Research Journal of Pharmacy and Technology

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Analysis of Adverse Drug Reactions Associated with Anti-tubercular Drugs – a Retrospective Study


Affiliations
1 Adverse Reaction Monitoring Center, SDSTRC and RGICD, Bangalore -29., India
2 Department of Pharmacy Practice, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty, Nilgiris, Tamil Nadu, India
     

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Background: Adverse Drug Reactions (ADR’s) to anti-TB drugs might contribute to the extension of treatment period, final termination, drug resistance and treatment failure as Anti-TB medications are the main stay treatment in Tuberculosis. These ADR’s may cause unintended interruption of treatment which may pose a challenge in TB management. Aim: This study aims to explore and observe adverse reactions of 1st line antitubercular drugs in DOTS treatment. Methodology: This is a analysis of ADRs of antitubercular drugs that were reported to ADR monitoring centre (AMC), SDSTRC and RGICD ,Bangalore either by spontaneous reporting or found by active surveillance methods. This study was for about 32 months. During this period all the ADRs caused by antitubercular drugs reported to the AMC were collected and classified based on WHO causality assessment. Later all those data were analyzed and results were generated Results: A total of 507 ADR’s were reported and out of which the majority of ADR’s were reported in adult population (45%). Based on gender, Male had a higher incidence of ADR (324, 63.9%). Based on WHO causality assessment scale, 69.4% of ADRs were ‘possible’ followed by 25.2% being ‘probable’ and 4.1% being ‘certain’. Conclusion: Monitoring of patients on Anti tubercular treatment with early identification and appropriate management of ADR becomes very essential. The timely and aggressive management of adverse effects of anti-tubercular drugs greatly facilitates patient adherence.

Keywords

Anti-TB drugs, Adverse drug reactions, Causality assessment, Tuberculosis.
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  • www.who.int/tb/publications/global_report/gtbr2017

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

  • Lalit Kumar, Rajan, Vivek Sharma. Tuberculosis: A Brief Overview. Asian J. Pharm. Res.2012; 2(2): 59-62.

  • Manohar D. Kengar, Kiran K. Patole, Akshay K. Ade, Sumesh M. Kumbhar, Chetan D. Patil, Ashutosh R. Ganjave. Introduction to Pharmacovigilance and Monitoring. Asian J. Pharm. Res. 2019; 9(2): 116-122. doi:10.5958/2231-5691.2019.00019.4

  • Abdullahi Rabiu Abubakar, Nordin Bin Simbak, Mainul Haque. Adverse Drug Reactions: Predisposing Factors, Modern Classifications and Causality Assessment. Research J. Pharm. and Tech. 2014;7(9): 1091-1098.doi: 10.5958/0974-360X

  • Forget EJ, Menzies D. Adverse reactions to first-line antituberculosis drugs. Expert Opin Drug Saf. 2006 Mar;5(2):231-49. doi: 10.1517/14740338.5.2.231. PMID: 16503745.

  • Gulbay BE et al. Side effects due to primary anti-tuberculosis drugs during the initial phase of therapy in 1149 hospitalized patients for tuberculosis. J Respir Med. 2006;10: 1834–1842, https://doi.org/10.1016/j.rmed.2006.01.014

  • Tan WC, Ong CK, Lo Kang SC, Abdul Razak M. Two years review of cutaneous adverse drug reaction from first line anti-tuberculous drugs. Med J Malaysia. 2007; 62:143–146

  • Kaona FA, Tuba M, Siziya S, Sikaona L. An assessment of factors contributing to treatment adherence and knowledge of TB transmission among patients on TB treatment. BMC Public Health 2004; 4:68. doi: 10.1186/1471-2458-4-68

  • World Health Organization. Requirements for Adverse Reaction Reporting. Geneva, Switzerland: World Health Organization; 1975.

  • Edwards R, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000; 356:1255–1259. doi: 10.1016/S0140-6736(00)02799-9

  • Radha K. et al .A Guide to the Management of Tuberculosis in Patients with Chronic Liver Disease. J Clin Exp Hepatol. 2012; 2(3): 260–270. doi: 10.1016/j.jceh.2012.07.007

  • Abideen SP et al. Implementation of Self Reporting Pharmacovigilance in Anti Tubercular Therapy Using Knowledge Based Approach.J Pharmacovigilance 2013; 1:101. doi:10.4172/jp.1000101

  • Archana B. Chavhan, Dipali M. Bhoi. Pharmacovigillance: Drug Safety Monitoring. Asian J. Pharm. Tech. 2019; 9(1):49-52. doi: 10.5958/2231-5713.2019.00009.6. doi: 10.5958/2231-5713.2019.00009.6.

