Extension of Points on Clarifying Terminology in Drug Safety

Excerpt

Congratulations to Aronson and Ferner[1] on their comprehensive and thoughtful exploration of fuzzy ideas and terminology in drug safety. We accept the authors’ invitation to use their article as a starting point for further discussion by extending points that might be of specific practical interest to the ‘drug safety expert’ and could be of potential assistance in identifying/prioritising those reports of adverse drug effects (ADEs) that might require more in-depth analysis. We make a point about rethinking the original alphabetic (A/B) classification of Rawlins and Thomas.[2] We believe it should be rethought, as do Aronson and Ferner[1] with their discerning reformulation, and will show how its extension to signal detection makes this a valuable approach. We also will provide two descriptive categories of ADEs (‘surprise’ and ‘paradoxical’ reactions), which we believe represent a useful conceptual typology for the purposes of pharmacovigilance. Finally, we would like to comment on causality assessments and the use of the term ‘signal generation’. …