Safety evaluation of antitubercular therapy under Revised National Tuberculosis Control Programme in India

D.K. Tak, L.D. Acharya, K. Gowrinath, G.M. Rao Padma, P. Subish

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

Introduction: The World Health Organization declared tuberculosis (TB) as a global emergency in 1993. To intensify the efforts to control TB, the Government of India gradually replaced the National Tuberculosis Programme by the Directly Observed Short Course Therapy (DOTS) programme which is now known as the Revised National Tuberculosis Programme (RNTCP). Objectives: The present study was carried out to evaluate the safety of the DOTS therapy by monitoring adverse drug reactions (ADRs). Methodology: All the TB patients admitted at the DOTS centre Kasturba Hospital, Manipal, and at the DOTS Centre, Udupi, were enrolled as per the study criteria and were monitored for ADRs. The data were evaluated for patient demography, types of TB, types of DOTS treatment, incidence of ADRs, predisposing factors for developing ADRs and the types, onset, management and outcome of the ADRs. ADRs were also assessed for their causality and severity as per the standard algorithms. Results: Out of 94 TB patients, a majority of them were males (70%) and belonged to the age group of 18-40 years (52%). The incidence of ADRs was 17.02%. Gastritis was the most common ADR and multiple drug therapy was the major predisposing factor. We found that 28.51% of the total ADRs belonged to Type-A ADRs. In 87.1% of the cases, the suspected drug was continued in spite of the ADR, without any complications. On evaluation of the causality of ADRs, a majority of them were found to be 'possible' by both WHO and Naranjo's scales. The severity assessment of ADRs showed that 31(51%) reactions were moderate and 30 (49%) were of the 'mild' nature. Conclusion: We found DOTS therapy to be safer. But regular monitoring is required for ADRs, so that certain percentage of ADRs can be prevented.
Original languageEnglish
Pages (from-to)1395-1401
Number of pages7
JournalJournal of Clinical and Diagnostic Research
Volume3
Issue number2
Publication statusPublished - 2009

Fingerprint

Drug-Related Side Effects and Adverse Reactions
India
Tuberculosis
Safety
Pharmaceutical Preparations
Therapeutics
Causality
Drug therapy
Incidence
Monitoring
Gastritis
Emergencies
Age Groups

