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Highly Commended at the BMA Medical Book Awards 2015 Mann's Pharmacovigilance is the definitive reference for the science of detection, assessment, understanding and prevention of the adverse effects of medicines, including vaccines and biologics. Pharmacovigilance is increasingly important in improving drug safety for patients and reducing risk within the practice of pharmaceutical medicine. This new third edition covers the regulatory basis and the practice of pharmacovigilance and spontaneous adverse event reporting throughout the world. It examines signal detection and analysis, including…mehr
Highly Commended at the BMA Medical Book Awards 2015 Mann's Pharmacovigilance is the definitive reference for the science of detection, assessment, understanding and prevention of the adverse effects of medicines, including vaccines and biologics. Pharmacovigilance is increasingly important in improving drug safety for patients and reducing risk within the practice of pharmaceutical medicine. This new third edition covers the regulatory basis and the practice of pharmacovigilance and spontaneous adverse event reporting throughout the world. It examines signal detection and analysis, including the use of population-based databases and pharmacoepidemiological methodologies to proactively monitor for and assess safety signals. It includes chapters on drug safety practice in specific organ classes, special populations and special products, and new developments in the field. From an international team of expert editors and contributors, Mann's Pharmacovigilance is a reference for everyone working within pharmaceutical companies, contract research organisations and medicine regulatory agencies, and for all researchers and students of pharmaceutical medicine. The book has been renamed in honor of Professor Ronald Mann, whose vision and leadership brought the first two editions into being, and who dedicated his long career to improving the safety and safe use of medicines.
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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
Inhaltsangabe
Contributors xi Foreword xxi 1 Introduction: Updated from Second Edition 1 Ronald D. Mann and Elizabeth B. Andrews 2 History of Pharmacovigilance 11 Judith K. Jones and Elyse Kingery I The Regulatory Basis Of Pharmacovigilance 3 Legal Basis: European Union 27 Brian Edwards, Calvin Johnson, and Shelley Gandhi 4 Ethical Oversight, Consent, and Confi dentiality 37 Suzanne L. West and Wendy A. Visscher 5 Pharmacovigilance-Related Topics at the Level of the International Conference on Harmonisation 47 Priya Bahri 6 The Council for International Organizations of Medical Sciences Working Groups and Their Contributions to Pharmacovigilance 63 Gunilla Sjölin-Forsberg and William Gregory 7 Terminologies in Pharmacovigilance 77 Elliot Brown and Daniel von Sydow 8 Nonclinical Toxicological Support for Phase I Trials 95 David R. Jones and James W. MCBlane 9 The Evaluation of Adverse Events in Clinical Trials (with a Particular Focus on the Use of Meta Analysis) 109 Jesse A. Berlin, Brenda Crowe, and H. Amy Xia 10 Case Reports as Evidence in Pharmacovigilance 121 Jeffrey K. Aronson 11 Periodic Safety Update Reports 139 Patrice Verpillat and Mondher Toumi 12 The Principles behind Risk Management in the European Union 153 Stella C.F. Blackburn and June M. Raine II Pharmacovigilance Systems Pharmacovigilance in Europe 