Stephens' Detection and Evaluation of Adverse Drug Reactions. Principles and Practice

Description

Written with practitioners in mind, this new edition of Stephen’s Detection of Adverse Drug Reactions: Principle and Practice continues to be one of the corner stones of the pharmaceutical medicine list. The classic text covers the issues and problems involved in the detection of adverse drug reactions (ADRs) throughout the life cycle of a medicine from animal studies through to clinical trials, its introduction to the market, followed by wide clinical use, and eventual decline in use or withdrawal. The sixth edition is completely revised and updated including five new chapters on pharmacogenomics, ADRs with herbal medicines, safety of medical devices, safety issues with oncology drugs, and economic aspects of ADRs. All tables and web information needed in order to practice are included to make this sixth edition a complete primer for the new practitioner and a reference for the more experienced.

Table of Contents

• Foreword
• Preface to the Sixth Edition
• List of Contributors
• Acknowledgements

1. Adverse Drug Reactions: History, Terminology, Classification, Causality, Frequency, Preventability
   Jeffrey K. Aronson
1. Introduction
2. Defining pharmacovigilance
3. The modern history of pharmacovigilance
4. Terminology and definitions in pharmacovigilance
5. Medication errors
6. Pharmacological classification of adverse drug reactions
7. Drug interactions
8. Reporting suspected adverse drug reactions
9. Causality assessment
10. Frequencies of adverse drug reactions
11. Risk perception and adverse drug reactions
12. Class effects of drugs
13. Unlicensed indications, off-label uses, and orphan drugs
14. Preventing adverse drug reactions
15. Publishing accounts of adverse drug reactions
16. References
2. Pharmacogenetics of Adverse Drug Reactions
   Sudeep P. Pushpakom and Munir Pirmohamed
1. Introduction
2. Historical review
3. Sources of genetic variability
4. Role of pharmacogenetic factors in drug pharmacokinetics
5. Role of pharmacogenetic factors in drug pharmacodynamics
6. The role of pharmacogenetics in pharmaceutical companies
7. The impact of pharmacogenetics on regulatory agencies
8. The impact of pharmacogenetics on clinical practice
9. Conclusions
10. References
3. Toxicology and Adverse Drug Reactions
   D. J. Snodin and A. Suitters
1. Introduction
2. Toxicity testing
3. Drug discovery and development
4. Data interpretation and risk assessment
5. Adverse drug reactions detected after marketing authorization
6. Examples of toxicological investigation of ADRs
7. Conclusions
8. Acknowledgements
9. References
4. Clinical Trials—Collecting Safety Data and Establishing the Adverse Drug Reactions Profile
   John Talbot, Marianne Keisu, and Lars St°ahle
1. Introduction
2. Adverse events
3. Clinical studies and safety
4. The emerging safety profile
5. Presentation of safety data
6. Conclusions
7. References
5. Clinical Laboratory Safety Data
   Alan Craig
1. Introduction
2. Factors that influence the interpretation of clinical laboratory data
3. Sample collection procedure
4. Analytical variation
5. Reference ranges
6. Intra-individual biological variation
7. Detecting adverse events during drug development
8. Test selection
9. Exclusion criteria and “panic levels”
10. Harmonization of data from different laboratories
11. Data analysis and presentation
12. Conclusions
13. Appendix
14. References
6. Statistics: Analysis and Presentation of Safety Data
   Stephen J. W. Evans and Dorothea Nitsch
1. Introduction and background
2. Problems with efficacy trials for detecting adverse drug reactions
3. Analysis and presentation of data from trials
4. Statistical measures of the occurrence of adverse events
5. Combining data from several trials—meta-analysis
6. Use of statistical methods for signal detection from spontaneous reports
7. Analysis and presentation of data from observational studies
8. Summary and conclusions
9. Acknowledgements
10. References
7. Proactive Pharmacovigilance and Risk Management
   June Raine, Lesley Wise, John Talbot, and Jeffrey K. Aronson
1. Introduction
