Comparative Analysis of Adverse drug Reactions in Directly Observed Treatment Short Course (DOTS) in TB Patients

Table of contents

1. Introduction

eographically, the burden of TB is highest in Asia and Africa. India and China together account for almost 40% of the world's TB cases (WHO, 2012). TB is a highly infectious disease caused by Mycobacterium tuberculosis, which is the second leading cause of death d u e t o infection in the world. TB is a major public health problem in Bangladesh. The country ranks 6 th on the list of 22 highest burden TB countries in the world. Each hour eight persons die of the disease for which very effective treatment, free of cost, is available in Bangladesh. Before 1993 TB control was limited to TB clinics and TB hospitals. Field implementation of TB control integrated into the general health services, delivered by Upazila Health Complexes (UHC's), started back in 80s. However, National TB Control Programme (NTP) Bangladesh revised its strategies and adopted DOTS in 1993. NGO's have been involved since 1994 (NTP). detect 70% of new smear-positive pulmonary TB cases and cure at least 85 % of them by the year 2005 and be maintained thereafter to reach the Millennium Development Goal (MDG) by 2015 (NTP).

As the treatment of TB almost always involves combinations of drugs that are to be taken for a prolonged period of time, the occurrence of ADR is quite likely. Moreover, the adverse effect of one drug may be enhanced by the associated drug used which is one of the major reasons for the faulty patient treatment.

The common ADRs observed in DOTS involved mild gastritis, central nervous system, peripheral nervous system, psychiatric, Thus, a comprehensive understanding of the various ADRs along with their management is mandatory for the prevision, detection, and effectual TB management. It has become quite imperative to monitor the ADRs of patients on DOTS through the monitoring of ADRs and hence, the current study was undertaken.

2. II.

3. Materials and Methos

Ten years ADR data (from 2002 to 2012) in the DOTS therapy caused by anti-TB drugs previously reported in various articles were searched from referred sources and observed carefully. The observed cases of different regions are listed in Table 1.

4. III.

5. Results and Discussion

A total of 10219 patients were observed from previously studied articles. Among them 8047 (78.75%) patients showed at least one type of ADR. Dermatological ADRs were predominant (42.95%) which was followed by hepatotoxic reactions (15.99%). Different types of ADRs and there prevalence occuraence is depicted in Table 2 and Figure1 The overall goal of the NTP is to reduce morbidity, mortality and transmission of TB until the disease is no longer a public health problem. The objectives are to

The study says that, Isoniazid, rifampicin, and ethambutol are the drugs responsible for the skin reactions (F. Kurniawati et al., 2012). Arthralgia or gout which is prevalent in adults is mainly caused by isoniazid, ethambutol, and pyrazinamide that can be managed by Nonsteroidal Anti-inflammatory Drugs (NSAIDs). Children are less prone to hepatitis as compared to adults, mainly shown by pyrazinamide alone, isoniazid and rifampicin, isoniazid alone, and rifampicin alone. It can be reduced by starting therapy with ethambutol and pyrazinamide (F. Kurniawati et al., 2012).

The occurrence of ADRs among the female patients was marginally higher as compared to the male patients.This phenomenon is attributed to the alteration of drug responses mainly due to their lower body weight compared to the males. Different phases of life such as, pregnancy, menstruation cycles etc. also contribute to some extent in this regard (J J Furin et al., 2001; D.K. Tak et al., 2009).

ADR management should involve proper monitoring of the adverse reactions, postponing medication regimens, continuing the medication again without change and finally changing patient's treatment regimens. To reduce GI disorders antiemetic drugs and to alleviate dermatological antihistamines can be administered as add on therapies.

IV.

6. Conclusion

The occurrence of ADRs in the patients with DOTS is highly alarming; and immediate measures should be taken for the prevention of this phenomenon in order to minimize the potential serious health hazards including death. Pharmacists can play a significant role in the management of ADRs through patient counseling and improving their awareness.