Cite this

@article{a882f1ff56a743789b78e2fc30066a60,
title = "Safety evaluation of antitubercular therapy under Revised National Tuberculosis Control Programme in India",
abstract = "Introduction: The World Health Organization declared tuberculosis (TB) as a global emergency in 1993. To intensify the efforts to control TB, the Government of India gradually replaced the National Tuberculosis Programme by the Directly Observed Short Course Therapy (DOTS) programme which is now known as the Revised National Tuberculosis Programme (RNTCP). Objectives: The present study was carried out to evaluate the safety of the DOTS therapy by monitoring adverse drug reactions (ADRs). Methodology: All the TB patients admitted at the DOTS centre Kasturba Hospital, Manipal, and at the DOTS Centre, Udupi, were enrolled as per the study criteria and were monitored for ADRs. The data were evaluated for patient demography, types of TB, types of DOTS treatment, incidence of ADRs, predisposing factors for developing ADRs and the types, onset, management and outcome of the ADRs. ADRs were also assessed for their causality and severity as per the standard algorithms. Results: Out of 94 TB patients, a majority of them were males (70{\%}) and belonged to the age group of 18-40 years (52{\%}). The incidence of ADRs was 17.02{\%}. Gastritis was the most common ADR and multiple drug therapy was the major predisposing factor. We found that 28.51{\%} of the total ADRs belonged to Type-A ADRs. In 87.1{\%} of the cases, the suspected drug was continued in spite of the ADR, without any complications. On evaluation of the causality of ADRs, a majority of them were found to be 'possible' by both WHO and Naranjo's scales. The severity assessment of ADRs showed that 31(51{\%}) reactions were moderate and 30 (49{\%}) were of the 'mild' nature. Conclusion: We found DOTS therapy to be safer. But regular monitoring is required for ADRs, so that certain percentage of ADRs can be prevented.",
author = "D.K. Tak and L.D. Acharya and K. Gowrinath and {Rao Padma}, G.M. and P. Subish",
note = "Cited By :5 Export Date: 10 November 2017 Correspondence Address: Acharya, L.D.; Dept. of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Udupi District, Karnataka, India; email: leela.da@manipal.edu Chemicals/CAS: diclofenac, 15307-79-6, 15307-86-5; ethambutol, 10054-05-4, 1070-11-7, 3577-94-4, 74-55-5; isoniazid, 54-85-3, 62229-51-0, 65979-32-0; pyrazinamide, 98-96-4; rifampicin, 13292-46-1; streptomycin, 57-92-1 References: Maher, D., Raviglione, M., Global Epidemiology of Tuberculosis (2005) Clinics in Chest Medicine, 26, pp. 167-182; Banavaliker NJ. Control in high prevalence countries. In: Davies PDO. Clinical tuberculosis, Mumbai: KM. Varghese Company, 2003; 381-401; Shashikant. Control of tuberculosis. In: Sharma. S.K, Mohan, Tuberculosis. New Delhi: Jaypee Brothers, 2004; 556-58; Tripathi, K.D., (2003) Antitubercular drugs, Essentials of Medical Pharmacology, pp. 705-708. , New delhi: Jaypee Brothers; Devi S, Ramchandran R, Santha S. Adverse reaction to antituberculosis drugs and their management. Bulletin 1997 July and Oct; 4 (3 and 4); Bedi, R.S., Pyrazinamide- induced hypersensitivity reaction (1990) Indian Journal of Tuberculosis, 37, p. 41; Tandon, R.K., Garg, P.K., (2004) Antituberculosis treatment induced hepatotoxicity, p. 500. , Sharma. SK, Mohan, Tuberculosis. New Delhi: Jaypee Brothers; Stork CM, Hoffman RS. Toxicology of Antituberculosis drugs. In: Rom. W.N, Gary. S., Tuberculosis. Newyork: Little, Brown and company, 1996; 829-837; Yew WW. Chemotherapy of Tuberculosis: present future and beyond . In: Davies P.D.O, Clinical tuberculosis, Mumbai: K.M. Varghese Company, 2003: 191-200; Edwards, I.R., Aronson, J.K., Adverse drug reactions: Definition; diagnosis and management (2000) Lancet, 356, pp. 1255-1259; Parthasarthi, G., Karin, N., Milap, C., Nahata, A., (2001) Text of Clinical Pharmacy Practice, Essential Concepts of Skills, pp. 84-97. , 1st Edition, Orient Longman, India; Naranjo, C.A., Busto, U., Sellers, E.M., A method of Estimating the probability of Adverse Drug Reactions (1981) Clin Pharm Ther, 30, pp. 239-245; Hartwig, S.C., Sieegel, J.J., Schneider, P.J., Preventability and severity assessment in Reporting Adverse Drug Reactions (1992) Am J Hosp Pharm, 49, pp. 2229-2232; A controlled trial of 3-month, 4 month and 6 month regimens of chemotherapy for sputum- smear-negative pulmonary tuberculosis. Results at 5years (1989) Am Rev Respir Dis, 139, pp. 871-876. , Hong Kong chest service /Tuberculosis research centre, Madras/ British medical research council; Controlled trial of four thrice -weekly regimens and a daily regimen all given for 6 months for pulmonary tuberculosis (1981) Lancet, 1, pp. 171-174. , Hong Kong chest service/ British medical research council; Zierski, M., Bek, E., Side effects of drug regimens used in short-course ... tuberculosis: A controlled clinical study (1980) Tubercle, 61, pp. 41-49; Poole, G., Stradling, P., Worlledge, S., Potentially serious side effects of High-dose twice -weekly rifampicin (1971) Br Med J, 3, pp. 343-347; (2002) Treatment of tuberculosis: Guidelines for national programmes, , http://www.hiv.gov.gy/edocs/who_gl_tbtreatment.pdf, Third edition, Available on; Dhingra, V.K., Rajpal, S., Aggarwal, N., Aggarwaln, J.K., Shadab, K., Jain, S.K., Adverse drug reactions observed during DOTS (2004) J Commun Dis, 36, pp. 251-259; Dosumu A. Side Effects Of drugs Used in Directly Observed Treatment Short - Course In Newly Diagnosed Pulmonary Tuberculosis Subjects In Neigerians : A controlled Clinical Study. Niger Post Grad Medical Journal-2002; 9(1): 34-7; Ormerod, L.P., Horsfield, N., Frequency and Type of reactions to antituberculosis drugs: Observations in routine treatment (1996) Tubercle and Lung Disease, 77, pp. 37-42; Daphne, Y., Marthe, P., Incidence of serious side effects from First-line antituberculosis drugs among patients treated for Active Tuberculosis (2003) Am J Resp Crit Care Med, 167, pp. 1472-1477",
year = "2009",
language = "English",
volume = "3",
pages = "1395--1401",
journal = "Journal of Clinical and Diagnostic Research",
issn = "2249-782X",
publisher = "Journal of Clinical and Diagnostic Research",
number = "2",

}

Safety evaluation of antitubercular therapy under Revised National Tuberculosis Control Programme in India. / Tak, D.K.; Acharya, L.D.; Gowrinath, K.; Rao Padma, G.M.; Subish, P.

