Principles and Practice of Pharmacovigilance and Drug Safety

Dr. Jimmy Jose is an Associate Professor in Pharmacy Practice/Clinical Pharmacy in the School of Pharmacy at the University of Nizwa, Sultanate of Oman. His previous major academic appointments include in International Medical University, Malaysia. Dr. Jose was awarded his PhD in the field of pharmacovigilance. He is an experienced teacher; has taught MPharm, PharmD, M Pharm program (twinning program with University of Strathclyde) and BPharm. He was trained in clinical pharmacy at Michigan hospitals, USA, and has international clinical pharmacy experience in both Oman and India. His primary field of research is hospital-based pharmacovigilance. He has published a book chapter on pharmacovigilance and several articles on drug safety/pharmacovigilance in peer reviewed journals. He has contributed extensively to the training of the health care professionals on medication safety with the national pharmacovigilance team in Oman. He serves as an Associate Editor for the journal Pharmacoepidemiology and Drug Safety and as an Editorial/Advisory Board Member for various other journals including International Journal of Pharmacy Practice and European Journal of Hospital Pharmacy. He has led internally and externally funded multidisciplinary research projects in the field of drug safety. Professor Anthony Cox is a Professor in Clinical Pharmacy and Drug Safety at the University of Birmingham UK. A hospital pharmacist with 20 years experience, he obtained his PhD in pharmacovigilance while working at the MHRA’s Yellow Card Centre West Midlands – where he holds an honorary position. He has published several book chapters on drug safety, and research on pharmacovigilance, the use of medicines by patients, and other areas related to safe use of medicines. He is the Head of the School of Pharmacy, and leads the Medicines Safety Research Group, at the University of Birmingham. He has been an external examiner for three postgraduate pharmacovigilance programmes. He is on the editorial board of Drug Safety and an Associate Editor International Journal of Pharmacy Practice. He is a fellow of both the Royal Pharmaceutical Society and the British Pharmacological Society. Professor Vibhu Paudyal is a Professor of Health Services Research at Kings College London and previously Associate Professor of Clinical Pharmacy at University of Birmingham, UK. He trained with GlaxoSmithKline Pharmaceuticals soon after his BPharm degree and worked as an industrial pharmacist. He then undertook postgraduate MSc studies in Clinical Pharmacology and PhD in Pharmacy Practice. He is the Fellow of European Society of Clinical Pharmacy (ESCP) and past chair of ESCP Research Committee. He has researched and published extensively in the area of drug safety and pharmacovigilance including theory informed research to understand and mitigate medication errors in healthcare settings and on the perspectives of non-medical prescribers on safety. He has supervised 12 PhDs to completion and published over 120 peer reviewed published papers. He is also the Associate Editor of International Journal of Clinical Pharmacy. He has led externally funded research programmes including those funded by UK NIHR as the Chief Investigator focused on harm reduction resulting  from misuse of prescribed medicines and illicit substance use in vulnerable populations.

“This is a must-read book for anyone involved in patient medication safety. ... Its clear structure and detailed summaries provide an easy-to-follow format which allows easy transfer of theory into practice which makes it additionally valuable for a self-study approach.” (Anita Elaine Weidmann, International Journal of Clinical Pharmacy, Vol. 47 (2), 2025) "Principles and Practice of Pharmacovigilance and Drug Safety, was inspired by their own quest for a single reference text that captures the needs of educators, clinical practitioners, researchers, policymakers, patient/public societies, and wider stakeholders. … this book is a valuable addition to reference texts on pharmacovigilance and drug safety.” (Ian W. Boyd, Drug Safety, 2025)

• Part I. Principles and Practice of Pharmacovigilance and Drug Safety.- Overview of Drug Safety.- An Overview Of Immunological Reactions To Drugs.- Predisposing Factors for Adverse Drug Reactions.- Drug interactions and their management.- Economics of medication safety.- Principles Of Pharmacovigilance And Drug Regulation.- Clinical Trials Safety Data.- Causality Assessment in Pharmacovigilance.- A Retrospective and Prospective Look at Pharmacoepidemiology.- Communicating drug safety.- Patient involvement in pharmacovigilance.- Collaborative Approaches to Establishing and Implementing Pharmacovigilance Systems.- Part II. Safer Prescribing and Drug use in Practice.- Medication Errors in Healthcare.- Spontaneous Reporting Systems.- Methods to Identify, Prevent, Predict and Manage Adverse Drug Reactions in Pharmacovigilance and Clinical Practice.- Ethics in Pharmacovigilance.- Information Sources for Drug Safety and Communicating Risks in Clinical Practice.- Polypharmacy and Deprescribing.- Medication Prescribing and Safety Monitoring in Paediatrics.- Prescribing and Safety Monitoring in the Older Person.- Safe Prescribing and Drug use in Pregnancy and Breastfeeding.- Safe Prescribing in Patients with Renal and Hepatic Diseases.- Clinical Application of Pharmacogenomics in Improving Drug Safety.