Textbook of Pharmacovigilance SK Gupta
INDEX
ABCDEFGHIJKLMNOPRSTUVWYZ
A
Abdominal pain 144
Absolute risk 1, 2
Absorption 46
Acetylation of isoniazid 48
Active surveillance 1, 31
Adverse
drug
interactions 52
reaction 1, 39, 66, 93, 164, 170
event 1, 39
relationship 198
reporting 149, 151
experience 39
health effect 104
Advisory committee 96
Age and gender specific terms 160
Agência Nacional de Vigilância Sanitária 178
Allium sativum 146
Allopathy 1
Amiodarone induced hepatitis 83
Anatomical therapeutic chemical 79
Angioedema 144
Annual safety report 2
Antagonism 53
Applications of MedDRA 155
Aris global total safety suite 200
Aristolochic acid nephropathy 146
Attributable risk 2
Automated quantitative signal detection 65
B
Bayesian confidence propagation neural network 68, 135
Benefit
risk
analysis 2
assessment 105, 109
score 112
Blood products 23
Body site specific terms 161
Bones 47
C
Case reports in literature 64
Causality
assessment 2
classification 42
Caveat document 2
Central drugs standard control organization 3, 19, 29, 101
Centralized or decentralized reporting 98
Changing
pharmaceutical marketing strategies 22
physician and patient preferences 22
Chemically reactive metabolite
51
Chest pain 144
Chinese materia medica 152
Classification of adverse drug interactions 53
Clinical trial
authorization 3
duration 76
Cohort studies 29, 87
Collaborative perinatal project 88
Combination
database 3
term 160
Common adverse reactions 112
Communication division 130
Comparative observational studies 28, 33
Compare
allopathy 6
homeopathy 2
Compassionate use program 3
Complementary and alternative medicine 152
Computer based
methods 194
system approach 192
Computer software for case report management 138
Concomitant medications 78
Conduct randomized 153
Confidentiality 3
Conflicting 160
Consumer 3
Continuous drug use 41
Control group 3
Controlled
clinical trial 153
situation of clinical trials 88
Council for international organizations of medical 1, 3, 18, 66, 109
Crisis 119
handling 125
in pharmacovigilance 120
management 121
cycle 122
in pharmacovigilance 119
model 124
response 123
Criteria for term selection 159
Current methods of pharmacovigilance 28
Cytochrome p450 enzyme family 165
D
Data
lock point 4
mining 4
and signal detection 212
safety monitoring board 4
standards and interoperable systems 195
Database research and monitoring 89
Dermatitis 144
Descriptive studies 28
Development safety update report 4
Diarrhea 144
Direct
interaction 53
pharmacodynamic interactions 53
Drug
controller general of India 9, 179
event monitoring 32
interactions 162
monitoring program 18
safety technology vendors 200
utilization
data 4
studies 28, 36
E
Effect of
concomitant medications 198
preexisting disease 198
Environmental risk assessment working party 172
Epidemiology 5
Essential medicines 5
Establishing
strategic crisis planning team 126
tactical crisis management team 129
Estrogens 82
Eudravigilance 5
European
manufacturers associates 151
medicines
agency 5
evaluation agency 171
risk management strategy 172
scientific cooperative on phytotherapy 151
Example of
case control study 85
cross-sectional study 86
meta-analysis 89
Expanded access program 5
Exposure during pregnancy and breastfeeding 161
Extrapyramidal side effects 83
Eye 47
F
Face edema 144
Failure of therapy 42
Fats 47
Fever 144
Food and drug administration 5, 9
Framingham, heart study 87
French agency for safety of health products 177
Frequency classification 45
G
Gathering information 127
Germander hepatotoxicity 147
Gingko biloba induced thrombocytopenia 146
Gingko biloba 146
Global strategy for pharmacovigilance 139
Good
clinical practice 171, 178
laboratory practice 171
manufacturing practice 171
Grapefruit juice induced herb-drug interactions 148
Gray baby syndrome 49
H
Hairs 47
Halothane 82
Headache 144
Health care professional 6
communication 31
Hemovigilance 176
Hepatic veno-occlusive disease 152
