ABSTRACT:
Background: 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.
Objectives:
- To study the demographic profile of patients receiving Antitubercular therapy.
- To identify the pattern of ADRs caused by Antitubercular drugs in T.B. patients.
- To assess causality and severity of the reported ADRs.
Methodology:
A prospective observational study conducted for six months at PKTB Hospital of MMCRI, Mysore. All the T.B. patients admitted from November 2011 till April 2012 were included as per the study criteria and were monitored for ADRs. The data were evaluated for patient demography, type of T.B., type of DOTS treatment, type of ADRs and Organ site/system affected. ADRs were then subjected to causality assessment as per Narango algorithm and severity assessment as per Hartwig and Siegel method.
Statistical methods applied are Frequencies, Cross tabs and Chi-Square test.
Results:
Out of 133 patients, majority were males (87.2%), belonged to the age group of 31-40years(31.6%),of body weight 36-45kgs(43.6%),were from rural areas(61.7%) and were illiterates(72.9%).
Pulmonary type of T.B. was more common (95.5%), majority had smear status positive (73.7%) and were of category 1 type of DOTS (57.9%).The most common organ system involved was G.I.T. both alone and in association with C.N.S. The most common type of ADR was nausea, both as an individual ADR, as well as in association with other ADRs like gastritis, vomiting etc.
On evaluation of the causality of ADRs, majority were found to be possible (64.7%).The severity assessment showed that most of the patients ADRs were of mild level-1(81.2%).
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.
Keywords: Adverse drug reactions, Antitubercular drugs, Causality assessment ,Severity assessment.
Journal Authors
1 Dr. Hema N.G. MBBS, MD, 2 Dr. Bhuvana K.B. MBBS, 3 Dr. Virupaksha H.M
1 Professor, Dept of Pharmacology, Mysore Medical College and
Research Institute, Mysore.
2 Post graduate student, Mysore Medical College and Research Institute, Mysore.
3 Associate Professor, Dept of Chest Diseases and Thoracic Surgery,
Mysore Medial College and Research Institute, Mysore.