It is known that pharmacovigilance (FN) performs a socially significant function of ensuring the safety of circulation of medicinal products (MP) both at the stages before registration of a medicinal product (MP) and at the stages after its registration. In the latter case, FN is called post-marketing. In post-marketing PH, pharmaceutical enterprises (FP) are delegated the leading role in activities aimed at identifying and assessing unintended and adverse reactions for the body observed in humans when using drugs. Or pharmacovigilance services are outsourced, and the cost of pharmacovigilance services is included in the company’s balance sheet. Pharmaceutical enterprises of the Republic of Uzbekistan (RUz) fully implement the assessment of adverse drug reactions, coordinating their actions with the obligations enshrined in Art. 13 “Pharmacovigilance” of the Law of the Republic of Uzbekistan “On Medicines and Pharmaceutical Activity”. Pharmaceutical enterprises are obliged to inform in writing (by filing a message about this) the Ministry of Health of the Republic of Uzbekistan (MH RUz) about all cases of serious adverse events (SAE) when using drugs. In the structure of the Ministry of Health of the Republic of Uzbekistan, in accordance with the Resolution of the Cabinet of Ministers of the Republic of Uzbekistan “On Approval of the Regulations on the Procedure for State Registration of Medicines, Medical Devices and Medical Equipment, and Issuance of a Registration Certificate”, the Pharmacological Committee, in which the center of responsibility for the consolidation of messages on SAE is the State Unitary Enterprise “State Center for Expertise and Standardization of Medicines, Medical Products and Medical Equipment” (State Unitary Enterprise “GTsESLSIMNMT”). Thus, theoretically, the FN system in the Republic of Uzbekistan has a legal fundamental basis: the pharmaceutical enterprises of the Republic of Uzbekistan are implanted into the national FN system. For the implementation of theoretical tasks on FN within the FP, appropriate practical pharmacovigilance activities should be established. However, to date, no data has been published in the available literature on the features of practical post-marketing PH at enterprises of the pharmaceutical industry of the Republic of Uzbekistan, on the experience of FP in its organization, on the problems actualized by such experience. The obtained results of the study made it possible to formulate the following general conclusions:

  1. At present, the organization of post-marketing pharmacovigilance at pharmaceutical enterprises of the Republic of Uzbekistan has structural and functional deficiencies. The first include the quantitative and qualitative manifestations of the actual deficit of the necessary elements of the PH system (subjects, information, infrastructure, etc.). In this case, pharmacovigilance services provided by third-party organizations, outsourcing of pharmacovigilance in the case of an acceptable cost can be partly a way out of the situation. The second can be attributed to insufficient formation or complete absence of communicative relationships between the subjects of physical science, inaccessibility of information or weakness of informational influence, etc.
  2. Expert assessment of post-marketing pharmacovigilance activities at pharmaceutical enterprises of the Republic of Uzbekistan showed that it can be assessed as average and insufficiently effective. 43.75% of experts considered that the level of FN development in the company is average; the effectiveness of the FN system within companies was assessed by experts on average at 3.94 points out of 5 possible. Such low estimates can be justified by the identified shortcomings in the organization of the PH system at pharmaceutical enterprises, to which the experts attributed: combining the positions of an authorized person for pharmacovigilance (81.25% of respondents), the lack of a local approved form for filling out the information received on adverse reactions (37.5% ), the lack of the necessary knowledge on the organization of physical science (31.82%), lack of free Internet resources on physical science (18.18%), insufficient level of teaching physical science in educational institutions and insufficient qualifications of workers by FN in regulatory authorities (13.64% each). Here, pharmacovigilance services rendered by specialized organizations and outsourcing pharmacovigilance will be a necessary measure, even despite the cost of services.

E.V. SVECHNIKOVA, A.E. KRASHENINNIKOV, A.V. MATVEEV

Bulletin of RZN 2020. No. 5 Svechnikova.pdf