The State Expert Center of the Ministry of Health of Ukraine (hereinafter – the Center) held two Skype meetings with the participation of employees of the Health Administrations/Departments of regional state administrations and the city of Kyiv and representatives of the Center on pharmacovigilance issues in administrative-territorial units.
More than 100 healthcare professionals took part in the Skype meetings. On behalf of the Center, the participants were the Deputy Director of the Center for Pharmacovigilance Vasylieva V.A., Head of the Directorate Khoromska O.L., Head of the Division of Organizational and Methodological Support and Monitoring of Pharmacovigilance Implementation of the Directorate Yevko O.I., and expert of the Division of Organizational and Methodological Support and Monitoring of Pharmacovigilance Implementation of the Directorate Melnychuk V.V.
The main topics of the Skype meetings were the results of the work of the Center's pharmacovigilance representatives in the administrative-territorial units for 9 months of 2019 and the prospects for further work. Positive results of the work carried out in the regions were noted with regard to timely reporting of cases of adverse reactions (hereinafter – ARs) to medicinal products (hereinafter – MPs) and the provision of quality information, thanks to the Automated Pharmacovigilance Information System (APIS) introduced in 2017.
Special attention was paid to the quality of the information on adverse reactions following the use of vaccines and tuberculin provided to the Center in the form “Summary data on cases of adverse reactions following the use of vaccines and tuberculin” (hereinafter – summary data). Attention was drawn to the timeliness of completing the summary data form and its compliance with legislative requirements, and to the inadmissibility of entering unreliable data into it. In order to eliminate shortcomings and improve the work of the persons responsible for compiling summary data at the level of the Directorates/Departments of Health of regional state administrations and the city of Kyiv, they were informed about the possibility of obtaining an access code to the AISF, for the purpose of timely response and detection of discrepancies at the level of district healthcare facilities.
One of the areas of the Skype meetings was to familiarize participants with the results of the conducted analysis of fatal cases due to anaphylactic shock (hereinafter – AS) after the use of medicinal products over a period of 2015-2019 years. A detailed statistical analysis of them was presented and relevant conclusions were drawn. It was found that 79% of all fatal cases after the use of medicinal products were due to AS. Information was provided on the list of all medicinal products whose use led to AS. Attention was drawn to the unacceptability of using injectable forms of β-lactam antibiotics and their solvents at home, which makes it impossible to provide timely qualified medical care in the event of AS. Data were provided on the age and gender groups of patients with AS and the methods of administration of medicinal products were analyzed. And as a reminder, attention was drawn to the legislative framework on emergency medical care at the pre-hospital stage and primary, secondary (specialized) and tertiary (highly specialized) medical care in the event of AS.
In order to develop the pharmacovigilance system of Ukraine, optimize the implementation of pharmacovigilance and increase its effectiveness, further Skype meetings with specialists at the local and administrative-territorial levels of the healthcare sector are planned. A conscientious approach to monitoring the safety of medicinal products, vaccines, and tuberculin, providing information on adverse reactions, and analyzing situations related to adverse events following immunization will make it possible to optimize work on issues of the safety and effectiveness of the use of medicinal products, vaccines, and tuberculin.
