In my previous blog post, I had touched upon the basics of pharmacovigilance (PV), the different stakeholders and the various mechanisms available for reporting adverse events (AE) which could possibly be an adverse drug reaction (ADR). In this post, I want to focus on the reasons for under-reporting AEs, the importance of self-reporting, the different reporting mechanisms available and finally end with a short note urging relevant bodies to simplify their PV approach for maximum benefit of all stakeholders.

What do we mean by Spontaneous Reporting?

Spontaneous Reporting is the regulatory term for self-reporting of AEs by both consumers and healthcare professionals (HCPs) such as Nurses, Physicians…

For the benefit of those hearing the term ‘Pharmacovigilance’ (PV) for the first time, let me rephrase what is already available in the public domain, the word “Pharmacovigilance” is a neoclassical compound derived from “pharmakon” (Greek for ‘drug’) and “vigilare” (Latin for ‘to keep watch’).

What does it really mean?

In lay terms, PV entails all the steps that could lead to making drugs safer (for consumption) by studying the side effects of drugs. Undesired side effects which can be attributed to the consumption of drugs are called ‘Adverse Drug Reactions’ or ADRs. (scroll down for the acronym guide) Some…