Author(s):
Septi Muharni, Kusnandar Anggadiredja, I Ketut Adnyana, Dyah Aryani Perwitasari, Firda Amir Parumpu, Rinto Susilo
Email(s):
kusnandar@fa.itb.ac.id
DOI:
10.52711/0974-360X.2025.00352
Address:
Septi Muharni1,2, Kusnandar Anggadiredja1*, I Ketut Adnyana1, Dyah Aryani Perwitasari3, Firda Amir Parumpu1,4, Rinto Susilo5
1Department of Pharmacology and Clinical Pharmacy, School of Pharmacy, Institut Teknologi Bandung, Bandung, Indonesia.
2Department of Clinical Pharmacy and Community Pharmacy, Sekolah Tinggi Ilmu Farmasi Riau, Pekanbaru, Indonesia.
3Department of Clinical Pharmacy, Faculty of Pharmacy, Ahmad Dahlan University, Special Region of Yogyakarta, Indonesia.
4Department of Pharmacy, Tadulako University, Palu, Central Sulawesi, Indonesia.
5Department of Pharmacy, Sekolah Tinggi Farmasi Muhammadiyah Cirebon, West Java, Indonesia.
*Corresponding Author
Published In:
Volume - 18,
Issue - 6,
Year - 2025
ABSTRACT:
Lack of anti-tuberculosis adverse drug reactions reporting through pharmacovigilance practices is a significant factor in delaying drug cessation and providing a risk of tuberculosis therapy failure. Pharmacist contribution to pharmacovigilance practices in tuberculosis patients is expected to help tuberculosis control programs in Indonesia. Pharmacovigilance is one of the tasks of pharmacists in pharmaceutical services and requires the pharmacist's awareness to report adverse drug reactions. The study aims to conduct a qualitative study of the current situation of the role of pharmacists in pharmacovigilance practice among tuberculosis patients in Indonesia. The study is a qualitative study with a phenomenological design through in-depth interviews, video, and document studies with pharmacists working in the service department at Hospitals and Public Health Centres that perform tuberculosis patient services in several provinces in Indonesia. The province was chosen based on case notification data, treatment coverage, and success rates for tuberculosis patients in Indonesia. Participants were recruited using a convenient sampling method. The interview followed the interview guidelines that had been prepared and validated before use. The data obtained was analyzed thematically using NVivo 14 software. Twelve pharmacists scattered across twelve provinces in Indonesia were taken as samples. This qualitative analysis reveals five themes. Themes that have been identified are the limited knowledge of pharmacists on pharmacovigilance and ADR, the low involvement of the pharmacist in anti-tuberculosis pharmacovigilance practices in tuberculosis patients, the implementation of anti-tuberculosis pharmacovigilance practices among tuberculosis patients that are not optimal, the high barrier to pharmacologists in the practice of anti-tuberculosis pharmacovigilance in tuberculosis patients and efforts to maximize anti-tuberculosis pharmacovigilance practice in tuberculosis people. The role of pharmacists in anti-tuberculose pharmacovigilance practices in tuberculosis patients in Indonesia is still very low. It is estimated that efforts to improve pharmacists' active role in tuberculosis programs, increase knowledge through science updates and training-related pharmacovigilance anti-tuberculosis, and use technology-based instruments for simple anti-tuberculosis adverse drug reaction assessment will increase pharmacist self-confidence in implementing the practice of pharmacovigilance anti-tuberculosis in TB patients.
