Principles and Practice of Pharmacovigilance and Drug Safety

I am pleased to annouce the publication of a new textbook ‘Principles and Practice of Pharmacovigilance and Drug Safety’. It is an edited volume with over 50 expert authors with an international reach, with each chapter peer-reviewed.

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, postgraduate students, researchers, clinical practitioners – including those with prescribing responsibilities. It will also be useful for professionals moving from a clinical practice role to a specialist 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.

The seed of this project was planted 4 years ago, when in the midst of the pandemic in August 2020, Jimmy Jose contacted me with his ideas about creating a new textbook in the area of pharmacovigilance. We both had similar views on trying to create something that straddled the regulatory, scientific, and clinical practice. Co-ordinating such an endeavour was a massive under-taking, and we were grateful to have a third editor join us, Vibhu Paudyal. I hope we have succeeded in creating what we intended, and I thank the international authors for their hard work.

The two chapters I contributed to are:

van Hunsel, F., Younus, M.M., Cox, A.R. (2024). Patient and Public Involvement in Pharmacovigilance. In: Jose, J., Cox, A.R., Paudyal, V. (eds) Principles and Practice of Pharmacovigilance and Drug Safety. Springer, Cham. https://doi.org/10.1007/978-3-031-51089-2_12

Jose, J., Cox, A.R., Bate, A. (2024). Introduction to Drug Safety and Pharmacovigilance. In: Jose, J., Cox, A.R., Paudyal, V. (eds) Principles and Practice of Pharmacovigilance and Drug Safety. Springer, Cham. https://doi.org/10.1007/978-3-031-51089-2_1