E-ISSN 2231-3206 | ISSN 2320-4672
 

Original Research 


A retrospective cross-sectional study to evaluate the adverse drug reactions reported in the tertiary care health center in Northern India

Monica Aggarwal, Gopal Vishwas, Shilpa Chaudhary.

Abstract
Background: In terms of morbidity and death, adverse drug reactions (ADR) have been highlighted as a worldwide burden. Determining the origin of ADRs remains a tough issue and no one approach for determining causation has been adopted as the gold standard throughout the world.

Aim and Objectives: The objectives of the present study were (1) to evaluate the causality of ADRs using World Health Organization-Uppsala Monitoring Center (WHO-UMC) and Naranjo Algorithm ADRs causality assessment tools and (2) to evaluate the agreement and correlation between two universally used approaches for causality assessment of ADRs viz. WHO-UMC system and Naranjo algorithm. The secondary objective was to assess the reported ADRs in a tertiary care hospital in Northern India.

Materials and Methods: The present study was a retrospective cross-sectional study. A total of 180 patients of ADRs from different departments of tertiary care hospital which were reported by Pharmacovigilance unit over a period of April 2018 to May 2019 were assessed. The causality assessment for these reported ADRs were done by WHO-UMC system and Naranjo algorithm. The agreement between these two methods calculated by Cohen’s kappa (κ) statistics and Spearman’s correlation was used to evaluate the correlation between these two methods.

Results: According to WHO-UMC criteria, 55.5% of adverse event instances were of the probable type, 34.4% were possible, 9.4% of cases were improbable, and 0.5% of cases were definite. According to the Naranjo methodology, 80.5% of adverse outcomes were likely, while 19.4% were feasible. The WHO and Naranjo causality comparisons had a positive and fair agreement (= 0.29), according to Cohen’s kappa test. Between the WHO-UMC scale and the Naranjo algorithm, the Spearman’s correlation coefficient was determined to be 0.409.

Conclusion: “Probable” was the most common causality category observed by the WHO-UMC scale and the Naranjo algorithm. The WHO-UMC scale and the Naranjo algorithm have a good and reasonable agreement.

Key words: Adverse Drug Reactions; Causality Assessment; World Health Organization-Uppsala Monitoring Center System; Naranjo Algorithm; Kappa; Pharmacovigilance


 
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Pubmed Style

Aggarwal M, Vishwas G, Chaudhary S. A retrospective cross-sectional study to evaluate the adverse drug reactions reported in the tertiary care health center in Northern India. Natl J Physiol Pharm Pharmacol. 2022; 12(7): 952-957. doi:10.5455/njppp.2022.12.08309202117122021


Web Style

Aggarwal M, Vishwas G, Chaudhary S. A retrospective cross-sectional study to evaluate the adverse drug reactions reported in the tertiary care health center in Northern India. https://www.njppp.com/?mno=115992 [Access: December 01, 2022]. doi:10.5455/njppp.2022.12.08309202117122021


AMA (American Medical Association) Style

Aggarwal M, Vishwas G, Chaudhary S. A retrospective cross-sectional study to evaluate the adverse drug reactions reported in the tertiary care health center in Northern India. Natl J Physiol Pharm Pharmacol. 2022; 12(7): 952-957. doi:10.5455/njppp.2022.12.08309202117122021



Vancouver/ICMJE Style

Aggarwal M, Vishwas G, Chaudhary S. A retrospective cross-sectional study to evaluate the adverse drug reactions reported in the tertiary care health center in Northern India. Natl J Physiol Pharm Pharmacol. (2022), [cited December 01, 2022]; 12(7): 952-957. doi:10.5455/njppp.2022.12.08309202117122021



Harvard Style

Aggarwal, M., Vishwas, . G. & Chaudhary, . S. (2022) A retrospective cross-sectional study to evaluate the adverse drug reactions reported in the tertiary care health center in Northern India. Natl J Physiol Pharm Pharmacol, 12 (7), 952-957. doi:10.5455/njppp.2022.12.08309202117122021



Turabian Style

Aggarwal, Monica, Gopal Vishwas, and Shilpa Chaudhary. 2022. A retrospective cross-sectional study to evaluate the adverse drug reactions reported in the tertiary care health center in Northern India. National Journal of Physiology, Pharmacy and Pharmacology, 12 (7), 952-957. doi:10.5455/njppp.2022.12.08309202117122021



Chicago Style

Aggarwal, Monica, Gopal Vishwas, and Shilpa Chaudhary. "A retrospective cross-sectional study to evaluate the adverse drug reactions reported in the tertiary care health center in Northern India." National Journal of Physiology, Pharmacy and Pharmacology 12 (2022), 952-957. doi:10.5455/njppp.2022.12.08309202117122021



MLA (The Modern Language Association) Style

Aggarwal, Monica, Gopal Vishwas, and Shilpa Chaudhary. "A retrospective cross-sectional study to evaluate the adverse drug reactions reported in the tertiary care health center in Northern India." National Journal of Physiology, Pharmacy and Pharmacology 12.7 (2022), 952-957. Print. doi:10.5455/njppp.2022.12.08309202117122021



APA (American Psychological Association) Style

Aggarwal, M., Vishwas, . G. & Chaudhary, . S. (2022) A retrospective cross-sectional study to evaluate the adverse drug reactions reported in the tertiary care health center in Northern India. National Journal of Physiology, Pharmacy and Pharmacology, 12 (7), 952-957. doi:10.5455/njppp.2022.12.08309202117122021