Introduction: One of the innovative trends in the modern development of the pharmaceutical sector is the introduction of integrated management systems (IMS) at the enterprises for the production and distribution of medicines. The aim: to substantiate and develop a process model and approaches to the regulation and documentation, performance evaluation and improvement of the IMS within the pharmaceutical institution (PI) and hospital pharmaceutical service (HPS). Materials and methods: research materials used: international standards, regulations and guidelines of the Ministry of Health of Ukraine, scientific publications, information of PI and hospitals, placed on official websites and collected in the process of direct observation. Research methods are: systemic-review, generalization, observation, documentary, structural-logical and graphic modeling. Results: Based on the requirements of good practices and international standards in the field of management of quality, ecology, occupational health and safety, social responsibility, a typical process model of the IMS of PI and HPS (pharmaceutical integrated management system − PIMS) has been substantiated and developed. The content of each process of a typical PIMS model is described and structured. The expected results (outputs) of the PIMS processes are determined. The approaches to the regulation and documentation of the PIMS processes in the conditions of functioning of the four-level documented information system are substantiated. A matrix of responsibility and authority of the staff of PI and hospitals within the PIMS is developed. The structurally hierarchical model of the performance evaluation and improvement of the PIMS has been designed and described. Conclusions: The results are the basis for the establishing, regulating and documenting of the PIMS and the development of a system for its performance evaluation and continual improvement.
Національна медична академія післядипломної освіти імені П. Л. Шупика, м. Київ, УкраїнаМета роботи -змістовий аналіз і методологічне обґрунтування професійних функцій Уповноважених осіб (УО), відповідальних за забезпечення якості лікарських засобів (ЛЗ) в аптечних і лікувально-профілактичних закладах.Матеріали та методи. Використано методи дослідження: системного та порівняльного аналізу, узагальнення, систематизації, графічного моделювання, спостереження. Матеріали дослідження: нормативно-правові акти, нормативні документи, рекомендації міжнародних організацій; інформація гуртових і роздрібних фармацевтичних підприємств, закладів охорони здоров'я (ЗОЗ), а саме аптечних (АЗ) і лікувально-профілактичних закладів (ЛПЗ), фахових громадських організацій, розміщена на офіційних веб-сайтах і зібрана у процесі безпосереднього спостереження.Результати. Обговорено кадрово-кваліфікаційні аспекти професійної діяльності УО АЗ і ЛПЗ. На підставі аналізу сучасної нор-мативно-правової бази сформовано загальний перелік професійних функцій УО ЗОЗ. Здійснено змістовий аналіз і порівняння кількості функцій УО, що виконуються в ЗОЗ різного типу. Розглянуто нові функції УО ЗОЗ. Обґрунтовано управлінський характер професійних функцій УО та доцільність їх доповнення лідерськими функціями. На основі міжнародних стандартів управління, вимог GPP і GPEP здійснено систематизацію функцій УО ЗОЗ на групи та підгрупи.Висновки. Виконано узагальнення та систематизацію професійних функцій УО ЗОЗ на п'ять класифікаційних груп функцій: лідерські, планувальні, організаційні, контрольні та інформаційні, з них найбільша частина виконується на рівні гуртових фармацевтичних підприємств (79 %) і має організаційний характер (33,5 %). Обґрунтовано доцільність включення до переліку професійних функцій УО ЗОЗ консультативної та інформаційно-просвітницької функції, а також групи лідерських функцій, що охоплюють цільові, со-ціально-етичні та психологічні аспекти її професійної діяльності. Здійснено структурування професійних функцій УО ЗОЗ у вигляді дерева функцій, що є основою для розробки типових процесних моделей системи забезпечення якості ЛЗ в АЗ і ЛПЗ. Материалы и методы. Использованы методы исследования: системного и сравнительного анализа, обобщения, систематизации, графического моделирования, наблюдения. Материалы исследования: нормативно-правовые акты, нормативные документы, рекомендации международных организаций; информация оптовых и розничных фармацевтических предприятий, учреждений здравоохранения (УЗ), а именно аптечных (АУ) и лечебно-профилактических учреждений (ЛПУ), профессиональных общественных организаций, размещенная на официальных сайтах и собранная в процессе непосредственного наблюдения.Результаты. Обсуждены кадрово-квалификационные аспекты профессиональной деятельности УЛ АУ и ЛПУ. На основе ана-лиза современной нормативно-правовой базы сформирован общий перечень профессиональных функций УЛ УЗ. Осуществлен содержательный анализ и сравнение количества функций УЛ, выполняемых в УЗ различного типа. Рассмотрены новые функции УЛ УЗ. Обоснов...
