As with any other study method, spontaneous reporting'in pharmacovigilance is a process of data acquisition, assessment, presentation and interpretation.
The provision of information (i.e. of interpreted data) concerning previously unknown, or otherwise important adverse drug reactions is a major goal.
The assessment of case reports in spontaneous reporting takes place in 2 steps : first the assessment of each case individually, and secondly the interpretation of the aggregated data.
The latter step is only completed for a minority of case reports, such as when actions or measures are deemed necessary.
Uncertainty in case reports regarding the involvement of the suspected drugs is an inherent drawback of spontaneous reporting.
Standardised case-causality assessment has become a routine at pharmacovigilance centres around the world.
It aims at a decrease in ambiguity of the data and plays a role in data exchange and the prevention of erroneous conclusions.
A variety of systems for standardised causality assessment have been developed, ranging from short questionnaires to comprehensive algorithms.
Since none of the available assessment systems has been validated (i.e. shown to consistently and reproducibly produce a fair approximation of the truth), causality assessment has only limited scientific value.
Causality assessment neither eliminates nor quantifies uncertainty but, at best. categorises it in a semiquantitative way. (...)
Mots-clés Pascal : Article synthèse, Pharmacovigilance, Médicament, Toxicité, Causalité, Etude cas, Diagnostic, Etiologie, Facteur risque, Prévention
Mots-clés Pascal anglais : Review, Pharmacovigilance, Drug, Toxicity, Causality, Case study, Diagnosis, Etiology, Risk factor, Prevention
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 98-0090547
Code Inist : 002B02A06. Création : 14/05/1998.