13a Regulatory Pharmacovigilance in the European Union 173 Priya Bahri and Peter Arlett 13b Spontaneous Reporting: United Kingdom 185 Mick Foy, Paul Barrow, and June M. Raine 13c Spontaneous Reporting: France 203 Jacques Caron, Sophie Gautier, and Michel Mallaret 13d How Pharmacovigilance is Organized in Germany 207 Ulrich Hagemann and Norbert Paeschke 13e Organization of Pharmacovigilance in the Netherlands 213 Eugène Van Puijenbroek and Kees Van Grootheest 13f Pharmacovigilance in Spain 217 Dolores Montero, Miguel Angel Maciá, and César De La Fuente 13g Italian Pharmacovigilance System 221 Laura Sottosanti and Fernanda Ferrazin 13h Pharmacovigilance in Turkey 225 Sinem Ezgi Gülmez Pharmacovigilance in the Americas 14a Spontaneous Reporting and Pharmacovigilance Practice: USA 229 Min-Chu Chen, Solomon Iyasu, Alfred Sorbello, and Linda Scarazzini 14b Spontaneous Reporting in Mexico 241 Alejandra Rosete and Ricardo Benítez-Vázquez 14c Pharmacovigilance in Argentina: A Lot Done, A Lot To Do 245 Luis Alesso and Raquel Herrera Comoglio Pharmacovigilance in Asia 15a Pharmacovigilance and Risk Management in Japan 249 Kiyoshi Kubota and Tsugumichi Sato 15b Pharmacovigilance in Hong Kong 259 Thomas Y.K. Chan 15c Pharmacovigilance in China 263 Hong-Hao Zhou, Fan-Dian Zeng, and Jie Tang 15d China 267 Kenneth Hartigan-Go and Althea Bongat 15e Malaysia 271 Kenneth Hartigan-Go and Althea Bongat 15f Philippines 273 Kenneth Hartigan-Go and Althea Bongat 15g Singapore 277 Kenneth Hartigan-Go and Althea Bongat 15h Thailand 279 Kenneth Hartigan-Go and Althea Bongat 15i Vietnam 283 Kenneth Hartigan-Go and Althea Bongat 15j Pharmacovigilance in India 285 Pipasha Biswas Pharmacovigilance in New Zealand and Australia 16a Pharmacovigilance in New Zealand 291 Mira Harrison-Woolrych, Michael Tatley, and Desiree Kunac 16b Pharmacovigilance: Australia 295 John MCEwen Pharmacovigilance in Africa 17 Pharmacovigilance in Africa 299 Alexander N.O. Dodoo and Haggar H. Ampadu III Signal Detection/Generation in Spontaneous Reporting Programs and Other Sources: From Spontaneous Reporting To Pharmacoepidemiology 18 Vaccine Safety Surveillance 305 Emily Jane Woo, Jerry Labadie, and M. Miles Braun 19 How We Assess Causality 319 Judith K. Jones and Elyse Kingery 20 Quantitative Signal Detection and Analysis in Pharmacovigilance 331 Andrew Bate, Antoine Pariente, Manfred Hauben, and Bernard Bégaud 21 Self-Controlled Case Series Analysis 355 Paddy Farrington 22 Prescription-Event Monitoring (PEM): The Evolution to the New Modifi ed PEM and its Support of Risk Management 359 Deborah Layton and Saad Shakir 23 Prescription-Event Monitoring in New Zealand 385 Mira Harrison-Woolrych 24 A Description of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance as a Global Resource for Pharmacovigilance and Pharmacoepidemiology 403 Thomas Goedecke and Peter Arlett 25 Overview of North American Databases 409 Brian L. Strom, Rita Schinnar, and Judith L. Kinman 26 The Clinical Practice Research Datalink: The New 54 Million Fully Integrated Research Data and Clinical Trial System 421 John Parkinson 27 Active Surveillance: The United States Food and Drug Administration's Sentinel Initiative 429 Ryan M. Carnahan, Carlos J. Bell, and Richard Platt 28 Leveraging Routinely Collected Healthcare Data to Scale Up Drug Safety Surveillance: The EU-ADR Experience 439 Gianluca Trifi rò and Preciosa Coloma 29 Development and Evaluation of Infrastructure and Analytic Methods for Systematic