Cutaneous adverse drug reactions to modern medicines and initial experiences from a spontaneous adverse drug reaction reporting program in a tertiary care teaching hospital of Western Nepal

Background: Cutaneous adverse drug reactions (ADRs) affect 2-3% of hospitalized patients; most are usually mild and respond to topical drugs. These reactions can arise as a result of immunologic or non-immunologic mechanisms. Extremes of age, female sex, previous history of ADRs and environmental factors are the major risk factors. The Naranjo algorithm is widely used to determine the causality of an ADR. Objective: To share the authors' experience of spontaneous adverse drug reaction reporting program Nepal. Patients and methods During a period from September, 2004 to March, 2005, any patient who experienced a dermatological ADR were asked to report the Pharmacovigilance Cell of the Manipal Teaching Hospital, Pokhara, Nepal. Morphology of the eruption was recorded. Results A total of 45 cutaneous ADRs were reported during the study period. Maculopapular rash (15 reports) was the most common, followed by contact dermatitis (7 reports), fixed drug eruptions (6 reports) and erythema (4 reports). Conclusion Considering its effectiveness, the pharmacovigilance program in Manipal Teaching Hospital should be strengthened and transformed to a full-fledged active reporting program. The nationwide extension of this program would be beneficial.