Content analysis of combined anti-tuberculosis drugs
DOI:
https://doi.org/10.5281/zenodo.15662640Keywords:
tuberculosis, MDR-TB, fixed-dose combinations, anti-tuberculosis drugs, pharmaceutical mark, treatment strategyAbstract
Introduction. The fight against tuberculosis remains one of the main challenges in global public health. The emergence of multidrug-resistant tuberculosis (MDR-TB) has significantly complicated the effectiveness of standard anti-TB therapy. The use of combined fixed-dose drug formulations is a key approach to increase treatment adherence and therapeutic efficacy. Materials and methods. The study involved a content analysis of the assortment of combined anti-tuberculosis medicines registered in Ukraine. The data were grouped by manufacturers using Sturges' formula to create discrete variation series and a frequency polygon. The availability of drugs in the State Formulary and the national legislation was also analyzed as of the current edition approved by Order of the Ministry of Health of Ukraine dated March 12, 2024, No. 418. Results and discussion. The study found that the use of combined anti-tuberculosis drugs is critical for the treatment of MDR-TB. The analysis showed that fixed-dose combinations offer pharmacological benefits, improve patient compliance, and reduce the risk of developing resistance. The Ukrainian pharmaceutical market offers a limited number of such combinations, with a significant share represented by foreign manufacturers. The current State Formulary reflects the need to expand access to essential anti-tuberculosis drug combinations. Conclusions. The combined use of anti-tuberculosis drugs is an effective strategy in MDR-TB treatment. Ensuring availability and expanding the range of fixed-dose combinations in Ukraine is vital for improving treatment outcomes and aligning with WHO recommendations.
References
World Health Organization. Global tuberculosis report 2023. Geneva: WHO; 2023. URL: https://www.who.int/publications/i/item/9789240076729
Shapovalova V. Forensic and pharmaceutical risks in the organization of pharmacotherapy of covid, post-covid and long-covid disorders. COVID-19 and vaccination practice standards. SSP Modern Pharmacy and Medicine. 2022. Vol. 2. No. 4. P. 1–24. URL: https://doi.org/10.53933/sspmpm.v2i4.69
Shapovalova V. The ICD-11 For the Twenty-First Century: The First View from the Organizational, Legal, Clinical and Pharmacological Aspects. SSP Modern Pharmacy and Medicine. 2022. Vol. 2. No. 1. P. 1–13. URL: https://doi.org/10.53933/sspmpm.v2i1.37
World Health Organization. Tuberculosis treatment: coverage and outcomes. WHO. 2022. URL: https://www.who.int/teams/global-tuberculosis-programme/tb-reports/global-tuberculosis-report-2023/tb-diagnosis---treatment/tb-treatment-and-treatment-coverage
Osyntseva A. Tuberculosis: pharmacognosy, medicinal plant raw materials, medicinal plants, phytotherapy. SSP Modern Pharmacy and Medicine. 2024. Vol. 4. No. 1. P. 1–10. URL: https://doi.org/10.53933/sspmpm.v4i1.130
Kendall E.A., Fofana M.O., Dowdy D.W. Burden of transmitted multidrug resistance in epidemics of tuberculosis: a transmission modelling analysis. The Lancet Respiratory Medicine. 2015. Vol. 3. No. 12. P. 963–972. URL: https://doi.org/10.1016/S2213-2600(15)00458-0
Blomberg B., Spinaci S., Fourie B., Laing R. The rationale for recommending fixed-dose combination tablets for treatment of tuberculosis. Bulletin of the World Health Organization. 2001. Vol. 79. No. 1. P. 61–68. URL: https://www.who.int/bulletin/archives/79(1)61.pdf
Shapovalov V.V., Komar L.O., Omelchenko V.O. Control regime for medicinal products of different classification and legal groups. Combined medicinal products: a teaching and methodological manual for independent work. Kharkiv: KhMAPO, 2017. 26 p.
