Causality assessment, severity and preventability of adverse drug reactions due to first-line antitubercular agents
TB (Tuberculosis) is a common infectious disease affecting humans since very long time. Multidrug therapy with its associated adverse drug reactions is one of the major concerns for the management of TB. The current study has been conducted for identifying causality assessment, severity as well as preventability of first-line anti-tubercular agents. All the diagnosed patients of tuberculosis attending TB and chest department of tertiary care hospital of western India and received Anti-TB drugs over 6 months enrolled in the study. Demographic details, suspected drugs/groups, causality assessment, severity assessment, and preventability assessment were analyzed from reported suspected ADR (adverse drug reaction) forms. Throughout the research period of 6 months, 500 patients received Anti-TB drugs. Among them, (10%) 50 patients developed 121 adverse drug reactions. According to the WHO causality scale, 66 (54.54%) ADRs were classified as ‘probable’ and 53 (43.8%) ADR were ‘possible’. More than half of the reactions (31, 62%) were mild on the severity scale while most of the ADRs were definitely (34, 68%) preventable as per the preventability scale. Gastrointestinal system is the most common affected system (54, 47.62%) followed by dermatological disorders (26, 23.01%) and Liver and biliary system (20, 16.52%). Isoniazid (46, 38%) and Rifampicin (40, 33%) were the common cause of first-line antitubercular agents for ADRs. ADRs to antitubercular agents are a major concern for patient compliance. Patient education, intensive reporting, and management can be helpful to improve the outcome of antitubercular therapy.
Agbabiaka, T. B., SavoviÄ‡, J., & Ernst, E. (2008). Methods for causality assessment of adverse drug reactions. Drug Safety, 31(1), 21-37. https://doi.org/10.2165/00002018-200831010-00003
Ali, M.K. , Karanja, S. , Karama, M. (2017). Factors associated with tuberculosis treatment outcomes among tuberculosis patients attending tuberculosis treatment centres in 2016-2017 in Mogadishu, Somalia. Pan Africam Medical Journal,, 28,197. https://doi.org/10.11604/pamj.2017.28.197.13439
Alomar, M. J. (2014). Factors affecting the development of adverse drug reactions (Review article). Saudi Pharmaceutical Journal, 22(2), 83-94. https://doi.org/10.1016/j.jsps.2013.02.003
Anand, A., Seth, A., Paul, M., & Puri, P. (2006). Risk factors of Hepatotoxicity during anti-tuberculosis treatment. Medical Journal Armed Forces India, 62(1), 45-49. https://doi.org/10.1016/s0377-1237(06)80155-3
Farazi, A., Sofian, M., Jabbariasl, M., & Keshavarz, S. (2014). Adverse reactions to Antituberculosis drugs in Iranian tuberculosis patients. Tuberculosis Research and Treatment, 2014, 1-6. https://doi.org/10.1155/2014/412893
Francoise, B. E., ThÃ©rese, A. M., Jacques, Z. J., Ubald, O. M., Philippe, A. A., Bouba, I., Mabouang VR, S., & Emmanue, A. Z. (2019). Tuberculosis in the elderly: Epidemiology and outcomes at JAMOT Hospital of Yaounde. The Journal of Medical Research, 5(2), 65-68. https://doi.org/10.31254/jmr.2019.5206
Gupta, A., Kumar, V., Natarajan, S., & Singla, R. (2020). Adverse drug reactions & drug interactions in MDR-TB patients. Indian Journal of Tuberculosis, 67(4), S69-S78. https://doi.org/10.1016/j.ijtb.2020.09.027
Hartwig, S. C., Siegel, J., & Schneider, P. J. (1992). Preventability and severity assessment in reporting adverse drug reactions. American Journal of Health-System Pharmacy, 49(9), 2229-2232. https://doi.org/10.1093/ajhp/49.9.2229
Imam, F., Sharma, M., Khayyam, K. U., Al-Harbi, N. O., Rashid, M. K., Ali, M. D., Ahmad, A., & Qamar, W. (2020). Adverse drug reaction prevalence and mechanisms of action of first-line anti-tubercular drugs. Saudi Pharmaceutical Journal, 28(3), 316-324. https://doi.org/10.1016/j.jsps.2020.01.011
Javadi, M. R., Shalviri, G., Gholami, K., Salamzadeh, J., Maghooli, G., & Mirsaeedi, S. M. (2007). Adverse reactions of anti tuberculosis drugs in hospitalized patients: Incidence, severity and risk factors. Pharmacoepidemiology and Drug Safety, 16(10), 1104-1110. https://doi.org/10.1002/pds.1468
Lv, X., Tang, S., Xia, Y., Wang, X., Yuan, Y., Hu, D., Liu, F., Wu, S., Zhang, Y., Yang, Z., Tu, D., Chen, Y., Deng, P., Ma, Y., Chen, R., & Zhan, S. (2013). Adverse reactions due to directly observed treatment strategy therapy in Chinese tuberculosis patients: A prospective study. PLoS ONE, 8(6), e65037. https://doi.org/10.1371/journal.pone.0065037
Maciel, E. L., Guidoni, L. M., Favero, J. L., Hadad, D. J., Molino, L. P., Jonhson, J. L., & Dietze, R. (2010). Adverse effects of the new tuberculosis treatment regimen recommended by the Brazilian National Ministry of Health. Journal Brasileiro de Pneumologia, 36(2), 232-238. https://doi.org/10.1590/s1806-37132010000200012
