Characteristics and contributing factors of adverse drug reactions: an analytical study of patients with tuberculosis receiving treatment under the National TB Program of India [version 2; peer review: 1 approved, 2 approved with reservations, 1 not approved]
Background Tuberculosis (TB) continues to pose a serious threat to the public health system in India. Although the National Tuberculosis Elimination Program (NTEP) is providing a wide range of interventions from early diagnosis to complete treatment to reduce morbidity and mortality from TB, adverse...
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F1000 Research Ltd
2024-07-01
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| author | Jay Patel Priya Bhavsar Harsh Shah Sandul Yasobant Deepak Saxena Anish Sinha Somen Saha Yogesh Patel |
| author_facet | Jay Patel Priya Bhavsar Harsh Shah Sandul Yasobant Deepak Saxena Anish Sinha Somen Saha Yogesh Patel |
| author_sort | Jay Patel |
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| description | Background Tuberculosis (TB) continues to pose a serious threat to the public health system in India. Although the National Tuberculosis Elimination Program (NTEP) is providing a wide range of interventions from early diagnosis to complete treatment to reduce morbidity and mortality from TB, adverse drug reactions (ADR) remain a challenge in treatment adherence and completion. Methods An observational cross-sectional study was conducted in selected districts of Gujarat state. A total of 593 reported TB patients were recruited with an adjusted unified distribution based on the type of cases, site of diseases, and service facility through a simple random sampling method. A semi-structured questionnaire tool was used to collect socio-demographic, clinical, and ADR-related data from the TB patients. Data was analyzed for the frequency, percentage, chi-squared, and adjusted odds ratio to find the association between the variables. Results The majority of the study participants were male (87.2%), aged 15 to 60 (57.8%), daily laborers (22.4%), and married (64.2%). Over 75% of individuals had pulmonary TB, with 87% having experienced their first episode, 83% being new cases, and 44.7% having a history of addiction. ADR with mild symptoms was reported by more than a quarter (29%) of TB patients during the intensive phase (77%). The association between ADR experience and drug susceptibility was significant (p<0.005) and drug-resistant TB patients experience two times more ADRs than drug-sensitive TB patients (OR 2.04). Binomial logistic regression was carried out to describe the association between various variables and occurrence of ADRs. Conclusion The study highlighted a need to enhance health care providers’ capacity and program structure for managing ADRs among TB patients. In order to completely eliminate TB across the country, it also emphasized the attention for a holistic and all-encompassing strategy for managing TB patients at the field level. |
| format | Article |
| id | doaj-art-efae2cf99ba44b45bf6a7d071f557d1e |
| institution | Kabale University |
| issn | 2046-1402 |
| language | English |
| publishDate | 2024-07-01 |
| publisher | F1000 Research Ltd |
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| series | F1000Research |
| spelling | doaj-art-efae2cf99ba44b45bf6a7d071f557d1e2025-02-11T01:00:00ZengF1000 Research LtdF1000Research2046-14022024-07-0111169379Characteristics and contributing factors of adverse drug reactions: an analytical study of patients with tuberculosis receiving treatment under the National TB Program of India [version 2; peer review: 1 approved, 2 approved with reservations, 1 not approved]Jay Patel0https://orcid.org/0000-0003-1486-0821Priya Bhavsar1Harsh Shah2https://orcid.org/0000-0003-3349-7562Sandul Yasobant3https://orcid.org/0000-0003-1770-8745Deepak Saxena4Anish Sinha5Somen Saha6https://orcid.org/0000-0002-8043-3388Yogesh Patel7Department of Public Health Science, Indian Institute of Public Health, Gandhinagar, Gandhinagar, Gujarat, 382042, IndiaDepartment of Public Health Science, Indian Institute of Public Health, Gandhinagar, Gandhinagar, Gujarat, 382042, IndiaDepartment of Public Health Science, Indian Institute of Public Health, Gandhinagar, Gandhinagar, Gujarat, 382042, IndiaDepartment of Public Health Science, Indian Institute of Public Health, Gandhinagar, Gandhinagar, Gujarat, 382042, IndiaDepartment of Public Health Science, Indian Institute of Public Health, Gandhinagar, Gandhinagar, Gujarat, 382042, IndiaDepartment of Public Health Science, Indian Institute of Public Health, Gandhinagar, Gandhinagar, Gujarat, 