Drug Safety Surveillance: Lessons and Resources from the Observational Medical Outcomes Partnership 453 Paul Stang, Patrick Ryan, Abraham G. Hartzema, David Madigan, J. Marc Overhage, Emily Welebob, Christian G. Reich, and Thomas Scarnecchia IV Pharmacovigilance and Drug/System Organ Classes 30 Mechanisms of Adverse Drug Reactions 465 Munir Pirmohamed 31 Fatal Medication Errors and Adverse Drug Reactions 489 Robin E. Ferner and Sarah E. Mcdowell 32 Dermatological Adverse Drug Reactions 503 Laurence Valeyrie-Allanore and Jean-Claude Roujeau 33 Gastrointestinal Adverse Drug Reactions 513 Angel Lanas Arbeloa and Carlos Sostres Homedes 34 Hematological Adverse Drug Reactions 527 Peter J. Carey 35 Hepatic Adverse Drug Reactions 539 Guruprasad P. Aithal and Dominique Larrey 36 Ocular Side Effects of Prescription Medications 557 Frederick W. Fraunfelder 37 Renal Adverse Drug Reactions 567 Gert A. Verpooten 38 The Cardiovascular Spectrum of Adverse Drug Reactions 577 Charles Schubert and Judith Hsia 39 Neurological Adverse Events 585 Bradford B. Walters Special Populations 40 Drug Safety in Pregnancy 611 Christina D. Chambers and Elizabeth B. Andrews 41 Pharmacovigilance in Pediatrics 625 M. Dianne Murphy, Judith Cope, and Solomon Iyasu 42 Drugs and the Elderly 639 Jamie J. Coleman Special Product Classes 43 Anesthetic Adverse Drug Reactions 659 Anita Holdcroft and Karine Nouette-Gaulain 44 Pharmacoepidemiology as Part of Pharmacovigilance for Biologic Therapies 685 John Acquavella, Brian Bradbury, Cathy Critchlow, Jason B. Litten, J. Michael Sprafka, and John Sullivan 45 Surveillance for Medical Devices: USA 703 Thomas P. Gross 46 The Effi cacy and Safety of Selective Serotonin Reuptake Inhibitors for the Treatment of Depression in Children and Adolescents 719 J. Magno Zito, D.J. Safer, and Satish Valluri 47 Nonsteroidal Anti-infl ammatory Drugs - Cyclooxygenase-2 Inhibitors: Risks and Benefits 735 K. Arnold Chan 48 Introduction to Pharmionics: The Vagaries in Ambulatory Patients' Adherence to Prescribed Drug Dosing Regimens, and Some of Their Clinical and Economic Consequences 751 John Urquhart and Bernard Vrijens 49 Design and Implementation of Surveys to Assess Patient and Healthcare Provider Understanding of Risks and Safe Use Conditions 769 Kelly Hollis and Alicia Gilsenan VI Training and Education And Directions 50 Eu2P: The First European Online Public-Private Joint Training Program in Pharmacovigilance and Pharmacoepidemiology 787 Karine Palin, Christa Bataille, Stéphane Liège, Ralph Schimmer, and Annie Fourrier-Réglat 51 Teaching and Learning Pharmacovigilance 793 Frank May 52 Practical Experience in Teaching Pharmacovigilance 805 Stephen Evans and Ian Douglas 53 An Historical Perspective of the Future of Pharmacovigilance 807 Nicholas Moore Index 819
Contributors xi Foreword xxi 1 Introduction: Updated from Second Edition 1 Ronald D. Mann and Elizabeth B. Andrews 2 History of Pharmacovigilance 11 Judith K. Jones and Elyse Kingery I The Regulatory Basis Of Pharmacovigilance 3 Legal Basis: European Union 27 Brian Edwards, Calvin Johnson, and Shelley Gandhi 4 Ethical Oversight, Consent, and Confi dentiality 37 Suzanne L. West and Wendy A. Visscher 5 Pharmacovigilance-Related Topics at the Level of the International Conference on Harmonisation 47 Priya Bahri 6 The Council for International Organizations of Medical Sciences Working Groups and Their Contributions to Pharmacovigilance 63 Gunilla Sjölin-Forsberg and William Gregory 