Mann′s Pharmacovigilance

Elizabeth B. Andrews PhD, MPH, FISPE, Vice President, Pharmacoepidemiology and Risk Management, RTI Health Solutions, Research Triangle Park, NC, USA Nicholas Moore MD, PhD, FRCP(Edin), FISPE, Professor of Clinical Pharmacology, Service Hospitalo-Universitaire de Pharmacologie, Bordeaux, France

Introduction Updated from Second edition 1 History of Pharmacovigilance Judith K. Jones and Elyse E. Kingery I The Regulatory Basis of Pharmacovigilance 2 Legal Basis European Union Brian Edwards, Calvin Johnson, Shelley Gandhi 3 Ethical Oversight, Consent and Confidentiality Suzanne L West and Wendy A Visscher 4 Pharmacovigilance-Related Topics at the Level of the International Conference on Harmonisation Priya Bahri 5 CIOMS Working Groups and their Contributions to Pharmacovigilance Gunilla Sjolin-Forsberg and William Gregory 6 Terminologies in Pharmacovigilance Elliot Brown and Daniel von Sydow 7 Non-Clinical Toxicological Support for Phase I Trials David R Jones and JW McBlane 8 The Evaluation of Adverse Events in Clinical Trials Jesse A. Berlin, Brenda Crowe and Amy Xia 9 Case Reports as Evidence in Pharmacovigilance J K Aronson and William Kelly 10 Periodic Safety Update Reports Patrice Verpillat and Mondher Toumi 11 The Principles behind Risk Management in the EU Stella CF Blackburn, June M Raine II Spontaneous Reporting Systems 12 Pharmacovigilance in Europe 12 Regulatory Pharmacovigilance in the European Union Priya Bahri a Spontaneous Reporting United Kingdom Sarah Davis, Bridget King and June M. Raine b Spontaneous Reporting France Jacques Caron, Sophie Gautier and Michel Mallaret c How Pharmacovigilance is Organized in Germany Ulrich Hagemann and Norbert Paeschke d Organisation of Pharmacovigilance in the Netherlands Eugene van Puijenbroek and Kees van Grootheest e Pharmacovigilance in Spain Dolores Montero, Miguel Angel Macia and Cesar de la Fuente f Italian Pharmacovigilance System Laura Sottosanti g Pharmacovigilance in Turkey Sinem Ezgi Gulmez 13 Pharmacovigilance in the Americas a Spontaneous Reporting and Pharmacovigilance Practice United States Min-Chu Chen, Solomon Iyasu, Alfred Sorbello and Linda Scarazzini b Spontaneous Reporting in Mexico Alejandra Rosete and Ricardo Benitez-Vazquez c Pharmacovigilance in Argentina: A lot done, a lot to do Luis Alesso and Raquel Herrera Comoglio 14 Pharmacovigilance in Asia a Pharmacovigilance and Risk Management in Japan Kiyoshi Kubota b Pharmacovigilance in Hong Kong Thomas Y.K. Chan c Pharmacovigilance in China Fan-Dian Zeng, Jie Tang and Hong-Hao Zhou d China Kenneth Hartigan-Go and Althea G Bongat e Malaysia Kenneth Hartigan-Go and Althea G Bongat f Philippines Kenneth Hartigan-Go and Althea G Bongat g Singapore Kenneth Hartigan-Go and Althea G Bongat h Thailand Kenneth Hartigan-Go and Althea G Bongat i Vietnam Kenneth Hartigan-Go and Althea G Bongat j Pharmacovigilance in India The Use of Allopathic and Ayurvedic Medicines Pippa Biswas 15 Pharmacovigilance in New Zealand and Australia a Pharmacovigilance in New Zealand Mira Harrison-Woolrych, Michael Tatley and Desiree L Kunac b Pharmacovigilance Australia. John McEwen 16 Pharmacovigilance in Africa Alexander N. O. Dodoo 17 Vaccine Safety Surveillance Emily Jane Woo, Jerry Labadie and M. Miles Braun III Signal Detection/Generation in Spontaneous Reporting Programs and Other Sources: From Spontaneous Reporting to Pharmacoepidemiology 18 Assessing Suspected Adverse Event Causality Judith K Jones and Elyse Kingery 19 Quantitative Signal Detection and Analysis in Pharmacovigilance Andrew Bate, A Pariente, M Hauben and B Begaud 20 Self-Controlled Case Series