A Short Practical Method for Triage of Adverse Drug Reactions

Abstract

Most of the structured causality assessment methods for adverse drug reactions (ADRs) are not practical for large scale application. Global judgment is still the most commonly used method of assigning an adverse reaction report to a causality category. The proposed method involves answering seven important questions which are usually taken into consideration for global assessment and the answers are numerically weighted. Average score is used to assign the causality category: A (probable), B (possible), or O (unlikely or insufficient data). The advantage of this method is that it is simple and standardized for routinely assessing a large number of ADRs. It can be incorporated into the adverse drug reactions report form and requires only a few minutes to complete. In case of a disagreement between assessors, the points of difference can be identified from the score sheet and discussed. In a pilot trial with 100 cases, there was disagreement between two assessors in 16 cases when global judgment was used but this occurred only in nine cases when the proposed method was used.