The evaluation of effectiveness of public selective control in the system of counteraction to turnover of nonstandard medications

Abstract

The developing activity of Roszdravnadzor concerning implementation of its powers serves as a serious obstacle for intrusion of falsified counterfeit and of poor quality medications into Russian market. However, support of population of Russia with high quality medications continues to be a serious and until now unresolvable problem for public authorities. The study was carried out to evaluate the actual system of measures concerning public controlling quality of medications. The system is implemented by Roszdravnadzor and its territorial boards in all federal okrugs following by selective sampling of medications. The study included data from the web-sites of Minzdrav of Russia, Minzdrav of the Republic of North Ossetia-Alaniya, Roszdravnadzor, The Republican center of control and certification of medications (hereinafter referred to as the Republican center). The techniques of repetition-free sampling was applied in sociological survey. The total of processed questionnaires amounted to 20. The study was carried out in the North ossetia state medical academy during 201402016 conjointly with the Republican center. The particular shortcomings of actual practice of implementation of state selective control of quality of medications were investigated. The necessity of further enhancement of the system of state control and surveillance at actual stage of development of administrative reform is reasoned. It is proved that at the regional level a new concept of coordination of interdependent structures is needed concerning territorial boards of Roszdravnadzor, the Russian Federation subjects' departments of licensing and regional expertise organizations on issues of quality of pharmaceutical production. The conclusion is drawn that the normative legal base requires further development. The core issues are organization and implementation of controlling compliance of medications in circulation with established obligatory requirements to quality, including in the course of selected control of quality of medications. The development of conceptual apparatus is needed for comprehension and interpretation of processes related to implementation of selective control of quality of medications.