The WHO mission was aimed at identifying gaps in the implementation of pharmacovigilance, determining their causes, and developing recommendations for eliminating them, with the aim of strengthening the national pharmacovigilance system.
All this is necessary, as WHO experts emphasized, to prepare the country for the use of new medicinal products (MPs), which, on the one hand, are urgently needed and, on the other, involve a number of uncertainties, especially regarding safety issues. However, these MPs can be registered under certain conditions or used thanks to humanitarian aid. Among such MPs in Ukraine, bedaquiline became the “pioneer”. Treatment of 200 patients with MR and MMR tuberculosis with this MP has already begun at the F.G. Yanovsky National Institute of Phthisiology and Pulmonology of the National Academy of Medical Sciences of Ukraine. According to WHO, a well-established pharmacovigilance system must be a mandatory condition for the use of this type of MP. It will make it possible to obtain the necessary data that will help close existing gaps in knowledge about the MP.
Over three days, the experts assessed the key elements of Ukraine's pharmacovigilance system, both at the regulatory level and at the level of the healthcare system. WHO can learn about a country's readiness to use new medicinal products and the state of its pharmacovigilance system by applying the universal questionnaire tool it has developed, which is what was used.
On the first day of the mission's work, a meeting was held at the Pharmacovigilance Department of the Center. WHO experts, in terms of assessing the pharmacovigilance system, conducted a survey in the following areas:
- legislation regulating the conduct of pharmacovigilance in Ukraine;
- organization of the pharmacovigilance system in Ukraine, the place of pharmacovigilance in regulatory processes;
- tools used to collect information on cases of adverse reactions (ARs) and lack of efficacy (LoE) of medicinal products in Ukraine;
- analysis of medicinal product safety information in Ukraine;
- the risk management process, communication with all stakeholders on medicinal product safety issues.
WHO experts toured the Center's Pharmacovigilance Department, met its staff and learned about the processes taking place in it.
The information retrieval tool (Automated Pharmacovigilance Information System – AISF), thanks to which information on cases of adverse reactions and lack of efficacy of medicinal products is now collected and analyzed, received high praise.
The experts emphasized that a comprehensive approach to the processes carried out in the Department is justified, and that the collection of information on adverse reactions to medicinal products and the use of these data in the expert evaluation of documents created within pharmacovigilance is an extremely important element of regulating the circulation of medicinal products.
On the second day, WHO experts met with doctors at health care facilities where tuberculosis patients are treated, and held meetings with staff of the Public Health Center and the PATH project. On that day, a survey of medical workers was conducted and the practical aspects of safety monitoring of medicinal products were assessed.
The last day of the WHO mission took place at the WHO regional office in Ukraine with the participation of Center staff, the Public Health Center, and representatives of the “Doctors Without Borders” program.
WHO experts Noha Iessa and Viola Macolic demonstrated the strengths and weaknesses of the system to all participants of the meeting and presented preliminary survey results, conclusions and recommendations. During the discussion, questions that had arisen among the experts and those present regarding the presented data were discussed. Based on the results of the discussion, a decision was made on the need to hold a series of trainings, primarily on active cohort monitoring. A plan of further actions of all stakeholders aimed at building Ukraine's pharmacovigilance system was also discussed.
