28 Quantitative aspects of veterinary pharmacovigilance
659
Adverse Reactions to Veterinary Medicinal Products 29 Veterinary adverse reactions and crisis management
673
Adverse Reactions to Veterinary Medicinal Products 30 The role of veterinary pharmacovigilance in risk analysis and the influence of risk perception...
691
Adverse Reactions to Veterinary Medicinal Products 31 The role of quality assurance in veterinary pharmacovigilance
709
Adverse Reactions to Veterinary Medicinal Products 32 Concordance between results from animal toxicology studies and adverse reactions in animals
715
Adverse Reactions to Veterinary Medicinal Products Index
751
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About the author (2009)

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).

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