  • Deepalakshmi M, Anu Vikashini.R, Dinesh.R, Jerlin Anusha.R, Dharini, Arun K.P. A rare case of Isoniazid-induced SJ syndrome in a secondary care hospital in rural South India - A Case Report. Research J. Pharm. and Tech 2020; 13(2):758-760. doi: 10.5958/0974-360X.2020.00143.2

  • The use of the WHO-UMC system for standardised case causality assessment. [1] [Internet] [Cited 2015July 4]. Available from: http://who-umc.org/Graphics/24734. pdf.

  • Marra F et al. Adverse drug reactions associated with first line anti tuberculosis drug regimens. Int J Tuberc Lung Dis 2007;11: 868 75. PMID: 17705952.

  • Dela, A., Tank, N., Singh, A. and Piparva, K. Adverse drug reactions and treatment outcome analysis of DOTS-plus therapy of MDR-TB patients at district tuberculosis center: A four year retrospective study. Lung India.2017; 34(6):.522. doi: 10.4103/0970-2113.217569

  • Sinha K, Marak I, Singh W. Adverse drug reactions in tuberculosis patients due to directly observed treatment strategy therapy: Experience at an outpatient clinic of a teaching hospital in the city of Imphal, Manipur, India. J Assoc Chest Physicians. 2013;1(2):50. doi: 10.4103/2320-8775.123213

  • Dhanlakshmi et al .A Study on Adverse Drug Reactions in Tuberculosis Patients Maintained on DOTS Protocol in Government Chest andTBHospital Warangal District.IOSR Journal of Dental and Medical Sciences.2017;16(11):1-5

  • Nandy M et al. Adverse drug reaction monitoring through active surveillance of antitubercular therapy in an urban tertiary care center. Community Acquired Infection. 2016;3(2):51. doi:10.4103/2225-6482.184913

  • Nagpal M, Devgun P, Kalra R, Chawla N. Study on the adverse effects affecting treatment outcome in smear positive tuberculosis patients under DOTS in Amritsar city. Int. j. community med. public health. 2018;5(2):801.

  • Dhingra VK et al.Adverse drug reactions observed during DOTS. J Commun Dis.2004;36:251–259. doi: http://dx.doi.org/10.18203/2394-6040.ijcmph20180272

  • Gonzalez Montaner LJ, Dambrosi A, Manassero M, Dambrosi VM . Adverse effects of antituberculosis drugs causing changes in treatment. Tubercle.1982;63:291–294. doi: 10.1016/s0041-3879(82)80018-4


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  • Analysis of Adverse Drug Reactions Associated with Anti-tubercular Drugs – a Retrospective Study

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Authors

Dharini Boopathi
Adverse Reaction Monitoring Center, SDSTRC and RGICD, Bangalore -29., India
Akshatha J S
Adverse Reaction Monitoring Center, SDSTRC and RGICD, Bangalore -29., India
Uma Buggi
Adverse Reaction Monitoring Center, SDSTRC and RGICD, Bangalore -29., India
Hema Siva
Department of Pharmacy Practice, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty, Nilgiris, Tamil Nadu, India
Arun K P
Department of Pharmacy Practice, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty, Nilgiris, Tamil Nadu, India
Deepalakshmi Mani
Department of Pharmacy Practice, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty, Nilgiris, Tamil Nadu, India

Abstract


Background: Adverse Drug Reactions (ADR’s) to anti-TB drugs might contribute to the extension of treatment period, final termination, drug resistance and treatment failure as Anti-TB medications are the main stay treatment in Tuberculosis. These ADR’s may cause unintended interruption of treatment which may pose a challenge in TB management. Aim: This study aims to explore and observe adverse reactions of 1st line antitubercular drugs in DOTS treatment. Methodology: This is a analysis of ADRs of antitubercular drugs that were reported to ADR monitoring centre (AMC), SDSTRC and RGICD ,Bangalore either by spontaneous reporting or found by active surveillance methods. This study was for about 32 months. During this period all the ADRs caused by antitubercular drugs reported to the AMC were collected and classified based on WHO causality assessment. Later all those data were analyzed and results were generated Results: A total of 507 ADR’s were reported and out of which the majority of ADR’s were reported in adult population (45%). Based on gender, Male had a higher incidence of ADR (324, 63.9%). Based on WHO causality assessment scale, 69.4% of ADRs were ‘possible’ followed by 25.2% being ‘probable’ and 4.1% being ‘certain’. Conclusion: Monitoring of patients on Anti tubercular treatment with early identification and appropriate management of ADR becomes very essential. The timely and aggressive management of adverse effects of anti-tubercular drugs greatly facilitates patient adherence.

Keywords


Anti-TB drugs, Adverse drug reactions, Causality assessment, Tuberculosis.

References