Military action is a global health problem. Disruption of health care and inadequate pharmaceutical provision can lead to serious complications and even death of the patient, making the population particularly vulnerable. Emergency care always focuses on injuries, infectious diseases and other acute conditions, and chronic diseases, including diabetes, have historically been a low priority. The aim of the work was to study the needs and problems of patients with diabetes, which arose during the martial law in the dynamics and to outline the main aspects of recommendations for improving the treatment of patients with diabetes in humanitarian crisis. Materials and methods. The analysis of the needs and problems of patients with diabetes was studied by a questionnaire (February‒May 2022). People with diabetes and members of their families took part in the study. Relevant official documents and international recommendations about providing diabetic care to the population during crisis situations are analyzed. Content analysis, bibliosemantic, analytical, generalizing analyzes were used. The studied needs and problems of patients with diabetes during martial law and their dynamics depending on time. Restrictions on medical care and rapid resumption of the pharmacy, which released, including insulin, have been established. The dynamics of actions on medical and pharmaceutical provision of patients with diabetes were analyzed, which showed that the health care system was not ready for martial law, but the Government took urgent appropriate actions on medical and pharmaceutical provision of patients with diabetes, which allowed to provide continuous treatment of patients with diabetes. The acute problem of not being able to supply the necessary drugs, including insulin, clean water, food to the occupied territories, creates a critical situation for the population in these regions, including those with diabetes, which can be fatal. Based on the elaboration of international documents, the main aspects of recommendations for improving the medical and pharmaceutical provision of patients with diabetes in emergencies are outlined.
One of the most important issues of interest to scientists and practitioners of pharmacy is medicines quality assurance at all stages of their life cycle. From 2021 in Ukraine, the retail trade of medicines via the Internet was allowed. The system of electronic (distance) retail trade (ERT) has its obvious advantages for consumers of pharmaceutical services, but also its potential risks for the medicines quality being sold. The aim of the study is analysis of legislative innovations on ERT in medicines, determination of advantages and possible problems of ERT in medicines, identification of potential risks to the medicines quality during ERT and determination of organizational and practical measures to prevent and minimize them. The research materials were scientific publications, legislative and regulatory acts of Ukraine and the EU, public information of public authorities and pharmaceutical enterprises, data from own observations. The following methods were used in the work: system and content analysis, generalization, systematization, structural-logical, visual-graphic. The analysis of sources of scientific and professional literature showed that domestic and foreign scientists have studied the legal, socio-economic and marketing aspects of ERT in medicines. We studied this issue from the standpoint of quality assurance and risk management for the medicines quality. The paper provides a system and content analysis of legislative innovations on ERT in medicines, summarizes and systematizes the general and special requirements for the procedure for ERT in medicines, identifies the advantages and possible problems of ERT in medicines. The structural and logical scheme of the ERT in medicines process is developed. It is proposed to use this scheme as a basis for the regulation and documentation of the ERT in medicines process by developing appropriate regulatory and instructional documents (regulations or techniques for performing the process, standard operating procedures, work instructions, etc.). According to the research results, the potential risks for the medicines quality in the conditions of ERT are identified and the complex of organizational and practical measures for their prevention and minimization is determined. It is proposed to implement this complex in the overall risk management process for the medicines quality and pharmaceutical services, which should be an integral part of the quality management system of the pharmaceutical enterprise that performs ERT in medicines. These measures should be taken into account when developing standard operating procedures for different stages of ERT in medicines and documentation on risk management for the medicines quality (passports of risk profiles, risk register, risk management plan, etc.).
During the martial law, the role of pharmacists increases, but they must be educated for such activities. It will ensure pharmaceutical care according to Good Pharmacy Practice. Currently, there are no developed standards for the provision of pharmaceutical care to patients with diabetes mellitus (DM) during the martial law. The purpose of the work is to analyze the legislative changes that took place in the pharmaceutical provision for diabetes patients during the martial law. Recommendations for pharmacists to provide pharmaceutical care to diabetes patients in humanitarian disasters have been developed. The regulatory framework of Ukraine for the provision of diabetes patients and international recommendations for the provision of pharmaceutical assistance to diabetes patients during humanitarian disasters. Content analysis, bibliosemantic, analytical, generalizing analyzes were used. To prevent the consequences of humanitarian disasters for people with diabetes, there must be universal access to insulin, other essential drugs and diagnostics for monitoring of blood glucose level and blood pressure in the conditions of humanitatian crises. The peculiarities of the pharmaceutical supply of patients with diabetes during the martial law have been established. Patients with diabetes in Ukraine can receive insulin and other tableted sugar-reducing drugs in pharmacies, which are reimbursed by medical guarantee program (free of charge or with copayment by the patient), or patients can receive insulin free of charge in regional centers (hospitals) wich were received as humanitarian aid from other countries. The importance to use international gidiline recommendations when receiving drugs as humanitarian aid was underlined. The information about insulin, which are reimbursed now according to the ATC classification, taking into account the duration of action of insulin, has been analyzed and summarized. This information is important for practical use by pharmacists who dispenses insulin according to the newly introduced order (by classification of duration of action of insulin). During the martial law, the role of pharmaceutical workers increases. Recommendations for pharmacists have been developed on the basis of international recommendations and the results of scientific research. These recommendations are appropriate for pharmaceutical care to diabetes patients according to Good Pharmacy Practice during the martial law.
Cardiovascular diseases (CVD), in particular arterial hypertension (AH), are the main causes of morbidity and mortality, Ukraine is on the 1st place in Europe for mortality from these diseases. Modern clinical guidelines emphasize the use of combined antihypertensive drugs, and improving the accessibility of these medicines for Ukrainian patients with hypertension is relevant. In Ukraine, at the end of 2022, there were no combined antihypertensive drugs in the List of reimbursed drugs. Therefore, there is a need to develop scientific and practical approaches to improve the «Affordable Medicines» reimbursement program in accordance with modern trends in the treatment of hypertension. The aim of the study is to formulate scientific and practical proposals for the inclusion of combined antihypertensive drugs in the state reimbursement program «Affordable Medicines» and to improve external reference pricing. Оbjects of the study were Orders of the Ministry of Health of Ukraine, national and international clinical guidelines, WHO ATC/DDD methodology guidelines. The study used content analysis, methods of comparative and logical analysis. At the 1st stage of the study, it was found that the current legislation of Ukraine does not prohibit the inclusion of combined antihypertensive drugs in the National List of Essential Medicines, and it is not limited solely to WHO recommendations. In the second stage of the study, it is proposed to use the data of pharmacoepidemiological studies and data of studies of actual consumption of combinated antihypertensive drugs in Ukraine, for further state HTA assessment and inclusion in the National List of Essential Medicines and «Affordable Medicines» program. The third and fourth stages of the study showed that the mechanism of external reference pricing needs to be improved and an algorithm for conducting external reference pricing for combined antihypertensive drugs, consisting of five consecutive stages, was developed and proposed. The current regulatory framework of Ukraine provides the possibility of including combined antihypertensive drugs in the state program «Affordable Medicines», and the initiation of the inclusion of medicines is within the competence of the Ministry of Health and the NHSU. A scientific and practical approach to the use of pharmaco-epidemiological research data to identify the most used doses of combined antihypertensive drugs as potential candidates for inclusion in the «Affordable Medicines» program is proposed. A scientific and practical algorithm for external reference pricing for combinated antihypertensive drugs was developed, considering current regulatory and methodological aspects.
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