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

by Talbot, John; Aronson, Jeffrey K.

• ISBN13: 9780470986349
• ISBN10: 0470986344
• Edition: 6th
• Format: Hardcover
• Copyright: 2011-12-19
• Publisher: Wiley-Blackwell

Summary

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.

Author Biography

John Talbot, Senior Lecturer, University of Hertfordshire, UK. Formerly, Director, Patient Safety, AstraZeneca R D Jeffrey K. Aronson, Reader in Clinical Pharmacology, Department of Primary Health Care, University of Oxford, UK

Table of Contents

Foreword	p. xi
Preface to the Sixth Edition	p. xiii
List of Contributors	p. xv
Acknowledgements	p. xvii
Adverse Drug Reactions: History, Terminology, Classification, Causality, Frequency, Preventability	p. 1
Introduction	p. 1
Defining pharmacovigilance	p. 1
The modern history of pharmacovigilance	p. 3
Terminology and definitions in pharmacovigilance	p. 6
Medication errors	p. 25
Pharmacological classification of adverse drug reactions	p. 32
Drug interactions	p. 53
Reporting suspected adverse drug reactions	p. 59
Causality assessment	p. 64
Frequencies of adverse drug reactions	p. 69
Risk perception and adverse drug reactions	p. 77
Class effects of drugs	p. 78
Unlicensed indications, off-label uses, and orphan drugs	p. 80
Preventing adverse drug reactions	p. 84
Publishing accounts of adverse drug reactions	p. 95
References	p. 101
Pharmacogenetics of Adverse Drug Reactions	p. 121
Introduction	p. 121
Historical review	p. 121
Sources of genetic variability	p. 122
Role of pharmacogenetic factors in drug pharmacokinetics	p. 123
Role of pharmacogenetic factors in drug pharmacodynamics	p. 133
The role of pharmacogenetics in pharmaceutical companies	p. 139
The impact of pharmacogenetics on regulatory agencies	p. 141
The impact of pharmacogenetics on clinical practice	p. 143
Conclusions	p. 145
References	p. 145
Toxicology and Adverse Drug Reactions	p. 157
Introduction	p. 157
Toxicity testing	p. 157
Drug discovery and development	p. 168
Data interpretation and risk assessment	p. 174
Adverse drug reactions detected after marketing authorization	p. 186
Examples of toxicological investigation of ADRs	p. 199
Conclusions	p. 200
Acknowledgements	p. 201
References	p. 201
Clinical Trials-Collecting Safety Data and Establishing the Adverse Drug Reactions Profile	p. 215
Introduction	p. 215
Adverse events	p. 216
Clinical studies and safety	p. 236
The emerging safety profile	p. 267
Presentation of safety data	p. 271
Conclusions	p. 280
References	p. 281
Clinical Laboratory Safety Data	p. 291
Introduction	p. 291
Factors that influence the interpretation of clinical laboratory data	p. 294
Sample collection procedure	p. 300
Analytical variation	p. 301
Reference ranges	p. 304
Intra-individual biological variation	p. 307
Detecting adverse events during drug development	p. 309
Test selection	p. 333
Exclusion criteria and "panic levels"	p. 335
Harmonization of data from different laboratories	p. 337
Data analysis and presentation	p. 339
Conclusions	p. 344
Appendix	p. 345
References	p. 346
Statistics: Analysis and Presentation of Safety Data	p. 349
Introduction and background	p. 349
Problems with efficacy trials for detecting adverse drug reactions	p. 352
Analysis and presentation of data from trials	p. 355
Statistical measures of the occurrence of adverse events	p. 356
Combining data from several trials-meta-analysis	p. 364
Use of statistical methods for signal detection from spontaneous reports	p. 365
Analysis and presentation of data from observational studies	p. 373
Summary and conclusions	p. 384
Acknowledgements	p. 385
References	p. 386
Proactive Pharmacovigilance and Risk Management	p. 389
Introduction	p. 389
Risk management-definition and general principles	p. 390
Defining the knowledge base-the safety specification	p. 391
Extending the knowledge of safety and characterizing risk-the pharmacovigilance plan	p. 394
Minimizing risks	p. 395
Special challenges for risk management	p. 397
