Meet the editors

Prof. Dr. Maria Teresa Herdeiro has a Ph.D. in Public Health and Pharmacoepidemiology from the University of Santiago de Compostela, Galicia, Spain. She is a regulatory affairs expert by the Portuguese Pharmacist College and an assistant professor and principal investigator at Aveiro University, Portugal, where she is also a coordinator of the Master's in Clinical Research Management Program. She received the Scientific Research Doctor

Odette dos Santos Ferreira award from the Portuguese Pharmacist College in 2012 and the Clinical Epidemiology prize from the Lisbon Society of Medical Sciences and MSD in 2016. Dr. Herdeiro has published more than 60 articles in pharmacovigilance, epidemiology, and public health, and more than 100 oral communications in national and international conferences. She is an editor for six international journals and a member of several financed projects by Fundação para a Ciência e Tecnologia (FCT), Instituto de Salud Carlos III, Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq), and Quadro de Referência Estratégico Nacional (QREN).

Prof. Dr. Fátima Roque has a Ph.D. in Pharmaceutical Sciences. She is an adjunct professor at the School of Health Sciences, Polytechnic Institute of Guarda, Portugal, and a researcher at the Health Sciences Research Center, University of Beira Interior, Portugal. Dr. Roque is a regulatory affairs expert by Portuguese Pharmacist College. Her research interests include clinical pharmacy, pharmacoepidemiology, and public health. She was award-

ed the Clinical Epidemiology prize from the Lisbon Society of Medical Sciences and MSD in 2016. She is editor and referee for international journals, as well as the author of more than 40 papers and book chapters in the fields of pharmacoepidemiology and public health, and more than 100 conference communications. Dr. Roque is a member of financed projects by Fundação para a Ciência e Tecnologia (FCT).

Prof. Dr. Adolfo Figueiras has a degree in Pharmacy, a Ph.D. in Medicine, and a master's in Public Health from the University of Santiago de Compostela, Galicia, Spain, and a master's in Pharmacoepidemiology from the Autonomous University of Barcelona. He is a group leader of the Center for Biomedical Research (CIBER) in Epidemiology and Public Health, coordinator of the Epidemiology, Public Health and Evaluation of Health Services

group of the Health Research Institute of Santiago de Compostela (IDIS), and coordinator of the Public Health Master's Degree Program, University of Santiago de Compostela. Dr. Figueiras has more than 100 publications in the fields of epidemiology and public health, has conducted nine projects of the Spanish National Research Plan, and directed fourteen doctoral theses. He has four first prizes from the Spanish Society of Epidemiology, the Spanish Society of Primary Care Pharmacists, and the fourth edition of the Esteves awards.

Dr. Tânia Magalhães Silva is a biochemist with a Ph.D. in Biochemistry, with a specialization in Molecular/Cell Biology, from the University of Coimbra, Portugal, and Lund University, Sweden. She has postdocs in Microbiology and Immunology of Infection, and Cell Division, both from the Institute for Molecular and Cellular Biology (IBMC)/i3S, Porto University, Portugal. Dr. Silva was Assistant Professor of Biochemistry and Microbiology at ES-

Contents

**Section 1**

**Section 2**

*by Md. Shah Amran*

*and Maria Teresa Herdeiro*

*and Gwendolin Sabrina Simper*

*by Sayna Jabalpeikar*

**Preface XI**

Introduction **1**

**Chapter 1 3**

Recent Findings and New Advances of Adverse Drug Reactions **13**

**Chapter 2 15**

**Chapter 3 31**

**Chapter 4 45**

**Chapter 5 65**

**Chapter 6 91**

Introductory Chapter: Pharmacovigilance and Public Health Safety *by Maria Teresa Herdeiro, Tânia Magalhães Silva, Inês Ribeiro-Vaz,* 

Adverse Drug Reactions Associated with Anti-Tuberculosis Therapy

Prevalence and Significance of Antibiotic-Associated Adverse Reactions *by Tânia Magalhães Silva, Eva Rebelo Gomes, Inês Ribeiro-Vaz, Fátima Roque* 

