scholarly journals Adverse Drug Reactions Monitoring in Patients on Antitubercular Treatment in Tertiary Care Hospital, Mandya

2021 ◽  
Vol 14 (02) ◽  
pp. 701-708
Author(s):  
Kiran M ◽  
Nagabushan H

Background: Tuberculosis is one of the major public health concerns in India. Treatment of tuberculosis need multidrug combinations, which is associated with increased incidence of adverse drug reactions (ADRs). Hence there is a need of active monitoring for adverse effects in patients who are on antitubercular treatment (ATT). Objectives: To study the pattern of ADRs caused by antitubercular drugs and to assess causality, severity and predisposing factors. Methodology: A prospective observational study was conducted for 6 months in tertiary care hospital of Mandya. A total of 74 patients of tuberculosis who experienced ADRs were included in the study after obtaining informed consent. Their demographic, treatment and ADR data were collected and analysed. Causality was assessed using WHO scale and Naranjo’s algorithm, whereas severity was assessed by Modified Hartwig and Siegel scale. Results: Among 74 patients, 55(74.32%) were males and 19 (25.67%) were females. A total of 86 ADRs were recorded amongst 74 patients, as 11 patients experienced two ADRs. During intensive and continuation phase of treatment, 65 (87.63%) and 9 (12.16%)patients experienced ADRs respectively. Gastrointestinal side effects and hepatotoxicity were the most frequently observed ADRs with 23 (26.7%) each, followed by pruritus and rashes in 18 (20.93%) patients.63.51% of ADRs had an association with fixed dose combination (FDC) of isoniazid, rifampicin, pyrazinamide and ethambutol. As per WHO scale and Naranjo’s algorithm majority of ADRs were probable with 44 (59.45%) and 58 (78.37%) respectively. Most of the ADRs belonged to mild (67.56%) category as per Modified Hartwig and Siegel scale. Conclusion: ADRs induced by ATT are common. Hence counselling of patients regarding their life style along with early detection and management will minimize the occurrence of ADRs and improvethe adherence to treatment.

2013 ◽  
Vol 7 (5) ◽  
pp. 384-388
Author(s):  
Harmeet S. Rehan ◽  
Deepti Chopra ◽  
Ravinder K. Sah ◽  
Ritu Mishra

Author(s):  
Gajanan P. Kulkarni ◽  
Lokesh V. Patil

Objective: To assess ADRs with reference to causative drugs, organ systems involved and seriousness of reactions.Methods: A prospective study conducted over a period of 1 y. The spontaneous adverse drug reactions reported between July 2016 and July 2017 at AMC centre BRIMS, Bidar were analyzed using Naranjo’s scale. Causality assessment of suspected drugs involved, system affected, and seriousness of reactions was assessed.Results: GIT system was most commonly involved, followed by generalized features, skin and appendages, CNS i. e, extrapyramidal system and dizziness, hearing and vestibular systems.Conclusion: Majority of the ADRs reported were mild to moderate severity and 20% can be categorized as severe reactions, which needed to treat under hospitalization


2020 ◽  
Vol 61 (10) ◽  
pp. 875 ◽  
Author(s):  
Jung Eun Lee ◽  
Kang Ryul Min ◽  
Soo Hyun Kim ◽  
Alec Hyungtack Kim ◽  
Seong Taek Kim

Author(s):  
Mirza Shiraz Baig ◽  
Monali Raghunath Kale ◽  
Avinash Lamb

Background: The emergence of drug resistant mycobacteria has become a significant public health problem world over creating an obstacle to effective TB control. ADRs are common in patients of MDR-TB on DOTs-Plus drug regimen. Present study was carried out in tertiary care hospital. Identification of types and frequency of adverse drug reactions in Intensive and continuation phase of MDR-TB Patients.Methods: It was a prospective observational study conducted in Department of TB- Chest and Medicine, Govt. Medical College, Aurangabad, Maharashtra, India. All the MDR-TB patients admitted at the directly observed treatment, short course plus (DOTS plus) Center at Medical College Hospital were enrolled and were monitored for ADRs. The causality and severity of the reactions were determined using Naranjo algorithm and Hartwig questionnaire, respectively.Results: A total of 121 tuberculosis patients of MDR-TB on DOTS therapy were enrolled for the study. Out of 121 patients, 13 were dropouts, 6 died, 7 defaulted so 108 patients assessed for ADRs, 48 patients developed 61 (56.48%) adverse drug reactions. The higher numbers of ADRs were observed in age group 31-40yrs followed by 21-30yrs which were more common in men. Majority of adverse drug reactions were Gastrointestinal (GI) problems 32 (52.45%), followed by Ototoxicity 7 (11.48%) and Psychiatric Manifestations 6 (9.84%) and skin problems 3 (4.92%). On evaluation of the causality of ADRs, majority were found to be Possible (59.02%). The severity assessment showed that most of the patients ADRs were of moderate level (50.82%).Some patients required treatment withdrawal and replacement with other drug and most of the patients were managed with supportive medication without removing anti-tubercular drug from their treatment regimen.Conclusions: ADRs are major factor limiting completion of drug therapy under RNTCP and occurrence of drug resistance which requires attention of all health care professionals.


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