A RETROSPECTIVE STUDY OF ADVERSE DRUG REACTION IN MULTIDRUG-RESISTANT TUBERCULOSIS PATIENTS AT TERTIARY CARE HOSPITAL
DOI:
https://doi.org/10.22159/ajpcr.2022.v15i8.45174Keywords:
Multidrug-resistant tuberculosis, Adverse drug reaction, National TB elimination program, Rifampicin resistantAbstract
Objective: The objective of the study was to the analysis of different parameters including admission type, demographics, type of reaction, the seriousness of reaction, classification of organ system, drugs involved, action taken and outcome of reactions, causality assessment, severity assessment, and the preventability of ADRs for multidrug-resistant tuberculosis patients.
Methods: This retrospective observational study was conducted during the period of September 2017 to June 2020 (34 months) at ADR Monitoring Centre, Department of Pharmacology, Jawaharlal Nehru Medical College, Ajmer, Rajasthan. All spontaneously reported ADRs were evaluated using various parameters such as type of reaction, causality assessment, preventability, and severity.
Results: In the present study, 92 (9.29%) ADRs were reported in relation to 68 MDR-TB patients. The majority of ADRs were considered probable (73.92%), moderate (41.30%), and definitely preventable (42.39%) in nature. In our study, most of the suspected drug names were included: 23 (25%) pyrazinamide, followed by 22 (23.91%) kanamycin, 12 (13.04%) cycloserine, and 11 (11.96%) linezolid. The majority of ADRs were non-serious (67.39%) in nature. ADRs were most commonly reported, with 17 (18.48%) reporting ototoxicity and 17 (18.48%) reporting joint pain, followed by 4 (4.35%) reporting burning feet syndrome, 4 (4.35%) reporting generalized itching, and 4 (4.35%) reporting psychosis.
Conclusion: Our study included 36 different types of suspected ADRs that were reported with multiple frequencies due to 16 categories of drugs and combinations of drugs. The majority of patients were recovering and recovered from concerns associated with ADR after necessary medical intervention and management. Our purpose is to rationale the use of medicines for drug safety as well as patient safety.
Downloads
References
World Health Organization. The Magazine of the World Health Organization. World Health TB a Global Emergency, 46th Year. Vol. 4. Geneva: World Health Organization; 1993.
Central TB Division. Directorate General of Health Services, Ministry of Health and Family Welfare, India TB Report. New Delhi: Government of India; 2022.
World Health Organization. Global Tuberculosis Reports. Geneva:int/tb/data
Central TB Division, Ministry of Health and Welfare, Government of India. National TB Elimination Programme, Guidelines for Programmatic Management of Drug Resistant Tuberculosis in India; 2021.
Indian Pharmacopoeia Commission, National Coordination Centre- Pharmacovigilance programme of India. Guidance Document for Spontaneous Adverse Drug Reaction Reporting. Vers. 1.0, Ch. 3. India: Indian Pharmacopoeia Commission, National Coordination Centre- Pharmacovigilance programme of India; 2014. p. 10-3.
Rawlins MD, Thompson JW. Pathogenesis of adverse drug reactions. In: Davies DM, editor. Textbook of Adverse Drug Reactions. 1st ed. Oxford: Oxford University Press; 1977. p. 44.
Medical Dictionary for Regulatory Activities Maintance and Support Services Organization. (MedDRAMSSO). Available from: https:// www.meddramsso.com
World Health Organization. Collaborating Centre for International Drug Monitoring. WHO Programme for International Drug Monitoring: Guide to Participating Countries-submission in E2B Format. Geneva: World Health Organization; 2007.
World Health Organization. Collaborating Centre for Drug Statistics Methodology; 2007. Available from: https://www.whocc.no/atc-ddd-index
The Use of the WHO-UMC System for Standardized Case Causality Assessment. Available from: https://www.who.int/medicines/areas/ quality-safety/safety-efficacy/WHOcausality-assessment.pdf
Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm 1992;49:2229-32. doi: 10.1093/ajhp/49.9.2229, PMID 1524068
Schumock GT, Thornton JP. Focusing on the preventability of adverse drug reactions. Hosp Pharm 1992;27:538. PMID 10118597
Lau PM, Stewart K, Dooley MJ. Comment: hospital admission resulting from preventable adverse drug reactions. Ann Pharmacother 2003;37:303-4; author reply 304. doi: 10.1177/106002800303700229, PMID 12549969
Rathod KB, Borkar MS, Lamb AR, Suryavanshi SL, Surwade GA, Pandey VR. Adverse events among patients of multi-drug resistant tuberculosis receiving second line anti TB treatment. Int J Sci Rep 2015;1:253-7. doi: 10.18203/issn.2454-2156.IntJSciRep20150955
Hire R, Kale AS, Dakhale GN, Gaikwad N. A prospective, observational study of adverse reactions to drug regimen for multidrug- resistant pulmonary tuberculosis in central India. Mediterr J Hematol Infect Dis 2014;6:e2014061. doi: 10.4084/MJHID.2014.061, PMID 25237474
Fatima S, Syeda MF, Adla N, Devi R. Ambispective study of adverse drug reaction in multi-drug resistant tuberculosis patients in Warangal, Telangana. Lung India. 2021;38:330-7. doi: 10.4103/lungindia. lungindia_118_19, PMID 34259171
Dela AI, Tank NK, Singh AP, Piparva KG. Adverse drug reaction and treatment outcome analysis of DOTS-plus therapy of MDR-TB patients at district tuberculosis centre: A four year retrospective study. Lung India 2017;34:522-6. doi: 10.4103/0970-2113.217569, PMID 29098997
KapadiaVishakha K, Tripathi Sanjay B. Analysis of 63 patients of MDR TB on DOTS plus regimen: An LG hospital, TB Unit Ahmadabad experience. Guj Med J 2013;68:52-7.
Patel SV, Bhikhubhai NK, Patel AB, Shringarpure KS, Mehta KG, Shukla LK. Adverse drug reactions in patients put on multi dug resistant tuberculosis (MDR-TB) treatment in seven districts of Central Gujarat. J Young Pharm 2015;7:425.
Joseph P, Desai VB, Mohan NS, Fredrick JS, Ramachandran R, Raman B. Outcome of standardized treatment for patients with MDR-TB from Tamil Nadu, India. Indian J Med Res 2011;133:529-34.
Published
How to Cite
Issue
Section
Copyright (c) 2022 SAURABH KUMAR JAIN SAURABH KUMAR JAIN
This work is licensed under a Creative Commons Attribution 4.0 International License.
The publication is licensed under CC By and is open access. Copyright is with author and allowed to retain publishing rights without restrictions.