Standardization of an analytical pharmacist’s work: methodological approaches

Introduction. Providing the population with effective, safe, and high-quality medicines is the main task of a pharmacy facility, the performance of which is determined by both the functioning of the facility as a whole and the direct activity of specialists in the workplaces. The quality control of medicines, one of the important elements of the quality system (QS) consists of a sequence of actions that are known and fully understood by an analytical pharmacist, but its qualitative conduct is ensured by a massive amount of information and the exact observance of all the details of the analysis, so it is important to regulate the order for conducting key working procedures, which will ensure control over many local parameters that in their combination have a rather large impact on the quality of work and the correctness of yielded results. The analytical pharmacist’s work requires a systematic increase in the level of professional knowledge, the use of the current advances in drug quality control, the introduction of advanced experience, and the scientific organization of labor. Objective: to analyze the activities of pharmacy specialists who perform functions of controlling the quality of medicines and developing methodological approaches to standardizing the activities of an analytical pharmacist. Materials and methods. The personnel arrangements of 60 pharmacies that are part of the network of AO «Petersburg Drugstores», which produce drugs on prescription and by the requirements of healthcare facilities, job descriptions of an analytical pharmacist. An individual working time photography method was used. Results. The investigation revealed the characteristics of the age structure and service length in the vast majority of analytical pharmacists and identified the need to develop special approaches to labor adaptation and organization from the point of view of methodological support to these workers. The investigators defined the pattern of an analytical pharmacist’s working day and identified working processes that took the most execution time: quality control of an extemporal formulation, intrapharmacy procurement, and pharmaceutical substances. The above types of work account for 84.8% of the total working time. Five standard operating procedures (SOPs) were developed to be used in the working place of an analytical pharmacist. A total of 27 algorithms for analyzing various drugs, such as the internal normative documents of the QS, which contain a sequential order of actions in all types of intrapharmacy quality control for a specific prescription, were developed and introduced in the pharmacy facilities. Conclusion. An analysis of the expenditure of an analytical pharmacist’s working time allowed the authors to propose approaches to standardizing significant working processes as QS documents, such as SOPs, analysis algorithms that describe the optimal sequence of the specialists’ actions to achieve the required quality of the process, its effectiveness and efficiency.