E-ISSN 2231-3206 | ISSN 2320-4672
 

Original Research 


Antimicrobial-associated adverse drug reaction profiling and assessing the agreement between the WHO-UMC scale and the Naranjo algorithm for causality assessment at a tertiary care teaching hospital in India

Gandham Ravi, Gaurav Chikara, Arkapal Bandyopadhyay, Shailendra Handu.

Abstract
Background: Adverse drug reactions (ADRs) are not uncommon due to medications, especially antimicrobials (AMs), given to the patients during their stay in the hospital.

Aim and Objective: The present study aims to assess the ADRs related to AMs, causality assessment using the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) causality assessment scale and the Naranjo scale and to evaluate their agreement.

Materials and Methods: A prospective, observational study conducted over a period of one year in general medicine and pulmonary medicine wards, including 206 patients. WHO-UMC scale and the Naranjo algorithm were used to assess the causality followed by evaluating the agreement between these two scales.

Results: The most common antibiotic accounted for ADRs was Piperacillin+Tazobactam (36.10%). The most common organ system involved was gastrointestinal (83.30%), followed by skin and soft tissue (11.10%) and immunological (5.60%). While 58.30% of the ADRs were latent in onset, 30.60% and 11.10% were sub-acute and acute, respectively. The majority of the ADRs were mild (66.70%), followed by moderate (22.20%) and severe (11.10%) in nature. As per the WHO-UMC scale, 19.4% ADRs were certain, 47.2% were probable, 27.8% were possible, and 5.6% were found to be unlikely. As per Naranjo algorithm, 75% of the ADRs were probable and 25% were of possible. Overall agreement analysis showed “Poor” agreement between the WHO-UMC scale and the Naranjo algorithm (kappa statistics with 95% confidence interval = 0.2195 [0.0065, 0.4325]).

Conclusion: Using both the WHO-UMC scale and the Naranjo algorithm is advisable for better evaluation of ADRs related to AMs.

Key words: Antimicrobials; Agreement; World Health Organization-UMC Scale; Naranjo Scale; Causality Assessment


 
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How to Cite this Article
Pubmed Style

Ravi G, Chikara G, Bandyopadhyay A, Handu S. Antimicrobial-associated adverse drug reaction profiling and assessing the agreement between the WHO-UMC scale and the Naranjo algorithm for causality assessment at a tertiary care teaching hospital in India. Natl J Physiol Pharm Pharmacol. 2020; 10(11): 945-949. doi:10.5455/njppp.2020.10.06170202012072020


Web Style

Ravi G, Chikara G, Bandyopadhyay A, Handu S. Antimicrobial-associated adverse drug reaction profiling and assessing the agreement between the WHO-UMC scale and the Naranjo algorithm for causality assessment at a tertiary care teaching hospital in India. http://www.njppp.com/?mno=119277 [Access: October 31, 2020]. doi:10.5455/njppp.2020.10.06170202012072020


AMA (American Medical Association) Style

Ravi G, Chikara G, Bandyopadhyay A, Handu S. Antimicrobial-associated adverse drug reaction profiling and assessing the agreement between the WHO-UMC scale and the Naranjo algorithm for causality assessment at a tertiary care teaching hospital in India. Natl J Physiol Pharm Pharmacol. 2020; 10(11): 945-949. doi:10.5455/njppp.2020.10.06170202012072020



Vancouver/ICMJE Style

Ravi G, Chikara G, Bandyopadhyay A, Handu S. Antimicrobial-associated adverse drug reaction profiling and assessing the agreement between the WHO-UMC scale and the Naranjo algorithm for causality assessment at a tertiary care teaching hospital in India. Natl J Physiol Pharm Pharmacol. (2020), [cited October 31, 2020]; 10(11): 945-949. doi:10.5455/njppp.2020.10.06170202012072020



Harvard Style

Ravi, G., Chikara, . G., Bandyopadhyay, . A. & Handu, . S. (2020) Antimicrobial-associated adverse drug reaction profiling and assessing the agreement between the WHO-UMC scale and the Naranjo algorithm for causality assessment at a tertiary care teaching hospital in India. Natl J Physiol Pharm Pharmacol, 10 (11), 945-949. doi:10.5455/njppp.2020.10.06170202012072020



Turabian Style

Ravi, Gandham, Gaurav Chikara, Arkapal Bandyopadhyay, and Shailendra Handu. 2020. Antimicrobial-associated adverse drug reaction profiling and assessing the agreement between the WHO-UMC scale and the Naranjo algorithm for causality assessment at a tertiary care teaching hospital in India. National Journal of Physiology, Pharmacy and Pharmacology, 10 (11), 945-949. doi:10.5455/njppp.2020.10.06170202012072020



Chicago Style

Ravi, Gandham, Gaurav Chikara, Arkapal Bandyopadhyay, and Shailendra Handu. "Antimicrobial-associated adverse drug reaction profiling and assessing the agreement between the WHO-UMC scale and the Naranjo algorithm for causality assessment at a tertiary care teaching hospital in India." National Journal of Physiology, Pharmacy and Pharmacology 10 (2020), 945-949. doi:10.5455/njppp.2020.10.06170202012072020



MLA (The Modern Language Association) Style

Ravi, Gandham, Gaurav Chikara, Arkapal Bandyopadhyay, and Shailendra Handu. "Antimicrobial-associated adverse drug reaction profiling and assessing the agreement between the WHO-UMC scale and the Naranjo algorithm for causality assessment at a tertiary care teaching hospital in India." National Journal of Physiology, Pharmacy and Pharmacology 10.11 (2020), 945-949. Print. doi:10.5455/njppp.2020.10.06170202012072020



APA (American Psychological Association) Style

Ravi, G., Chikara, . G., Bandyopadhyay, . A. & Handu, . S. (2020) Antimicrobial-associated adverse drug reaction profiling and assessing the agreement between the WHO-UMC scale and the Naranjo algorithm for causality assessment at a tertiary care teaching hospital in India. National Journal of Physiology, Pharmacy and Pharmacology, 10 (11), 945-949. doi:10.5455/njppp.2020.10.06170202012072020