Introduction to Pharmacovigilance and Monitoring

Abstract

Pharmacovigilance has its own unique terminology that is important to understand. Pharmacovigilance also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. As such, pharmacovigilance heavily focuses on adverse drug reactions, or ADRs, which are defined as any response to a drug which is noxious and unintended, including lack of efficacy (the condition that this definition only applies with the doses normally used for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological disorder function was excluded with the latest amendment of the applicable legislation). Hence, need of pharmacovigilance arises which include, securing the early detection of new adverse reactions or patients subgroups of exceptional sensitivity; and introducing certain measures in order to manage such risks. Moreover, it is essential that new and medically still evolving treatments are monitored for their effectiveness and safety under real-life conditions after being marketed. The role of pharmacovigilance is to check the safety monitoring in clinical trials involves collecting adverse events, laboratory investigations and details of the clinical examination of patients. Pharmacovigilance staff may be involved to varying degrees in all phases of clinical trials, including the planning, execution, data analysis and reporting of safety.