Study of adverse drug reactions in tuberculosis patients under rntcp dots in tertiary teaching hospital

Introduction: Tuberculosis is one of the leading causes of deaths worldwide. DOTS is a measure implemented under RNTCP with STOP TB STRATEGY to control the rise of incidences of all types of tuberculosis cases. It comprises of multidrug regimen treatment for longer duration of time. Almost every anti tubercular drug is associated with some or the other adverse drug reaction (ADR’s). Patients decision to stop the treatment were influenced majorly by adverse drugreactions occurring during the treatment and also because of lack of knowledge regarding the adverse drug reactions and the importance of early reporting at the first sign and symptom of its occurrence to the treating physician. In view of above we undertook the present study to evaluate the burden of adverse drug reactions due to tuberculosis treatment in our hospital, we also tried to evaluate the cause of adverse drug reactions in these patients. Material and methods: A total number of 100 patients were included in the study from the pulmonary medicine department of D.Y. Patil University School of Medicine and hospital for period of 11 months. Those patients who fulfilled the inclusion criteria of the study were taken into the study after obtaining a written informed consent form. The case record files of patient included in the study were scrutinized and statistically analyzed using frequency and percentages. Causality and Severity was analyzed using Naranjo’s causality scale and Modified Hartwig’s and Siegel scale. No laboratory parameters analysis was done to assess the adverse drug reaction or to find the cause of the reaction. The causal drug for any adverse reaction was evaluated with the help of treating physician and the findings of causal drug were purely knowledge based. Results: 75% of patients had ADR’s. Females were more affected with adverse drug reaction during the treatment as compared to males. Majority of study population was in the age group of 30-40years and high no. of adverse drug reaction was observed in the age group of 20-40 years of age. There was no association of alcohol intake, smoking or tobacco use in occurrence of adverse drug reaction.44% of total population had suffered from ADR in the intensive phase of treatment and 14% in the continuation phase. Vomiting was the most common adverse drug reaction seen in patients with almost 24% of patients suffering from it. GIT was the most common system involved. Isoniazid was found to be the most common drug responsible for majority of adverse drug reactions. 60% of patients out of the total suffering from ADR required management of ADR by the treating physician. 54% of patients scored Probable causality assessed and treated by the treating physician Majority of Patients i.e. 84% had ADR of mild severity. Conclusion: Anti TB drugs may cause high incidences of adverse drug reactions resulting in non-compliance and sometimes stoppage of treatment. This leads to increase in mortality and morbidity. The study concluded that there is high burden of adverse drug reactions among patients taking ant tubercular drugs. Early detection of adverse drug reactions and its notification to the treating physician is very important for early remission and patient compliance. Counseling of patients for early detection, prevention and management of adverse drug reaction is highly suggestive.