Dooley K.E., Kim P.S., Williams D. et al. TB and HIV therapeutics: pharmacology research priorities. AIDS Research and Treatment. 2012. Vol. 2012. Article ID 524918. P. 1–11. URL: https://doi.org/10.1155/2012/524918
Ustinov O.V. Multidrug-resistant tuberculosis in Ukraine: causes of spread and ways to overcome it. Ukrainian Medical Journal. 2018. February 5. URL: https://www.umj.com.ua/uk/publikatsia-120173-multirezistentnij-tuberkuloz-v-ukrayini-prichini-poshirennya-ta-shlyahi-podolannya
Vovk D., Puhach O., Bachynska L. et al. The role of the general practitioner-family doctor in the pharmacotherapy of tuberculosis during the war. SSP Modern Pharmacy and Medicine. 2023. Vol. 3. No. 3. P. 1–7. URL: https://doi.org/10.53933/sspmpm.v3i3.102
Petrenko V.I., Todoriko L.D., Grishchuk L.A. et al. Phthisiology: a national textbook. Edited by V.I. Petrenko. Kyiv: VSV "Medicine", 2015. 472 p.
Gudzenko A.O., Osintseva A.O., Shapovalova V.O. et al. Content analysis of the circulation of alcohol-based medicines by dosage form and registration certificates. Copyright 79473 (Ukraine). Application No. 80713 dated 24.05.2018. Publ. 01.06.2018.
Shapovalova V.O., Zbrozhek S.I., Shapovalov V.V. (Jr.) et al. Content analysis of pharmacies in Ukraine, which produce extemporaneous drugs. Public Health. 2017. Vol. 6. No. 3–4. P. 77–83. DOI: 10.22141/2306-2436.6.3.2017.123498.
Christy J., Ledford W. Content Analysis of Internet Marketing Strategies: How Pharmaceutical Companies Communicate about Contraceptives with Consumers Online. J. Med. Internet Res. 2009. URL: https://journals.sagepub.com/doi/abs/10.1080/15245000903038308
Davis J. Content analysis of efficacy descriptions on branded pharmaceutical websites. Journal of Medical Marketing. 2012. Vol.12, N. 4. Р. 211-220. DOI:10.1177/1745790412465425
Shapovalova V.O. et al. Content analysis of alcohol circulation in healthcare facilities at the stage of budget procurement. Copyright N. 79456 (Ukrainian). Publ. 05/31/18
Gudzenko A.A., Osyntseva A.A., Shapovalova V.O. Content analysis of alcohol circulation by dosage forms and registration certificates. Copyright 79473 (Ukrainian). Publ. 06/01/18
Hsieh Hsiu-Fang, Shannon Sarah E. Three approaches to qualitative content analysis. ResearchGate. 2005. DOI:10.1177/1049732305276687. Retrieved from https://www.researchgate.net/publication/7561647_Three_Approaches_to_Qualitative_Content_Analysis
Gryzodub O., Shapovalov V. Quality systems in Pharmacy: multidisciplinary context of the State Pharmacopoeia of Ukraine. SSP Modern Law and Practice. 2023. Vol.3. No.1. P.1–23. URL: https://doi.org/10.53933/sspmlp.v3i1.81
World Health Organization. Tuberculosis: Multidrug-resistant (MDR-TB) or rifampicin-resistant TB (RR-TB). 2023. URL: https://www.who.int/news-room/questions-and-answers/item/tuberculosis-multidrug-resistant-tuberculosis-(mdr-tb)(World Health Organization (WHO))
Mitnick C.D., Shin S.S., Seung K.J., et al. Comprehensive treatment of extensively drug-resistant tuberculosis. The Lancet. 2004. Vol. 364, No. 9432. P. 1539–1545. URL: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(04)15596-2/fulltext(The Lancet)
European Centre for Disease Prevention and Control. Antimicrobial resistance for Tuberculosis. 2023. URL: https://www.ecdc.europa.eu/en/tuberculosis/antimicrobial-resistance(ecdc.europa.eu)
Nahid P., Dorman S.E., Alipanah N. et al. Official American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America Clinical Practice Guidelines: Treatment of drug-susceptible tuberculosis. Clinical Infectious Diseases. 2016. Vol. 63. No. 7. P. e147–e195. URL: https://doi.org/10.1093/cid/ciw376
