DOI: http://dx.doi.org/10.18203/2319-2003.ijbcp20170941

A study of adverse drug reactions among pulmonary tuberculosis patients treated under dots in a tertiary care hospital

Priyadarshini Bai G., Ravikumar P., Umme Salma

Abstract


Background: DOTS under RNTCP is the current treatment available for Pulmonary Tuberculosis. This treatment exhibit a greater level of efficacy with a small degree of toxicity. The present study aims to determine demography of patients with pulmonary tuberculosis and to study the ADRs caused by anti tubercular drugs and to assess the causality and severity of the reported ADRs.

Methods: We studied cases of Pulmonary Tuberculosis diagnosed and treated under category I DOTS at Department of Pulmonary Medicine for the period of one year (during 2015). Adverse effects observed during treatment course were recorded in standard ‘Adverse Drug Event Reporting Form’. ADRs were also assessed for their causality and severity by using WHO-UMC criteria and Hartwig’s scale.

Results: Pulmonary cases accounted for 67.6% of total TB cases. Among 434 cases of pulmonary tuberculosis 33 (7.6%) patients were defaulters; among them 3(9.5%) cases were defaulters due to ADRs. In our study 96 patients developed 123 ADRs of various types and most of the ADRs noted within first 2 weeks of initiation of treatment. Gastritis was the most common ADRs (28/22.7%) followed by anorexia (26/21.1%).

Conclusions: In our study 22.1% of patients developed ADRs. ADRs recorded in our study were categorised under ‘probable’ and ‘possible’ causes and severity assessment showed 48% are moderate and 52% are ‘mild’ in nature. Still ADRs accounted for 9% default rate. Hence implementations of good patient care oriented programs are needed for early diagnosis and to reduce default rate and drug resistance.


Keywords


Hartwig’s scale, Naranjo’s causality assessment scale, Pulmonary Tuberculosis

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References


WHO report 2009 Global tuberculosis control Epidemiology, strategy, financing. Geneva: World Health Organization; 2009.

Bhargava A, Pinto L, Pai M. Mismanagement of tuberculosis in India: Causes, con-sequences, and the way forward. Hypothesis. 2011:9:e7.

Parthasarathi G, Hansen KN, Nahata MC. Textbook of clinical pharmacy practice. India: Universities press private Ltd; 2004:104-22.

Schaberg T, Rebhan K, Lode H. Risk factors for side effects of isoniazid, and pyra-zinamide in patients hospitalized for pulmonary tuberculosis. Eur Respir J. 1996;9:2026-30.

Balasubramanian VN, Oommen K, Samuel R. DOT or not? Direct observation of anti-tuberculosis treatment and patient outcomes, Kerala State, India. Int J Tuberc Lung Dis. 2000;4:409-13.

World Health Organization. An expanded DOTS framework for effective tuberculosis control. Stop TB Communicable Diseases. Geneva: WHO Press; 2002:120.

Zaka Ur Rehman Z, Jamshaid M, Chaudhry A. Clinical evaluation and monitoring of adverse effects for fixed multidose combination against single drug therapy in pulmonary tuberculosis patients. Pak J Pharm Sci. 2008;21:185-94.

Vieira DE, Gomes M. Adverse effects of tuberculosis treatment: Experience at an outpatient clinic of a teaching hospital in the city of São Paulo, Brazil. JBras Pneumol. 2008;34:1049-55.

Dhingra VK, Rajpal S, Aggarwal N, Aggarwal JK, Shadab K, Jain SK. Adverse drug reactions observed during DOTS. J Commun Dis. 2004;36:251‑9.

Marra F, Marra CA, Bruchet N, Richardson K, Moadebi S, Elwood RK, et al. Adverse drug reactions associated with first‑line anti‑tuberculosis drug regimens. Int J Tuberc Lung Dis. 2007;11:868‑75.

Chukanov VI, Kaminskaia GO, Livchane E. Frequency and pattern of adverse reactions due to treatment of patients with pulmonary tuberculosis with antitubercular reserve drugs. Probl Tuberk Bolezn Legk. 2004;10:610.

Awofeso N. Anti‑tuberculosis medication side‑effects constitute major factor for poor adherence to tuberculosis treatment. Bull World Health Organ. 2008;86:BD.

Abideen SP, Chandrasekaran K, Maheswaran U, Vijayakumar A, Kalaiselvan V, Mishra A, et al. Implementation of Self Reporting Pharmacovigilance in Anti Tuber cular Therapy Using Knowledge Based Approach. J Pharmacovigilance. 2013;1:101.

Xia YY, Hu DY, Liu FY, Wang XM, Yuan YL, Tu DH. Design of the anti-tuberculosis drugs induced adverse reactions in China national Tuberculosis prevention and cotroscheme study. BMC Public Health. 2010;10:267-76.

Gholami K, Kamali E, Hajiabdolbagh Mi, Shalviri G. Evaluation of antituberculosis induced adverse reactions in hospitalized patients. Pharmacy Practice. 2006;4:134-8.

Tak DK, Acharya LD, Gowrinath K, Rao PGM, Subish P. Safety Evaluation Of Antitubercular Therapy Under Revised National Tuberculosis Control Programme In India. Journal of Clinical and Diagnostic Research. 2009;3:1395-401.

Chandir S, Hussain H, Amir M, Lotia I, Khan AJ, Salahuddin N, et al. Extra pulmonary Tuberculosis: A retrospective review of 194 cases at a tertiary care hospital in Karachi, Pakistan. JPMA; 2010:1-6.

Okanurak K, Kitayapor D, Wanarangsikul W, Koompong C. Effectiveness of DOT for tuberculosis treatment outcome: a prospective study in Bangkok, Thailand Int J Tuberc Lung QQ disease. 2007;11(7):762-8.

Diel R, Niemann S. Outcome of tuberculosis treatment in Hamburg: a survey 1997-2001. Int J Tuberc Lung Dis. 2003;7(2):124-31.

Khan MA, Basit A, Javaid ZA. Outcome of tuberculosis patients registered during 2007 in major teaching hospitals of Peshawar. JPMI. 2009;23(04):358-62.

Chandrashekaran V, Gopi PG, Subramani R, Thomas A, Jaggarajamma K, Narayanan PR. Default during the intensive phase of treatment under DOTS programme. Indian J Tuberc. 2005;52:197-02.

Tekle B, Mariam DH, Ali A. Defaulting from DOTS and its determinants in three districts of Arsi Zone in Ethiopia lnt J Tuberc Lung Dis. 2002;6(7):573-9.

Yee D, Valiquette C, Pelletier M, Parisien I, Rocher I, Menzies D. Incidence of serious side effects from first- Line antitiberculosis drugs among patients treated for active tuberculosis, Am J Respir Crit Care Med. 2003;167:1472-7.

Tak DK. Safety Evaluation of Antitubercular Therapy Under Revised National Tuberculosis Control Programme In India, JCDR. 2009;3:1395-401.

Daphne Y, Marthe P. Incidence of serious side effects from First-line antituberculosis drugs among patients treated for Active Tuberculosis, Am J Resp Crit Care Med. 2003;167:1472-7.