DOI: http://dx.doi.org/10.18203/2319-2003.ijbcp20182671

A prospective observational pharmacovigilance study of adverse drug reaction monitoring in patients of MDR-TB at tertiary care hospital

Mirza Shiraz Baig, Monali Raghunath Kale, Avinash Lamb

Abstract


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.


Keywords


Adverse drug reactions, Antitubercular drugs, Causality assessment, Severity assessment

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References


Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India; New Delhi. Central TB Division. Guidelines on Programmatic Management of Drug Resistant TB (PMDT) in India. New Delhi: May 2012.

WHO. Global Tuberculosis Report 2016. [Internet]. 2016. Available at: http://scholar.google.com/scholar?hl=enandbtnG=Searchandq=intitle:No+Title#0

National and state statistics TB statistics for India. Organisation WH, Control GT. MDRTB Statistics for India. 2015:1-9.

Joseph P, Desai VB, Mohan NS, Fredrick JS, Ramachandran R, Raman B, et al. Outcome of standardized treatment for patients with MDR-TB from Tamil Nadu, India. The Ind J of Med Resea. 2011 May;133(5):529.

Prasad R. Management of multi-drug resistant tuberculosis Practitioner’s view point. Indian Journal of Tuberculosis. 2007;54:3-11.

Arora VK, Sarin R, Singla R, Khalid UK, Mathuria K, Singla N, et al. DOTS-Plus for patients with multidrug-resistant tuberculosis in India: early results after three years. Ind J of Che Disea and All Scienc. 2007;49(2):75.

Singla R, Sarin R, Khalid UK, Mathuria K, Singla N, Jaiswal A, et al. Seven-year DOTS-Plus pilot experience in India: Results, constraints and issues. The International Journal of Tuberculosis and Lung Disease. 2009;13:976-81.

Hire R, Kale AS, Dakhale GN, Gaikwad N. A prospective, observational study of adverse reactions to drug regimen for multi-drug resistant pulmonary tuberculosis in Central India. Medit J of Hem and Infec Disea. 2014;6(1).

Singh BD, Ghulam H, Kadri SM, Qureshi W, Kamili MA, Singh H et al. Multidrug-Resistant and extensively drug resistant tuberculosis in Kashmir, India. J Infect Dev Ctries. 2010;4(1):19-23.

Kapadia VK, Tripathi SB. Analysis of 63 patients of MDR TB on DOTS plus regimen: An LG hospital, TB Unit, Ahmadabad experience. Guj Med J. 2013;68(2);52-7.

Singh R, Gothi D, Joshi JM. Multidrug Resistant Tuberculosis: Role of Previous Treatment with Second Line Therapy on Treatment Outcome. Lung India. 2007;24:54-7.

Furin JJ, Mitnick CD, Shin SS, Bayona J, Becerra MC, Singler JM, et al. Occurrence of serious adverse effects in patients receiving community-based therapy for multidrug-resistant tuberculosis. Int J tuberc lung dis. 2001;5(7):648-55.

Jain K, Desai M, Dikshit RK. Treatment outcome of standardized regimen in patients with multidrug resistant tuberculosis. J Pharmacol Pharmacother. 2014;5(2):145-9.

Bloss E, Kukša L, Holtz TH, Riekstina V, Skripčonoka V, Kammerer S, et al. Adverse events related to multidrug-resistant tuberculosis treatment, Latvia, 2000–2004. Int J tuberc lung dis. 2010 Mar 1;14(3):275-81.

Törün T, Güngör G, Özmen I, Bölükbaşı Y, Maden E, Bıçakçı B, Atac G, Sevim T, Tahaoğlu K. Side effects associated with the treatment of multidrug-resistant tuberculosis. Int J tuberc lung dis. 2005 Dec 1;9(12):1373-7.

Wai yew W, Kuen CC, Hung CC, Cheeuk MTC. Outcomes of patients with multidrug resistant pulmonary tuberculosis treated with Ofloxacin/Levofloxacin containing regimens. Chest. 2000;177:744-51.