Methodology of the formation of National standards of Good Pharmacy Practice and standard operating procedures system

Abstract

The aim of the work is the development of system of National standards of Good Pharmacy Practice (GPP) and standard operating procedures (SOPs). Materials and methods. The research materials were legal acts of Ukraine, Guidelines on GPP, materials of professional public organizations of different countries on the issues of quality assurance of pharmacy services. Methods of logical and system-structural analysis, modeling processes were used. Results. A comparative analysis of the definitions of the term “standard operating procedure” in the domestic legislation has been conducted. A number of advantages of SOPs in practice have been highlighted. The normative regulation of pharmaceutical activity in developed countries and post-Soviet countries has been analyzed, which allows to assert the use of SOPs to meet the requirements of the quality standards of pharmacy services. Different approaches to the definition of GPP standards and the establishment of the list of SOPs have been identified. Taking into account international experience and national peculiarities of the implementation of good practices, the following structure of the Guidance with GPP in Ukraine was proposed. It consists of: Introduction, Glossary, 8 process guides (Quality management; Receiving, storing and disposing of medicines and medical products; Preparation of medicines in the pharmacy; Prescription and non-prescription medicines delivery and medical products; Providing effective pharmacotherapy; Professional development of pharmacy staff; Improving the effectiveness of the public health system; Self-Inspection); Sources of information. This structure of the proposed Guidance with GPP is focused on the content and functional-role approach to the development of national standards of pharmacy practices. They establish rules and give recommendations for the development of the list of SOPs for a particular pharmacy. Conclusions. There is no definition of the term SOP in normative legal acts which directly regulate the activity of pharmacy establishments in Ukraine. Different approaches to the formation of the list of SOPs in the countries of Europe and the post-Soviet area were found. The structure of the GPP Guidance was proposed based on a functional-role approach to the development of national standards, which includes eight separate process guides that are specific to pharmacies activity.