Pharmacovigilance of first line anti-tubercular therapy in category I patients of pulmonary tuberculosis

Authors

  • Rahul Agarwal Department of Pharmacology, GMC Amritsar, Punjab, India
  • Ashok Goel Department of Pharmacology, GMC Amritsar, Punjab, India
  • Jaswant Rai Department of Pharmacology, GMC Amritsar, Punjab, India
  • Nirmal Chand Kajal Department of Chest and TB, GMC Amritsar, Punjab, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20170829

Keywords:

Adverse drug reactions, Causality, Severity, Tuberculosis

Abstract

Background: Study was done to determine incidence of ADR’s in sputum positive, pulmonary TB patients, on DOTS category I and to determine the effect of ADR’s on sputum conversion.

Methods: Open, prospective, observational, non-comparative study conducted in the Department of Pharmacology in collaboration with Department of Tuberculosis and Chest Diseases, Government Medical College, Amritsar for the duration of 18 months (March 2015 to September 2016). One hundred sputum positive patients of pulmonary tuberculosis on DOTS category I, of either sex, in age group of 14 years to 65 years, were recruited and followed up during intensive phase of therapy at end of 1st and 2nd month. Causality and Severity assessment were done by using WHO-UMC causality scale and Hartwig’s severity scale respectively.

Results: Out of 100 patients 84 (84%) developed one or more ADR’s and a total of 118 ADR’s occurred in our study. The most common ADR was GI upset 45(38.13%), followed by hepatitis 42 (35.59%), rash 12 (10.16%), CNS 8 (6.77%), arthritic symptoms 5 (4.23%), visual disturbance 2 (1.69%), bleeding problems 2 (1.69%), hyperuricemia 1 (0.84%) and peripheral neuropathy 1 (0.84%). Causality assessment revealed that most of ADR’s(60) were in probable category and severity assessment revealed that most of ADR’s(55) belonged to level 4 (Moderate severity). Most of the ADR’s occurred within 30 days of the start of treatment (84.74%).

Conclusions: With such a high incidence of ADR’s there is a need of incorporating pharmacovigilance programme into this vital health programme for more comprehensive monitoring of tuberculosis patients on DOTS for timely prevention, detection, and management of ADR’s. This will decrease non-adherence and dropouts, and thus result in better treatment outcomes.

References

Ananthanarayan R. Textbook of microbiology. 9th ed. Hyderabad: University Press (India); 2013:345-358.

TB India. Part 1: Ministry of Health and Family Welfare. 2016. Available from: http://tbcindia.nic.in/showfile.php?lid=3180.

TB India. Part 2: Ministry of Health and Family Welfare. 2016. [cited 2016 Nov 18]. Available from: http://tbcindia.nic.in/showfile.php?lid=3181

Bulletin on adverse drug reaction. Lokmanya Tilak Municipal Medical College and General Hospital. 2012 Apr;2(1):40.

DiPiro JT. Pharmacotherapy. A pathophysiologic approach. 9th ed; New York: McGraw-Hill; 2014:2586.

Gholami K, Kamali E, Hajiabdolbaghi M, Shalviri G. Evaluation of anti-tuberculosis induced adverse reactions in hospitalized patients. Pharm Pract. 2006;4(3):134-8.

Chandrasekaran K SAP. Implementation of Self Reporting Pharmacovigilance in Anti Tubercular Therapy Using Knowledge Based Approach. J Pharmacovigil. 2013;1(1). Available from: http://www.esciencecentral.org/journals/implementation-of-self-reporting-pharmacovigilance-in-anti-tubercular-therapy-using-knowledge-based-approach-2329-6887.1000101.php?aid=10726

Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000 Oct 7;356(9237):1255-9.

Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Health Syst Pharm. 1992 Sep 1;49(9):2229-32.

Koju D, Rao B, Shrestha B, Shakya R, Makaju R. Occurrence Of Side Effects From Anti-Tuberculosis Drugs In Urban Nepalese Population Under DOTS Treatment. Kathmandu Univ J Sci Eng Technol. 2005 Sep;1:9.

Rajanandh MG, Nageswari AD, Ramasamy C, Dinesh V. Side effects of anti tubercular drugs on directly observed treatment strategy under revised national tuberculosis control programme in a teaching hospital. Glob J Pharmacol. 2012 Jan 1;6(1):29-32.

Sahithi K, Rao GP, Lohith MN, Rao DGC, Umar Pharm. D DKM, Rao Nadendla M. Pharm and Ph.D. FIC PR. Evaluation of incidence and severity of anti-tubercular drugs induced adverse drug reactions in tuberculosis patients. Eur J Biomed Pharm Sci. 2016;3(8):166-72.

Honnaddi DUC, Honnaddi DMU, SR DT, Hossain DT, Somani DR. Adverse Drug Reactions to First Line Anti-Tubercular Drugs - A Pharmacovigilance Study. Int J Pharmacol Res. 2016 Feb 28;6(2):51-4.

Sinha K, Marak ITR, Singh WA. 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 Associations Chest Physicians. 2013;1(2):50-3.

Abideen P, Chandrasekran K, Maheshwaran U, Kumar V, Kalaiselvan V, Mishra P, et al. Implementation of Self Reporting Pharmacovigilance in Anti Tubercular Therapy Using Knowledge Based Approach. J Pharmacovigil. 2013;1(1):5.

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Published

2017-02-24

How to Cite

Agarwal, R., Goel, A., Rai, J., & Kajal, N. C. (2017). Pharmacovigilance of first line anti-tubercular therapy in category I patients of pulmonary tuberculosis. International Journal of Basic & Clinical Pharmacology, 6(3), 643–647. https://doi.org/10.18203/2319-2003.ijbcp20170829

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Original Research Articles