Recognition and assessment of adverse drug reactions in children

Recognition of a drug safety problem is connected with the perception of severity, rare occurrence of the suspected event in non-drug related pathology, knowledge of such drug-ADR association occurring and clearness of the clinical picture. With regard to children knowledge of differences between adult and child is of further help in particular in prevailing pathologies. A lesser variety of pathologies means a lesser variety of drugs used, what should facilitate recognition of an ADR. In the process of assessment the question of causality arises. In epidemiological studies the higher incidence of the event in the treated group suggests causal relationship in general probability terms. With individual cases it is done on the grounds of the strength of evidence provided in each case. The assessment of causality is done either by experts according to their knowledge or with a method of standardized assessment. A true expert does not need a method of standardized assessment but a less experienced evaluator would benefit from such a method or at least using it in addition to his unstructured judgement would benefit from a sort of a double-check. (Tab. 5, Fig. 2, Ref. 6.)