7 Terminologies in Pharmacovigilance 77 Elliot Brown and Daniel von Sydow 8 Nonclinical Toxicological Support for Phase I Trials 95 David R. Jones and James W. MCBlane 9 The Evaluation of Adverse Events in Clinical Trials (with a Particular Focus on the Use of Meta Analysis) 109 Jesse A. Berlin, Brenda Crowe, and H. Amy Xia 10 Case Reports as Evidence in Pharmacovigilance 121 Jeffrey K. Aronson 11 Periodic Safety Update Reports 139 Patrice Verpillat and Mondher Toumi 12 The Principles behind Risk Management in the European Union 153 Stella C.F. Blackburn and June M. Raine II Pharmacovigilance Systems Pharmacovigilance in Europe 13a Regulatory Pharmacovigilance in the European Union 173 Priya Bahri and Peter Arlett 13b Spontaneous Reporting: United Kingdom 185 Mick Foy, Paul Barrow, and June M. Raine 13c Spontaneous Reporting: France 203 Jacques Caron, Sophie Gautier, and Michel Mallaret 13d How Pharmacovigilance is Organized in Germany 207 Ulrich Hagemann and Norbert Paeschke 13e Organization of Pharmacovigilance in the Netherlands 213 Eugène Van Puijenbroek and Kees Van Grootheest 13f Pharmacovigilance in Spain 217 Dolores Montero, Miguel Angel Maciá, and César De La Fuente 13g Italian Pharmacovigilance System 221 Laura Sottosanti and Fernanda Ferrazin 13h Pharmacovigilance in Turkey 225 Sinem Ezgi Gülmez Pharmacovigilance in the Americas 14a Spontaneous Reporting and Pharmacovigilance Practice: USA 229 Min-Chu Chen, Solomon Iyasu, Alfred Sorbello, and Linda Scarazzini 14b Spontaneous Reporting in Mexico 241 Alejandra Rosete and Ricardo Benítez-Vázquez 14c Pharmacovigilance in Argentina: A Lot Done, A Lot To Do 245 Luis Alesso and Raquel Herrera Comoglio Pharmacovigilance in Asia 15a Pharmacovigilance and Risk Management in Japan 249 Kiyoshi Kubota and Tsugumichi Sato 15b Pharmacovigilance in Hong Kong 259 Thomas Y.K. Chan 15c Pharmacovigilance in China 263 Hong-Hao Zhou, Fan-Dian Zeng, and Jie Tang 15d China 267 Kenneth Hartigan-Go and Althea Bongat 15e Malaysia 271 Kenneth Hartigan-Go and Althea Bongat 15f Philippines 273 Kenneth Hartigan-Go and Althea Bongat 15g Singapore 277 Kenneth Hartigan-Go and Althea Bongat 15h Thailand 279 Kenneth Hartigan-Go and Althea Bongat 15i Vietnam 283 Kenneth Hartigan-Go and Althea Bongat 15j Pharmacovigilance in India 285 Pipasha Biswas Pharmacovigilance in New Zealand and Australia 16a Pharmacovigilance in New Zealand 291 Mira Harrison-Woolrych, Michael Tatley, and Desiree Kunac 16b Pharmacovigilance: Australia 295 John MCEwen Pharmacovigilance in Africa 17 Pharmacovigilance in Africa 299 Alexander N.O. Dodoo and Haggar H. Ampadu III Signal Detection/Generation in Spontaneous Reporting Programs and Other Sources: From Spontaneous Reporting To Pharmacoepidemiology 18 Vaccine Safety Surveillance 305 Emily Jane Woo, Jerry Labadie, and M. Miles Braun 19 How We Assess Causality 319 Judith K. Jones and Elyse Kingery 20 Quantitative Signal Detection and Analysis in Pharmacovigilance 331 Andrew Bate, Antoine Pariente, Manfred Hauben, and Bernard Bégaud 21 Self-Controlled Case Series Analysis 355 Paddy Farrington 22 Prescription-Event Monitoring (PEM): The Evolution to the New Modifi ed PEM and its Support of Risk Management 359 Deborah Layton and Saad Shakir 23 Prescription-Event Monitoring in New Zealand 385 Mira Harrison-Woolrych 24 A Description of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance as a Global Resource for Pharmacovigilance and Pharmacoepidemiology 403 Thomas Goedecke and