Pontali E., Raviglione M.C., Migliori G.B. Regimens to treat multidrug-resistant tuberculosis: past, present and future perspectives. European Respiratory Review. 2019. Vol. 28. No. 152. Article 190035. P. 1–12. URL: https://doi.org/10.1183/16000617.0035-2019
The Global Fund. Results Report 2024. Geneva: The Global Fund. 2024. https://www.theglobalfund.org/media/15032/core_2024-results-tuberculosis_report_en.pdf
Tiberi S., du Plessis N., Walzl G. et al. Tuberculosis: progress and advances in development of new drugs, treatment regimens, and host-directed therapies. The Lancet Infectious Diseases. 2018. Vol. 18. No. 7. P. e183–e198. URL: https://doi.org/10.1016/S1473-3099(18)30110-5
Dheda K., Gumbo T., Maartens G. et al. The epidemiology, pathogenesis, transmission, diagnosis, and management of multidrug-resistant, extensively drug-resistant, and incurable tuberculosis. The Lancet Respiratory Medicine. 2017. Vol. 5. No. 4. P. 291–360. URL: https://doi.org/10.1016/S2213-2600(17)30079-6
Conradie F., Diacon A.H., Ngubane N. et al. Treatment of highly drug-resistant pulmonary tuberculosis. New England Journal of Medicine. 2020. Vol. 382. P. 893–902. URL: https://doi.org/10.1056/NEJMoa1901814
Gopal M., Padayatchi N., Metcalfe J.Z. et al. Systematic review of clofazimine for the treatment of drug-resistant tuberculosis. International Journal of Tuberculosis and Lung Disease. 2013. Vol. 17. No. 8. P. 1001–1007. URL: https://doi.org/10.5588/ijtld.13.0030
McKenna L., Frick M. The Global Drug-Resistant TB Crisis: A Time for Action. Treatment Action Group. 2016. URL: https://www.treatmentactiongroup.org/wp-content/uploads/2016/05/TB_Report_2016_FINAL.pdf
National Institute for Health and Care Excellence (NICE). Tuberculosis. NICE guideline [NG33]. 2016. Updated 2023. URL: https://www.nice.org.uk/guidance/ng33
Lunge V.R., Ruffino-Netto A., Dalcin P.T.R. Impact of smoking on sputum culture conversion and pulmonary tuberculosis treatment outcomes in Brazil. International Journal of Tuberculosis and Lung Disease. 2013. Vol. 17. No. 7. P. 878–883. URL: https://doi.org/10.5588/ijtld.12.0834
Matteelli A., Roggi A., Carvalho A.C.C. Extensively drug-resistant tuberculosis: epidemiology and management. Clinical Epidemiology. 2014. Vol. 6. P. 111–118. URL: https://doi.org/10.2147/CLEP.S40725
World Health Organization. WHO consolidated guidelines on drug-resistant tuberculosis treatment. Geneva: WHO; 2022. URL: https://www.who.int/publications/i/item/9789240063125
Skrahina A., Hurevich H., Zalutskaya A. et al. Multidrug-resistant tuberculosis in Belarus: the size of the problem and associated risk factors. Bulletin of the World Health Organization. 2013. Vol. 91. No. 1. P. 36–45. URL: https://doi.org/10.2471/BLT.12.104588
Walker T.M., Kohl T.A., Omar S.V. et al. Whole-genome sequencing for prediction of Mycobacterium tuberculosis drug susceptibility and resistance: a retrospective cohort study. The Lancet Infectious Diseases. 2015. Vol. 15. No. 10. P. 1193–1202. URL: https://doi.org/10.1016/S1473-3099(15)00062-6
Bevz G. M., Bevz V. G. Elements of mathematical statistics. Kyiv: Higher School, 2007. P. 145-147. URL: https://library.udpu.edu.ua/library_files/math/2011.08.10_Bevz.pdf
Lytvynenko S. F., Prokopchuk V. A. Statistics: a textbook. Kyiv: Center for Educational Literature, 2014. P. 120-123.URL: https://cul.com.ua/books/statistika-2014
Lane D. M. Online Statistics Education: A Multimedia Course of Study. Rice University. 2017. URL: https://onlinestatbook.com/2/index.html
Silver N. R. Introductory Statistics. OpenStax, Rice University. 2019. URL: https://openstax.org/books/introductory-statistics/pages/2-2-frequency-polygons
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