Abstract
OBJECTIVES: To determine the incidence and estimate the direct cost incurred for the management of adverse drug reaction in ambulatory psychiatric patients METHODS: This prospective active surveillance pharmacovigilance study carried out over a period of two year. Patients of any age presented with psychiatric illness receiving at least one psychotropic agent were included. Economic burden associated with the management of ADRs was calculated by considering the cost of medications, medical devices, bed charges, laboratory investigations charges and other relevant charges. RESULTS: Of the total 1913 patients observed,763 were identifies with 1058 ADR, which translates to an ADR rate of 39.8%. The average number of ADRs in a patient was 1.3 (range 1 to 8). Majority of ADRs were observed in females [n=456 (59.7%)], patients receiving 3-4 drugs [n=323 (42.3%)], and in patient with co-morbid medical condition [n=386 (50.5%)]. Of the total ADRs, 27.9% of the ADR resulted in economic burden to patients. Total direct cost incurred in the management of 296 ADRs was INR 144731.00 (2,125.00 USD). Average cost incurred per ADR was INR 488.95 (7.17USD) [range: INR 10 (0.14USD) to INR 7846 (115.2 USD)]. Bed charge [INR 75460.00 (1108.11 USD)] and other charges [INR 3430.00 50.36USD] were observed as the highest and Lowest burden of cost to the patient. The average cost incurred in the management of 'mild', 'moderate' and 'severe' reactions were INR 166.6 (2.44 USD), INR 427.47 (6.27USD) and INR 5280(77.54 USD) respectively. CONCLUSIONS: Inour study Adverse drug reactions added an economic burden in patients. Educating the patient and the care giver for early detection and management of ADRs may give a more favorable outcome in psychiatrice practice.