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...
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.
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.).
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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