Adverse drug reaction monitoring through active surveillance of antitubercular therapy in an urban tertiary care center

Abstract

Background and Objectives: Antitubercular drugs just like other drugs used in clinical practice are not free from ADRs(Adverse drug reactions).The added problem is that combination of drugs are used for prolonged periods of time. Moreover the ADRs to drugs used is one of the major reasons for patient default, hence leading to emergence of resistant organisms. Identification of the ADR profile of drugs in a hospital setup can be useful for the prevention, early detection and management of ADRs. 1) We aim to study the demographic profile of patients receiving Antitubercular therapy. 2) To identify the pattern and incidence of ADRs in the intensive phase Antitubercular therapy following DOTS strategy. Materials and Methods: A descriptive longitudinal study conducted for twelve months at tertiary care hospital in Eastern India. All the adult T.B. patients attending the outpatient department from January 2015 till December 2015 were included as per the study criteria and were monitored for ADRs. The data were evaluated for patient demography, type of DOTS treatment, type of ADRs and Organ site/system affected. ADRs were then subjected to severity assessment as per Hartwig scale.Statistical analysis was done using statistical software Graf Pad Prism version 4.03 for Windows. Results: Out of 296 patients, majority were males (59.79%), belonged to the age group of 20-30years(53.37%). Out of 296 patients 196 patients developed 312 detected ADRS mostly reported in the 5th week of DOTS therapy. In 11(5.61%) cases drugs were withdrawn, 21(10.71%) cases drugs were reduced and remaining 164 (83.67%) cases drugs were continued in original dose. Among them 164 cases received symptomatic treatment. The most common organ system involved was G.I.T. The most common type of ADR was nausea and vomiting (23.07%). On evaluation of severity assessment showed that most of the patients ADRs were of mild level-1(79.39%). Conclusion: Regular ADR monitoring is required to reduce morbidity and development of multiple drug resistance among patients with ADRs and also to improve patient compliance.