Why Pharmacovigilance?

What is the probability of a house catching fire? Very bleak, right.

In the society where my parents live, the lane surrounding the building is narrow. Due to the lack of ample parking area, the extra cars are parked on the lane, which leaves not much space. There was a talk from RWA some time ago on building sheds for that parking space so that people get the covered parking (something builder had promised).

Elders from the society started resisting that move giving the reason that it will become a permanent structure and no big vehicle (e.g. a fire brigade) can then be brought in easily – in case of a fire incident. The team insisting on building sheds did not seem to get the point, whats the probability of a house catching fire, right??

However, the elders kept their foot down and even filed a case to stop this from happening. The project was stalled.

And then it happened! The flat diagonally opposite ours (on the same floor) caught fire. It was an accident and in a matter of half an hour, the fire reached the flats above. The fire extinguishers installed in the society were faulty and were not working. The fire brigade was called. It took some time to remove the cars from there, so that a fire brigade vehicle can enter. It took hours extinguishing the fire and the house was devastated.

Now, imagine, had they built the sheds, how fire brigade would have entered! Yes, fire incidents happen rarely but does that mean we do not plan for them? Risk management, assessment and mitigation is a very important part of any process.

Why am I telling you this story?

The main purpose of pharmacovigilance is also risk mitigation and management. The possibility of an Adverse event happening might be 1 in a million, but the data we collect and assess gives us an understanding on how to manage that risk. Clotting events with vaccines is a rare event, but if a patient unfortunately experiences it, the knowledge can help in early diagnosis and management of the event (when we know the cause) and can save lives! This is the reason, we need a robust reporting and analytics system in Pharmacovigilance, so that risks can be assessed and mitigated.

Are you reporting?

#riskmanagement #pharmacovigilance #pvpi 3Analytics Sushil Jha Dr. Dharani Munirathinam Dr Manoj Swaminathan MBBS, MPH, MRQA amitav banerjee Dr J Vijay Venkatraman Dr. Subhrojyoti Bhowmick, MD