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.
Table of Contents:
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
