Assessment of cutaneous adverse drug reactions reported by spontaneous reporting system

The safety profile of a drug requires a continuous monitoring of its adverse drug reactions (ADRs) by means of an effective Pharmacovigilance system. Spontaneous reporting system plays a vital role in the assessment of risk-benefit profile of a drug. Our present study aims to assess the cutaneous adverse drug reactions associated with commonly used drugs in the clinical practice. A prospective non-interventional observational study was conducted from January 2017 to July 2017 with prior orientation on the importance of pharmacovigilance and spontaneous reporting system. A total of 71 ADR reports were collected and were assessed for incidence, age group involved, common drug class and individual drugs associated with cutaneous ADRs, causality assessment and the outcome of the patient. Majority of cutaneous reactions were occurred in female patients (43, 60.56) in the age group of 18-44 yrs. The most common cutaneous ADRs were found to be rash (28, 39.44%) followed by Urticaria (09, 12.68%) and the common offending suspected class were found to be antimicrobials (42, 59.15%). About (61, 85.92%) reactions were recovered and causality assessment was probable in 60 (84.51%) cases. Current study contributes to the patient safety and rational use of drug by assessing, reporting and treating ADRs.