Rational Organisation of Adverse Drug Reaction Monitoring

Abstract

The main pharmacoepidemiological method for assessing the efficacy and safety of ongoing pharmacotherapy involves the collection of spontaneous reports on adverse drug reactions (ADRs) associated with the use of medicines.The aim of the study was to analyse approaches to organising a system for collecting information on ADRs associated with the use of medicinal products, taking the Omsk region as a case study.Materials and methods: the authors analysed 200 ADR reporting forms received by the Regional Centre for the Study of Side Effects of Drugs (RCSSED) in 2019.Results: the analysis determined the ways of receiving the forms in the RCSSED. According to the analysis, the ADR reports were submitted by medical organisations in Omsk (86%) and the Omsk region (0.5%), as well as directly by patients (13.5%). The leading sources of reports were clinical pharmacologists (80% of the forms). Most of the reports were on ADRs associated with the use of psychotropic (41%) and antitumour (10%) medicinal products; it is explained by the proactive attitude and high commitment of medical personnel from the specialised clinics in Omsk towards their professional duties. Other important sources of reports in the Omsk region, which contributed to the number of spontaneous reports from patients, were the patient hotline and free consultation appointments with the clinical pharmacologist of the RCSSED on side effects of medicinal products. The article emphasises the leading role of the RCSSED clinical pharmacologist in educating medical personnel—in pharmacovigilance, collecting information about the development of ADRs, and the quality of reporting form filling—and coordinating the activities of the medical and pharmacy services, including the stages of laboratory assessment of medicinal product quality and pharmaceutical consultation of general public.Conclusions: using the example of the Omsk region, the authors demonstrated the structural organisation of the collection of information about adverse reactions associated with the use of medicinal products. An important direction for further improvement of the organisation of ADR monitoring is the interaction with employees of pharmacy organisations, including additional training events for them.