Introduction
Tuberculosis (TB) remains one of the leading causes of death from infectious diseases in the world. The
situation is complicated by the increasing prevalence of multidrug-resistant forms of the pathogen Mycobacterium
tuberculosis against the background of covid, post-covid, long-covid disorders, which requires improving
approaches to pharmacotherapy according to the requirements of ICD-11. According to the World Health
Organization, more than ten million new cases of tuberculosis are registered in the world annually, while
about one million three hundred thousand patients die [15]. Standard treatment of active tuberculosis,
recommended by the World Health Organization, involves the use of a combination of at least three or four anti
tuberculosis drugs. This approach allows you to effectively combat the bacterial load, reduce the risk of developing drug resistance, shorten the duration of therapy, and reduce the frequency of relapses of the disease [6].
Fixed-dose combination drugs, which contain several active pharmaceutical ingredients in one dosage form, are designed to increase patient adherence to treatment and prevent dosing errors. These drugs are particularly relevant in countries with high tuberculosis incidence rates, where non-adherence to treatment regimens is common. Numerous studies have shown that fixed-dose combination drugs provide efficacy and safety comparable to single drugs, and reduce the risk of drug resistance [7, 8]. However, the use of fixed-dose combination
drugs has certain limitations. Among patients with human immunodeficiency virus co-infection, pharmacokinetic
interactions between anti-tuberculosis and antiretroviral drugs are possible. This can lead to changes in the
concentration of active substances in the blood, reduced treatment efficacy, or increased toxicity [9]. In addition,
the use of fixed-dose combination drugs may be inappropriate in cases of individual intolerance to one of
the components or if dosage adjustment is necessary for a particular patient. Thus, despite the advantages of fixed-dose combination anti-tuberculosis drugs, their use requires an individual approach and constant monitoring of the effectiveness and safety of therapy. The rational use of such drugs in national tuberculosis control programs is a key factor in the successful control of this global health problem [10]. Overcoming multidrug-resistant tuberculosis is a challenging task, as the bacteria that cause this infection can develop resistance to standard anti-TB drugs. However, combination antimycobacterial chemotherapy remains the mainstay of treatment. It involves the use of at least three anti-TB drugs to which the bacteria are still susceptible, and the duration of treatment is at least 6 months [11, 12]. The main principles of anti-TB chemotherapy are:
• Combination use of anti-TB drugs: The use of several drugs simultaneously reduces the risk of the development
of resistance of TB bacteria to one of the drugs.
• Use of standard drug combinations: Certain combinations of anti-TB drugs are defined as standard and
are used to treat patients with new cases of TB and relapses of the disease.
• Monitoring by healthcare professionals: Healthcare professionals should ensure that patients take their
medications correctly and adhere to their treatment regimen.
• Avoid adding one anti-TB drug after treatment failure: If a patient does not respond to treatment, adding another anti-TB drug to the regimen may lead to further failure. In addition, antimicrobial therapy is administered
under the supervision of healthcare professionals, which allows for monitoring of drug use and prevention of
potential complications.
Regarding the convenience of taking medications, the development of combination drugs that contain the
active pharmaceutical ingredients necessary for pharmacotherapy can help patients to facilitate their treatment regimen, improve adherence to the therapy protocol, and ensure the quality of the drugs [12]. Overall, the fight against multidrug-resistant tuberculosis requires a comprehensive approach, active collaboration between healthcare professionals and patients, as well as continuous improvement of anti-TB strategies and the development of new drugs to treat this dangerous infection. The purpose of the study was to conduct a content
analysis of the modern range of combined anti-tuberculosis drugs registered on the pharmaceutical market of Ukraine, considering the current requirements of domestic legislation in the field of healthcare. Particular attention is paid to the study of the clinical feasibility of using fixeddose combination drugs in the pharmacotherapy of
tuberculosis in accordance with the provisions of the sixteenth edition of the State Formulary of Medicines,
approved by the Order of the Ministry of Health of Ukraine dated March 12, 2024 No. 418 “On Approval and
Implementation of the Sixteenth Edition of the State Formulary of Medicines”. The work also analyzed current
scientific sources on the effectiveness, safety, and impact of combined anti-tuberculosis pharmacotherapy on
reducing the level of chemoresistance and increasing patient adherence to treatment.
Materials and methods The study is of a content analysis nature and is based on a comprehensive study of open information sources related to combined anti-tuberculosis drugs. The main information resources were: scientific publications from professional domestic and international medical and pharmaceutical journals, official documents of the World Health Organization, analytical materials of international initiatives to combat tuberculosis, as well as current regulatory legal acts of Ukraine in the field of health care. The analysis of the range of combined anti
tuberculosis drugs registered in Ukraine was carried out using data from the State Register of Medicines of Ukraine. Particular attention was paid to drugs included in the sixteenth edition of the State Formulary of Medicines, approved by the Order of the Ministry of Health of Ukraine dated March 12, 2024 No. 418 “On Approval and Implementation of the Sixteenth Edition of the State Formulary of Medicines”. International non-proprietary names of active pharmaceutical ingredients, trade names of medicines, release forms, dosages, as well as their availability in state reimbursement programs were studied. In the process of research, methods of content
analysis of scientific literature, comparative analysis of regulatory sources, classification method, as well as
elements of a statistical approach for quantitative assessment of the presence of combined drugs on the
pharmaceutical market of Ukraine, previous studies of foreign and domestic scientists in the direction of content
analysis, quality of drugs [13-20] were applied. Special attention was paid to comparing data on the advantages and disadvantages of combination therapy in the context of international and national clinical guidelines, [21-23].
The research of the article is a fragment of research works of Private Scientific Institution "Scientific
and Research University of Medical and Pharmaceutical Law" and Danylo Halytsky Lviv National Medical
University on the topic "Diagnosis, treatment, pharmacotherapy of inflammatory, traumatic and onco
thoracic pathology using instrumental methods" (state registration number 0125U000071, implementation period
2025-2031); Lviv Medical Institute on the topic of "Improving the system of circulation of drugs during
pharmacotherapy on the basis of evidentiary and forensic pharmacy, organization, technology, biopharmacy and
pharmaceutical law" (state registration 0120U105348, implementation period 2021-2026); Private Scientific Institution "Scientific and Research University of Medical and Pharmaceutical Law" on the topic “Multidisciplinary research of post-traumatic stress disorders during war among patients (primarily combatants)” (state registration number 0124U002540, implementation period 2024-2028).