Stephens'Detection and Evaluation of Adverse Drug Reactions, 6ed

John Talbot

ISBN: 9788126556120

752 pages

Exclusively distributed by Mehul Book Sales 

INR 5995


This book covers the issues and problems involved in the detection of adverse drug reactions throughout the life cycle of a medicine from animal studies through to clinical trials, market approval, post-market monitoring of clinical use and eventual decline in use or withdrawal. This theme is supported by topics that reach across the life cycle of a drug, such as causality assessment, legal aspects, dictionaries and coding and ethical issues. Written with practitioners in mind, the text is a corner stone of the pharmaceutical medicine list, one of two major works on pharmacovigilance.



Preface to the Sixth Edition

List of Contributors



1 Adverse Drug Reactions: History, Terminology, Classification, Causality, Frequency, Preventability
1.1 Introduction  

1.2 Defining pharmacovigilance  

1.3 The modern history of pharmacovigilance  

1.4 Terminology and definitions in pharmacovigilance  

1.5 Medication errors

1.6 Pharmacological classification of adverse drug reactions

1.7 Drug interactions

1.8 Reporting suspected adverse drug reactions

1.9 Causality assessment

1.10 Frequencies of adverse drug reactions

1.11 Risk perception and adverse drug reactions

1.12 Class effects of drugs

1.13 Unlicensed indications, off-label uses and orphan drugs

1.14 Preventing adverse drug reactions

1.15 Publishing accounts of adverse drug reactions


2 Pharmacogenetics of Adverse Drug Reactions
2.1 Introduction

2.2 Historical review

2.3 Sources of genetic variability

2.4 Role of pharmacogenetic factors in drug pharmacokinetics

2.5 Role of pharmacogenetic factors in drug pharmacodynamics

2.6 The role of pharmacogenetics in pharmaceutical companies

2.7 The impact of pharmacogenetics on regulatory agencies

2.8 The impact of pharmacogenetics on clinical practice

2.9 Conclusions


3 Toxicology and Adverse Drug Reactions

3.1 Introduction

3.2 Toxicity testing

3.3 Drug discovery and development

3.4 Data interpretation and risk assessment

3.5 Adverse drug reactions detected after marketing authorization

3.6 Examples of toxicological investigation of ADRs

3.7 Conclusions


4 Clinical Trials--Collecting Safety Data and Establishing the Adverse Drug Reactions Profile
4.1 Introduction

4.2 Adverse events

4.3 Clinical studies and safety

4.4 The emerging safety profile

4.5 Presentation of safety data

4.6 Conclusions


5 Clinical Laboratory Safety Data
5.1 Introduction

5.2 Factors that influence the interpretation of clinical laboratory data

5.3 Sample collection procedure

5.4 Analytical variation

5.5 Reference ranges

5.6 Intra-individual biological variation

5.7 Detecting adverse events during drug development

5.8 Test selection

5.9 Exclusion criteria and "panic levels"

5.10 Harmonization of data from different laboratories

5.11 Data analysis and presentation


6 Statistics: Analysis and Presentation of Safety Data
6.1 Introduction and background

6.2 Problems with efficacy trials for detecting adverse drug reactions

6.3 Analysis and presentation of data from trials

6.4 Statistical measures of the occurrence of adverse events

6.5 Combining data from several trials--meta-analysis

6.6 Use of statistical methods for signal detection from spontaneous reports

6.7 Analysis and presentation of data from observational studies

6.8 Summary and conclusions


7 Proactive Pharmacovigilance and Risk Management
7.1 Introduction

7.2 Risk management--definition and general principles

7.3 Defining the knowledge base--the safety specification

7.4 Extending the knowledge of safety and characterizing risk--the pharmacovigilance plan

7.5 Minimizing risks

7.6 Special challenges for risk management

7.7 Experience with risk evaluation and mitigation strategies (REMS) in the USA

7.8 A possible method for risk management when a new adverse reaction is discovered after marketing

7.9 Future challenges for risk management

7.10 Conclusions


8 Regulatory Aspects of Pharmacovigilance
8.1 Introduction

8.2 The standardization and harmonization of safety data collection and reporting: CIOMS and ICH

8.3 The European Union

8.4 The UK

8.5 France

8.6 Germany

8.7 USA

8.8 Japan


9 Legal Aspects of Pharmacovigilance in the European Union
9.1 Introduction  

9.2 Application of EU legislation in Member States

9.3 Interpretation of EU law  

9.4 Relationship between law and guidelines

9.5 Issues in interpreting EU pharmacovigilance legislation

9.6 Legal responsibility for pharmacovigilance activities

9.7 Failures to meet pharmacovigilance requirements

9.8 Enforcement and sanctions

9.9 European powers and procedures in the event of a product safety issue

9.10 Civil liability

9.11 Personal data privacy  

9.12 Safety in research products


10 Dictionaries and Coding in Pharmacovigilance
10.1 Introduction

10.2 Scope of this chapter

10.3 What is a dictionary?

10.4 Drug dictionaries

10.5 Disease classifications

10.6 Medical Dictionary for Regulatory Activities, MedDRA

10.7 Common Terminology Criteria for Adverse Events (CTCAE)

10.8 Definition of adverse reaction terms

10.9 Dictionaries used in electronic health records

10.10 Use of dictionaries in standard product information  

10.11 Conclusions


11 Adverse Drug Reactions: Societal Considerations
11.1 Introduction

11.2 Adverse drug reactions at the population level

11.3 The social production of ADRs

11.4 Trust

11.5 Information about ADRs

11.6 Conclusions


12 Safety of Biotherapeutics
12.1 Introduction

12.2 Properties of proteins

12.3 Classification of biotherapeutics

12.4 Monitoring for adverse events due to biotherapeutics

12.5 Conclusions


13 Vaccine Safety Surveillance
13.1 Introduction

13.2 What is special about vaccine safety compared with other drugs?

13.3 Pathogenesis of vaccine reactions

13.4 Criteria for establishing causality after vaccine-related adverse events

13.5 Pre-licensing evaluation of vaccine safety

13.6 Objectives of an ideal post-licensing vaccine safety surveillance system

13.7 Conclusions


14 Assessing the Safety of Drugs Used in Oncology
14.1 Introduction

14.2 Factors to consider when assessing the safety of drugs used in oncology

14.3 Sources of adverse effect data

14.4 Nature of the data

14.5 Assessment of adverse effects data in oncology

14.6 Conclusions


15 Adverse Drug Reactions and Pharmacovigilance of Herbal Medicines
15.1 Introduction

15.2 Herbal medicines: definitions and descriptions

15.3 Characteristics of herbal medicines

15.4 Regulation of herbal medicines and pharmacovigilance requirements

15.5 Access to and use of herbal medicines

15.6 Adverse reactions associated with herbal medicines

15.7 Methods for pharmacovigilance of herbal medicines

15.8 Responding to safety concerns associated with herbal medicines

15.9 The future for pharmacovigilance of herbal medicines

15.10 Conclusions


Appendix 1 Web Sites Relevant to Pharmacovigilance--An Analysis of Contents
Appendix 2 Guidelines and a Checklist for Reporting Suspected
 Adverse Drug Reactions Anecdotally in Journals