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.
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.
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.
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.).
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