A Comparative Study of Active and Passive Adverse Drug Reaction Monitoring Methods in Category I Tuberculosis Patients at a Tertiary Care Hospital in India

Bansal, Alka; Advani, Uma; Agrawal, Ashish; Sharma, Lokendra; Jain, Smita; Sharma, Sudhir

Volume 6, Issue 4 (12-2020) Journal of Research in Applied and Basic Medical Sciences 2020, 6(4): 262-271 | Back to browse issues page

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Bansal A, Advani U, Agrawal A, Sharma L, Jain S, Sharma S. A Comparative Study of Active and Passive Adverse Drug Reaction Monitoring Methods in Category I Tuberculosis Patients at a Tertiary Care Hospital in India. Journal of Research in Applied and Basic Medical Sciences 2020; 6 (4) :262-271
URL: http://ijrabms.umsu.ac.ir/article-1-142-en.html

A Comparative Study of Active and Passive Adverse Drug Reaction Monitoring Methods in Category I Tuberculosis Patients at a Tertiary Care Hospital in India

Alka Bansal ^*

, Uma Advani

, Ashish Agrawal

, Lokendra Sharma

, Smita Jain

, Sudhir Sharma

SMS Medical College, Jaipur, India , alkabansal04@gmail.com

Abstract: (2401 Views)

Background & Aims: Adverse Drug Reactions (ADRs) are common with drug treatment. They can be collected by active and passive methods. The aim of the study was to compare active and passive ADR monitoring methods in terms of yield and lag period in category I tuberculosis patients.
Materials & Methods: A prospective observational analytical study was done in a directly observed therapy short-course (DOTS) center and pharmacovigilance center of SMS hospital, Jaipur, Rajasthan, India from 1.1.2019 to 31.12.2019. A total of 303 category I tubercular patients on DOTS were divided into groups A (150) and B (153). Group A (active) patients were interviewed personally or telephonically for ADRs on 0,3,7,15,30, 90,180 days of therapy as per pre-structured & pre-validated questionnaire. Group B (passive) patients were asked to report ADRs themselves to pharmacovigilance center directly or through a drop box. Collected ADRs were compared statistically using software Minitab 14, Pennsylvania, USA.
Results: The yield of ADRs in active method was 4.5 times higher than the passive method. GIT related ADRs were similar in both groups, cutaneous were higher in active and CNS concerned were higher in passive method. However, consistency of ADR reporting was more in passive method. Mean lag period between onset and reporting of ADRs by active and passive methods were 5.72 and 22.4 days, respectively.
Conclusion: Active method initially and numerically facilitates ADR reporting together with decreased lag period but passive method gives consistent yield in chronic diseases like TB, hence, an integrated approach to identify and manage ADRs will be most beneficial for patients.

Keywords: Tuberculosis, Adverse drug reactions (ADRs), Yield, Lag period, Active and passive monitoring

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Type of Study: orginal article | Subject: General

References

1. Syed Hussain F, Sathyanarayanan V, Jamuna Rani R. Analysis of adverse drug reactions encountered in a tertiary care hospital: a cross sectional study. Int J Basic Clin Pharmacol 2018;7(6):1164. [DOI:10.18203/2319-2003.ijbcp20182100]

2. Xia YY, Liu FY, Wang XM, Yuan YL, Chen YX, Zhou L, et al. Design of the anti-tuberculosis drugs induced adverse reactions in China National Tuberculosis Prevention and Control Scheme Study (ADACS). BMC public health 2010;10(1):267 [DOI:10.1186/1471-2458-10-267] [PMID] [PMCID]

3. Moses C, Celi LA, Marshall J. Pharmacovigilance: an active surveillance system to proactively identify risks for adverse events. Population Health Management 2013; 16(3):147-9. [DOI:10.1089/pop.2012.0100] [PMID] [PMCID]

4. Lindquist MA, Edwards IR. The WHO Programme for International Drug Monitoring, its database, and the technical support of the Uppsala Monitoring Center. J Rheumatol 2001;28(5):1180-7. [Google Scholar]

5. Kalaiselvan V, Srivastava S, Singh A, Gupta SK. Pharmacovigilance in India: present scenario and future challenges. Drug Saf 2019;42(3):339-46. [DOI:10.1007/s40264-018-0730-7] [PMID]

6. Kessler DA. Introducing MEDWatch: A new approach to reporting medication and device adverse effects and product problems. J Adolesc Health1994;15(4):281-5. [ScienceDirecct]

7. https://www.fda.gov/media/75240/download (Last accessed on 30.11.2020) [FDA]

