Adverse events among pulmonary drug-resistant tuberculosis patients in Banten, Indonesia

  • Mita Restinia Department of Pharmacy, Faculty of Health Sciences, Universitas Islam Negeri Syarif Hidayatullah Jakarta, Tangerang Selatan, Banten, 15419, Indonesia
  • Alyya Siddiqa Department of Pharmacology, Faculty of Medicine, Universitas Islam Negeri Syarif Hidayatullah Jakarta, Tangerang Selatan, Banten, 15419, Indonesia
  • Wulan Purnama Sari Department of Pharmacy, Faculty of Health Sciences, Universitas Islam Negeri Syarif Hidayatullah Jakarta, Tangerang Selatan, Banten, 15419, Indonesia
DOI: https://doi.org/10.35814/jifi.v23i1.1704

Abstract

Drug-resistant Tuberculosis (DR-TB) treatment requires an extended duration, making adverse events (AEs) a common concern. This study aimed to assess the frequency of AEs, time to events, and their association with treatment outcomes among DR- pulmonary TB patients. A retrospective cohort study was conducted on patients aged >18 years at one of public hospitals at Tangerang, Banten, Indonesia, from March 2021 to May 2023. Bivariate analysis was used to analyze the association between AEs and treatment outcomes. Among 53 patients included in the study, all experienced at least one AEs. Number of AEs mean ± SD; 9.724 ± 4.86. Mild AEs were reported in 100% of patients, while 75.5% experienced moderate AEs, and 81.1% experienced severe AEs. The most common AEs included nausea (90.6%), anemia (73.6%), vomiting (62.3%), decreased appetite (60.4%), and joint pain (60.4%). The AEs were frequently reported during intensive phase (4-6 months). AEs have association with treatment outcome (P<0.05).  The frequency of AE among DR-TB patients was high. Early detection and effective management of AEs are essential to improving treatment outcomes for DR-TB patients.

References

[1] World Health Organization, Global tuberculosis report 2023. Geneva: World Health Organization, 2023.

[2] M. Restinia, S. Khairani, and R. Manninda, "Risk factors causing multi-drug resistant tuberculosis: a systematic review," Pharmaceutical and Biomedical Science Journal, vol. 3, no. 1, pp. 9-16, 2021.

[3] World Health Organization, WHO consolidated guidelines on tuberculosis: module 4: treatment: drug-resistant tuberculosis treatment, 2022 update ed. Geneva: World Health Organization, 2022.

[4] Y. Zhang et al., "Adverse events associated with treatment of multidrug-resistant tuberculosis in China: an ambispective cohort study," Med Sci Monit, vol. 23, pp. 2348-2356, 2017.

[5] A. S. D. L. P. S. H. M. S. M. S. Mugusi, "Prevalence and predictors of adverse events among patients receiving Multi-Drug Resistant Tuberculosis treatment at Kibong’oto Infectious Disease Hospital, Tanzania: a retrospective study,” Tanzania Journal of Health Research, vol. 24, no. 2, pp. 107–120, 2023.

[6] A. Massud, S. A. Syed Sulaiman, N. Ahmad, M. Shafqat, L. Chiau Ming, and A. H. Khan, "Frequency and management of adverse drug reactions among drug-resistant tuberculosis patients: analysis from a prospective study," Front Pharmacol, vol. 13, p. 883483, 2022.

[7] M. Atif et al., "Frequency and factors associated with adverse events among multi-drug resistant tuberculosis patients in Pakistan: a retrospective study," Frontiers in Medicine, Original Research vol. 8, 2022-March-01 2022, doi: 10.3389/fmed.2021.790718.

[8] Y. Jiang et al., "Factors associated with loss to follow-up before and after treatment initiation among patients with tuberculosis: A 5-year observation in China," Front Med (Lausanne), vol. 10, p. 1136094, 2023.

[9] Ministry of Health, 2019.

[10] D. E. S. Marsh, "Drug Allergies," 2023. [Online]. Available: Retrieved from https://www.msdmanuals.com/home/drugs/adverse-drug-reactions/severity-of-adverse-drug-reactions.

[11] World Health Organization, The WHO Document Production Service.Communicable Diseases, Cluster Communicable Diseases, Cluster, Companion handbook to the WHO guidelines for the programmatic management of drug-resistant tuberculosi, Geneva, Switzerland: WHO, 2014.

[12] World Health Organization, WHO operational handbook on tuberculosis: module 6: tuberculosis and comorbidities, 2nd ed. Geneva: World Health Organization, 2024.

[13] A. A. Ganiyu, Y.K.Avong, A. Akinyede, O. Ige, O. El tayeb, F. Taleatu, A. Omayeka, V. Babawale. and I. Oreagba, "Prevalence of Adverse drug reactions to second line anti tuberculosis drugs in Nigeria: a cross-sectional study,"Journal of Tuberculosis Research, vol. 9, pp. 90-102., 2021.

