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Table. 1.

Table. 1.

Causality assessment using WHO-UMC criteria

Causality termAssessment criteriaCheck
Certain• Event or laboratory test abnormality, with plausible time relationship to drug intake • Cannot be explained by disease or other drugs • Response to withdrawal plausible (pharmacologically, pathologically) • Event definitive pharmacologically or phenomenologically 10Rechallenge satisfactory, if necessary

Probable/likely• Event or laboratory test abnormality, with reasonable time relationship to drug intake • Unlikely to be attributed to disease or other drugs • Response to withdrawal clinically reasonable • Rechallenge not required

Possible• Event or laboratory test abnormality, with reasonable time relationship to drug intake • Could also be explained by disease or other drugs • Information on drug withdrawal may be lacking or unclear

Unlikely• Event or laboratory test abnormality, with a time to drug intake that makes a relationship improbable (but not impossible) • Disease or other drugs provide plausible explanations

Conditional/ Unclassified• Event or laboratory test abnormality • More data for proper assessment needed, or • Additional data under examination

Unassessable/ Unclassifiable• Report suggesting an adverse reaction • Cannot be judged because information is insufficient or contradictory • Data cannot be supplemented or verified

World Health Organization-Uppsala Monitoring Center, WHO-UMC

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