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![](https://www.biomedpharmajournal.org/wp-content/uploads/2017/11/orcid_16x16.png)
![](https://www.biomedpharmajournal.org/wp-content/uploads/2017/11/orcid_16x16.png)
![](https://www.biomedpharmajournal.org/wp-content/uploads/2017/11/orcid_16x16.png)
![](https://www.biomedpharmajournal.org/wp-content/uploads/2017/11/orcid_16x16.png)
![](https://www.biomedpharmajournal.org/wp-content/uploads/2017/11/orcid_16x16.png)
1Department 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