In: Journal of Clinical and Diagnostic Research, Vol. 3, No. 2, 2009, p. 1395-1401.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Safety evaluation of antitubercular therapy under Revised National Tuberculosis Control Programme in India

AU - Tak, D.K.

AU - Acharya, L.D.

AU - Gowrinath, K.

AU - Rao Padma, G.M.

AU - Subish, P.

N1 - Cited By :5 Export Date: 10 November 2017 Correspondence Address: Acharya, L.D.; Dept. of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Udupi District, Karnataka, India; email: leela.da@manipal.edu Chemicals/CAS: diclofenac, 15307-79-6, 15307-86-5; ethambutol, 10054-05-4, 1070-11-7, 3577-94-4, 74-55-5; isoniazid, 54-85-3, 62229-51-0, 65979-32-0; pyrazinamide, 98-96-4; rifampicin, 13292-46-1; streptomycin, 57-92-1 References: Maher, D., Raviglione, M., Global Epidemiology of Tuberculosis (2005) Clinics in Chest Medicine, 26, pp. 167-182; Banavaliker NJ. Control in high prevalence countries. In: Davies PDO. Clinical tuberculosis, Mumbai: KM. Varghese Company, 2003; 381-401; Shashikant. Control of tuberculosis. In: Sharma. S.K, Mohan, Tuberculosis. New Delhi: Jaypee Brothers, 2004; 556-58; Tripathi, K.D., (2003) Antitubercular drugs, Essentials of Medical Pharmacology, pp. 705-708. , New delhi: Jaypee Brothers; Devi S, Ramchandran R, Santha S. Adverse reaction to antituberculosis drugs and their management. Bulletin 1997 July and Oct; 4 (3 and 4); Bedi, R.S., Pyrazinamide- induced hypersensitivity reaction (1990) Indian Journal of Tuberculosis, 37, p. 41; Tandon, R.K., Garg, P.K., (2004) Antituberculosis treatment induced hepatotoxicity, p. 500. , Sharma. SK, Mohan, Tuberculosis. New Delhi: Jaypee Brothers; Stork CM, Hoffman RS. Toxicology of Antituberculosis drugs. In: Rom. W.N, Gary. S., Tuberculosis. Newyork: Little, Brown and company, 1996; 829-837; Yew WW. Chemotherapy of Tuberculosis: present future and beyond . In: Davies P.D.O, Clinical tuberculosis, Mumbai: K.M. Varghese Company, 2003: 191-200; Edwards, I.R., Aronson, J.K., Adverse drug reactions: Definition; diagnosis and management (2000) Lancet, 356, pp. 1255-1259; Parthasarthi, G., Karin, N., Milap, C., Nahata, A., (2001) Text of Clinical Pharmacy Practice, Essential Concepts of Skills, pp. 84-97. , 1st Edition, Orient Longman, India; Naranjo, C.A., Busto, U., Sellers, E.M., A method of Estimating the probability of Adverse Drug Reactions (1981) Clin Pharm Ther, 30, pp. 239-245; Hartwig, S.C., Sieegel, J.J., Schneider, P.J., Preventability and severity assessment in Reporting Adverse Drug Reactions (1992) Am J Hosp Pharm, 49, pp. 2229-2232; A controlled trial of 3-month, 4 month and 6 month regimens of chemotherapy for sputum- smear-negative pulmonary tuberculosis. Results at 5years (1989) Am Rev Respir Dis, 139, pp. 871-876. , Hong Kong chest service /Tuberculosis research centre, Madras/ British medical research council; Controlled trial of four thrice -weekly regimens and a daily regimen all given for 6 months for pulmonary tuberculosis (1981) Lancet, 1, pp. 171-174. , Hong Kong chest service/ British medical research council; Zierski, M., Bek, E., Side effects of drug regimens used in short-course ... tuberculosis: A controlled clinical study (1980) Tubercle, 61, pp. 41-49; Poole, G., Stradling, P., Worlledge, S., Potentially serious side effects of High-dose twice -weekly rifampicin (1971) Br Med J, 3, pp. 343-347; (2002) Treatment of tuberculosis: Guidelines for national programmes, , http://www.hiv.gov.gy/edocs/who_gl_tbtreatment.pdf, Third edition, Available on; Dhingra, V.K., Rajpal, S., Aggarwal, N., Aggarwaln, J.K., Shadab, K., Jain, S.K., Adverse drug reactions observed during DOTS (2004) J Commun Dis, 36, pp. 251-259; Dosumu A. Side Effects Of drugs Used in Directly Observed Treatment Short - Course In Newly Diagnosed Pulmonary Tuberculosis Subjects In Neigerians : A controlled Clinical Study. Niger Post Grad Medical Journal-2002; 9(1): 34-7; Ormerod, L.P., Horsfield, N., Frequency and Type of reactions to antituberculosis drugs: Observations in routine treatment (1996) Tubercle and Lung Disease, 77, pp. 37-42; Daphne, Y., Marthe, P., Incidence of serious side effects from First-line antituberculosis drugs among patients treated for Active Tuberculosis (2003) Am J Resp Crit Care Med, 167, pp. 1472-1477

