Causality Assessment for ADR Reporting

Attribution definitions for causality assessment are divided into five categories and are as follows:

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• Not related​

Adverse Event (AE) that is not related to the use of the drug.​

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• Doubtful ​

AE for which an alternative explanation is more likely, e.g., concomitant drug(s), concomitant disease(s) or the relationship in time suggests that a causal relationship is unlikely.​

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• Possible​

AE that might be due to the use of the drug. An alternative explanation, e.g., concomitant drug(s) or concomitant disease(s) is inconclusive. The relationship in time is reasonable, therefore, the causal relationship cannot be excluded.​

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• Probable​

AE that might be due to the use of the drug. The relationship in time is suggestive, e.g., confirmed by de-challenge. An alternative explanation is less likely, e.g., concomitant drug(s), concomitant disease(s).​

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• Certain (very likely)​

AE that is listed as a possible adverse reaction and cannot be reasonably explained by an alternative explanation, e.g., concomitant drug(s), concomitant disease(s). The relationship in time is suggestive, e.g., confirmed by de-challenge and rechallenge.​

The Drug-resistant TB Centre (DR-TBC) committee, in coordination with the Adverse Drug Reaction (ADR) Monitoring Centre (AMC) will review and confirm the causality of all serious events/ reactions in relation to therapy.​​​

​Resources

• Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, March 2021.
• Ready Reckoner for Medical Officer - Adverse Drug Reactions Associated with Anti-TB Drugs Identification and Management, 2019.

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