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

Author: John Talbot

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  • ISBN: 9780470986349
  • Author: John Talbot
  • Publ Date: 2011-12-09
  • Edition: 6
  • Pages: 750
  • Imprint: BLACKWELL *#
  • Status: ACT
  • ID - 5864

Table of Contents :

Foreword xi
Preface to the Sixth Edition xiii
List of Contributors xv
Acknowledgements xvii
1 Adverse Drug Reactions: History, Terminology,Classification, Causality, Frequency, Preventability 1 Jeffrey K. Aronson
1.1 Introduction 1
1.2 Defining pharmacovigilance 1
1.3 The modern history of pharmacovigilance 3
1.4 Terminology and definitions in pharmacovigilance 6
1.5 Medication errors 25
1.6 Pharmacological classification of adverse drug reactions32
1.7 Drug interactions 53
1.8 Reporting suspected adverse drug reactions 59
1.9 Causality assessment 64
1.10 Frequencies of adverse drug reactions 69
1.11 Risk perception and adverse drug reactions 77
1.12 Class effects of drugs 78
1.13 Unlicensed indications, off-label uses, and orphan drugs80
1.14 Preventing adverse drug reactions 84
1.15 Publishing accounts of adverse drug reactions 95
References 101
2 Pharmacogenetics of Adverse Drug Reactions 121 Sudeep P. Pushpakom and Munir Pirmohamed
2.1 Introduction 121
2.2 Historical review 121
2.3 Sources of genetic variability 122
2.4 Role of pharmacogenetic factors in drug pharmacokinetics123
2.5 Role of pharmacogenetic factors in drug pharmacodynamics133
2.6 The role of pharmacogenetics in pharmaceutical companies139
2.7 The impact of pharmacogenetics on regulatory agencies141
2.8 The impact of pharmacogenetics on clinical practice 143
2.9 Conclusions 145
References 145
3 Toxicology and Adverse Drug Reactions 157 D. J. Snodin and A. Suitters
3.1 Introduction 157
3.2 Toxicity testing 157
3.3 Drug discovery and development 168
3.4 Data interpretation and risk assessment 174
3.5 Adverse drug reactions detected after marketingauthorization 186
3.6 Examples of toxicological investigation of ADRs 199
3.7 Conclusions 200
Acknowledgements 201
References 201
4 Clinical Trials Collecting Safety Data andEstablishing the Adverse Drug Reactions Profile 215 John Talbot, Marianne Keisu, and Lars Stdegreeahle
4.1 Introduction 215
4.2 Adverse events 216
4.3 Clinical studies and safety 236
4.4 The emerging safety profile 267
4.5 Presentation of safety data 271
4.6 Conclusions 280
References 281
5 Clinical Laboratory Safety Data 291 Alan Craig
5.1 Introduction 291
5.2 Factors that influence the interpretation of clinicallaboratory data 294
5.3 Sample collection procedure 300
5.4 Analytical variation 301
5.5 Reference ranges 304
5.6 Intra-individual biological variation 307
5.7 Detecting adverse events during drug development 309
5.8 Test selection 333
5.9 Exclusion criteria and panic levels 335
5.10 Harmonization of data from different laboratories 337
5.11 Data analysis and presentation 339
5.12 Conclusions 344
5.13 Appendix 345
References 346
6 Statistics: Analysis and Presentation of Safety Data349 Stephen J. W. Evans and Dorothea Nitsch
6.1 Introduction and background 349
6.2 Problems with efficacy trials for detecting adverse drugreactions 352
6.3 Analysis and presentation of data from trials 355
6.4 Statistical measures of the occurrence of adverse events356
6.5 Combining data from several trials meta-analysis364
6.6 Use of statistical methods for signal detection fromspontaneous reports 365
6.7 Analysis and presentation of data from observational studies373
6.8 Summary and conclusions 384
Acknowledgements 385
References 386
7 Proactive Pharmacovigilance and Risk Management 389 June Raine, Lesley Wise, John Talbot, and Jeffrey K.Aronson
7.1 Introduction 389
7.2 Risk management definition and general principles390
7.3 Defining the knowledge base the safety specification391
7.4 Extending the knowledge of safety and characterizingrisk the pharmacovigilance plan 394
7.5 Minimizing risks 395
7.6 Special challenges for risk management 397
7.7 Experience with risk evaluation and mitigation strategies(REMS) in the USA 398
7.8 A possible method for risk management when a new adversereaction is discovered after marketing 399
7.9 Future challenges for risk management 405
7.10 Conclusions 406
References 407
8 Regulatory Aspects of Pharmacovigilance 411 Kristina Leila Strutt and Barry David Charles Arnold
8.1 Introduction 411
8.2 The standardization and harmonization of safety datacollection and reporting: CIOMS and ICH 412
8.3 The European Union 447
8.4 The UK 481
8.5 France 483
8.6 Germany 485
8.7 USA 487
8.8 Japan 500
Acknowledgements 505
References 506
Useful web sites 509
9 Legal Aspects of Pharmacovigilance in the European Union511 Christine H. Bendall
9.1 Introduction 511
9.2 Application of EU legislation in Member States 511
9.3 Interpretation of EU law 514
9.4 Relationship between law and guidelines 515
9.5 Issues in interpreting EU pharmacovigilance legislation517
9.6 Legal responsibility for pharmacovigilance activities519
9.7 Failures to meet pharmacovigilance requirements 522
9.8 Enforcement and sanctions 524
9.9 European powers and procedures in the event of a productsafety issue 528
9.10 Civil liability 534
9.11 Personal data privacy 537
9.12 Safety in research products 538
References 541
10 Dictionaries and Coding in Pharmacovigilance 545 E. G. Brown and J. E. Harrison
10.1 Introduction 545
10.2 Scope of this chapter 546
10.3 What is a dictionary? 546
10.4 Drug dictionaries 547
10.5 Disease classifications 554
10.6 Medical Dictionary for Regulatory Activities, MedDRAR557
10.7 Common Terminology Criteria for Adverse Events (CTCAE)567
10.8 Definition of adverse reaction terms 567
10.9 Dictionaries used in electronic health records 568
10.10 Use of dictionaries in standard product information570
10.11 Conclusions 571
Acknowledgements 571
References 571
11 Adverse Drug Reactions: Societal Considerations 573 Nicky Britten
11.1 Introduction 573
11.2 Adverse drug reactions at the population level 574
11.3 The social production of ADRs 576
11.4 Trust 579
11.5 Information about ADRs 581
11.6 Conclusions 583
References 583
12 Safety of Biotherapeutics 585 Andrew Erdman, James Nickas, and Benton Brown
12.1 Introduction 585
12.2 Properties of proteins 586
12.3 Classification of biotherapeutics 587
12.4 Monitoring for adverse events due to biotherapeutics589
12.5 Conclusions 598
References 598
13 Vaccine Safety Surveillance 603 E. Miller and J. Stowe
13.1 Introduction 603
13.2 What is special about vaccine safety compared with otherdrugs? 604
13.3 Pathogenesis of vaccine reactions 605
13.4 Criteria for establishing causality after vaccine-relatedadverse events 608
13.5 Pre-licensing evaluation of vaccine safety 610
13.6 Objectives of an ideal post-licensing vaccine safetysurveillance system 611
13.7 Conclusions 620
References 620
14 Assessing the Safety of Drugs Used in Oncology 625 Anne Kehely
14.1 Introduction 625
14.2 Factors to consider when assessing the safety of drugs usedin oncology 627
14.3 Sources of adverse effect data 632
14.4 Nature of the data 634
14.5 Assessment of adverse effects data in oncology 635
14.6 Conclusions 641
References 642
15 Adverse Drug Reactions and Pharmacovigilance of HerbalMedicines 645 Joanne Barnes
15.1 Introduction 645
15.2 Herbal medicines: definitions and descriptions 646
15.3 Characteristics of herbal medicines 647
15.4 Regulation of herbal medicines and pharmacovigilancerequirements 648
15.5 Access to and use of herbal medicines 655
15.6 Adverse reactions associated with herbal medicines 656
15.7 Methods for pharmacovigilance of herbal medicines 666
15.8 Responding to safety concerns associated with herbalmedicines 673
15.9 The future for pharmacovigilance of herbal medicines674
15.10 Conclusions 675
References 676
Appendix 1 Web Sites Relevant to Pharmacovigilance AnAnalysis of Contents 685 Charlotte I. S. Barker, John Talbot, and Jeffrey K.Aronson
A1.1 Introduction 685
A1.2 Ten national pharmacovigilance web sites 685
A1.3 Twelve institutional web sites 689
Acknowledgements 697
References 697
Appendix 2 Guidelines and a Checklist for ReportingSuspected Adverse Drug Reactions Anecdotally inJournals 699 Jeffrey K. Aronson
A2.1 Introduction 699
A2.2 Notes on the checklist 700
A2.3 Conclusions 706
Note 706
References 706
Index 709