[14] A. Jakasania et al., "Side effects--part of the package": a mixed methods approach to study adverse events among patients being programmatically treated for DR-TB in Gujarat, India," BMC Infect Dis, vol. 20, no. 1, p. 918, Dec 2 2020.

[15] N. B. Ngoc et al., "Active surveillance for adverse events in patients on longer treatment regimens for multidrug-resistant tuberculosis in Viet Nam," PLOS ONE, vol. 16, no. 9, p. e0255357, 2021.

[16] N. Ahmad, A. Javaid, S. A. Syed Sulaiman, A. K. Afridi, Zainab, and A. H. Khan, "Occurrence, management, and risk factors for adverse drug reactions in multidrug resistant tuberculosis patients," Am J Ther, vol. 25, no. 5, pp. e533-e540, 2018.

[17] F. U. Khan et al., "Assessment of adverse drug events, their risk factors, and management among patients treated for multidrug-resistant TB: A prospective cohort study from Pakistan," Front Pharmacol, vol. 13, p. 876955, 2022.

[18] P. M. Ategyeka et al., "Prevalence and factors associated with reported adverse-events among patients on multi-drug-resistant tuberculosis treatment in two referral hospitals in Uganda," BMC Infect Dis, vol. 23, no. 1, p. 149, 2023.

[19] A. Gupta, V. Kumar, S. Natarajan, and R. Singla, "Adverse drug reactions & drug interactions in MDR-TB patients," Indian J Tuberc, vol. 67, no. 4s, pp. 69-78, 2020.

[20] F. Mirzayev et al., "World Health Organization recommendations on the treatment of drug-resistant tuberculosis, 2020 update," European Respiratory Journal, vol. 57, no. 6, p. 2003300, 2021.

[21] A. I. Dela, N. K. D. Tank, A. P. Singh, and K. G. Piparva, "Adverse drug reactions and treatment outcome analysis of DOTS-plus therapy of MDR-TB patients at district tuberculosis centre: A four year retrospective study," Lung India, vol. 34, no. 6, pp. 522-526, 2017.

[22] H. Aslam et al., "Treatment outcomes and adverse drug reactions among patients with drug–resistant tuberculosis receiving all-oral, long–term regimens: First record viewing report from Pakistan," Asian Pacific Journal of Tropical Medicine, vol. 16, no. 2, pp. 58-64, 2023.

[23] R. Prasad, A. Singh, and N. Gupta, "Adverse drug reactions in tuberculosis and management," Indian J Tuberc, vol. 66, no. 4, pp. 520-532, 2019.

[24] K. Schnippel et al., "Severe adverse events during second-line tuberculosis treatment in the context of high HIV Co-infection in South Africa: a retrospective cohort study," BMC Infect Dis, vol. 16, no. 1, p. 593, 2016.

[25] J. Lecai, P. Mijiti, H. Chuangyue, G. Qian, T. Weiguo, and C. Jihong, "Treatment outcomes of multidrug-resistant tuberculosis patients receiving ambulatory treatment in Shenzhen, China: a retrospective cohort study," Frontiers in Public Health, Original Research vol. 11, 2023,.
Published
2025-04-30
How to Cite
RESTINIA, Mita; SIDDIQA, Alyya; SARI, Wulan Purnama. Adverse events among pulmonary drug-resistant tuberculosis patients in Banten, Indonesia. JURNAL ILMU KEFARMASIAN INDONESIA, [S.l.], v. 23, n. 1, p. 83-91, apr. 2025. ISSN 2614-6495. Available at: <http://jifi.farmasi.univpancasila.ac.id/index.php/jifi/article/view/1704>. Date accessed: 04 may 2025. doi: https://doi.org/10.35814/jifi.v23i1.1704.
Citation Formats
Issue
Vol 23 No 1 (2025): JIFI In press
Section
Articles
Creative Commons License

This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.

Licencing
All articles in Jurnal Ilmu Kefarmasian Indonesia are an open-access article, distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License which permits unrestricted non-commercial used, distribution and reproduction in any medium.

This licence applies to Author(s) and Public Reader means that the users mays :

  • SHARE:
    copy and redistribute the article in any medium or format
  • ADAPT:
    remix, transform, and build upon the article (eg.: to produce a new research work and, possibly, a new publication)
  • ALIKE:
    If you remix, transform, or build upon the article, you must distribute your contributions under the same license as the original.
  • NO ADDITIONAL RESTRICTIONS:
    You may not apply legal terms or technological measures that legally restrict others from doing anything the license permits.

It does however mean that when you use it you must:

  • ATTRIBUTION: You must give appropriate credit to both the Author(s) and the journal, provide a link to the license, and indicate if changes were made. You may do so in any reasonable manner, but not in any way that suggests the licensor endorses you or your use.

You may not:

  • NONCOMMERCIAL: You may not use the article for commercial purposes.

Creative Commons License

This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.