Causality Assessment: WHO-UMC [UPSALA Monitoring Centre] Causality Categories for ADR Reporting

Causality Assessment: WHO-UMC [UPSALA Monitoring Centre] Causality Categories for ADR Reporting

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Causality Assessment: WHO-UMC [UPSALA Monitoring Centre] Causality Categories for ADR Reporting

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The World Health Organisation-Uppsala Monitoring Centre (WHO-UMC) system has been developed as a practical tool for the assessment of case reports.

The table below lists the various causality categories and their assessment criteria that have been developed under this system.

Table: WHO-UMC Causality Categories; *Source: WHO-UMC System for Standardised Case Causality Assessment, p2.*
CAUSALITY TERM/ CATEGORY	ASSESSMENT CRITERIA
Certain/ Very Likely	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 (i.e., an objective and specific medical disorder or a recognized pharmacological phenomenon) Rechallenge 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 is needed, or additional data under examination
Unassessable/ Unclassifiable	Report suggesting an adverse reaction Cannot be judged because the information is insufficient or contradictory Data cannot be supplemented or verified

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