Description:

Written with practitioners in mind, this new edition of Stephen s Detection of Adverse Drug Reactions: Principleand Practice continues to be one of the corner stonesof the pharmaceutical medicine list. The classic text covers theissues and problems involved in the detection of adverse drugreactions (ADRs) throughout the life cycle of a medicine fromanimal studies through to clinical trials, its introduction to themarket, followed by wide clinical use, and eventual decline in useor withdrawal. The sixth edition is completely revised and updatedincluding five new chapters on pharmacogenomics, ADRs with herbalmedicines, safety of medical devices, safety issues with oncologydrugs, and economic aspects of ADRs. All tables and web informationneeded in order to practice are included to make this sixth editiona complete primer for the new practitioner and a reference for themore experienced.

Review:


A vast array of experts in the science ofpharmacovigilance contribute to this book, but the editors havemaintained a clarity of presentation, keeping in mind thatcommunication is a key factor in pharmacovigilance. (Doody s, 27 July 2012)

Author Biography:

John Talbot, Senior Lecturer, University of Hertfordshire, UK.Formerly Director, Global Drug Safety, AstraZeneca R&DCharnwood, Loughborough, Leicestershire, UK
Jeffrey Aronson, Reader in Clinical Pharmacology, University ofOxford, Oxford, UK and President Emeritus of the BritishPharmacological Society


 

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