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Table. 3.

Table. 3.

Causality assessment using Korean causality assessment algorithm (ver.2)

 Items Question Answer
Chronological relationshipIs there any information on chronological relationship of the suspected drug and ADR?Appropriate chronologic relationship (+3)
 Appropriate chronologic relationship (+3), contradictory chronologic relationship (-3), no information (0)
Dose reduction or discontinuationIs there any information on dose reduction or discontinuation? Clinical response after dose reduction or discontinuation (+3), clinical progress irrespective to the dose reduction or discontinuation (-2), not done dose reduction or discontinuation (0), no information (0)not done dose reduction (0)
Past ADR historyHave you ever experienced ADR with the same or similar drug? Yes (+1), no (-1), no information (0)no information (0)
Concomitant medicationIs there any information on drugs being taken concomitantly? Cannot explain the association between ADR and the concomitant drug alone (+2), can explain the association between ADR and the concomitant drug alone (-3), data available by interaction with suspicious drug (+2), no available data for the concomitant drug (0), no information (0)Cannot explain the association between ADR and the concomitant drug alone (+2)
Non-drug causeIs there any information on non-drug cause? ADR not explained by non-drug cause (+1), ADR explained by non-drug cause (-1), no information (0)ADR not explained by non-drug cause (+1)
Any known information on the suspected drugIs there any information on the suspected drug? Indicated in the drug label (+3), not indicated but case reported (+2), unknown (0)Indicated in the drug label (+3)
Re-administrationIs there any information on re-administration? Similar response to re-administration (+3), no response to re-administration (-2), no re-administration (0), no information (0)no information (0)
Specific testsSpecific tests such as plasma drug concentration monitoring? Positive (+3), negative (-1), unknown (0), no information (0)no information (0)
Total score9
Causality evaluationProbable

Certain: ≥12, Probable: 6-11, Possible: 2-5, Unlikely: ≤1

Korean J Clin Pharm 2019;29:209-14 https://doi.org/10.24304/kjcp.2019.29.3.209
© 2019 Korean J Clin Pharm