Pharmacovigilance in Medical Organisations: Regional Reporting Experience on Adverse Drug Reactions and New Roszdravnadzor Requirements

INTODUCTION. On 1 March 2025, an updated Pharmacovigilance procedure of medicinal products came into force complying with order of Roszdravnadzor No. 3518 as of 17 June 2024. Analysing reports submitted to Roszdravnadzor is a method that allows to adapt pharmacovigilance of a healthcare facility to the new requirements. AIM. This study aimed to assess completeness and accuracy of reporting adverse drug reactions (ADR) to Roszdravnadzor. These data are essential to draft recommendations for filling out “Adverse drug reaction / no effect” form. MATERIALS AND METHODS. The authors performed a post-hoc analysis of ADR reporting forms over 2009–2019 taken from Irkutsk region Safety monitoring centre and local data from Roszdravnadzor Automated Information System (2019–2023). Naranjo scale was used to assess the accuracy of the causal relationship between ADRs and medicinal product. RESULTS. During the study period, medical facilities of Irkutsk region have submitted 2,655 spontaneous reports. The reporting deadlines were met in 91.3% of the cases. The ADR summary fully described the patient and medicinal products in 87.1% of the cases. Of the 2,655 ADRs, 72.3% described the underlying disease. The most common mistake (3.1%) was incomplete patient information (weight, allergic reactions, and laboratory findings). Lack of therapeutical effect was described in 2.0% of the cases. Drug misuse was reported in 21.5% of spontaneous reports (mostly prescribing antibacterials for viral infections). Causal relationship between the ADR and medicinal products was found in most of the cases (94.5%), the accuracy being classified as certain (25.0%), probable (23.2%), possible (23.2%), and doubtful (3.5%). CONCLUSIONS. The analysis showed that most ADR reports were submitted in due time and in the scope stipulated by regulatory documents. In order to correctly assess the accuracy of ADR reports, the form should include as much data on the patient, medicinal products, and ADR as possible. Regularly improving staff awareness of pharmacovigilance procedure and reporting deadlines will increase pharmacovigilance effectiveness of a medical organisation.