At the beginning of 2020, one of the most significant health problems for humanity is the pandemic of coronavirus disease 2019 (COVID-19). Here, we identify features and develop simple epidemic model of COVID-19 on the basis of available epidemiological data and existing trends worldwide. Modeling of COVID-19 epidemic process was based on a classic model. A key parameter of the model, i.e. transmission parameter of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), was determined numerically with the use of available epidemiological daily reports of COVID-19 from 17 April to 23 May 2020. Numerical determination of transmission parameter of SARS-CoV-2 according to the absolute number of COVID-19 cases in Ukraine, Indonesia and worldwide data showed its global tendency to decrease over time. Approximation of the obtained numerical values of the transmission parameter of SARS-CoV-2 was carried out using the exponential function. The results of prognostic modeling showed that by the end of summer 2020, above 30 thousand COVID-19 cases are expected in Ukraine, 100 thousand COVID-19 cases in Indonesia, and 12 million COVID-19 cases worldwide. Thus, predicting the possible consequences of the implementation of various health care control programs COVID-19 involves a comprehensive study of the epidemic process of the disease as a whole and for certain periods of time with the subsequent construction of an adequate prediction model.
The aim: To analyze, summarize and substantiate modern approaches to the formation of the professional competencies of pharmacists on issues of medicine quality assurance in Ukraine. Materials and methods: In this study, we performed systematic review, systematic and comparative analysis, content analysis, generalization, document analysis, logical and graphical modeling to address those issues. Conclusions: We showed that the curriculum and program of the «Basic foundations of the functioning of quality systems in pharmacy institutions» thematic improvement cycle for pharmacists have been substantiated and developed. The content of the program provides an opportunity to prepare pharmacists for independent work in the field of implementation and support of effective quality systems in pharmacy institutions and hospital pharmacy services. In the context of substantiation of modern approaches to the preparation of pharmacists in the field of medicines quality assurance, the experience and advantages of such modern forms of training of pharmacists as the use of training bases and blended learning have been studied. The modern approaches to the formation of the professional competencies of pharmacists on issues of medicine quality assurance in Ukraine have been analyzed, summarize and substantiated.
The aim: To study and substantiate normative, organizational and methodical approaches to the conducting of enlightenment activities in the field of health preservation and proper use of medicines in the context of the prospect of implementation of Good Pharmacy Practice (GPP) in Ukraine. Materials and methods: The research methods are: questionnaire survey, bibliographic, systemic review, systemic analysis, generalization, graphical modeling. The questionnaire survey was conducted by filling out questionnaires by pharmacists on paper or electronic media. Results: It is found that 51,5 % of the pharmacies surveyed are involved in sanitary enlightenment activities on health preservation and proper use of medicines. The need for introducing mechanisms to encourage pharmacy institutions to participate more actively in sanitary enlightenment among the population is substantiated. The expediency of combination of active and passive forms of sanitary enlightenment in pharmacies is shown. The enlightenment program «Health and Medicines» for the population has been developed. Methodical approaches to conducting enlightenment classes have been worked out. The algorithm infographic, describing the content of main consumer (patient) measures towards quality control of medicines purchased in the pharmacies, has been developed. Conclusions: The implementation of the results of the study into the professional activities of pharmacists will significantly increase the erudition of citizens on preserving health and proper use of medicines and is the important element in the implementation of international GPP standard in domestic pharmacies.
Modern domestic public activism as a phenomenon that has become widespread relatively recently, creates new challenges for the pharmaceutical sector of the health care branch. Legal and ethical aspects of the interaction of pharmacists and doctors with public control subjects of the quality assurance of medicines remain insufficiently studied, which causes a lack of awareness on these issues among pharmacists and doctors, and therefore errors in interaction with representatives of public organizations, the media or community activists. The aim of the work was the scientific substantiation of the legal and ethical basis of the interaction of pharmacists and doctors with public control subjects of the quality assurance of medicines at the stages of their sale and medical use in Ukraine. To obtain the results of the work, library-semantic, formal-logical and structural-functional methods, methods of comparative legal and technical-legal analysis of legal and ethical, doctrinal and journalistic sources in the chosen direction were used. The work identifies public media control and public monitoring as the forms of public control of the quality assurance of medicines at the stages of their sale and medical use most closely related to the workplaces of pharmacists and doctors. It has been established that the legal basis for the interaction of pharmacists (doctors) and journalists, as subjects of public media control, is determined by the Constitution of Ukraine, scattered groups of regulatory and protective legislation. The ethical basis of such interaction is determined by generally accepted ethical standards, sources of professional pharmaceutical (medical) ethics, sources of professional ethics of journalists. It has also been established that currently in the current legislation of Ukraine there are no separate or special requirements defining the mechanism of interaction between pharmacists (doctors) and public activists who carry out appropriate public control in the form of public monitoring. It was determined that the concretized methods of lawful and ethical interaction of pharmacists (doctors) with journalists and public activists, as subjects of public control of the quality assurance of medicines at the stages of their sale and medical use, require further research. The paper proposed promising areas for improving the legal and ethical mechanisms for realization public control of the quality assurance of medicines at the stages of their sale and medical use by creating a special legislative and ethical-regulatory basis for this type of activity; introducing specialized training in mastering relevant legal and ethical competences for pharmacists (doctors) and for public controllers, which can be either pharmacists (doctors) or any other caring person; introduction of the institute of public inspections to the quality assurance of medicines at the indicated stages of their life cycle, carried out by public inspectors who have passed the specified training.
