A Study of Agreement between WHO-UMC Causality Assessment System and the Naranjo Algorithm for Causality Assessment of Adverse Drug Reactions Observed in Medical ICU of a Tertiary Care Teaching Hospital
Tejas A. Acharya1
, Madhav D. Trivedi1*, Krupal J. Joshi2, Sunita B. Chhaiya1 and Dimple S. Mehta11Department of Pharmacology, C. U. Shah Medical College, Surendranagar, India 363001
2Department of Community Medicine, C. U. Shah Medical College, Surendranagar, India 363001
Corresponding Author E-mail : madhavtrivedi.pharmacology@gmail.com
Abstract: Causality assessment is crucial step involved during assessment of Adverse Drug Reactions (ADRs). WHO-UMC causality assessment system and Naranjo algorithm are widely used methods for analysis of ADRs. Study was carried out to evaluate agreement between WHO-UMC causality assessment system and the Naranjo algorithm for causality assessment of ADRs observed in medical ICU of a tertiary care teaching hospital. Causality assessment of all ADRs was done by both WHO-UMC causality assessment system as well as the Naranjo algorithm and classified accordingly. Total 59 ADRs were analyzed. According to WHO-UMC system causal relationship between drug and ADR was certain in 16 ((27.12%), probable in 22 (37.29%), possible in 17 (28.81%), unclassified in 01 (01.69%) and unclassifiable in 03 (05.09%). As per Naranjo algorithm causality was definite in 10 (16.95%), probable in 26 (44.07%) and possible in 23 (38.98%) cases. The agreement between two scales was highest for probable (84.2%) category followed by possible (73.92%) and certain/definite (62.5%) category. on comparing overall agreement between WHO-UMC causality assessment system and Naranjo algorithm using weighted Kappa (κ) test “Moderate” agreement was established (Kappa statistics with 95% confidence interval = 0.60 [0.441,0.758]). For Better evaluation it is recommended to use both the criteria while assessment of causality of ADRs.
Keywords: Causality Assessment; Naranjo Algorithm; WHO-UMC System Back to TOC