Cite this article:
Septi Muharni, Kusnandar Anggadiredja, I Ketut Adnyana, Dyah Aryani Perwitasari, Firda Amir Parumpu, Rinto Susilo. A Qualitative Study of The Current Situation of The Role of Pharmacists in Antituberculosis Pharmacovigilance Practice in Tuberculosis patients in Indonesia. Research Journal of Pharmacy and Technology. 2025;18(6):2466-4. doi: 10.52711/0974-360X.2025.00352
Cite(Electronic):
Septi Muharni, Kusnandar Anggadiredja, I Ketut Adnyana, Dyah Aryani Perwitasari, Firda Amir Parumpu, Rinto Susilo. A Qualitative Study of The Current Situation of The Role of Pharmacists in Antituberculosis Pharmacovigilance Practice in Tuberculosis patients in Indonesia. Research Journal of Pharmacy and Technology. 2025;18(6):2466-4. doi: 10.52711/0974-360X.2025.00352 Available on: https://rjptonline.org/AbstractView.aspx?PID=2025-18-6-5
REFERENCES:
1. WHO. Global Tuberculosis Report 2022. 2022. Available from: https://www.ptonline.com/articles/how-to-get-better-mfi-results
2. WHO. Global Tuberculosis Report 2023. Geneva: World Health Organization; 2023.
3. Menkes RI. Pedoman Nasional Pelayanan Kedokteran, Tata Laksana Tuberkulosis, Menteri Kesehatan Republik Indonesia. Jakarta: Menteri Kesehatan Republik Indonesia; 2019.
4. WHO. Tuberculosis. Geneva: World Health Organization; 2021.
5. BPOM, JICA. Modul Farmakovigilans Untuk Tenaga Profesional Kesehatan, Proyek Ensuring Drug and Food Safety. Badan Pengawas Obat dan Makanan. 2020.
6. Sahilu T, Getachew M, Melaku T, Sheleme T. Adverse Drug Events and Contributing Factors Among Hospitalized Adult Patients at Jimma Medical Center, Southwest Ethiopia: A Prospective Observational Study. Curr Ther Res. 2020; 93: 100611. Available from: https://linkinghub.elsevier.com/retrieve/pii/S0011393X20300370
7. Fatima S, Syeda MF, Adla N, Devi R. Ambispective study of adverse drug reactions in multi-drug resistant tuberculosis patients in Warangal, Telangana. 2021; https://doi.org/10.4103/lungindia.lungindia_118_19
8. Massud A, Syed Sulaiman SA, Ahmad N, Shafqat M, Chiau Ming L, Khan AH. Frequency and Management of Adverse Drug Reactions Among Drug-Resistant Tuberculosis Patients: Analysis From a Prospective Study. Front Pharmacol. 2022; 13(June): 1–15. https://doi.org/10.3389/fphar.2022.883483
9. Gebreweld FH, Kifle MM, Gebremicheal FE, Simel LL, Gezae MM, Ghebreyesus SS, et al. Factors influencing adherence to tuberculosis treatment in Asmara, Eritrea: A qualitative study. J Heal Popul Nutr. 2018; 37(1): 1–9. https://doi.org/10.1186/s41043-017-0132-y
10. Ausi Y, Santoso P, Sunjaya DK, Barliana MI. Between Curing and Torturing: Burden of Adverse Reaction in Drug-Resistant Tuberculosis Therapy. Patient Prefer Adherence. 2021; 15: 2597–607. https://doi.org/10.2147/PPA.S333111
11. Susilo R, Diantini A, Lukman K, Perwitasari DA, Kunaedi A. Translation and Validation of the Indonesian Version of the Adverse Drug Reaction Severity Level Instruments in Colorectal Cancer Patients. J Multidiscip Healthc. 2022; 15(April): 1153–61. https://doi.org/10.2147/JMDH.S353325
12. Trifirò G, Crisafulli S. A New Era of Pharmacovigilance: Future Challenges and Opportunities. Front Drug Saf Regul. 2022; 2(February): 2020–3. https://doi.org/10.3389/fdsfr.2022.866898
13. Chauhan S. Pharmacovigilance- A drug safety monitoring tool. J Pharmacovigil Drug Res. 2021; 2(3): 15–20. https://doi.org/10.53411/jpadr.2021.2.3.4
14. Vivekanandan Kalaiselvan SS, Santhanakrishnan Ramesh Kumar NM, Raghuvanshi PK and RS. Adverse Drug Reactions Associated with Anti-Tuberculosis Therapy Vivekanandan. Intech [Internet]. 2021; 11(tourism): 13. Available from: https://www.intechopen.com/books/advanced-biometric-technologies/liveness-detection-in-biometrics
15. BPOM. Farmakovigilans (Keamanan Obat) : Panduan Deteksi dan Pelaporan Efek Samping Obat Untuk Tenaga Kesehatan. Pus Farmakovigilans Nas. 2019;1–26.
