Theoretical and practical approaches to pharmaceutical safety

Abstract

Over the years the pharmaceutical system of the Republic of Moldova as a component of the healthcare system has faced many problems, such as the reduction of both availability due to the disappearance of vital medicines from the pharmaceutical market, and affordability due to the imperfection of the drug pricing mechanism; the involvement of non-specialists in pharmaceutical activities, which leads to a drastic decrease in the quality of pharmaceutical services; monopolization of some processes and products in the chain of drug supply actions, etc. In recent years, various aspects that directly or indirectly related to pharmaceutical safety (PS) and related health risks have been increasingly discussed in the Republic of Moldova.

Aim. To substantiate theoretically and scientifically the concepts of PS using the principles of the systematic approach and assess the quality and degree of legislative support for pharmaceutical safety in the Republic of Moldova.

Materials and methods. The research was conducted according to the methodology based on the systemic approach, including analysis and synthesis; the study of factors and processes; decomposition and construction of systems; the analysis of legislation; the argumentation and preparation of draft legislative acts, norms, strategies, programs.

Results. The analysis conducted in the course of the study demonstrates that the concept of “pharmaceutical safety” in different countries by different authors covers several aspects – the quality, safety and effectiveness of medicines, their transportation and storage according to the requirements, availability and import independence, their ethical development and promotion, their rational use, etc. In the course of the study, the definition of factors affecting and characterizing the PS system was proposed – “elements that determine the functionality and characterize the state of the pharmaceutical safety system in the country”. Three groups of factors affecting and characterizing the PS system of the Republic of Moldova were argued. Based on the classification of the factors, the method of analysis using the quantitative and qualitative expertise was developed. The quality of the PS system in the Republic of Moldova was assessed taking into account the current state of the safety level. To assess the quality of this system, the 7-point scale was used, the relative quality coefficient was determined, which was – 1.03; experts rated the quality of the PS system as “low”. To determine the degree of legislative coverage of the PS system, the algorithm was developed; it was used as a methodological tool for determining the degree of legislative and regulatory coverage of the PS system. The results of the studies allowed the elaboration of legislative proposals, which were put forward and adopted.

Conclusions. The legislative framework of the PS system was created by the adoption of Law No. 312 of 30.11.2018, which amended the Law on pharmaceutical activities, the Law on medicines, the Law on health protection, the Law on state material reserves and mobilization. The advanced training program in the field of pharmaceutical management and legislation to train practicing pharmacists has been supplemented with the topic “Pharmaceutical safety”.