Pharmacovigilance Study of Adverse Cutaneous Drug Reactions in a Tertiary Care Hospital

Background: The wide and indiscriminate use of drugs has increased the incidence and the modes of presentation of cutaneous drug reaction. Adverse cutaneous drug reactions are common, comprehensive information about their incidence, severity and ultimate health effects are unavailable. Objective: To study and evaluate incidence of adverse cutaneous drug reaction (ACDR) at our tertiary care hospital and assess the impact of active surveillance on adverse drug reaction (ADR) reporting. Materials and Methods: Prospective study involving 29,156 patients was carried out by active observation of patients attending Dermatology department over a period of 21 months. Retrospective study involving 61000 patients attended Dermatology OPD over last 4 years was carried by available data of dermatology department. Both the studies were compared by chi square test. Results: In prospective study 48 (0.17%) were diagnosed as having ACDR. Acneform eruption (25%) followed by fixed drug eruption (FDE) (22.92%) were the most common morphological forms. The most common drugs responsible were betamethasone, isoniazid and rifampicin for acneform eruption, while metronidazole and paracetamol for FDE. WHO causality assessment showed 13 were certain, 24 were probable and 11 were possible in nature. Hartwig severity assessment revealed 40 were moderate, 07 were mild and 01 was severe. Modified Schomock and Thronton scale showed 37.5% were definitely preventable, 33.33% were probably preventable and 29.17% were not preventable. In retrospective study 63 (0.10%) ACDRs were reported, out of them FDE was most common (28.57%), followed by acneform eruption (11.11%). Antimalarials and metronidazole were most commonly responsible for FDE while systemic steroids were responsible for acneform eruption. There is significant association between both the studies with higher incidence in prospective study (p<0.05). Conclusion: Most common ACDRs were acneform eruptions and FDE in both prospective study and retrospective study. Pharmacovigilance activity is significantly effective in increasing the reporting of ADRs.