Hepatitis 83, 144
Herbal medicines 6, 142
Heterogeneous patients 198
High
dimension of data 198
level
group term 156, 157
term 156, 157
quality safety data 195
Homeopathy 6
Human resource 95
Hypersensitivity 45
Hypertension 144
Hypothesis
generating methods 28
testing methods 28, 29
I
Ibufenac and liver damage 83
Idiosyncrasy 45
Indexing and hyperlinking 194
Individual case safety report 6
Informatics in pharmacovigilance 194
Information
component 70
exchange 135
Initiation of drug monitoring centers 94
Intensive hospital-based drug surveillance system 63
Interactions due to
absorption of drugs 54
distribution of drugs 54
excretion of drugs 56
metabolism of drugs 54
International
birth date 6
classification of diseases 66
conference on harmonization 18, 178
drug
information center 66
monitoring 93
organizations of medical sciences 66
Ion channels 167
J
Jaundice 82
K
Kidneys 47
L
Large size of database 198
Liver 47
Lowest level term 156, 157
Lungs 47
M
Major problem in conducting a case control study 85
Marketing authorization holder 6
Martindale 6
MedDRA 7
and SMQ in signal detection 162
rules 158
structure 156
versioning 162
Medical
devices 23
dictionary for
drug regulatory affairs 156
regulatory activities 55
Medwatch 7
Member countries 7
Methodological research 139
Methods of safety data analysis 193
Methyldopa 83
Metoclopramide 83
Mianserine 83
Multisource product 5
N
N-acetyl P-benzoquinone imine 51
Nalidixic acid 82
National
health surveillance agency 178
patient safety agency 176
pharmacovigilance
centers 7, 101
system 83
Natural history of disease 36
Nausea 144
Neoplasms 161
Neural network 7
New drug application 16
Non-representative patient selection 77
Nonsteroidal anti-inflammatory drugs 25
Nucleic acids 47
O
Objectives of MedDRA 155
Organosulfur compounds induced CYP inhibition 148
P
Paper-based method 193
Passive surveillance 29
Periodic safety update report 4, 7
P-glycoprotein 166
Pharmaceutical interactions 53, 57
Pharmacodynamic interactions 53
Pharmacoeconomics 7
Pharmacoepidemiology 7
Pharmacogenetics 7, 164
Pharmacogenomics 8
Pharmacokinetic interactions 53, 54
Pharmacology 8
Pharmacovigilance 1, 8, 13, 18, 164, 170
centers in India 101
in 18th century 13, 15, 17
in Europe 170
methods 28
of herbal
drugs 142
medicines 148
Phocomelia 8
Phytotherapy 8
Piroxicam 83
Planning for crisis management 126
PMS methodologies 78
Polypharmacy 8
Post-crisis 123
Post-marketing surveillance 8
Post-registration safety study 8
Practical challenges of pharmacogenomics 167
Precrisis
conditions 122
planning 124
Pre-existing medical conditions
161
Prescription
event monitoring 9, 28, 64
only medicine 9
Prethalidomide 15
Priority areas of pharmacovigilance 23
Process of regulatory pharmacovigilance 172
Prophylaxis 9
Proportional ADR reporting ratio 69
Protriptyline-photosensitivity 82
Providing training and consultancy support 137
Pruritus 144
Pulegone toxicity 147
Purpose of pharmacovigilance 23
R
Rare adverse reactions 112
Rash 144
erythematous 144
Rational drug use 9
Regional pharmacovigilance centers 177
Regulations for traditional Chinese medicine 182
Regulatory
authority 9
status/historical overview 156
Reporting
FDA form 3500A 189
odds ratio 69
Restructuring capabilities 197
Retrospective study 10
Review of adverse drug experiences 187
Role of
national pharmacovigilance centers in sign 64
WHO program for international drug monitor 135
S
Safety database
mining 213
querying 213
Salvia miltiorrhiza 146
Scanning existing structure 127
Scientific literature 188
Se Massengill company 192
Sentinel sites 32
Serious adverse
events 19, 176
reaction 176
Seriousness classification 44
Setting up of pharmacovigilance center 93
Severity classification 43
Signal
absorption 211
detection in pharmacovigilance 60
generation 61
masking 211
strengthening 61
testing, evaluation and explanation 62
Single nucleotide polymorphisms 164
Skin 47