16. Kengar MD, Patole KK, Ade AK, Kumbhar SM, Patil CD, Ganjave AR. Introduction to Pharmacovigilance and Monitoring. Asian J Pharm Res. 2019; 9(2): 116. https://doi.org/10.5958/2231-5691.2019.00019.4
17. Naik SA. Review on Pharmacovigilance. Asian J Pharm Res. 2020; 10(2): 123. https://doi.org/10.5958/2231-5691.2020.00024.6
18. Birhane H, Islam M, H/mariam D, Singh V. Pharmacovigilance: adverse drug reactions (Adrs) in pediatric patients in Ethiopia. retrospective study. Res J Pharm Technol [Internet]. 2021; 14(3): 1499–506. Available from: https://www.scopus.com/inward/record.uri?eid=2-s2.0-85109389167&doi=10.5958%2F0974-360X.2021.00266.3&partnerID=40&md5=0acadc687e27f552794ec6d5c0b92c4c
19. Umar BU, Haque M. Adverse drug reactions in Bangladeshi health care setup: An update. Res J Pharm Technol. 2015; 8(11): 1598–602. https://doi.org/10.5958/0974-360X.2015.00287.5
20. Sharma M, Baghel R, Thakur S, Adwal S. Surveillance of adverse drug reactions at an adverse drug reaction monitoring centre in Central India: A 7-year surveillance study. BMJ Open. 2021; 11(10): 1–8. https://doi.org/10.1136/bmjopen-2021-052737
21. Kudri AM, Barliana MI. Pengetahuan dan Kesadaran Apoteker dan Pasien dalam Melaporkan Adverse Drug Reaction (ADR) terhadap Keamanan Obat. Farmaka [Internet]. 2018; 16(2): 525–30. Available from: http://jurnal.unpad.ac.id/farmaka/article/view/17602
22. Defer G, Fedrizzi S, Chevanne D, Montastruc F, Briant AR, Parienti JJ, et al. Adverse Drug Reaction Reporting Using a Mobile Device Application by Persons with Multiple Sclerosis: A Cluster Randomized Controlled Trial. Drug Saf. 2021; 44(2): 223–33. https://doi.org/10.1007/s40264-020-01009-z
23. Khan FU, Khan A, Khan FU, Hayat K, Rehman A ur, Chang J, et al. Assessment of Adverse Drug Events, Their Risk Factors, and Management Among Patients Treated for Multidrug-Resistant TB: A Prospective Cohort Study From Pakistan. Front Pharmacol. 2022; 13(May): 1–10. https://doi.org/10.3389/fphar.2022.876955
24. Boopathi D, Akshatha JS, Buggi U, Siva H, Arun KP, Mani D. Analysis of Adverse Drug Reactions associated with Anti-tubercular drugs – A Retrospective Study. Res J Pharm Technol. 2022; 15(4): 1483–6. https://doi.org/10.52711/0974-360X.2022.00246
25. Alqurbi M, Atiah M. The role of clinical pharmacists in reducing adverse drug reactions. Int J Med Dev Ctries. 2020; 4(1): 236–9.
