Swati Paul

Studies on Pharmacovigilance in Bangladesh: Patient Safety Issues & Pharmacy Practice Swati Paul

An increase in drug safety concerns in recent years with some high profile drug withdrawals have led to raising the block by various stakeholders, more importantly by the regulatory authorities. The number of adverse drug reactions (ADRs) reported, have also resulted in an increase in the volume of data handled. To understand pharmacovigilance a high level of capability is required to rapidly detect drug risks as well as to defend the product against an inappropriate removal. Positive pharmacovigilance throughout the product life cycle is the way forward and the future direction for drug safety. It is a challenge to arrange and regiment the act of signal detection and risk management in the context of clinical trials and post- marketing pharmacovigilance. With more clinical trials and clinical research activity being conducted in Bangladesh, there is an immense need to understand and implement pharmacovigilance. This book describes and discusses the various strategies and proposals to build, maintain and implement a robust pharmacovigilance system for various stakeholders and eventually make it happen in Bangladesh.