Sources and methods of signal detection 62
Spontaneous reporting system 62, 78
Stakeholders 121
Standardized MedDRA queries 162
State food and drug administration 181
Statistical classification 45
Stimulation of reporting 98
Substandard medicines 23
Suicide 160
Sulphanilamide 170
Suspected
serious adverse reaction 44
unexpected serious adverse reaction 11, 44
System organ class 156, 157
T
Targeted clinical investigations
28, 5
Thalidomide 11
tragedy 192
Therapeutic goods administration 183
Threat sources for crisis in pharmacovigilance 121
Thrombocytopenia 144
Thromboembolism 82
Traditional
and complementary medicines 23
Chinese medicines 152
medicine 11
Turbo model 112
Type B adverse reactions 50
U
UMC signalling process 70
Unexpected adverse reaction 11
Unreliability of preclinical safety data 21
Uppsala monitoring center 1, 11, 93, 213
Urticaria 144
V
Vigibase 12
Vigiflow 12
Vigimed 12
Vigisearch 12
Vioxx saga 25
Volume of data for analysis
198
Vomiting 144
W
World Health Organization 39, 93
Y
Yellow card scheme 175
Z
Zonal pharmacovigilance centers 102
×
Chapter Notes

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1Textbook of PHARMACOVIGILANCE
2Textbook of PHARMACOVIGILANCE
Editor SK Gupta PhD Dean and Director General Institute of Clinical Research (India) New Delhi, India Formerly Professor and Head Department of Pharmacology All India Institute of Medical Sciences New Delhi, India Foreword Surinder Singh Drugs Controller General India
3Published by
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Textbook of Pharmacovigilance
© 2011, Institute of Clinical Research (India), New Delhi, India
All rights reserved. No part of this publication should be reproduced, stored in a retrieval system, or transmitted in any form or by any means: electronic, mechanical, photocopying, recording, or otherwise, without the prior written permission of the ICRI and the publisher.
Institute of Clinical Research (India), C-6, Sainik Farms, New Delhi-110017 www.icriindia.com
This book has been published in good faith that the material provided by editor is original. Every effort is made to ensure accuracy of material, but the publisher, printer and editor will not be held responsible for any inadvertent error(s). In case of any dispute, all legal matters are to be settled under Delhi jurisdiction only.
First Edition: 2011
9789350252062
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4Contributors
Foreword
Before a pharmaceutical product is launched in the market, it is extensively studied in clinical trials to ensure its safety and efficacy profile. However, the data is limited by various factors such as patient numbers, duration of trial as well as by the highly controlled conditions of the trials. The conditions under which patients are studied during the premarketing phase do not necessarily reflect the way the medicine will be used in the hospital or in general practice. Information about rare but serious adverse drug reactions, chronic toxicity, use in special groups (e.g. pregnant women, children, elderly) and drug interactions is often incomplete or not available.
Pharmacovigilance is therefore one of the important postmarketing tools in ensuring the safety of pharmaceutical and related health products. With a number of new drugs being regularly approved for marketing, there is need for a vibrant pharmacovigilance system to protect the multi-ethnic population from the potential harm that may be caused by some of these new drugs. There are considerable social and economic consequences of adverse drug reactions and the pharmacovigilance system needs to develop a well-structured program that engages health care professionals and the public at large, to synergize adverse drug reaction monitoring in order to achieve its objectives of collating data, analyzing it and using the inferences to recommend informed regulatory interventions.
