IX. Add I.5. Methods aimed at specific circumstances of medicines use

In addition to the description of the clinical manifestation of the suspected adverse reaction, ICSRs may include information on the circumstances of medicine use which could have contributed to the occurrence of the adverse reaction, e.g. abuse, misuse, overdose, medication error or occupational exposure (see GVP Annex I).

Although the coding of these circumstances is enabled as Preferred Terms in MedDRA (see GVP Annex IV), they are qualitatively different from the clinical circumstances which are the focus of disproportionality-based signal detection. Firstly, they are manifestly related to at least one medicinal product identified in the ICSR. With suspected adverse reactions in normal circumstances of use this relationship is a matter of clinical judgement. Secondly, the circumstances described by each of these terms differ depending on the product concerned. Hence between-medicine comparisons of reporting frequency of ICSRs with MedDRA-codes describing these circumstances are both unnecessary and potentially misleading.

However, knowledge of these circumstances can appreciably alter the assessment of causality when reviewing a potential signal. Thus, it is recommended that the numbers of ICSRs with the respective MedDRA codes should be displayed for each DEC in signal detection listings.