Analysis Paddy Farrington 21 Prescription-Event Monitoring (PEM) the Evolution to the New Modified PEM and its Support of Risk Management Deborah Layton and Saad Shakir 22 Prescription Event Monitoring (PEM) in New Zealand Mira Harrison-Woolrych 23 A Description of ENCePP as a Global Resource for Pharmacovigilance and Pharmacoepidemiology Thomas Goedecke and Peter Arlett 24 Overview of North American Databases Brian L. Strom, Rita Schinnar and Judith L. Kinman 25 The Clinical Practice Research Datalink (CPRD) The New 52M Fully Integrated Research Data and Clinical Trial System John Parkinson 26 Active Surveillance: The United States Food and Drug Administration s Sentinel Initiative Ryan M. Carnahan, Carlos J. Bell and Richard Platt 27 Leveraging Routinely Collected Healthcare Data to Scale Up Drug Safety Surveillance: the European Union-Adverse Drug Reaction Experience Gianluca Trifiro & Preciosa Coloma 28 Development and Evaluation of Infrastructure and Analytic Methods for Systematic Drug Safety Surveillance: Lessons and Resources from the Observational Medical Outcomes Partnership Paul Stang, Patrick Ryan, Abraham G. Hartzema, David Madigan, J Marc Overhage, Emily Welebob, Christian G. Reich, Thomas Scarnecchia IV Pharmacovigilance and Drug/System Organ Classes 29 Mechanisms of Adverse Drug Reactions Munir Pirmohamed 30 Fatal Medication Errors and Adverse Drug Reactions Robin E. Ferner and Sarah E. McDowell 31 Dermatological Adverse Drug Reactions Laurence Valeyrie-Allanore and Jean-Claude Roujeau 32 Gastrointestinal Adverse Drug Reactions Angel Lanas Arbeloa and Carlos Sostres Homedes 33 Haematological Adverse Drug Reactions Peter J. Carey 34 Hepatic Adverse Drug Reactions Guruprasad P. Aithal and Dominique Larrey 35 Ocular Side Effects Frederick W. Fraunfelder 36 Renal Adverse Drug Reactions Gert A. Verpooten 37 The Cardiovascular Spectrum of Adverse Drug Reactions Charles Schubert and Judith Hsia 38 Neurological Adverse Events Bradford B Walters Special Populations 39 Drug Safety in Pregnancy Christina D. Chambers and Elizabeth B. Andrews 40 Pharmacovigilance in Pediatrics Dianne Murphy, Judith Cope and Solomon Iyasu 41 Drugs and the Elderly Jamie J Coleman Special Product Classes 42 Anaesthetic Drug Reactions Karine Nouette-Gaulain 43 Pharmacoepidemiology as Part of Pharmacovigilance for Biologic Therapies John Acquavella, Brian Bradbury, Cathy Critchlow, Jason Litten, J. Michael Sprafka and John Sullivan 44 Surveillance for Medical Devices United States Thomas P. Gross V Current Topics 45 The Efficacy and Safety of Selective Serotonin Reuptake Inhibitors (SSRIs) for the Treatment of Depression in Children and Adolescents Julie Magno Zito, DJ Safer and Satish Valluri 46 NSAIDs COX-2 Inhibitors Risks and Benefits K Arnold Chan and S Christopher Jones 47 Introduction to Pharmionics: The Vagaries in Ambulatory Patients Adherence to Prescribed Drug Dosing Regimens and some of their Clinical and Economic Consequences John Urquhart and Bernard Vrijens 48 Design and Implementation of Surveys to Assess Patient and Health Care Provider Understanding of Risks and Safe Use Conditions Kelly Hollis and Alicia Gilsenan VI Training and Education and Directions 49 Eu2P: The First European Online Public Private joint Training Programme in Pharmacovigilance and Pharmacoepidemiology Karine Palin, Christa Bataille, Stephane Liege, Ralph Schimmer and Annie Fourrier-Reglat (on behalf of the Eu2P consortium) 50 Teaching and Learning Pharmacovigilance Frank May 51 Practical Experience in Teaching Pharmacovigilance Stephen Evans 52 The past, present and future of pharmacovigilance Nicholas Moore