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Principles and Practice
ofPharmacovigilance
and Drug Safety
JimmyJose
AnthonyR.Cox
VibhuPaudyal
Editors
1 3
Principles and Practice of
Pharmacovigilance and Drug Safety
Jimmy Jose • Anthony R. Cox
Vibhu Paudyal
Editors
Principles and Practice
of Pharmacovigilance
and Drug Safety
Editors
Jimmy Jose
Pharmacy Practice
School of Pharmacy
College of Health Sciences
University of Nizwa
Nizwa, Oman
Vibhu Paudyal
Clinical Pharmacy
School of Pharmacy
College of Medical and Dental Sciences
University of Birmingham
Birmingham, UK
Health Services Research and
Inequalities
Florence Nightingale Faculty of
Nursing, Midwifery and Palliative Care
King’s College London
London, UK
Anthony R. Cox
Clinical Pharmacy and Drug Safety
School of Pharmacy
College of Medical and Dental Sciences
University of Birmingham
Birmingham, UK
ISBN 978-3-031-51088-5 ISBN 978-3-031-51089-2 (eBook)
https://doi.org/10.1007/978-3-031-51089-2
© The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature
Switzerland AG 2024
This work is subject to copyright. All rights are solely and exclusively licensed by the Publisher,
whether the whole or part of the material is concerned, specically the rights of translation,
reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microlms or in any
other physical way, and transmission or information storage and retrieval, electronic adaptation,
computer software, or by similar or dissimilar methodology now known or hereafter developed.
The use of general descriptive names, registered names, trademarks, service marks, etc. in this
publication does not imply, even in the absence of a specic statement, that such names are
exempt from the relevant protective laws and regulations and therefore free for general use.
The publisher, the authors, and the editors are safe to assume that the advice and information in
this book are believed to be true and accurate at the date of publication. Neither the publisher nor
the authors or the editors give a warranty, expressed or implied, with respect to the material
contained herein or for any errors or omissions that may have been made. The publisher remains
neutral with regard to jurisdictional claims in published maps and institutional afliations.
This Springer imprint is published by the registered company Springer Nature Switzerland AG
The registered company address is: Gewerbestrasse 11, 6330 Cham, Switzerland
If disposing of this product, please recycle the paper.
This book is dedicated to our spouses Beena, Dianne, and
Pawana, and also to our children Marita, Norah, Leana,
Lauren, James, Tanisi, and Avyan who greatly supported and
sacriced much to complete this project.
Thanks to our parents, brothers and sisters, and other family
members who always inspired us to do our best.
We are thankful to our friends who supported us always,
teachers who inculcated the passion for promoting safer drug
use, students who helped us to be better teachers, and patients
who motivated us to be better practitioners. Finally, we would
like to gratefully remember the support of one of the pioneers
in the eld of pharmacovigilance, Sten Olson (1950–2023). He
was a dear friend to the pharmacovigilance community.
Foreword
Drug safety is like automobile safety—perfection is unachievable. The pharmacological actions of drugs inevitably can cause harm, just as the social and
economic benets of cars to individuals can only be realised if their risks are
accepted. We should, nonetheless, try to use medicines as safely as possible.
The authors are to be congratulated, therefore, on providing a guide to detecting and avoiding harm from medicines suitable for a wide audience.
The reader is introduced to the main terms and concepts in drug safety.
This is a difcult task both for adverse drug reactions and for medication
errors, which have been variously dened by different groups. The old binary
classication into Type A, ‘augmented’, adverse drug reactions that can be
explained by the known pharmacology of a drug and Type B, ‘bizarre’, reactions that cannot is of limited use. The authors overcome this difculty by
describing fully the Type A/B dichotomy, the expansion to Types A–F, and
the DoTS classication.
There is also discussion of those factors that predispose to adverse reactions. These predisposing factors depend partly on the properties of the drug
and its formulation, and partly on the susceptibilities of the person to whom
it is prescribed, including the other drugs that they may be taking. This leads
to important considerations of drug–drug interactions. Increasing the number
of prescribed drugs increases the risk of interactions, so it is timely that the
authors consider polypharmacy and how the burden of drug treatments may
be reduced while beneting patients—deprescribing.
