ENLIGHTENMENT ACTIVITIES IN THE FIELD OF HEALTH AND MEDICINES IN THE CONTEXT OF GOOD PHARMACY PRACTICE.

OBJECTIVE: 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. PATIENTS AND METHODS: 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: 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 Medicines¼ 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. CONCLUSION: 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 APPROACHES TO THE FORMATION OF PROFESSIONAL COMPETENCIES OF PHARMACISTS ON ISSUES OF MEDICINES QUALITY ASSURANCE.

OBJECTIVE: 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. PATIENTS AND METHODS: 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. CONCLUSION: Conclusions: We showed that the curriculum and program of the «Basic foundations of the functioning of quality systems in pharmacy institutions¼ 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.

QUALITY ASSURANCE OF MEDICINES: THE STATE AND TRENDS OF THE EUROPEAN UNION AND UKRAINE LEGISLATION DEVELOPMENT.

OBJECTIVE: The aim: Scientific substantiation of the state and tendencies of development at the present stage of the legislation of the European Union and Ukrainian legislation on quality assurance of medicines. PATIENTS AND METHODS: Materials and methods: Using the biblio-semantic, systematic-review, analytical, formal-legal and comparative-law methods, the individual regulatory sources of pharmaceutical legislation of the EU and Ukraine were studied. CONCLUSION: Conclusions: The paper identifies that pharmaceutical legislation of the EU and Ukraine on quality assurance of medicines at the present stage of their development have common features, which include the number, disorder of existing legal acts, which creates conflicts between them and the potential for gaps in regulation. The main trend in the development of this legislation in the EU and Ukraine is the disparity of legal acts and the lack of significant legislative efforts to codify them.

A cost minimization analysis of α2b-interferon supplementation in complex pharmacotherapy of rotavirus infection in newborns.

Rotavirus is one of the most important causative agents of gastroenteritis in both infants and children worldwide, resulting in high mortality and morbidity, mainly in low-income, developing countries. Respective analysis of medical records of newborns hospitalized with acute gastroenteritis showed that the use of α2b-interferon in complex pharmacotherapy was characterized by faster reverse development of clinical manifestations of the disease than in patients who did not receive interferon. In our study, we also aimed to estimate the effectiveness of α2b-interferon supplementation in combination pharmacotherapy of newborns with suspected rotavirus infection. Achievement of this goal was possible with the construction of a decision tree model and determination of decision rules for inclusion of α2b-interferon supplementation into the complex pharmacotherapy. The input parameters of the model were hospitalization days of patients stratified by such signs as the presence or absence of rotavirus infection, as well as the additional inclusion of α2b-interferon supplementation in complex pharmacotherapy. The criterion for prediction and decision-making was global retrospective rotavirus prevalence. The feature of the simulation was that the costs were expressed as relative to each other, which allowed unifying the proposed methodology. Retrospective analysis of the clinical database of Ukrainian newborns with acute diarrhea has proved that the decision of α2b-interferon supplementation as additional treatment could be cost-saving under 7.4 times its lower price.

Process model of the pharmaceutical integrated management system.

OBJECTIVE: 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). PATIENTS AND METHODS: 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: 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. CONCLUSION: 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.