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Indian Journal of Pharmacy and Pharmacology

Precedence of Cognizant Adverse Drug Reactions (ADRs) Reporting in a South Indian Tertiary Care Hospital: A Prospective Study

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Author Details: Nimisha Raveendran, Sharath Kumar K, Mohandas Rai, Arun Ravindran, Chandrashekar R

Volume : 3

Issue : 2

Online ISSN : 2393-9087

Print ISSN : 2393-9079

Article First Page : 39

Article End Page : 43


Objectives: The present study was conducted with the objectives to analyze the ADRs reported to the ADR Monitoring Centre at a tertiary care hospital in Dakshina Kannada district, South India.
Methods: Adverse drug reaction (ADRs) reports were collected over a span of two years for assessing an agreement between two causality assessment tools; WHO-UMC criteria and Naranjo algorithm.
Results: There were 30 (46%) males and 36 (54%) females reported which were categorized into Type A (Augmented) and Type B (Bizarre) ADRs having 24 (36.4%) and 42 (63.6%), respectively, based on Modified Rawlins and Thompson Scale where majority of cases were ‘Probable’, followed by ‘Possible’ categories. Criteria for avoidability were determined to be 44(66.7%) as Not avoidable and 22 (33.3%) as possibly avoidable. Severity of ADRs were determined to be 54(81.8%) for moderate, and 6 (9.1%) for each of mild and severe categories. Amongst the drug classes concerned, 28 (42.4%) cases were attributed to Anti-infective followed by Anti-Diabetic and Radiocontrast Media constituting 18(27.3%) and 7(10.6%) cases respectively. Cephalosporins were the most common class of drugs associated with ADRs constituting 16 (24.2%) cases. Kappa test was utilized to assess the comparison of agreement between the two causality assessment criteria of WHO-UMC scale and Naranjo Algorithm and the value was 0.2.
Conclusions: This study is indicative of ‘poor’ agreement between the two widely used criteria of WHO-UMC scale and Naranjo Algorithm.

Adverse drug reactions, Precedence, Reporting