PY - 2009

Y1 - 2009

N2 - Introduction: The World Health Organization declared tuberculosis (TB) as a global emergency in 1993. To intensify the efforts to control TB, the Government of India gradually replaced the National Tuberculosis Programme by the Directly Observed Short Course Therapy (DOTS) programme which is now known as the Revised National Tuberculosis Programme (RNTCP). Objectives: The present study was carried out to evaluate the safety of the DOTS therapy by monitoring adverse drug reactions (ADRs). Methodology: All the TB patients admitted at the DOTS centre Kasturba Hospital, Manipal, and at the DOTS Centre, Udupi, were enrolled as per the study criteria and were monitored for ADRs. The data were evaluated for patient demography, types of TB, types of DOTS treatment, incidence of ADRs, predisposing factors for developing ADRs and the types, onset, management and outcome of the ADRs. ADRs were also assessed for their causality and severity as per the standard algorithms. Results: Out of 94 TB patients, a majority of them were males (70%) and belonged to the age group of 18-40 years (52%). The incidence of ADRs was 17.02%. Gastritis was the most common ADR and multiple drug therapy was the major predisposing factor. We found that 28.51% of the total ADRs belonged to Type-A ADRs. In 87.1% of the cases, the suspected drug was continued in spite of the ADR, without any complications. On evaluation of the causality of ADRs, a majority of them were found to be 'possible' by both WHO and Naranjo's scales. The severity assessment of ADRs showed that 31(51%) reactions were moderate and 30 (49%) were of the 'mild' nature. Conclusion: We found DOTS therapy to be safer. But regular monitoring is required for ADRs, so that certain percentage of ADRs can be prevented.

AB - Introduction: The World Health Organization declared tuberculosis (TB) as a global emergency in 1993. To intensify the efforts to control TB, the Government of India gradually replaced the National Tuberculosis Programme by the Directly Observed Short Course Therapy (DOTS) programme which is now known as the Revised National Tuberculosis Programme (RNTCP). Objectives: The present study was carried out to evaluate the safety of the DOTS therapy by monitoring adverse drug reactions (ADRs). Methodology: All the TB patients admitted at the DOTS centre Kasturba Hospital, Manipal, and at the DOTS Centre, Udupi, were enrolled as per the study criteria and were monitored for ADRs. The data were evaluated for patient demography, types of TB, types of DOTS treatment, incidence of ADRs, predisposing factors for developing ADRs and the types, onset, management and outcome of the ADRs. ADRs were also assessed for their causality and severity as per the standard algorithms. Results: Out of 94 TB patients, a majority of them were males (70%) and belonged to the age group of 18-40 years (52%). The incidence of ADRs was 17.02%. Gastritis was the most common ADR and multiple drug therapy was the major predisposing factor. We found that 28.51% of the total ADRs belonged to Type-A ADRs. In 87.1% of the cases, the suspected drug was continued in spite of the ADR, without any complications. On evaluation of the causality of ADRs, a majority of them were found to be 'possible' by both WHO and Naranjo's scales. The severity assessment of ADRs showed that 31(51%) reactions were moderate and 30 (49%) were of the 'mild' nature. Conclusion: We found DOTS therapy to be safer. But regular monitoring is required for ADRs, so that certain percentage of ADRs can be prevented.

M3 - Article

VL - 3

SP - 1395

EP - 1401

JO - Journal of Clinical and Diagnostic Research

JF - Journal of Clinical and Diagnostic Research

SN - 2249-782X

IS - 2

ER -