Cutaneous drug reactions notified by ADR monitoring centre in a tertiary care hospital of Bihar

Abstract

Background: Cutaneous drug reactions are most frequent drug related adverse events which lead to early treatment discontinuations, high treatment cost and leading cause of morbidity and mortality. The aim of this study is to analyze the clinical patterns and offending drugs as well as their causality, severity and preventive strategies.Methods: All adverse drug reactions (ADRs) forms filled from May 2015 to April 2016 were scrutinized and forms with cutaneous drug reactions were analyzed and assessed for causality, severity and preventability.Results: Out of 300 ADR forms, 160 (53.34%) included cutaneous drug reactions. 68 (42.50%) patients were male and 92 (57.50%) were female. Maculopapular rash 58 (36.25%), fixed drug eruption (FDE) 31 (19.37), pruritus 27 (16.87%) and urticaria 19 (11.87%) were the common clinical patterns of cutaneous drug reactions. Most common offending drug classes included antibiotics, anti-inflammatory and steroidal agents. Causality assessment was done by using Naranjo’s algorithm. The result showed that out of 160 cutaneous drug reactions 141 (88.12%) ADRs were probable, 15 (9.37%) were classified as possible; 2 (1.25) doubtful and 2 (1.25%) were definitely related to the drug.Conclusions: The present study shows cutaneous drug reactions are commonly reported at ADR monitoring centre of this tertiary care hospital. Our study suggests that there is a need of intensive monitoring for ADRs in tertiary care hospital for early detection and to ensure the patient safety.

Analysis of spontaneously reported cutaneous adverse drug reactions in a tertiary care teaching hospital in South India

“…Variability observed in the severity of the reported cases across various studies could be due to difference in the clinical settings and the difference in speciality healthcare services provided by different hospitals. 25,37,38 It was observed that 8.62% of the reported cutaneous ADRs were probable preventable and the remaining 91.38% were not preventable and this is in accordance with a previous study. 37 As this is a retrospective analytical study, we could analyse the reactions and suspected medications as notified in the reporting form.…”

“…With the exception of palmar plantar erythrodysesthesia and acne, the occurrence of other cutaneous ADRs were in conformity with other studies. 10,22,24,25 The higher occurrence of palmar plantar erythrodysesthesias in the present study compared to other studies is due to cancer chemotherapy drugs used in medical oncology department of this institute. These variations observed among various studies could be due to different patterns of drug usage as per the scope and services of the respective hospitals.…”

An assessment of reported adverse drug reactions in a Tertiary Care Hospital in South India: A retrospective cross-sectional study

“…[ 20 ] The result of the study by Manjhi et al ., 2017 showed that 88.12% ADRs were probable, 9.37% were classified as possible; 1.25 doubtful and 1.25% were definitely related to the drug as per Naranjo algorithm. [ 21 ] The outcomes are consistent with other studies utilizing Naranjo's assessment. Our results showed [ Table 4 ] that as per LCAT, 4.8% possible, 61.9% probable and 33.3% definite.…”