Small Molecule/HLA Complexes Alter the Cellular Proteomic Content *by Gia-Gia Toni Hò, Wiebke Hiemisch, Andreas Pich, Michelle Matern,* 

Evaluation of the Medication Safety of Chemotherapy Drugs

*Lareen Sophi Gräser, Rainer Blasczyk, Christina Bade-Doeding* 

*Eva Rebelo Gomes, Adolfo Figueiras and Fátima Roque*

Adverse Drug Reactions and Pharmacovigilance

*by Vivekanandan Kalaiselvan, Shatrunajay Shukla, Santhanakrishnan Ramesh Kumar, Nikita Mishra, Pawan Kumar and Rajeev Singh Raghuvanshi*

SNorte–CVP, Oliveira de Azeméis, and Cell Culture Laboratory Assistant Professor at Lund University. She is currently a junior researcher at iBiMED, Aveiro University, with expertise in biomedical/health sciences, pharmacoepidemiology, clinical research, and public health. She has published more than twelve papers in indexed journals and two book chapters. She has also presented more than thirty oral/poster communications at national and international conferences. Dr. Silva is co-editor of several books published by IntechOpen, a referee of four international journals, and a team member of several financed research projects over the last ten years.

## Contents



Preface

Pharmacoepidemiology is a relevant emerging field that applies epidemiological methodologies to study the interactions between health products and large human populations in real-life settings, namely the effects, benefits, and risks of drug use, with the goal of endorsing/optimizing their rational use to improve health outcomes. Pharmacovigilance, or drug safety, is a significant area within pharmacoepidemiology, and addresses the assessment, detection, monitoring, and prevention of adverse drug reactions, thus being fundamental for recognizing the safety of medicines and, at the same time, preventing patients from potential harms.

*New Insights into the Future of Pharmacoepidemiology and Drug Safety* provides scientific information on important subjects within the fields of pharmacoepidemiology, pharmacovigilance, and drug safety, aiming to improve public health surveillance and shed light on some critical unexplored concepts. Furthermore, it allows readers to acquire an in-depth understanding of the main roles, key principles, developments, and practices adopted in these disciplines while also highlighting their latest advances. This book is for students and those working in pharmacology, epidemiology, drug safety, clinical research, regulatory affairs, pharmacovigilance, and risk management, including researchers, health professionals, and employees

The book contains ten chapters divided into four sections. The introductory chapter "Pharmacovigilance and Public Health Safety" offers a comprehensive overview of the key features of pharmacovigilance and its high importance in preserving public health by enhancing patient safety and quality of life. The remaining nine chapters

Section 2, "Recent Findings and New Advances of Adverse Drug Reactions," includes the following five chapters: "Adverse Drug Reactions and Pharmacovigilance," "Adverse Drug Reactions Associated with Anti-Tuberculosis Therapy," "Prevalence and Significance of Antibiotic-Associated Adverse Reactions," "Evaluation of the Medication Safety of Chemotherapy Drugs," and "Small Molecule/HLA Complexes Alter the Cellular Proteomic Content." These chapters explore the significant benefits of monitoring and reporting adverse drug reactions while a drug is in clinical trials as well as after its market authorization. Drugs examined include those used for anti-tuberculosis therapy and chemotherapy as well as antibiotics. Furthermore, this section also reviews the epidemiological data related to antibiotic-associated adverse reactions and analyzes drug–protein interactions within the human leukocyte antigen (HLA) system and its association with adverse drug reactions and disease.

Section 3, "Drug Safety among Older People," includes the two chapters:

pharmacovigilance practices among this special population.

"Pharmacovigilance in Older Adults" and "Drug-Induced Delirium among Older People." These chapters study the interactions between polypharmacy and adverse drug effects in older adults, such as delirium, namely through the prescription of inappropriate medication, thus highlighting the importance of encouraging

from clinical research organizations.

are included in the following sections.
