Causality Assessment

It is essential to recognise ADR and to establish a causal relationship between the drug and the adverse event. It is desirable that ADR should be objectively assessed and presented based on an acceptable “Probability Scale.” Many causality methods have been proposed to assess the relationship between a drug and an adverse event in a given patient, ranging from short questionnaires to comprehensive algorithms.

The causality assessment system proposed by the World Health Organization Collaborating Centre for International Drug Monitoring, the Uppsala Monitoring Centre (WHO–UMC), and the Naranjo Probability Scale are the generally accepted and most widely used methods for causality assessment in clinical practice as they offer a simple methodology.

The WHO–UMC causality system takes into account the clinical-pharmacologic aspects, whereas previous knowledge of the ADR plays a less prominent role.

The “Naranjo ADR Probability Scale,” which has gained popularity among clinicians because of its simplicity.

The above scales are structured, transparent, consistent, and easy to apply assessment methods.

As per the recommendation of 2^nd Quality Review Panel of Pharmacovigilance Programme of India (PvPI), it is mandatory to establish CAC in every ADR Monitoring Centre (AMC) to detect the causal relationship between the adverse event(s) and the suspected drug(s) of the reported case using WHO Causality Assessment scale.

The CAC in IGMC&RI constitutes the following Members (& invited members)

After the CAC meeting, the Patient Safety Pharmacovigilance Associate will enter the ICSRs in VIGIFLOW to NCC-PvPI (Serious adverse events- not later than 15 days)