Principles and Practice of Pharmacovigilance and Drug Safety

The science of drug safety and pharmacovigilance has rapidly evolved in the 21st century. The knowledge and principles it contains are of increasing importance in clinical and practice settings. The aim of this book is to deal with the gap in knowledge about pharmacovigilance and drug safety, including the application of pharmacovigilance knowledge to individual patient cases in clinical practice.

A holistic approach is taken with each chapter written from the perspective of a practitioner, industry personnel, researcher, or regulator, creating a synergy between drug safety, pharmacovigilance, and clinical practice. Chapters offer key material on adverse drug reactions, medication errors, prescribing safety, pharmacovigilance as well as data sources used in drug safety and pharmacovigilance. Each chapter is structured as a self-contained learning resource, with learning objectives, and worked cases.

The book is suitable for undergraduate healthcare professions, those in postgraduate studies, and for those in clinical practice - including those with prescribing responsibilities. It will also be useful for those professionals moving from a clinical practice role to a pharmacovigilance role. For those already in a pharmacovigilance role, the book offers insight into the theory and practice of drug safety and pharmacovigilance in clinical settings.

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.