26. Costa C, Abeijon P, Rodrigues DA, Figueiras A, Herdeiro MT, Torre C. Factors associated with underreporting of adverse drug reactions by patients: a systematic review. Int J Clin Pharm [Internet]. 2023; 45(6): 1349–58. Available from: https://doi.org/10.1007/s11096-023-01592-y
27. Royce Carandang R, Cao K, Beatrice Jose N, Diana Almonte F, Michael Tinio R. Knowledge and Attitudes on Adverse Drug Reaction Reporting of Selected Hospital-based Health Practitioners in Manila. Sch Acad J Pharm [Internet]. 2015; 4(6): 301–7. Available from: https://www.researchgate.net/publication/331563338
28. Aoki T, Yamamoto Y, Fukuhara S. Comparison of primary care experience in Hospital-based practices and community-based office practices in Japan. Ann Fam Med. 2020; 18(1): 24–9. https://doi.org/10.52711/0974-360X.2022.00246
29. Sarkar P, Sarkar A, Basu R. Sociodemographic factors influencing knowledge, attitude, and practices regarding the prevention of common cancers among adults in urban slum, Kolkata. Muller J Med Sci Res. 2022; 13(2): 85. https://doi.org/10.4103/mjmsr.mjmsr_41_22
30. Nar RR, Kumar A, Jeeva S. Assessment and comparison of knowledge and attitude regarding pulmonary tuberculosis and compliance to Anti-Tuberculosis Treatment (ATT) of pulmonary tuberculosis patients under intensive and continuation phase of treatment at selected DOTS centres of Amb. Asian J Nurs Educ Res [Internet]. 2012; 2(4): 3–194. Available from: http://ezproxy.laureate.net.au/login?url=https://search.proquest.com/docview/1464525667?accountid=176901
31. Thanmayi G, Shanmugasundaram P, Geetha P. Role of clinical pharmacist in improving patients compliance including risk factors among tuberculosis patients. Res J Pharm Technol. 2017; 10(9): 2945–8. https://doi.org/10.5958/0974-360X.2017.00521.2
32. Toklu HZ, Mensah E. Why do we need pharmacists in pharmacovigilance systems? Online J Public Health Inform. 2016; 8(2). https://doi.org/10.5958/0974-360X.2017.00521.2
33. Shinde S, Galgalo D, R. Jadhav J. Qualitative Assessment of Challenges in Tuberculosis Control in Public Health Facilities of Bule Hora Town, Ethiopia; Health Workers’ and Tuberculosis Control Program Coordinators’ Perspectives, 2020. A V Pub Int J Nurs Med Res. 2023; 2(03): 69–77. https://doi.org/10.52711/10.52711/ijnmr.2023.17
34. Ghozali MT, Murni IW. Knowledge and Attitude among Community Pharmacists regarding Pharmacovigilance – A Cross Sectional Survey. Indones J Pharm. 2023; 34(4): 686–94. https://doi.org/10.22146/ijp.5814
35. Musdar TA, Nadhafi MT, Lestiono L, Lichijati L, Athiyah U, Nita Y. Faktor yang Mempengaruhi Praktik Pelaporan Adverse Drug Reactions (ADRs) oleh Apoteker di Beberapa Rumah Sakit di Surabaya. JPSCR J Pharm Sci Clin Res. 2021; 6(2): 96. https://doi.org/10.20961/jpscr.v6i2.49794
36. Bahnassi A. A Qualitative Assessment of Current Pharmacovigilance Education in Lebanese Pharmacy Schools. Med Sci Educ. 2020; 30(2): 855–60. https://doi.org/10.20961/jpscr.v6i2.49794
37. Kazaryan I, Sevikyan A, Vardanyan L, Amirkhanyan A, Melikyan M. Role of community pharmacists in pharmacovigilance: pharmacists’ and patients’ perceptions. 2021; 353–4. https://doi.org/10.1093/eurpub/ckab165.365
