A STUDY TO ASSESS THE PREVALENCE OF ADVERSE DRUG REACTIONS AMONG PATIENTS TREATED WITH CATEGORY IV RNTCP REGIMEN AT DOTS PLUS SITE

Main Article Content

Danish Shaikh Qureshi
Anusha Vohra
Mohd Khalid Karigar
Mohammed Shoaib

Keywords

Prevalence, ADR, RNTCP, PMDT, DOTS

Abstract

India is the highest TB burden country in the world and accounts for nearly one fifth of global burden of tuberculosis. The prevalence is found to be at a low level in most of the country where it has been studied. Management of adverse drug reactions has a major role in treatment adherence and patient compliance. This was a hospital based analytical type of observational study and the confirmed cases of Multidrug Resistant Pulmonary Tuberculosis patients from various Tuberculosis Unit under PMDT site. This study was conducted using face to face administered questionnaires. Total 82.5 % patients show one or the other ADR while 17.5 % shows no ADR and average no. of events per patient=5.275. According to our findings in this prospective cohort study, there was no increased risk of TB-drug adverse events with the advancement of age. A higher percentage of female patients (91.7%) than the male (80.9%) patients experienced the ADR. study shows that DOTS Plus treatment is an effective and safe treatment strategy as most of the adverse drug reactions noted were of a mild variety and were managed with symptomatic medications.

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References

1. https://tbcindia.gov.in/WriteReadData/l892s/5704399160Annual%20Report%20TB%202006.pdf
2. Paramasivam C N 1998 An overview of drug resistant tuberculosis in India; Indian J. Tubercul.
3. Soyam, Vishal & Boro, Pallavi. (2015). Newer initiatives in revised national tuberculosis control programme and its current implementation status. Asian Journal of Medical Sciences. 6. 10.3126/ajms.v6i5.11945.
4. Forson A, Kudzawu S, Kwara A, Flanigan T. High Frequency of First-Line Anti-Tuberculosis Drug Resistance among Persons with Chronic Pulmonary Tuberculosis at a Teaching Hospital Chest Clinic. Ghana Med J. 2010 Jun; 44(2):42-6. doi: 10.4314/gmj.v44i2.68858. PMID: 21327002; PMCID: PMC2994151.
5. Nathanson, E & Gupta, Rajesh & Huamani, P & Leimane, Vaira & Pasechnikov, AD & Tupasi, Thelma & Vink, K & Jaramillo, E & Espinal, M. (2004). Adverse events in the treatment of multidrug-resistant tuberculosis: Results from the DOTS-Plus initiative. The international journal of tuberculosis and lung disease: the official journal of the International Union against Tuberculosis and Lung Disease. 8. 1382-4.
6. Paikray E, Das P, Pattnaik M, Mishra V. Adverse Drug Reaction Monitoring in Multidrug-Resistant Tuberculosis Patients Receiving Bedaquiline and Delamanid-Based Regimen. Cureus. 2022 Oct 27;14(10):e30764. doi: 10.7759/cureus.30764. PMID: 36447692; PMCID: PMC9701089.
7. Pablos-Mendez A, Raviglione MC, Battan R, Ramos-Zuniga R. Drug resistant tuberculosis among the homeless in New York City. N Y State J Med. 1990 Jul;90(7):351-5. PMID: 2117263. Pablos-Mendez A, Raviglione MC, Battan R, Ramos-Zuniga R. Drug resistant tuberculosis among the homeless in New York City. N Y State J Med. 1990 Jul;90(7):351-5. PMID: 2117263.
8. Kashyap RS, Nayak AR, Husain AA, Shekhawat SD, Satav AR, Jain RK, Raje DV, Daginawala HF, Taori GM. Impact of socioeconomic status and living condition on latent tuberculosis diagnosis among the tribal population of Melghat: A cohort study. Lung India. 2016 Jul-Aug;33(4):372-80. doi: 10.4103/0970-2113.184868. PMID: 27578928; PMCID: PMC4948223.
9. Mitchell SJ, Kane AE, Hilmer SN. Age-related changes in the hepatic pharmacology and toxicology of paracetamol. Curr Gerontol Geriatr Res. 2011;2011:624156. doi: 10.1155/2011/624156. Epub 2011 May 11. PMID: 21765826; PMCID: PMC3135080.
10. Hilmer, Sarah & Shenfield, Gillian & Couteur, David. (2005). Clinical implications of changes in hepatic drug metabolism in older people. Therapeutics and clinical risk management. 1. 151-6. 10.2147/tcrm.1.2.151.62914.
11. Fei CM, Zainal H, Ali IAH. Evaluation of Adverse Reactions Induced by Anti-Tuberculosis Drugs in Hospital Pulau Pinang. Malays J Med Sci. 2018 Sep;25(5):103-114. doi: 10.21315/mjms2018.25.5.10. Epub 2018 Oct 30. PMID: 30914867; PMCID: PMC6419878.
12. Singh H, Dulhani N, Kumar B, Singh P, Tewari P, Nayak K. A pharmacovigilance study in medicine department of tertiary care hospital in chhattisgarh (jagdalpur), India. J Young Pharm. 2010 Jan;2(1):95-100. doi: 10.4103/0975-1483.62222. PMID: 21331200; PMCID: PMC3035895.
13. Guo Y, Tian X, Wang X, Xiao Z. Adverse Effects of Immunoglobulin Therapy. Front Immunol. 2018 Jun 8;9:1299. doi: 10.3389/fimmu.2018.01299. PMID: 29951056; PMCID: PMC6008653.
14. Yang TW, Park HO, Jang HN, Yang JH, Kim SH, Moon SH, Byun JH, Lee CE, Kim JW, Kang DH. Side effects associated with the treatment of multidrug-resistant tuberculosis at a tuberculosis referral hospital in South Korea: A retrospective study. Medicine (Baltimore). 2017 Jul;96(28):e7482. doi: 10.1097/MD.0000000000007482. PMID: 28700490; PMCID: PMC5515762.
15. Hong H, Dowdy DW, Dooley KE, Francis HW, Budhathoki C, Han HR, Farley JE. Risk of hearing loss among multidrug-resistant tuberculosis patients according to cumulative aminoglycoside dose. Int J Tuberc Lung Dis. 2020 Jan 1;24(1):65-72. doi: 10.5588/ijtld.19.0062. PMID: 32005308; PMCID: PMC7594545.
16. Rafique S, Ahmad N, Khan S, Khan A, Atif M, Wahid A, Khan A, Waheed H. Frequency, management and impact of adverse events on treatment outcomes in patients with multidrug resistant tuberculosis in Balochistan, Pakistan. J Pharm Policy Pract. 2024 Apr 2;17(1):2332878. doi: 10.1080/20523211.2024.2332878. PMID: 38572376; PMCID: PMC10989201.
17. Breen RA, Miller RF, Gorsuch T, Smith CJ, Schwenk A, Holmes W, Ballinger J, Swaden L, Johnson MA, Cropley I, Lipman MC. Adverse events and treatment interruption in tuberculosis patients with and without HIV co-infection. Thorax. 2006 Sep;61(9):791-4. doi: 10.1136/thx.2006.058867. Epub 2006 Jul 14. PMID: 16844730; PMCID: PMC2117099.