The National Pharmacovigilance Program is sponsored and coordinated by the country's Central Drug Regulatory Agency—Central Drugs Standard Control Organization (CDSCO). It is largely based on the recommendations made in the WHO document titled “Safety Monitoring of Medicinal Products—Guidelines for Setting up and Running a Pharmacovigilance Center”.
The Institute of Clinical Research, India has played a pivotal role in the education and research in the country under the dynamic leadership of Professor SK Gupta. The book Textbook of Pharmacovigilance gives a comprehensive view on various aspects of Pharmacovigilance, i.e the Need of ADR Reporting Methods of Pharmacovigilance, Data Mining, Postmarketing Surveillance and Regulations in various countries, etc. This will go a long way in providing up-to-date and well-compiled information to the upcoming health care professionals both in academia and industry. It will aptly fulfill the long-felt need for such a publication in the country. I congratulate Professor SK Gupta for bringing out this excellent publication.
Dr Surinder Singh md
Drugs Controller General (India)
6Preface
Modern medicines have changed the way in which diseases are managed and controlled. However, despite their benefits, adverse reactions (ADRs) to medicines are common. Pharmacovigilance—an umbrella term used to describe the processes for monitoring and evaluating ADRs—is a key component of effective drug regulation systems, clinical practice and public health programs. The principal concern of pharmacovigilance is the detection of ADRs in real world clinical trial that are novel by virtue of their clinical nature, severity and/or frequency as soon as possible with minimum patient exposure.
The scope of pharmacovigilance needs to be extended beyond the strict confines of detecting new signals of safety concerns. Globalization, consumerism and the resulting explosion in free trade and communication across borders, and increasing use of the Internet have all changed the way medicinal products and information about them is accessed. These changing patterns in drug use require a shift in the approach to pharmacovigilance. The system and the key players in the field have to be geared up to be more closely linked, and more responsive towards the management of the ADRs.
Although many drugs have been extensively used and studied, their safety profile cannot necessarily be generalized. Special thrust needs to be laid on measures to improve drug safety monitoring. Effective links have been forged between Ministry of Health (CDSCO) and other stakeholders. Indian government through its National Pharmacovigilance Program is encouraging collaboration between academic investigators, drug companies, and regulatory agencies to undertake clinical studies in order to develop and compile database on common ADRs. This will need an extensive infrastructure and trained healthcare providers.
I had the opportunity to be at the helm of the affairs and saw the dawn of pharmacovigilance in India as Chief Coordinator, National Pharmacovigilance Center at AIIMS, New Delhi, associated with WHO International Drug Monitoring Center, Uppsala. For the past decade, I have been closely associated with the various aspects of pharmacovigilance including, Education, Reporting, Data Mining, Signal Detection, Regulations, etc. This book Textbook of Pharmacovigilance has been the concentrated effort to compile all the theoretical and practical aspects of pharmacovigilance, for easy accessibility to any new entrant in the field and serve as a ready reference for those actively involved in the area. The book introduces basic definitions, classifications, objectives and elaborates the practical aspects including setting up of pharmacovigilance center, regulations in various countries, data mining, risk-benefit assessment, etc. It also provides latest updates on key issues like pharmacogenetics and herbal drug monitoring.
SK Gupta
7Acknowledgments
I take this opportunity to congratulate the team of contributors for being part of this book that is expected to be the cornerstone of Pharmacovigilance. I extend my heartfelt gratitude to them for devoting their valuable time out of their busy schedule and pressing commitments in making this dream endeavor come true.
Special acknowledgment is due to Dr Sushma Srivastava, for her exemplary editorial assistance, without which it would have been difficult to bring this book into its current form.
I am also deeply thankful to my colleagues and students at DIPSAR and ICRI for their cooperation and help in this venture. My special thanks to Dr GJ Samathanam for his valuable suggestions and providing technical assistance for the publication.
Lastly I pay special thanks to my family without whom this task would have been meaningless.