Risk factors management in the provision of pharmaceutical services: Summary of the doctoral thesis in pharmaceutical sciences: 316.01 – Pharmacy

Abstract

Patient safety and the quality of pharmaceutical services are increasingly influenced by the growing risks in the pharmaceutical field. In the Republic of Moldova, these risks are also amplified by the shortage of pharmacists, staff overwork, prescription errors, similar trade names of medicines, lack of continuous training in the field of risks and the lack of an effective error reporting system. [4]. At an international level, pharmaceutical risk management is a current topic, with the objective of implementing standardized solutions to reduce medication errors. [23]. In the Republic of Moldova, alignment with these standards is essential for improving the quality of pharmaceutical services and adapting to the requirements of the European healthcare system [1]. The pharmaceutical industry is exposed to various risks, from medication errors and adverse reactions to financial losses and damage to the reputation of pharmacies. In the Republic of Moldova, these risks are exacerbated by the shortage of pharmacists, staff overwork, excessive multitasking and lack of ongoing training. [7]. Prescription errors and similar brand names of drugs are also critical factors that can increase the incidence of medication errors. In addition, the lack of an effective error reporting system prevents the real assessment of the situation and the implementation of necessary corrective measures. The purpose of the study was to analyze and evaluate the risk factors affecting pharmaceutical activity within community pharmacies, develop an integrated risk management methodology to improve the quality of pharmaceutical services, reduce medication errors and promote the training and continuous education of pharmacists in this field. In accordance with the purpose of the study, the following objectives were formulated: 1. Detailed analysis of bibliographic sources regarding existing research in the field of risk identification and assessment, RM and RFM, including in the pharmaceutical field; 2. Identification and assessment of risk factors (risks) in the exercise of the pharmacist's activity and their influence on the process of providing pharmaceutical services within community pharmacies; 3. Identification, classification and analysis of medication prescription errors as a major risk factor in the pharmacist's activity in assisting the population with medications; 4. Identifying and assessing the risks associated with similar drug names and developing strategies to prevent LASA errors; 5. Development and implementation of a risk management methodology in pharmaceutical practice, including solutions for safer medication, recommendations for minimizing risk factors and preventing medication errors; 6. Developing educational programs aimed at training and educating future specialists and practicing pharmacists in effective risk management during the exercise of pharmaceutical activity. Research hypothesis: Implementation of an integrated risk management system, standardization of pharmaceutical processes, training and continuous education of pharmacists in these areas will lead to a significant reduction in medication errors in community pharmacies. Scientific research methodology. The study used pharmacists' questionnaires, highlighting their perceptions of risks specific to pharmaceutical activity. The real-time risk monitoring technique allowed direct observation and documentation of the frequency and dynamics of medication errors in the community pharmacy environment. The Ishikawa diagram was used to

