Clinical Pattern and Causality Assessment of Drug-induced Cutaneous Reactions in a Tertiary Care hospital in India – A Prospective Study

Abstract

Background: Cutaneous Adverse Drug Reactions (ADRs) are very common and is an important challenge to the physician especially in situations of multiple comorbidities of the patient, polypharmacy and self-administration of over-the-counter medications. Objective: To analyze the clinical pattern and incidence of cutaneous ADRs and perform causality assessment using the WHO-UMC scale and Naranjo’s scale and severity of the reactions were determined by Hartwig scale. Method: This was conducted as a prospective observational study in patients admitted in SRM Medical College, Kattankulathur, Tamil Nadu, India, between November 2016 to August 2018 after obtaining Institutional Ethics Committee clearance, of all adverse drug reactions reported at the hospital. Results: Of the 158 ADRs reported during the time period, 101 were cutaneous ADRs, of which the most common presentation was maculopapular rash (n=42; 41.58%). The most common drug which produced cutaneous adverse reaction were antimicrobials (n=58; 57.42%) followed by NSAIDs (n=35; 34.6%). The causality assessment as per the Naranjo scale yielded 3.96% (4) cases as definite, 81.18 % (82) as probable and 14.85 % (15) as possible whereas the WHO scale yielded 9 (89.10%) certain, 64 (63.36%) probable and 28 (27.72%) possible cases. The severity of the cases determined as per the Hartwig scale yielded 82.17% cases as mild and 17.82 % as moderate. Conclusion: It is important to recognise the ADRs at the right time and exert caution in future use. This can minimise harm to the patient both physically and financially and improve outcome of the treatment.