Search

Background: India accounts for 2.42 million new Tuberculosis cases in 2022. Treatment adherence is major challenge, ADRs being one of the main causes of poor adherence. Early identification and addressing of ADRs can improve adherence, reducing associated morbidity and drug resistance. With introduction of daily FDC regimen in India, we intend to study incidence of ADRs and their determinants among Pulmonary TB patients who are on FDC daily regimen. Methodology: Newly diagnosed drug-sensitive PTB patients aged 18 years and above were recruited. A pretested questionnaire was administered and patients were followed up to document ADRs. Causality and severity were assessed using the WHO-UMC scale and Hartwig’s severity assessment scale respectively. Results: Among the study participants’, 95 (78.5%) developed any ADRs. Incidence rate was 13.2 (6.98–19.22) per 100-person month follow-up with GI symptoms being most common. Increasing age [OR=4.7(1.6–14.8)] and weight [OR=5.1(1.3–16.2)] were found to be significantly associated with ADRs. All ADRs were classified as ‘probable’ and ‘mild’ in nature according to WHO scale and Hartwig’s severity assessment scale respectively. Conclusion: Occurrence of ADRs is common, most of them are mild, and occurring in intensive phase. Hence, early identification and appropriate counselling during intensive phase is critical.

Background: The Pharmacovigilance Program of India recommends the use of the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) scale, while many clinicians prefer the Naranjo algorithm for its simplicity. In the present study, we assessed agreement between the two widely used causality assessment scales, that is, the WHO-UMC criteria and the Naranjo algorithm. Materials and Methods: In this study, 842 individual case safety reports were randomly selected from 1000 spontaneously reported forms submitted to the ADR Monitoring Center at a tertiary healthcare Institute in Central India between 2016 and 2018. Two well-trained independent groups performed the causality assessment. One group performed a causality assessment of the 842 ADRs using the WHO-UMC criteria and the other group performed the same using the Naranjo algorithm. The agreement between two ADR causality scales was assessed using the weighted kappa (κ) test. Results: Cohen's kappa coefficient (κ) statistical test was applied between the two scales (WHO-UMC scale and Naranjo algorithm) to find out the agreement between these two scales. “No” agreement was found between the two scales {Kappa statistic with 95% confidence interval = 0.048 (P < 0.001)}. Conclusion: There was no agreement found between the WHO-UMC criteria and the Naranjo algorithm in our study.

Background: The Pharmacovigilance Program of India recommends the use of the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) scale, while many clinicians prefer the Naranjo algorithm for its simplicity. In the present study, we assessed agreement between the two widely used causality assessment scales, that is, the WHO-UMC criteria and the Naranjo algorithm. Materials and Methods: In this study, 842 individual case safety reports were randomly selected from 1000 spontaneously reported forms submitted to the ADR Monitoring Center at a tertiary healthcare Institute in Central India between 2016 and 2018. Two well-trained independent groups performed the causality assessment. One group performed a causality assessment of the 842 ADRs using the WHO-UMC criteria and the other group performed the same using the Naranjo algorithm. The agreement between two ADR causality scales was assessed using the weighted kappa (κ) test. Results: Cohen's kappa coefficient (κ) statistical test was applied between the two scales (WHO-UMC scale and Naranjo algorithm) to find out the agreement between these two scales. "No" agreement was found between the two scales {Kappa statistic with 95% confidence interval = 0.048 (P < 0.001)}. Conclusion: There was no agreement found between the WHO-UMC criteria and the Naranjo algorithm in our study. [ABSTRACT FROM AUTHOR]