One of the most promising ways to increase the efficiency of pharmaceutical enterprises in the field of quality assurance of medicines is the introduction of integrated quality systems (IQS). The aim of the work is to study of the state of readiness of pharmaceutical institutions (pharmaceutical warehouses, pharmacies) and hospital pharmaceutical services of Ukraine for the implementation of integrated quality systems. The materials of the research are: scientific publications; regulatory legal acts of the Ministry of Health of Ukraine; public reporting information of the State Service of Ukraine on Medicines and Drug Control; information posted on professional specialized websites and official websites of pharmaceutical enterprises, hospitals, health departments of local government; information obtained in the process of direct observation and questionnaire survey. Research methods are: systematic review, generalization, observation, questionnaire survey, mathematical-statistical, graphical modeling. The paper analyzes the availability of certificates of conformity to the requirements of good distribution practice (GDP) in wholesale pharmaceutical enterprises of Ukraine. The geography of the location of certified pharmaceutical warehouses in different regions of Ukraine is considered. In the context of the prospect of formation of IQS, the experience of a wholesale pharmaceutical company with respect to environmental, hygiene and safety and social responsibility is demonstrated. Based on the study of public information, the state of implementation of certified quality management systems (QMS) based on the standard ISO 9001 in pharmacies and hospitals of Ukraine is considered. The expediency of the development of the pharmaceutical IQS as an integral part of the overall QMS of the hospital is shown. Through the questionnaire survey of pharmacists, the state of readiness of Ukrainian pharmacies for the implementation of IQS based on the requirements of good practices and international standards in the field of quality, ecology, health and safety and social responsibility was explored. The state of implementation of good pharmaceutical practice (GPP), the requirements of the ISO 9001 standard, the risk management process for medicines quality, corrective and preventive actions has been studied in pharmacies. Positive tendencies and problems in the context of the readiness of pharmacies of Ukraine for the implementation of IQS have been established. Priority steps for improving the state of readiness of Ukrainian pharmacies for the implementation of IQS are identified. The research results confirm that over the last years the pharmaceutical sector of Ukraine has made significant progress towards increasing the readiness of pharmaceutical institutions for the implementation of integrated quality systems.
To date, one of the advanced educational and research centers of Kiev and Ukraine, which is the improving qualification of pharmacists on quality questions of medicines, is the Department of Quality Control and Standardization of Medicines of Shupyk National Medical Academy of Post-Graduate Education (NMAPE). The aim of the work is to analyze the historical stages of formation and development of the Department of Quality Control and Standardization of Medicines of Shupyk NMAPE. The materials of the research are: archival and current documentation of the department, scientific publications, encyclopedic reference materials. Studies were conducted using methods: content analysis, historical documentary, generalization and systematization of historical data. In this work a retrospective analysis was performed and current state of activity of the Department of Quality Control and Standardization of Medicines of Shupyk NMAPE was considered. The basic stages of formation and historical development of the department during 1938 to 2018 are determined. The contribution to the development of pharmaceutical education and science of professors (prof. Ya.A. Fialkov, N.P. Maksyutina, O.M Gritsenko, N.O. Vetiutneva, etc.) was noted. The educational cycles, taught at the department, are shown, namely: specialization cycles, internships, pre-certification training in the specialties «Analytical Control Pharmacy», «General Pharmacy»; thematic improvement cycles on topical issues of pharmacy, quality assurance and prevention of falsification of medicines, functioning of quality systems of pharmacies (for pharmacists); cycles of improvement of assistant pharmacists; thematic improvement cycles on the scientific basis of phytotherapy and the use of modern medicines based on active ingredients of natural origin (for physicians). The basis of educational-methodical and scientific production of the department is described. The main areas of the scientific activity of the department are described, covering the following areas: development of methods for the investigation of complex synthetic compounds, methods for express analysis of extemporal multicomponent medicines, methods for quality control the of phytotherapeutic and homeopathic medicines; study of the composition and intermolecular interaction of biologically active compounds in plants and phytopreparations; synthesis and creation of new medicines and dietary supplements; study of the properties of crown compounds; study of the interaction of auxiliary substances with active ingredients; research on increasing the solubility of difficult soluble substances; substantiation of methodological and organizational-methodical principles of quality assurance of medicines at stages of wholesale, retail sale and medical use, etc. Analysis of the activities of the Department of Quality Control and Standardization of Medicines of Shupyk NMAPE during 1938 to 2018 testifies to its significant contribution and great potential for the development of pharmaceutical science and practice, in particular in the direction of the creation, standardization, assurance and control of quality of medicines and dietary supplements.
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