38. Shanableh S, Zainal H, Alomar M, Palaian S. A national survey of knowledge, attitude, practice, and barriers towards pharmacovigilance and adverse drug reaction reporting among hospital pharmacy practitioners in the United Arab Emirates. J Pharm Policy Pract [Internet]. 2023; 16(1): 1–19. Available from: https://doi.org/10.1186/s40545-023-00593-6
39. Solanki N, Patel P, Shah B, Nagar D, Patel B, Patel S, et al. Assessment of Knowledge, Attitude and Behavior on Adverse Drug Reactions Between Community and Hospital Pharmacists: a Questionnaire-Based Study. Indian Drugs. 2023; 60(4): 81–6. https://doi.org/10.53879/id.60.04.12923
40. Albayrak A, Karahalil B. Pharmacist’s Knowledge and Behaviors Toward Pharmacovigilance and Adverse Drug Reactions Reporting Process in Türkiye. Turkish J Pharm Sci. 2022; 19(6): 694–700. https://doi.org/10.53879/id.60.04.12923
41. Alworafi YM, Hasan S, Hassan NM, Gaili AA. Knowledge, Attitude and Experience of Pharmacists in the UAE towards Pharmacovigilance. Res J Pharm Technol. 2021; 14(1): 265–9. https://doi.org/10.5958/0974-360X.2021.00047.0
42. Sharma A, Amarnath S, Jaikumar S, Basalingappa S, Ramaswamy S, Thulasimani M. Assessment of knowledge about pharmacovigilance among medical students in Puducherry. Res J Pharm Technol. 2014; 7(4): 447–9. https://rjptonline.org/HTML_Papers/Research%20Journal%20of%20Pharmacy%20and%20Technology__PID__2014-7-4-2.html
43. Hussain R, Hassali MA, Ur Rehman A, Muneswarao J, Hashmi F. Physicians’ understanding and practices of pharmacovigilance: Qualitative experience from a lower middle-income country. Int J Environ Res Public Health. 2020; 17(7). https://doi.org/10.3390/ijerph17072209
44. Ravichandran M, Rajaram M, Munusamy M. Pharmacovigilance of Antitubercular Therapy in Tuberculosis. Cureus. 2022; 14(2): 1–7. https://doi.org/10.7759/cureus.21915
45. Shuka SS, Gidwani B, Pandey R, Rao SP, Singh V, Vyas A. Importance of Pharmacovigilance in Indian Pharmaceutical Industry. Asian J Res Pharm Sci [Internet]. 2012; 2(1): 4–8. Available from: http://indianjournals.com/ijor.aspx?target=ijor:ajrps&volume=2&issue=1&article=002
46. Ragul Viknesh V, Saranya P. Pharmacovigilance-An Overview in a Pharmacist Perspective. Res J Pharm Technol. 2020; 13(8): 3941–6. https://doi.org/10.7759/cureus.21915
47. Said ASA, Hussain N. Adverse drug reaction reporting practices among United Arab Emirates pharmacists and prescribers. Hosp Pharm. 2017; 52(5): 361–6. https://doi.org/10.1177/0018578717715364
48. Alshayban D, Mahmoud MA, Islam MA, Alshammari S, Alsulaiman D. Pharmacovigilance perception and knowledge among pharmacists and interns in Saudi Arabia. Risk Manag Health Policy. 2020; 13: 55–61. https://doi.org/10.2147/RMHP.S241265
49. Jha N, Palaian S, Shankar PR, Santosh KC, Kshetry PB. Situation analysis of the pharmacovigilance system in Nepal using the indicator-based pharmacovigilance assessment tool (IPAT). J Pharm Heal Serv Res. 2021; 12(4): 485–91. https://doi.org/10.1093/jphsr/rmab054
50. Asriwati, Yeti E, Niakurniawati, Usman AN. Risk factors analysis of non-compliance of Tuberculosis (TB) patients taking medicine in Puskesmas Polonia, Medan, 2021. Gac Sanit [Internet]. 2021; 35: S227–30. Available from: https://doi.org/10.1016/j.gaceta.2021.10.027
51. Anbeo ZG, Abacioğlu N. A Systematic Review of Healthcare Professionals’ Knowledge, Attitudes, and Practices Regarding Adverse Drug Reaction Reporting in Ethiopia. Turkish J Pharm Sci. 2023; 20(3): 198–209. https://doi.org/10.4274/tjps.galenos.2022.28034