A prospective study of incidence and assessment of Adverse Cutaneous Drug Reactions as a part of Pharmacovigilance from a rural northern Indian medical school

Background: The wide and indiscriminate use of drugs has increased the incidence and the modes of presentation of cutaneous drug reaction. Understanding the nature of ACDRs may help narrow down the search for the offending agent. Aim- The study aimed to evaluate incidence, assessment of causality, severity and preventability of Adverse Cutaneous Drug Reactions as a part of Pharmacovigilance from a rural northern Indian medical school. Material and methods: The current survey was executed by the department of Pharmacology in collaboration with Department of Dermatology, MSDS Medical College, Fatehgarh among 7692 patients attending Dermatology OPD during March-December 2014. CDSCO ADR Reporting Form, WHO causality assessment scale, Hartwig and Siegel’s Assessment scale and Modified Schomock and Thronton’s preventability assessment scale were used as study tools. All the doctors, residents, interns and students were encouraged to notify any suspected ACDRs. Patients were screened and recruited if they presented with visible skin lesions suspected to be drug related. As per Modified Schumock and Thornton Scale, 43.5% of ACDRs were ‘Definitely preventable’ followed by ‘Probably preventable’ (30.4%) and ‘Not preventable’ (26.1%). Results: 23 patients (0.3%) were detected to have one or other type of ACDRs. Fixed drug eruption was most common form (34.8%) of ACDRs followed by Acneform eruption and Urticaria in 21.7% and 13% respectively among study subjects. The most common drugs responsible for ACDRs were prednisolone, betamethasone and isoniazid for Fixed drug eruption, while metronidazole, cotrimoxazole and paracetamol for acneform eruption. Antimicrobials, other steroids and NSAIDs were responsible for other spectrum of ACDRs. On assessment of Causality of ACDRs, it was noted that more than half (52.2%) of them fall under probable category. Severity assessment of ACDRs revealed that majority (65.3%) of them was moderate in nature. Conclusion: Awareness on part of the physician can help in timely detection of cutaneous reactions, thereby restricting damage from them. Pharmacovigilance activity is significantly effective in increasing the reporting of ADRs. Study with long-term follow-up and monitoring of the patients with bigger sample size is warranted.