Spontaneous reporting is the core data-generating system of pharmacovigilance, relying on healthcare professionals (and in some places consumers) to identify and report any suspected adverse drug reaction to their national pharmacovigilance centre.
Through the analysis of spontaneous cases there is the opportunity to assess early signs of possible changes in the risk profile of the drug.
Initially, the spontaneous reporting is a suspect. It is necessary to verify whether there is causal link between the emergence of adverse effects and use of the product, or to what extent the drug may actually be involved with the adverse symptoms experienced by patients. It´s called Causality Assesment
Posted by Fernando Pereira at 12:00 PM