Detection of adverse drug reactions, initially reliant on clinical observation and then on spontaneous reporting systems, has advanced with the more
widespread introduction of patient reporting, and the use of large databases to
conrm pharmacovigilance signals—indications of effects, causally related
to medicines, that require verication—and the introduction of increasingly
sophisticated statistical methods and articial intelligence. This text rightly
stresses the need for cooperation between different professionals, patients,
and agencies in the detection and verication of signals of harm, and in the
evaluation of their harmful impact. The chapter on patient and public involvement in pharmacovigilance is an important contribution.
Detecting errors in medical treatment can be much harder than detecting
adverse drug reactions, and there remain real uncertainties about the frequency, consequences, and remedies for medication errors. That makes it
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hard to know how far the measures adopted since the inuential report To Err
Is Human was published by the Institute of Medicine in 2000 have led to
systemic improvements. There is also uncertainty about the extent to which
electronic prescribing systems have reduced the risk of error. What is clear,
though, is that awareness of the possibility of error, and repeated checking to
reduce errors in the medication process, from prescribing, through dispensing, to administration, can make the process safer.
Unusually, the authors consider the communication of risk from medicines, the ethics of pharmacovigilance, and the need to balance the needs of
individual patients against the wider public good. Students, practitioners, and
educators should nd this book very useful.
Department of Clinical Pharmacology RobinFerner
University of Birmingham
Birmingham, UK
Foreword
Preface
It is our great pleasure to nally introduce this book, Pharmacovigilance and
Drug Safety in Practice, to our readers. This book was inspired by our own
quest for a single reference text that captures the needs of educators, clinical
practitioners, researchers, policymakers, patient/public societies, and wider
stakeholders. The concept of pharmacovigilance and drug safety has evolved
over the years in the light of emerging research, policy, practice, and technological changes. However, the development and challenges vary across different countries and continents. An increasing number of drug therapies have
been developed to manage a wide range of complex health states, including
treatments, diagnostic drugs, and disease prevention. Emergent health technologies including pharmacogenomics, precision medicine, biological therapies, and novel formulations provide both solutions and challenges to safety.
The need for ethical, responsible, and accountable safety practices in the use
and monitoring of drugs has never been higher.
We have excellent textbooks written by experienced professionals in the
eld of pharmacovigilance. As educators, we have faced difculties nding a
reference which discusses pharmacovigilance and drug safety from different
perspectives, as others may have. We observed that most of the books on
pharmacovigilance are written from an industry or regulatory perspective or
presented as a detailed description of adverse drug reactions (ADRs) for individual drugs or affecting individual body systems. Books which discuss the
various aspects of safe use of medications in clinical practice in one volume
are lacking though they are discussed as part of the references of clinical
pharmacy, clinical pharmacology, and pharmacotherapy.
It would be wise to clarify what we mean by the terms ‘pharmacovigilance’ and ‘drug safety’. At times, these are often treated as synonyms, and
many would consider them mutually inclusive. For the purpose of discussion
in this book, drug safety is a broad concept that refers to the overall safety of
a drug product throughout its life cycle right from its development phase to
post-market surveillance and ongoing monitoring during clinical use by
healthcare professionals. This includes clinical practice of drug safety principles encompassing the prevention, monitoring, identication, and management of adverse effects, medication errors, and other drug-related problems.
It includes the individual clinical decision-making in patients to ensure safe
use of drugs. We have tended to restrict pharmacovigilance to a focus on
theories, research, and practices related to monitoring and managing the
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safety of drugs (adverse effects and other drug-related issues) mainly in the
post-marketing phase. It gives greater focus on the industrial or regulatory
side of pharmacovigilance. However, the overlap at times can be hard to
assess, and some cross-over may have crept in despite our best efforts.
We hope that this book will serve teachers and students who would like to
enhance or deliver knowledge on pharmacovigilance and drug safety. At the
same time, it is expected to function as a ‘reference source’ for clinical practitioners, researchers, industry professionals, and policymakers. The book
will address an important gap between clinical practice and pharmacovigilance, by integrating pharmacovigilance, drug safety, pharmacoepidemiology, medication errors, and prescribing skills into clinical practice, providing
a more holistic view of the broad topic of drug safety. It will also be useful for
those professionals moving from a clinical practice role to a pharmacovigilance role. Taking the reader through the key material in ADRs, medication
errors, prescribing safety, as well as data sources used in drug safety and
pharmacovigilance, the key benet of our text will be in bridging the divide
between the pharmacovigilance, pharmacoepidemiology, and wider drug
safety matters and clinical practice.