2. Risk management—definition and general principles
3. Defining the knowledge base—the safety specification
4. Extending the knowledge of safety and characterizing risk—the pharmacovigilance plan
5. Minimizing risks
6. Special challenges for risk management
7. Experience with risk evaluation and mitigation strategies (REMS) in the USA
8. A possible method for risk management when a new adverse reaction is discovered after marketing
9. Future challenges for risk management
10. Conclusions
11. References
8. Regulatory Aspects of Pharmacovigilance
   Kristina Leila Strutt and Barry David Charles Arnold
1. Introduction
2. The standardization and harmonization of safety data collection and reporting: CIOMS and ICH
3. The European Union
4. The UK
5. France
6. Germany
7. USA
8. Japan
9. Acknowledgements
10. References
11. Useful web sites
9. Legal Aspects of Pharmacovigilance in the European Union
   Christine H. Bendall
1. Introduction
2. Application of EU legislation in Member States
3. Interpretation of EU law
4. Relationship between law and guidelines
5. Issues in interpreting EU pharmacovigilance legislation
6. Legal responsibility for pharmacovigilance activities
7. Failures to meet pharmacovigilance requirements
8. Enforcement and sanctions
9. European powers and procedures in the event of a product safety issue
10. Civil liability
11. Personal data privacy
12. Safety in research products
13. References
10. Dictionaries and Coding in Pharmacovigilance
    E. G. Brown and J. E. Harrison
1. Introduction
2. Scope of this chapter
3. What is a dictionary?
4. Drug dictionaries
5. Disease classifications
6. Medical Dictionary for Regulatory Activities, MedDRA R
7. Common Terminology Criteria for Adverse Events (CTCAE)
8. Definition of adverse reaction terms
9. Dictionaries used in electronic health records
10. Use of dictionaries in standard product information
11. Conclusions
12. Acknowledgements
13. References
11. Adverse Drug Reactions: Societal Considerations
    Nicky Britten
1. Introduction
2. Adverse drug reactions at the population level
3. The social production of ADRs
4. Trust
5. Information about ADRs
6. Conclusions
7. References
12. Safety of Biotherapeutics
    Andrew Erdman, James Nickas, and Benton Brown
1. Introduction
2. Properties of proteins
3. Classification of biotherapeutics
4. Monitoring for adverse events due to biotherapeutics
5. Conclusions
6. References
13. Vaccine Safety Surveillance
    E. Miller and J. Stowe
1. Introduction
2. What is special about vaccine safety compared with other drugs?
3. Pathogenesis of vaccine reactions
4. Criteria for establishing causality after vaccine-related adverse events
5. Pre-licensing evaluation of vaccine safety
6. Objectives of an ideal post-licensing vaccine safety surveillance system
7. Conclusions
8. References
14. Assessing the Safety of Drugs Used in Oncology
    Anne Kehely
1. Introduction
2. Factors to consider when assessing the safety of drugs used in oncology
3. Sources of adverse effect data
4. Nature of the data
5. Assessment of adverse effects data in oncology
6. Conclusions
7. References
15. 15 Adverse Drug Reactions and Pharmacovigilance of Herbal Medicines, Joanne Barnes
1. Introduction
2. Herbal medicines: definitions and descriptions
3. Characteristics of herbal medicines
4. Regulation of herbal medicines and pharmacovigilance requirements
5. Access to and use of herbal medicines
6. Adverse reactions associated with herbal medicines
7. Methods for pharmacovigilance of herbal medicines
8. Responding to safety concerns associated with herbal medicines
9. The future for pharmacovigilance of herbal medicines
10. Conclusions
11. References

• Appendix 1 Web Sites Relevant to Pharmacovigilance—An Analysis of Contents, Charlotte I. S. Barker, John Talbot, and Jeffrey K. Aronson
• Introduction
• Ten national pharmacovigilance web sites
• Twelve institutional web sites
• Acknowledgements
• References

• Appendix 2 Guidelines and a Checklist for Reporting Suspected Adverse Drug Reactions Anecdotally in Journals, Jeffrey K. Aronson
• Introduction
• Notes on the checklist
• Conclusions
• Note
• References

• Index