Peter Arlett 25 Overview of North American Databases 409 Brian L. Strom, Rita Schinnar, and Judith L. Kinman 26 The Clinical Practice Research Datalink: The New 54 Million Fully Integrated Research Data and Clinical Trial System 421 John Parkinson 27 Active Surveillance: The United States Food and Drug Administration's Sentinel Initiative 429 Ryan M. Carnahan, Carlos J. Bell, and Richard Platt 28 Leveraging Routinely Collected Healthcare Data to Scale Up Drug Safety Surveillance: The EU-ADR Experience 439 Gianluca Trifi rò and Preciosa Coloma 29 Development and Evaluation of Infrastructure and Analytic Methods for Systematic Drug Safety Surveillance: Lessons and Resources from the Observational Medical Outcomes Partnership 453 Paul Stang, Patrick Ryan, Abraham G. Hartzema, David Madigan, J. Marc Overhage, Emily Welebob, Christian G. Reich, and Thomas Scarnecchia IV Pharmacovigilance and Drug/System Organ Classes 30 Mechanisms of Adverse Drug Reactions 465 Munir Pirmohamed 31 Fatal Medication Errors and Adverse Drug Reactions 489 Robin E. Ferner and Sarah E. Mcdowell 32 Dermatological Adverse Drug Reactions 503 Laurence Valeyrie-Allanore and Jean-Claude Roujeau 33 Gastrointestinal Adverse Drug Reactions 513 Angel Lanas Arbeloa and Carlos Sostres Homedes 34 Hematological Adverse Drug Reactions 527 Peter J. Carey 35 Hepatic Adverse Drug Reactions 539 Guruprasad P. Aithal and Dominique Larrey 36 Ocular Side Effects of Prescription Medications 557 Frederick W. Fraunfelder 37 Renal Adverse Drug Reactions 567 Gert A. Verpooten 38 The Cardiovascular Spectrum of Adverse Drug Reactions 577 Charles Schubert and Judith Hsia 39 Neurological Adverse Events 585 Bradford B. Walters Special Populations 40 Drug Safety in Pregnancy 611 Christina D. Chambers and Elizabeth B. Andrews 41 Pharmacovigilance in Pediatrics 625 M. Dianne Murphy, Judith Cope, and Solomon Iyasu 42 Drugs and the Elderly 639 Jamie J. Coleman Special Product Classes 43 Anesthetic Adverse Drug Reactions 659 Anita Holdcroft and Karine Nouette-Gaulain 44 Pharmacoepidemiology as Part of Pharmacovigilance for Biologic Therapies 685 John Acquavella, Brian Bradbury, Cathy Critchlow, Jason B. Litten, J. Michael Sprafka, and John Sullivan 45 Surveillance for Medical Devices: USA 703 Thomas P. Gross 46 The Effi cacy and Safety of Selective Serotonin Reuptake Inhibitors for the Treatment of Depression in Children and Adolescents 719 J. Magno Zito, D.J. Safer, and Satish Valluri 47 Nonsteroidal Anti-infl ammatory Drugs - Cyclooxygenase-2 Inhibitors: Risks and Benefits 735 K. Arnold Chan 48 Introduction to Pharmionics: The Vagaries in Ambulatory Patients' Adherence to Prescribed Drug Dosing Regimens, and Some of Their Clinical and Economic Consequences 751 John Urquhart and Bernard Vrijens 49 Design and Implementation of Surveys to Assess Patient and Healthcare Provider Understanding of Risks and Safe Use Conditions 769 Kelly Hollis and Alicia Gilsenan VI Training and Education And Directions 50 Eu2P: The First European Online Public-Private Joint Training Program in Pharmacovigilance and Pharmacoepidemiology 787 Karine Palin, Christa Bataille, Stéphane Liège, Ralph Schimmer, and Annie Fourrier-Réglat 51 Teaching and Learning Pharmacovigilance 793 Frank May 52 Practical Experience in Teaching Pharmacovigilance 805 Stephen Evans and Ian Douglas 53 An Historical Perspective of the Future of Pharmacovigilance 807 Nicholas Moore Index 819
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