In my last post we discussed about validity, seriousness of adverse event when reported for pharmacovigilance. It is necessary to classify the validity, seriousness and causality of adverse event to correctly update safety profile of any drug. Well now you have valid adverse event collected but how can we decide if that adverse event was actually caused by the drug patient took? Before we discuss how to assess the causality ( drug to event cause ) why we have to do it? For a simple reason to know if the drug causes adverse event or not?
and under what circumstances so that next time we can be careful. We have to make sure that the data of all adverse events is analysed properly to avoid falsely implicating useful drugs as unsafe and actually unsafe drug to be continued in market without proper safety action. So what are the factors that can be considered ? I will try to use my…