382042, IndiaDepartment of Public Health Science, Indian Institute of Public Health, Gandhinagar, Gandhinagar, Gujarat, 382042, IndiaDepartment of CGC Project, World Health Partners, Noida, Uttar Pradesh, 201301, IndiaBackground Tuberculosis (TB) continues to pose a serious threat to the public health system in India. Although the National Tuberculosis Elimination Program (NTEP) is providing a wide range of interventions from early diagnosis to complete treatment to reduce morbidity and mortality from TB, adverse drug reactions (ADR) remain a challenge in treatment adherence and completion. Methods An observational cross-sectional study was conducted in selected districts of Gujarat state. A total of 593 reported TB patients were recruited with an adjusted unified distribution based on the type of cases, site of diseases, and service facility through a simple random sampling method. A semi-structured questionnaire tool was used to collect socio-demographic, clinical, and ADR-related data from the TB patients. Data was analyzed for the frequency, percentage, chi-squared, and adjusted odds ratio to find the association between the variables. Results The majority of the study participants were male (87.2%), aged 15 to 60 (57.8%), daily laborers (22.4%), and married (64.2%). Over 75% of individuals had pulmonary TB, with 87% having experienced their first episode, 83% being new cases, and 44.7% having a history of addiction. ADR with mild symptoms was reported by more than a quarter (29%) of TB patients during the intensive phase (77%). The association between ADR experience and drug susceptibility was significant (p<0.005) and drug-resistant TB patients experience two times more ADRs than drug-sensitive TB patients (OR 2.04). Binomial logistic regression was carried out to describe the association between various variables and occurrence of ADRs. Conclusion The study highlighted a need to enhance health care providers’ capacity and program structure for managing ADRs among TB patients. In order to completely eliminate TB across the country, it also emphasized the attention for a holistic and all-encompassing strategy for managing TB patients at the field level.https://f1000research.com/articles/11-1388/v2Tuberculosis Adverse Drug Reactions National TB Program Indiaeng |
| spellingShingle | Jay Patel Priya Bhavsar Harsh Shah Sandul Yasobant Deepak Saxena Anish Sinha Somen Saha Yogesh Patel Characteristics and contributing factors of adverse drug reactions: an analytical study of patients with tuberculosis receiving treatment under the National TB Program of India [version 2; peer review: 1 approved, 2 approved with reservations, 1 not approved] F1000Research Tuberculosis Adverse Drug Reactions National TB Program India eng |
| title | Characteristics and contributing factors of adverse drug reactions: an analytical study of patients with tuberculosis receiving treatment under the National TB Program of India [version 2; peer review: 1 approved, 2 approved with reservations, 1 not approved] |
| title_full | Characteristics and contributing factors of adverse drug reactions: an analytical study of patients with tuberculosis receiving treatment under the National TB Program of India [version 2; peer review: 1 approved, 2 approved with reservations, 1 not approved] |
| title_fullStr | Characteristics and contributing factors of adverse drug reactions: an analytical study of patients with tuberculosis receiving treatment under the National TB Program of India [version 2; peer review: 1 approved, 2 approved with reservations, 1 not approved] |
| title_full_unstemmed | Characteristics and contributing factors of adverse drug reactions: an analytical study of patients with tuberculosis receiving treatment under the National TB Program of India [version 2; peer review: 1 approved, 2 approved with reservations, 1 not approved] |
| title_short | Characteristics and contributing factors of adverse drug reactions: an analytical study of patients with tuberculosis receiving treatment under the National TB Program of India [version 2; peer review: 1 approved, 2 approved with reservations, 1 not approved] |
| title_sort | characteristics and contributing factors of adverse drug reactions an analytical study of patients with tuberculosis receiving treatment under the national tb program of india version 2 peer review 1 approved 2 approved with reservations 1 not approved |
| topic | Tuberculosis Adverse Drug Reactions National TB Program India eng |
| url | https://f1000research.com/articles/11-1388/v2 |
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