Causality assessment
of ADRs
Determining which adverse event is caused by drugs with reasonable
certainty is an essential though difficult part of documenting ADRs. The
development of a symptom or detrimental outcome while taking a medication does
not establish the drug as the cause of the injury. Likewise, development of an
event or a disease remotely in time from the use of a drug does not exonerate
the therapy from being the source of the problem. In order to initiate
appropriate measures to prevent further occurrence of ADRs, it is necessary to
identify the causative drug. This can be done by carrying out the causality
assessment of the suspected drug. Causality assessment is carried out to
establish a causal relationship between a drug and ADR.