8. Onakpoya IJ, Heneghan CJ, Aronson JK. Post-marketing withdrawal of 462 medicinal products because of adverse drug reactions: a systematic review of the world literature. BMC medicine 2016;14(1):10. https://doi.org/10.1186/s12916-016-0735-y [DOI:10.1186/s12916-016-0553-2]

9. Sahu RK, Yadav R, Prasad P, Roy A, Chandrakar S. Adverse drug reactions monitoring: prospects and impending challenges for pharmacovigilance. Springerplus 2014;3(1):695. [DOI:10.1186/2193-1801-3-695] [PMID] [PMCID]

10. Tiberi S, Muñoz-Torrico M, Duarte R, Dalcolmo M, D'Ambrosio L, Migliori GB. New drugs and perspectives for new anti-tuberculosis regimens. Pulmonology 2018; 24 (2): 86-98. [DOI:10.1016/j.rppnen.2017.10.009] [PMID]

11. Wu T, Gao CC, Lin JS, Zha JL. Active Monitoring of Adverse Drug Reactions with Neural Network Technology. Chin Med J2017;130(12):1498. [DOI:10.4103/0366-6999.207468] [PMID] [PMCID]

12. Norén GN, Edwards IR. Modern methods of pharmacovigilance: detecting adverse effects of drugs. Clin Med 2009;9(5):486. [DOI:10.7861/clinmedicine.9-5-486] [PMID] [PMCID]

13. https://www.who.int/tb/areas-of-work/drug-resistant-tb/treatment/adsm_factsheet_2018.pdf (Last accessed on 30.11.2020) [WHO]

14. Huang YL, Moon J, Segal JB. A comparison of active adverse event surveillance systems worldwide. Drug Saf 2014;37(8):581-96. [DOI:10.1007/s40264-014-0194-3] [PMID] [PMCID]

15. Sahu RK, Yadav R, Prasad P, Roy A, Chandrakar S. Adverse drug reactions monitoring: prospects and impending challenges for pharmacovigilance. Springerplus 2014;3(1):695. [DOI:10.1186/2193-1801-3-695] [PMID] [PMCID]

16. Inácio P, Cavaco A, Airaksinen M. The value of patient reporting to the pharmacovigilance system: a systematic review. Br J Clin Pharmacol 2017;83(2):227-46. [DOI:10.1111/bcp.13098] [PMID] [PMCID]

17. Begaud B, Chaslerie A, Haramburu F. Organization and results of drug vigilance in France. Rev Epidemiol Sante Publique 1994;42(5):416-23. [Google Scholar]

18. Fei CM, Zainal H, Ali IA. Evaluation of Adverse Reactions Induced by Anti-Tuberculosis Drugs in Hospital Pulau Pinang. Malays J Med Sci 2018;25(5):103. [DOI:10.21315/mjms2018.25.5.10] [PMID] [PMCID]

19. Khedkar DT, Chitnis UB, Bhawalkar JS, Mamulwar MS. Revised national tuberculosis control program: evolution, achievements, and challenges. Medical Journal of Dr. DY Patil University 2014;7(1):5. [DOI:10.4103/0975-2870.122753]

20. Yun IS, Koo MJ, Park EH, Kim SE, Lee JH, Park JW, et al. A comparison of active surveillance programs including a spontaneous reporting model for phamacovigilance of adverse drug events in a hospital. The Korean journal of internal medicine 2012;27(4):443. [DOI:10.3904/kjim.2012.27.4.443] [PMID] [PMCID]

21. Lynn RM, Riding K, McIntosh N. The use of electronic reporting to aid surveillance of ADRs in children: a proof of concept study. Arch Dis Child2010;95(4):262-5. [Google Scholar]

23. Anusha N, Topno I, Purty AJ. Adverse drug reactions monitoring among TB patients on anti-tubercular drugs under RNTCP in Pondicherry. International Journal 2014;2(12):165-73. [Google Scholar]

24. Yang M, Pan H, Lu L, He X, Chen H, Tao B, et al. Home-based Anti-Tuberculosis Treatment Adverse Reactions (HATTAR) study: a protocol for a prospective observational study. BMJ open 2019;9(3):e027321. [DOI:10.1136/bmjopen-2018-027321] [PMID] [PMCID]

25. Palanisamy S, Arul Kumaran KS, Rajasekaran A. A study on assessment, monitoring, documentation and reporting of adverse drug reactions at a multi-specialty tertiary care teaching hospital in South India. Int J PharmTech Res 2009;4:1519-22. [Google Scholar]