Mann's Pharmacovigilance

Description

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

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 Sjölin-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
Eugène van Puijenbroek and Kees van Grootheest

e Pharmacovigilance in Spain
Dolores Montero, Miguel Angel Maciá and César de la Fuente

f Italian Pharmacovigilance System
Laura Sottosanti

g Pharmacovigilance in Turkey
Sinem Ezgi Gülmez

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 Benítez-Vázquez

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 Bégaud

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 Trifiró & 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, Stéphane Liège, Ralph Schimmer and Annie Fourrier-Réglat (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

Author Information

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