Pharmacovigilance of cutaneous drug reactions: A prospective observational study

Abstract

Objective: To determine the frequency, severity and morphological pattern of ACDRs and their correlation with various risk factors. Methodology: A prospective, observational study was conducted in Muzaffarnagar Medical College & hospital, Muzaffarnagar Uttar Pradesh from Feb 2013 to Jan 2014 for one year. All patients of either sex and all age groups with suspected ACDRs attending/referred to Dermatology department were included. Results: Total of 90 cases were reported over a period of one year. ACDRs were observed with 0.5% incidence of patients attending OPD. ACDRs were commonly seen in adult age group (mean age 36.93 yrs) and have 3 or more drugs prescribed with equal gender distribution. As per Naranjo Algorithm, maximum number of ACDRs were of Possible type (74%), while 23 cases were of "Probable" category with female and male preponderance respectively. 71 of ACDRs were Moderate in severity (79%) followed by 11% of mild and 10% of severe category. Most common clinical pattern was Urticaria with 32 cases followed by 24 cases of Maculopapular Eruptions, 9 cases of Acneiform eruptions and 8 of fixed drug reactions and SJ Syndrome. Commonest Drug groups causing ACDRs were Antibiotics (38%) and Antiepileptics (30%).This was followed by NSAIDs induced ACDRs (9%). Phenytoin was the most common drug causing 12 ACDRs followed by 6 with Cabamazipine and Ceftrixone each and 5 cases with ATT. Conclusion: Incidence was low as compare to global incidence; better steps must be needed to strengthen the activity of pharmacovigilance in this state of the country.