Causality assessment of suspected adverse drug reaction with anti-tubercular therapy by WHO probability scale.

ABSTRACT

The objectives of the study is to monitor and causality assessment of suspected ADRs by WHO Probability Scale in patients of tuberculosis undergoing treatment with anti-tuberculous drugs. An Open, Non- Comparative Study was carried out in the Medicine Department of Majeedia Hospital, Jamia Hamdard, over a period of 6 months. A total of 139 patients, satisfying Inclusion and Exclusion Criteria of the Study were enrolled. Potential study subjects were thoroughly interrogated for history in local dialect along with thorough clinical examination for both Pulmonary and Extra-pulmonary tuberculosis. The patients were followed upon a weekly basis during the period of treatment. Assessment of ADRs was done by formal methods; Timing, Pattern Recognition, Background Frequency and Re-challenge and the same was recorded in ADR Reporting and Documentation Form. All the categorical data was analysed by chi-square test on 120 patients. Causality assessment of ADRs was found to be statistically significant by WHO probability scale. 46.7% of patients reported ADRs to anti-tuberculous drugs. The severity of ADR’s was graded on 3- point scale (Mild-34.2%, Moderate-9.2%, Severe-3.3%). Close clinical monitoring in all tuberculosis patients for ADRs is important. ADRs remain one of the key factors for non-compliance of treatment, a reason for multi-drug resistance tuberculosis.