The analysis of regulatory decisions on drug safety in the context of harmonisation with international standards
DOI:
https://doi.org/10.24959/sphhcj.24.336Keywords:
drug safety; pharmacovigilance; State Administration on Medicinal Products; regulatory decisions; suspension of drug circulation; adverse reactionsAbstract
Aim. To analyze regulatory decisions of national authorities on the drug safety.
Materials and methods. The study materials were reports of the State Expert Centre of the Ministry of Health of Ukraine (SEC) and the State Service of Ukraine on Medicines and Drugs Control (SSMDC), regulatory acts of the SSMDC, and scientific publications. General scientific and special methods, including content analysis, synthesis, generalization, graphic methods, were used in the study.
Results. The analysis of the activities of national regulatory authorities on drug safety allowed us to identify the specificity of the decision-making procedure for suspending/ withdrawing suspected medicines from the circulation and conducting the quality control. Based on the results of monitoring of SRa websites regarding information on the drug safety and data on the SEC recommendations issued regarding the need to make changes to the instructions, update information on the drug safety, implement measures to minimize the risks of serious adverse reactions (ARs), and limit the use of medicines, it was determined that 60% of recommendations concerned changes to the instructions, 34 % of them related to updating information on the drug safety, while other types of recommendations were less than 6 %. The results of the analysis of regulatory decisions of the SSMDC based on information about serious and unforeseen ARs showed that 85 orders were issued to temporarily ban the circulation of medicines within 2020-2023; as a result of additional studies, a decision was made in 22 cases to completely ban the circulation, including 14 cases related to medicines imported to Ukraine as humanitarian aid and did not have the appropriate labeling. The analysis of the list of medicinal products temporarily banned from the circulation has revealed that 94 % of them are presented in the form of parenteral dosage forms, 78 % of the list are medicines of domestic production.
Conclusions. The analysis of the activities of the national regulatory authorities on the safety of medicines in Ukraine in 2020-2023 showed that the largest number of orders to temporarily suspend the drug circulation was issued by the State Administration on Medicines in 2023. In almost 60 % of cases, the reason for stopping the drug circulation was the death of a patient, and in 16 % of cases, orders for a complete ban on the circulation concerned medicines imported as humanitarian aid. Taking into account the trends towards changing the structure of national regulatory authorities in the healthcare sector, it is promising to further study the compliance of regulatory activities on safety issues with the international practice of strict regulatory agencies.
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