Medra org. (2020). Introductory Guide MedDRA Version 23.0 March 2020. WHO | World Health Organization. www.who.int/https://admin.new.meddra.org/sites/default/files/guidance/file/intguide_%2023_0_English.pdf
Meng Fei, C., Zainal, H., & Hyder Ali, I. A. (2018). Evaluation of adverse reactions induced by anti-tuberculosis drugs in hospital pulau Pinang. Malaysian Journal of Medical Sciences, 25(5), 103-114. https://doi.org/10.21315/mjms2018.25.5.10
Nahid, P., Dorman, S. E., Alipanah, N., Barry, P. M., Brozek, J. L., Cattamanchi, A., Chaisson, L. H., Chaisson, R. E., Daley, C. L., Grzemska, M., Higashi, J. M., Ho, C. S., Hopewell, P. C., Keshavjee, S. A., Lienhardt, C., Menzies, R., Merrifield, C., Narita, M., O'Brien, R., â€¦ Vernon, A. (2016). Official American Thoracic Society/Centers for disease control and prevention/Infectious Diseases Society of America clinical practice guidelines: Treatment of drug-susceptible tuberculosis. Clinical Infectious Diseases, 63(7), e147-e195. https://doi.org/10.1093/cid/ciw376
Ohkawa, K., Hashiguchi, M., Ohno, K., Kiuchi, C., Takahashi, S., Kondo, S., Echizen, H., & Ogata, H. (2002). Risk factors for antituberculous chemotherapy induced hepatotoxicity in Japanese pediatric patients. Clinical Pharmacology & Therapeutics, 72(2), 220-226. https://doi.org/10.1067/mcp.2002.126175
Rademaker, M. (2001). Do women have more adverse drug reactions? American Journal of Clinical Dermatology, 2(6), 349-351. https://doi.org/10.2165/00128071-200102060-00001
Saqib, A., Sarwar, M. R., Sarfraz, M., & Iftikhar, S. (2018). Causality and preventability assessment of adverse drug events of antibiotics among inpatients having different lengths of hospital stay: A multicenter, cross-sectional study in Lahore, Pakistan. BMC Pharmacology and Toxicology, 19(1). https://doi.org/10.1186/s40360-018-0222-5
Schumock, G.T., Thornton, J.P. (1992) Focusing on the preventability of adverse drug reactions. Hospital Pharmacy, 27(6),538.
Sevilla-Sanchez, D., Molist-Brunet, N., AmblÃ s-Novellas, J., Roura-Poch, P., Espaulella-Panicot, J., & Codina-JanÃ©, C. (2016). Adverse drug events in patients with advanced chronic conditions who have a prognosis of limited life expectancy at hospital admission. European Journal of Clinical Pharmacology, 73(1), 79-89. https://doi.org/10.1007/s00228-016-2136-8
Sriram, S., Senthilvel, N., (2013). Detection, Monitoring and Assessment of Adverse Drug Reactions at a Private Corporate Hospital. International Journal of Science and Research, 4,851-5.
Sharma, S. K., Balamurugan, A., Saha, P. K., Pandey, R. M., & Mehra, N. K. (2002). Evaluation of clinical and Immunogenetic risk factors for the development of Hepatotoxicity during Antituberculosis treatment. American Journal of Respiratory and Critical Care Medicine, 166(7), 916-919. https://doi.org/10.1164/rccm.2108091
Sundaran, S., Udayan, A., Hareendranath, K., Eliyas, B., Ganesan, B., Hassan, A., Subash, R., Palakkal, V., & Salahudeen, M. (2018). Study on the classification, causality, preventability and severity of adverse drug reaction using spontaneous reporting system in hospitalized patients. Pharmacy, 6(4), 108. https://doi.org/10.3390/pharmacy6040108
Talpur, B., Laghari, M., Syed Sulaiman, S., Khan, A., & Bhatti, Z. (2020). Adverse drug reactions of anti-tuberculosis treatment among children with tuberculosis. International Journal of Mycobacteriology, 9(3), 281. https://doi.org/10.4103/ijmy.ijmy_75_20
WHO. (2019). Global Tuberculosis Report 2019. Geneva: World Health Organization; 2019. https://apps.who.int/iris/bitstream/handle/10665/329368/9789241565714-eng.pdf?ua=1(
WHO. (2013). 12. The use of the WHO-UMC system for standardized case causality assessment. UMC | Uppsala Monitoring Centre. https://www.who-umc.org/Graphics/24734.pdf
Wondwossen Abera, Waqtola Cheneke, & Gemeda Abebe. (2016). Incidence of antituberculosis-drug-induced hepatotoxicity and associated risk factors among tuberculosis patients in Dawro zone, south Ethiopia: A cohort study. International Journal of Mycobacteriology, 5(1), 14-20. https://doi.org/10.1016/j.ijmyco.2015.10.002
Yang, M., Pan, H., Lu, L., He, X., Chen, H., Tao, B., Liu, W., Yi, H., & Tang, S. (2019). Home-based anti-tuberculosis treatment adverse reactions (HATTAR) study: A protocol for a prospective observational study. BMJ Open, 9(3), e027321. https://doi.org/10.1136/bmjopen-2018-027321
- There are currently no refbacks.
Copyright (c) 2022 Dr. Gunjan Upadhyay, Dr. Apexa B Shukla, Darshan J Dave
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.
Office: Faculty of Pharmacy, Universitas Ahmad Dahlan
Jl. Prof. Dr. Soepomo, S.H., Janturan, Warungboto, Umbulharjo, Yogyakarta, Indonesia
Kode pos 55164