Front cover image for Pharmacovigilance

Pharmacovigilance

eBook, English, ©2002
John Wiley & Sons, Chichester, West Sussex, England, ©2002
1 online resource (xxi, 560 pages) : illustrations
9780470852972, 9780470853092, 0470852976, 0470853093
51060908
List of Contributors.Preface. Foreword. PART I: BASIS OF PHARMACOVIGILANCE. Introduction (R. Mann and E. Andrews). Legal Basis--EU (N. Macfarlane, et al.). Legal Basis--US (R. Brady and M. Learn). Ethical Oversight, Consent and Confidentiality (D. Boswell and E. Andrews). Pre clinical Safety Evaluation (N. Kellet, S. Mair and W. Nimmo). Metabolic Mechanisms (M. Pirmohamed and B. Park). Drugs and the Elderly (U. Martin and C. George). Natural History (P. Stang). Responding to Signals (P. Waller and P. Arlett). Micturin and Torsades de Pointes (R. Wild). Withdrawal of Terodiline: A Tale of Two Toxicities (R. Shah). Nomifensine and Haemolytic Anaemia (P. Stonier and J. Edwards). PART II: SIGNAL GENERATION. WHO Programme--Global Monitoring (I. Edwards and S. Olsson). Regulatory Pharmacovigilance in the EU (P. Waller and P. Bahri). Spontaneous Reporting--UK (S. Davis and J. Raine). Spontaneous Reporting--France (N. Moore, C. Kreft Jais and A. Dahnani). Spontaneous Reporting--USA (D. Graham, S. Ahmad and T. Piazz Hepp). Algorithms (J. Clark). Overview--Spontaneous Signalling (J. Clark, S. Klincewicz and P. Stang). Statistical Methods of Signal Detection (S. Evans). Statistical Methods of Evaluating Pharmacovigilance Data (B. Begaud). Data Mining (I. Edwards et al.). Epidemiology of Adverse Events Associated with Epilepsy and Use of Lamotrigine (P. Tennis). Pharmacovigilance in the Netherlands (A. van Grootheest and E. van Puijenbroek). CIOMS Working Groups and their Contribution to Pharmacovigilance (S. Roden). PEM in the UK (S. Shakir). PEM in New Zealand (D. Coulter). MEMO in the UK (D. Steinke, J. Evan and T. Macdonald). GPRD in the UK (L. Wood). Overview of North American Databases (B. Storm and J. Kinman). Pharmacovigilance in the HMO Research Network (R. Platt et al.). Other Databases in Europe (M. Sturkenboom). Surveillance for Medical Devices--USA (T. Gross and L. Kessler). PART III: PHARMACOVIGILANCE AND SELECTED SYSTEM ORGAN CLASSES. Dermatological ADRs (L. Valeyrie and J. C. Roujeau). Gastrointestinal ADRs (J. Wood and G. Pipkin). Haematological ADRs (S. Davis and R. Mann). Hepatic Adverse Drug Reactions (G. Aithal and C. Day). Ocular ADRs (F.W. Fraunfelder and F.T. Fraunfelder). Drug Safety in Pregnancy (C. Chambers and E. Andrews). ADRs and Drug Safety 1999 2000 (P. Curel and R. Stather). PART IV: LESSONS AND DIRECTIONS. Teaching Pharmacovigilance (R. Meyboom, S. Olsson and M. Thorogood). Medical Errors and Lessons from Drug Related Deaths (R. Ferner and R. Whittington). Pharmacogenetics and the Genetic Basis of ADRs (P. Manasco et al.). Keynote Clinical Lessons from Pharmacovigilance (D. Lawson). Index.