Figure 1.
and ocular complications along with hypothyroidism, hepatitis, icterus, fever, and breathlessness (J. J. Furin et al., 2001; K. D. Tripathi, 2008; Rang & Dale, 2007).
Figure 2. Table 1 :
1
Figure 3. Table 2 :
2
Si. No. Different ADRs No. of Patients Percentage
Total no. of patients observed 10,219 100.00
1 Dermatological 4,389 42.95
2 Hepatitis 1,634 15.99
3 GI disturbance 1,004 9.82
4 Musculoskeletal 166 1.62
5 Central nervous system 86 0.84
6 Headache 37 0.36
7 Ocular 29 0.28
8 Fever 13 0.13
9 Otological 9 0.09
10 Peripheral nervous system 7 0.07
11 Renal 7 0.07
12 Breathlessness 4 0.04
13 Psychiatric 3 0.03
14 Miscellaneous 659 6.45
Total no. of ADRs observed 8,047 78.75
1

Appendix A

Appendix A.1 Acknowledgement

Authors are grateful to the Professor Dr. Abu Shara Shamsur Rouf for his prudent suggestions which greatly facilitated the research activity.

Appendix B

Appendix B.1 Global

Appendix C

  1. , http://www.ban.searo.who.int/en/Section15/Section16_25.htm NTP
  2. , December . 1.
  3. Safety Evaluation Of Antitubercular Therapy Under Revised National Tuberculosis Control Programme In India. D K Tak , L D Acharya , K Gowarinath , G Rao Padma , P Subish . Journal of Clinical and Diagnostic Research 2009April. (3) p. .
  4. Influence of Honey on Adverse Reactions Due to Anti-Tubercular Drugs in Pulmonary Tuberculosis Patients. D Pillai , Behera . Continental J. Pharmacology and Toxicology Research 2008. Nov (06. (2) .
  5. Adverse Drug Reactions of Primary Antituberculosis Drugs Among Tuberculosis Patients Treated in Chest Clinic. F Kurniawati , S A S Sulaiman , S W Gillani . Int. J. of Pharm. & Life Sci. (IJPLS) 0976-7126. 2012 Jan 1. (page no. 1331-1338.)
  6. , Geneva Who . Global Tuberculosis Control 2012. 2012.
  7. The Influence of Adverse Drug Reactions on First-line Anti-tuberculosis Chemotherapy in the Elderly Patients. Tuberculosis and Respiratory Diseases, J I Jeong , B H Jung , M H Kim , J M Lim , D C Ha , S W Cho . 2009 Oct. 67 p. .
  8. Occurrence of serious adverse effects in patients receiving community-based therapy for multidrug-resistant tuberculosis. J J Furin , C D Mitnick , S S Shin , J Bayona , M C Becerra , J M Singler . International Journal of Tuberculosis and Lung Diseases 2001 Jul. 5 (7) p. .
  9. A study of adverse drug reactions caused by first line anti-tubercular drugs used in Directly Observed Treatment, Short course (DOTS) therapy in western Nepal. K Chhetri , A Saha , S C Verma , S Palaian , P Mishra , P R Shankar . Pokhara. Journal Pakistan Medical Association 2008 October. 58 (10) .
  10. , K D Tripathi . Essentials of Medical Pharmacology by Jaypee Brothers Medical Publishers 2008. (6th edition)
  11. Evaluation of anti-tuberculosis induced adverse reactions in hospitalized patients. K Gholami , Hajiabdolbagh Kamali , Mi , Shalviri . Pharmacy Practice 2006. 4 (3) p. .
  12. A comparative study on the adverse effects of two antituberculosis drugs regimen in initial two-month treatment period. L Begum , A K M Nahar , M Mosharrof Hossain , D R Islam , Saha . Bangladesh Journal of Pharmacology 2006.
  13. Pattern of Adverse drug Reactions Experienced by Tuberculosis Patients in A tertiary Care Teaching Hospital in Nepal. P V Kishore , S Palaian , P Ojha , P R Shankar . Pakistan Journal of Pharmaceutical Sciences 2008 January. 21 (1) p. .
  14. Rang & Dale: A textbook of pharmacology by, 2007. Elsevier. (6th edition)
Notes
1
© 2013 Global Journals Inc. (US) © 2013 Global Journals Inc. (US)
Date: 2013-01-15