What is the aim of Pharmacovigilance

Anybody who understands Clinical Trials does know that pharmacovigilance is a critical part of any trial as it deals with the safety of humans. However, there are many questions pertaining to pharmacovigilance. Like: Is pharmacovigilance limited to any particular phase of study? What are the strategies involved in having a good pharmacovigilance plan? What are the key considerations required by regulatory authorities globally? And lastly, what is the ultimate aim of all these? Read further to know more.

The World Health Organization (WHO) defines pharmacovigilance as "the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications and biologics." Also, according to WHO, pharmacovigilance has four principal aims, they are, improve patient care and safety in relation to the use of medicines, and all medical and paramedical interventions; improve public health and safety in relation to the use of medicines; contribute to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective (including cost-effective) use; and promote understanding, education and clinical training in pharmacovigilance and its effective communication to health professionals and the public.

Pharmacovigilance plays a critical in every phase of the study, and most importantly, in the post-marketing phase. Once the product enters the market, the intake of an investigational product cannot be controlled by the sponsor. However, it is very important for the sponsor to monitor and assess data on its safety aspects. This can be done by a robust pharmacovigilance strategy that is technology-driven and harmonizes with the medicine and regulatory aspects as well.