New areas work of pharmacovigilance. Pharmacovigilance: analysis of work defects and consideration of new requirements. Results and resources of regional pharmacovigilance

Effective organization of adverse drug reaction monitoring is a key aspect of pharmacotherapy safety. Modern approaches to pharmacovigilance involve the active involvement of medical specialists in the work. Regulatory authorities are constantly improving the requirements for pharmacovigilance.

The aim. Analysis of regional pharmacovigilance data registered by specialists of medical organizations (MO) of the inpatient level of the Irkutsk region from 2009 to 2023, and consideration of opportunities for improvement of work.

Materials and methods. The object of the study was notification cards for adverse reactions received from medical organizations of the Irkutsk region for the period 20092023 for medicines. The analysis was carried out taking into account the completeness of filling out notifications, compliance with the deadlines for submission and the outcomes of registered cases. Narangeau scale was used to assess the causal relationship between the adverse reaction and the drug. Statistical data processing included methods of descriptive statistics; comparative statistics (Bonferroni-corrected χ² test for multiple comparisons). Processing was performed using MedCalc® software version 20.006 (MedCalc Software Ltd).

Results. The analysis showed that 89.5 % of the notice cards met the recommended form of filling. The most common defect was a lack of complete patient information. In 3.6 % of reports, there were shortcomings in the information about the history and concomitant therapy. Clinical manifestations of ADRs covered 11 classes of complications, of which 21.5 % met the criteria for serious adverse reactions. Resolution of complications was reported in 92.0 % of reports.

Conclusion. To improve the effectiveness of pharmacovigilance, it is necessary to strengthen the interaction between various medical specialists. It is important to ensure that healthcare professionals are constantly informed about the procedure for pharmacovigilance, types of adverse effects, rules for their detection and the timing of reporting, their compliance with the requirements of the new regulatory document – Order of Roszdravnadzor dated June 17, 2024 № 3518.

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