A study of adverse cutaneous drug reactions in the department of dermatology of a teaching hospital in Jamnagar, India

Abstract

Background: Adverse drug reactions cause significant morbidity and mortality in health care set up. They are responsible for a significant number of hospital admissions. The data for adverse cutaneous drug reactions (ACDRs) is limited our country. Thus, the present study emphasises on the need of an effective adverse drug reaction reporting programme.Methods: A prospective study to assess the ACDRs in Dermatology department was conducted in a teaching hospital of India. Male to female ratio, most common class of drug, individual drugs causing ACDRs, common types of ACDRs were studied. Other parameters like causality assessment, preventability and seriousness of ACDRs were also studied.Results: A majority of the patients (38%) with ACDR were in the age group of 25-44 years followed by 45-64 years (31%). The rate of ACDRs was more in males (54%). The most frequent ACDR reported was maculopapular rash (38%), followed by urticaria (19%) and fixed drug eruptions (12%). Most of the reactions (93%) were bizarre/ unpredictable in nature. Amongst drug groups, antimicrobials (48%) were most frequently associated with ACDRs followed by NSAIDs (30%) and antiepileptics (12%). Most of the reactions (94%) were mild-moderate in nature. Only 9% of ACDRs reported in this study were preventable. Paracetamol was the most common offending drug followed by cotrimoxazole, ibuprofen, amoxicillin, phenytoin in decreasing order. Causality assessment found ACDRs in probable category (68%) using WHO-UMC criteria.Conclusions: It is important to monitor and report adverse drug reactions in order to promote safe and rational use of medicines.

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.…”

“…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. Information on all the concomitant medications used by patients for other conditions is lacking in few reports.…”

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“…Males were found to be more affected than females in our study. This finding is in close approximation to studies done by Agrawal A et al, 10 58.1% (93) males, 41.9% (67) females), Modi A et al, 11 (55.2 % males, 44.8% females), Dhanani JG et al, 12 (54% males, 46% females), T N et al, 13 (77.7% of males, 2.3% females) and Joshi DB et al, 14 (54% males, 46% females). Similar to present study previous studies also indicate that males seem to be more susceptible than females for developing CADRs.…”

Adverse cutaneous drug reactions reporting in a tertiary care teaching hospital in Eastern India: a retrospective study

“…There were no definite or doubtful cases, which was similar by Modi et al 15 Other studies demonstrated more probable relationships with the suspected drug. 11,12,[17][18][19]22 According to modified Hartwig and Seigel scale in the current study, 78.5% and 21.5% of cutaneous reactions were mildly and moderately severe respectively. Similar results were also reported by Dhanani et al 19 Most of these patients managed by withdrawing the suspected medication and providing supportive therapy.…”

“…This is in contrast to antimicrobials (40%, 46%, 54%, 48%,), NSAIDs (35%, 18%, 23%, 30%,), and antiepileptics (8%, 10%, 11%, 12%,) in the study by Sharma et al, Modi et al, Anjaneyan et al, and Dhanani et al respectively. 12,15,16,19 Antimicrobials and NSAIDs are commonly prescribed by physicians and general practitioners, hence, higher chances of developing reactions to these groups of medications.…”