Methodological substantiation of the professional functions of Responsible persons of pharmaceutical and hospital institutions
Keywords:medicines, quality control, Responsible person, professional competence, pharmacy, hospital institution
The aim of the work is the content analysis and methodological justification of the professional functions of the Responsible persons for quality assurance of medicines in pharmaceutical and hospital institutions.
Materials and methods. The following research methods were used: system and comparative analysis, generalization, systematization, graphic modeling, observation. Research materials: normative legal acts, normative documents, recommendations of international organizations, information of wholesale and retail pharmaceutical companies, pharmaceutical and hospital institutions, professional non-governmental organizations, placed on official web-sites and collected in the process of direct observation.
Results. The personnel and qualification aspects of professional activity of Responsible persons of pharmaceutical and hospital institutions were discussed. On the basis of analysis of the modern legal and regulatory framework, a general list of professional functions of the Responsible persons of health care institutions had been formed. The content analysis and comparison of the number of the functions of Responsible persons performed in health care institutions of different types is carried out. The new functions of the Responsible persons of health care institutions are considered. The managerial nature of the professional functions of the Responsible persons and the expediency of their complementing with the leadership functions are substantiated. On the basis of international management standards, requirements of GPP and GPEP, systematization of the functions of the Responsible persons of health care institutions in the groups and subgroups was performed.
Conclusions. The generalization and systematization of the professional functions of the Responsible persons of health care institutions had been carried out for five classification groups of functions, namely: leadership, planning, organizational, control and information, of which the largest part is carried out at the level of wholesale pharmaceutical enterprises (79 %) and has organizational character (33.5 %). The expediency of inclusion in the list of professional functions of the Responsible person of an consultative and enlightenment function and a group of leadership functions covering the target, socio-ethical and psychological aspects of his professional activity is substantiated. Professional functions of the Responsible persons are structured in the form of a tree of functions, which is the basis for the development of typical process models of the quality assurance system of medicines in pharmaceutical and hospital institutions.
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