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classify and systematically organize risk factors/risks according to the stages of the pharmaceutical process. The risks were assessed by the Expert Analysis Method according to their impact and probability. Also, the analysis of prescription errors in medical prescriptions allowed the investigation of one of the most critical risk factors, highlighting the frequency and typology of errors that can influence the entire drug dispensing process. The analysis of the SNM facilitated the identification of risks associated with similar trade names of drugs, another important factor in the occurrence of medication errors. The scientific novelty of the research consists in the development, for the first time, of an integrated pharmaceutical risk management algorithm, which brings together in a practically applicable form, a complex set of quantitative and qualitative methods. This algorithm represents an innovative scientific synthesis, in which the essential stages of the pharmaceutical process – ordering, receiving, storing, preparing and dispensing drugs – are subjected to a systemic assessment, with the identification and prioritization of risk factors/risks that can generate medication errors. The application of this algorithm allowed for a detailed analysis of the main vulnerabilities in the pharmaceutical activity and highlighted, in particular, the negative impact of prescription errors, similar trade names of drugs and the lack of standardized procedures. At the same time, the research highlighted the significant discrepancy between the real number of medication errors identified by the applied methods and the lack of official reporting to the authorities, which underlines the urgency of implementing a functional risk monitoring and reporting system. Ultimately, the proposed algorithm allowed the formulation of clear strategies for reducing medication errors, standardizing pharmaceutical processes, and improving the professional training of pharmacists. Scientific issues addressed in the thesis. The research identified and classified risk factors in community pharmacies, providing solutions for preventing medication errors and improving patient safety. The analysis of medical prescriptions highlighted the frequency and typology of prescription errors, underlining the need for a correction and prevention system. The study assessed the risks associated with similar trade names of medicines, applying measures to reduce this error factor. An integrated risk management methodology was developed and implemented, including operational procedures, continuing education of pharmacists and optimization of pharmaceutical processes. The research contributed to the development of an educational program aimed at training future pharmacists in the prevention and management of pharmaceutical risks. Through this integrated approach, the work supports the development of an effective risk management system, applicable in pharmaceutical practice in the Republic of Moldova. Theoretical significance of the work. By integrating the results into the educational process, the work formed the basis for introducing the discipline "Pharmaceutical Risk Management" into the curriculum of the Pharmacy study program, and the thematic improvement course "Specialized Pharmaceutical Care for High-Risk Patients", contributing to the training of future pharmacists and practicing pharmacists. For future pharmacists, the Course Support and Methodological Recommendations for the Pharmaceutical Risk Management discipline were developed, and for pharmacists in community pharmacies - the Guide to Implementing Risk Management in Community Pharmacies. At the same time, the study provided theoretical support for the development of legislative amendments regarding similar names of medicines. The applicative value of the thesis. The research results represent application tools regarding the management of risk factors/risks in the drug authorization process (proposals for amending

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the Order No. 739/2012 of the MoH RM on regulating the authorization of medicinal products for human use and introducing post-authorization amendments, approved by Order No. 1041 of the MoH RM dated 15.11.2021, Implementation Act No. Rg02-001689 of 07.04.2022), provision of pharmaceutical services by pharmacists in community pharmacies (Guideline on the Implementation of Risk Management in Community Pharmacies examined and recommended at the meetings of the Department of Social Pharmacy "Vasile Procopișin", minutes no. 09 of 17.03.2023, the Scientific and Methodological Commission in the Pharmacy field, minutes no. 02 of 24.03.2023, the Quality Management Council, "Nicolae Testemițanu" SUMPh, minutes no. 06 of 25.04.2023, Council of Experts of the MoH RM, minutes no. 01 of 24.04.2024, approved by Order of the MoH RM no. 686 of 19.08.2024), training and improvement of pharmacist specialists in the teaching process (development of the course Pharmaceutical Risk Management (optional subject) for 4th year students in the Curriculum for the study program 0916.1 Pharmacy implemented in the academic year 2021-2022, Implementation Act no. 03-158 of 21.01.2022), (development of the Course Support and methodological recommendations for the discipline Pharmaceutical Risk Management. (examined and approved in the meetings of the Department of Social Pharmacy "Vasile Procopișin", minutes no. 06 of 13.01.2023, the Scientific and Methodological Commission for Pharmacy, minutes no. 01 of 18.01.2023, the Quality Management Council, "Nicolae Testemițanu” SUMPh, minutes no. 04 of 02.02.2023), (development of the thematic improvement course "Specialized pharmaceutical care for high-risk patients", Implementation Act no. 03-1453 of 02.05.2024). Thus, the study goes beyond the academic sphere, having a direct and tangible impact on the pharmaceutical system, contributing to increasing the quality of services and reducing pharmaceutical risks. Approval of results. The research results were presented in the form of oral communications within the following national and international activities: XXVIII National Meeting on the History of Pharmacy (2019, Sibiu, Romania); Annual Scientific Conference of Scientific and Didactic Staff, PhD Students, Master Students, Residents and Students (2019, Chisinau, Moldova); Scientific conference with international participation "Obtaining and pharmaceutical research of molecules and pharmaceutical products with therapeutic potential" within the framework of the Moldova-Belarus International Bilateral Project (2020, Chisinau, Moldova); Scientific and practical conference dedicated to the memory of university professor "Vasile Procopișin" - "The pharmacist and his role in the healthcare system" (2020, Chisinau, Moldova); Congress dedicated to the 75th anniversary of the founding of the "Nicolae Testemițanu" SUMPh (2020, Chișinău, Moldova); XXVII International Scientific and Practical Conference of Young Scientists and Students “Topical Issues of New Medicines Development”, Dedicated to the 150th Anniversary of the Birth of M.O. Valyashka (2021, Haricov, Ukraine); Scientific and practical conference with international participation "Medicine quality assurance system - problems and solutions" (2021, Chisinau, Moldova); Annual scientific conference: "Research in biomedicine and health: quality, excellence and performance" (2021, 2022, 2023, Chisinau, Moldova); Scientific and practical conference with international participation "Medicine quality assurance system - problems and solutions" (2021, Chisinau, Moldova); National scientific and practical conference with international participation "Current events and perspectives in the pharmaceutical study of medicinal plants" (2021, Chisinau, Moldova); Scientific and practical conference "Systemic approach - methodology in pharmaceutical research" (2021, Chisinau, Moldova); Scientific and practical conference "Doctor-pharmacist relations in the promotion of advanced pharmaceutical services", "Nicolae Testemițanu" SUMPh (2021, Chișinău, Moldova); The 9th International

