Research Scholar JSS Academy of Higher Education & Research, Mysuru Mysuru, India
Background: Adverse drug reactions (ADRs) are amongst the leading causes of morbidity and mortality hence, it is important to identify, report, and prevent these reactions early on, to reduce patient suffering and reduce the healthcare cost in its management.
Objectives: To assess the frequency, causality, and severity of reported ADRs associated with skin and subcutaneous tissue disorders
Methods: A retrospective analysis of 12-month spontaneously reported ARDs reported in a tertiary care teaching hospital associated with the skin and subcutaneous tissue disorders was carried. Each reported ADR was assessed for its causality using the WHO Probability scale. The criterion developed by Hartwig et al. was adapted to assess the severity of the ADR. The data obtained were assessed categorically and represented as [n (%)].
Results: A total of 141 ADRs were reported in 12 months related to skin and subcutaneous tissue disorders. Among these total reported ADRs, [71 (50.4%)] were females and [70 (49.6%)] were males. The ADRs were predominant among the age group 50-59 years [28 (19.9%)], followed by 40-49 years [27 (19.1%)], and 19-29 years [22 (15.6%)], with the mean age being 15.67 ±10.17 years. Rash [45 (31.9%)] was the most common ADR reported, followed by itching [27 (19.1%)], and urticaria [11 (7.8%)]. Ceftriaxone [11 (7.8%)] was the most implicated drug, followed by amlodipine and diclofenac [5 (3.8%)]. The causality of the reported ADRs was identified as certain [1 (0.7%)], possible [44 (31.2%)], probable [94 (66.7%)], and unlikely [2 (1.4%)] according to WHO probability scale. Majority [88 (62.4%)] of the reactions were ‘moderate’ in severity and [3 (2.1%)] were severe.
Conclusions: This study shows that skin and subcutaneous tissue disorders are a common form of ADRs. It is important to identify and report such reactions promptly to minimize the impact of ADRs on patients and healthcare costs. The results also suggest that more emphasis should be placed on educating patients and healthcare professionals on the recognition, reporting, and prevention of ADRs associated with skin and subcutaneous tissue disorders.