Experience with risk evaluation and mitigation strategies (REMS) in the USA	p. 398
A possible method for risk management when a new adverse reaction is discovered after marketing	p. 399
Future challenges for risk management	p. 405
Conclusions	p. 406
References	p. 407
Regulatory Aspects of Pharmacovigilance	p. 411
Introduction	p. 411
The standardization and harmonization of safety data collection and reporting: CIOMS and ICH	p. 412
The European Union	p. 447
The UK	p. 481
France	p. 483
Germany	p. 485
USA	p. 487
Japan	p. 500
Acknowledgements	p. 505
References	p. 506
Useful web sites	p. 509
Legal Aspects of Pharmacovigilance in the European Union	p. 511
Introduction	p. 511
Application of EU legislation in Member States	p. 511
Interpretation of EU law	p. 514
Relationship between law and guidelines	p. 515
Issues in interpreting EU pharmacovigilance legislation	p. 517
Legal responsibility for pharmacovigilance activities	p. 519
Failures to meet pharmacovigilance requirements	p. 522
Enforcement and sanctions	p. 524
European powers and procedures in the event of a product safety issue	p. 528
Civil liability	p. 534
Personal data privacy	p. 537
Safety in research products	p. 538
References	p. 541
Dictionaries and Coding in Pharmacovigilance	p. 545
Introduction	p. 545
Scope of this chapter	p. 546
What is a dictionary?	p. 546
Drug dictionaries	p. 547
Disease classifications	p. 554
Medical Dictionary for Regulatory Activities, MedDRA®	p. 557
Common Terminology Criteria for Adverse Events (CTCAE)	p. 567
Definition of adverse reaction terms	p. 567
Dictionaries used in electronic health records	p. 568
Use of dictionaries in standard product information	p. 570
Conclusions	p. 571
Acknowledgements	p. 571
References	p. 571
Adverse Drug Reactions: Societal Considerations	p. 573
Introduction	p. 573
Adverse drug reactions at the population level	p. 574
The social production of ADRs	p. 576
Trust	p. 579
Information about ADRs	p. 581
Conclusions	p. 583
References	p. 583
Safety of Biotherapeutics	p. 585
Introduction	p. 585
Properties of proteins	p. 586
Classification of biotherapeutics	p. 587
Monitoring for adverse events due to biotherapeutics	p. 589
Conclusions	p. 598
References	p. 598
Vaccine Safety Surveillance	p. 603
Introduction	p. 603
What is special about vaccine safety compared with other drugs?	p. 604
Pathogenesis of vaccine reactions	p. 605
Criteria for establishing causality after vaccine-related adverse events	p. 608
Pre-licensing evaluation of vaccine safety	p. 610
Objectives of an ideal post-licensing vaccine safety surveillance system	p. 611
Conclusions	p. 620
References	p. 620
Assessing the Safety of Drugs Used in Oncology	p. 625
Introduction	p. 625
Factors to consider when assessing the safety of drugs used in oncology	p. 627
Sources of adverse effect data	p. 632
Nature of the data	p. 634
Assessment of adverse effects data in oncology	p. 635
Conclusions	p. 641
References	p. 642
Adverse Drug Reactions and Pharmacovigilance of Herbal Medicines	p. 645
Introduction	p. 645
Herbal medicines: definitions and descriptions	p. 646
Characteristics of herbal medicines	p. 647
Regulation of herbal medicines and pharmacovigilance requirements	p. 648
Access to and use of herbal medicines	p. 655
Adverse reactions associated with herbal medicines	p. 656
Methods for pharmacovigilance of herbal medicines	p. 666
Responding to safety concerns associated with herbal medicines	p. 673
The future for pharmacovigilance of herbal medicines	p. 674
Conclusions	p. 675
References	p. 676
Web Sites Relevant to Pharmacovigilance-An Analysis of Contents	p. 685
Introduction	p. 685
Ten national pharmacovigilance web sites	p. 685
Twelve institutional web sites	p. 689
Acknowledgements	p. 697
References	p. 697
Guidelines and a Checklist for Reporting Suspected Adverse Drug Reactions Anecdotally in Journals	p. 699
Introduction	p. 699
Notes on the checklist	p. 700
Conclusions	p. 706
Note	p. 706
References	p. 706
Index	p. 709
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