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medical congress for students and young doctors. Medespera (2022, Chișinău, Moldova); The 4th Edition of the International Exhibition of Innovation and Technology Transfer Excellent Idea - 2025 (2025, Chișinău, Republica Moldova). Main scientific results. As part of the research, an integrated pharmaceutical risk management algorithm was developed and scientifically validated, which allowed the identification, evaluation and classification of 56 risk factors distributed across the stages of pharmaceutical activity, grouped into four priority levels – very high, high (13), medium (40) and low (3). The analysis of a sample of 1,500 medical prescriptions revealed that the number of prescription errors detected ranged from a minimum of one to a maximum of 12, with the predominance of omission errors, followed by commission errors. Following the analysis of the risks associated with similar names of medicines, 36 combinations of similar names were identified, with a high risk of confusion in the process of dispensing medicines. The findings of the study highlighted the legislative gaps in the management of this type of risk, which led to the development and promotion of legislative recommendations included in Order 739/2012 on the regulation of the authorization of medicinal products for human use and the introduction of post-authorization amendments, these amendments being approved by Order of the Ministry of Health of the Republic of Moldova no. 1041/2021. Questioning pharmacists and real-time risk monitoring confirmed the absence of standardized risk management procedures in community pharmacies. This necessitated the development of a Guide on the implementation of risk management in community pharmacies, which includes a coherent set of six standardized operational procedures, covering all stages of pharmaceutical activity – from ordering and receiving medicines to storage, preparation and dispensing. The Guide provides pharmaceutical staff with practical and easy-to-apply tools for identifying, assessing and reducing risks and was approved by Order MS RM no. 686/2024. The relevance and applicability of the Guide were confirmed by the mention with the Silver Medal at the 4th Edition of the International Exhibition of Innovation and Technology Transfer - Excellent Idea - 2025. In terms of education, the results of the thesis contributed to the development of the university curriculum and continuing professional training. Thus, in the Curriculum of the Study Program 0916.1 Pharmacy, the optional discipline "Pharmaceutical Risk Management" was introduced for 4th year students, and the Course Support and Methodological Recommendations for this discipline were also developed. At the same time, essential elements regarding risk management were included in the continuing professional training program "Specialized pharmaceutical care for high-risk patients", thus strengthening the training of pharmacists and supporting the development of their skills.