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
The contribution of major importance in a system of evaluation of suspected adverse reactions effectively is to see whether there is any causal relationship between the drug administered and the adverse event experienced by the patient.
ReplyDeleteAssessment of causality is the method by which the extent of the relationship between the drug and the appearance of adverse effects is established. The reactions produced by drugs often manifest itself by a nonspecific clinical picture, undifferentiated symptom of disease or the spontaneous.
In research to determine the causal relationship, the analyst is faced with a problem, since what is labeled as an adverse reaction may in fact be manifestations of the disease itself. Furthermore, most patients receive multiple drugs, which makes uncertain the assignment of a particular drug concerned. There is also the development of adverse phenomena due to negative psychological response of the patient.
Limitations of the system for analysis of spontaneous reports
ReplyDelete* Difficult to establish with certainty the causal link
*Fear or lack of information from doctors leads to underreporting. Medical personnel do not always see reporting as a priority. If the symptoms are not serious, they may not notice them at all. And even if the symptoms are serious, they may not be recognised as the effect of a particular drug.
Even so, spontaneous reports are a crucial element in the worldwide enterprise of pharmacovigilance