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

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