The book is designed to be a multidisciplinary resource, both for undergraduate healthcare professionals (in elds such as medical, pharmacy, nursing, and dental science) and for those in postgraduate studies. Particularly for
those with prescribing responsibilities, the book aims to improve the safety of
medicines. The book is aimed to be international in scope and context. Each
of the chapters is structured as a self-contained learning resource, with learning objectives, key points, worked cases, and additional reading materials
alongside the main text.
We would like to share in brief the steps involved in publishing this book.
All the authors are very passionate about the topic of pharmacovigilance and
drug safety and have signicant years of experience in teaching pharmacovigilance, clinical practice, and conducting research in this specic eld.
Interestingly, we feel that this book is a positive outcome of the COVID pandemic as the initiation of the idea and discussions in preparing the book happened during that period. Communications through online meetings became
so common and easy during the period that it gave us condence in contacting, interacting, and planning the work related to the book with people whom
we had not interacted with before. To ensure that the potential authors selected
were experts in various elds, academia, clinical practice, research, industry,
and regulatory, from multidisciplinary backgrounds and from around the
globe, we took initiative in identifying the authors based on their research
output and helped in forming teams to write the chapter. We believe this has
created a diverse and informed perspective. From the time the idea of the
book was initiated until its publication, there were lots of ups and downs with
the project over these years before the book could take its present shape. It
was not an easy task to take along this project with our other commitments,
but we are glad that we stayed together as a team and exhibited perseverance
in tackling these challenges and reached the present stage.
The rst two-thirds of the book focus on the principles and practice in
pharmacovigilance, covering core conceptual areas and the pharmacovigi-
Preface
Preface
xi
lance system at a population level, with the last third examining the use of
medicines at the level of the individual patient.
Chapter 1 introduces key concepts related to pharmacovigilance and drug
safety including epidemiology, denitions, classication, and predisposing
factors of ADRs, including a holistic view of drug safety in relation to medication errors, prescribing issues, and regulatory approaches. Chapter 2
focuses on the important area of drug allergy and hypersensitivity reactions.
Chapter 3 describes the predisposing factors for ADRs.
The ageing global population and associated comorbidities is linked to an
increase in polypharmacy. Preventing drug interactions, particularly those
that are clinically signicant, has become ever more important. Chapter 4
denes and describes various types of drug interactions, their mechanisms,
and the factors that increase the risk of their occurrence. It provides specic
details of important interactions and ways in which healthcare professionals
can prevent and manage drug interactions. An under-examined area of drug
safety has been the economic aspects. Chapter 5 explains how the economic
burden may be dened and measured, and lists associated challenges and
methods used to assess cost-effectiveness in relation to strategies used to
improve medication safety. The principles of pharmacovigilance and medicines regulation are discussed in Chap. 6, providing a comprehensive history
of the development of pharmacovigilance regulations over the years and
international effects on harmonisation. Laws governing pharmacovigilance
throughout the drug development life cycle, including post-authorisation
studies, are discussed. Safety monitoring is a critical component in the clinical development process. It is important to understand the process, guidelines, and outcome pertaining to this important component of clinical trials,
and these are discussed in Chap. 7. Chapter 8 discusses causality assessment,
which is an essential component and routine procedure in the pharmacovigilance system.
Pharmacoepidemiology and pharmacovigilance are very closely related,
and Chap. 9 outlines the most common epidemiological study designs using
real-world data sources. Even with the advancement of various methods to
monitor and capture adverse reactions to a drug during its life cycle, spontaneous reports still represent an irreplaceable source of information for pharmacovigilance. The role of spontaneous reporting in pharmacovigilance, the
contribution of various stakeholders, and the strengths and limitations of
pharmacovigilance are discussed in Chap. 10. Chapter 11 is about communicating drug safety and it focuses on risk communications. Patients have
played an increasing role in drug safety, and there should be an active and
collaborative interaction between patients and other stakeholders. Chapter 12
discusses the evolving role of patients in different areas of pharmacovigilance. An increasingly complex healthcare system requires collaborative
approaches to establishing and implementing pharmacovigilance systems.
Chapter 13 discusses the importance of collaboration and cooperation across
diverse disciplines, stakeholders, academia, patients, and carers as well as
capacity building in pharmacovigilance. The ethics of pharmacovigilance is
covered in depth in Chap. 14, outlining key ethical principles including the
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