In 2023, Ukraine sent 11 300 reports of adverse reactions associated with medicinal products or vaccines to the WHO database – almost twice as many as in 2022.
This is stated in the Activity Report of the State Enterprise State Expert Center of the Ministry of Health of Ukraine for 2023.
For more details, the report is available at the link http://surl.li/qmyeh
For comparison, during 2022, 6 470 reports were submitted to the WHO database, and during 2021, 5 299 reports of adverse reactions associated with medicinal products/vaccines.
As is known, safety monitoring of a finished medicinal product continues throughout the entire period of its use after the registration certificate has been obtained. This makes it possible to detect rare adverse reactions, individual manifestations of adverse reactions inherent in persons with concomitant pathology or special patient groups, to observe the effect of the product together with concomitant therapy, etc.
The Center monthly submits to the WHO global database VigiBase reports of adverse reactions associated with medicinal products/vaccines and receives information on safety signals of medicinal products.
The information is analyzed and implemented in Ukraine by providing recommendations to the applicant on updating the safety information in the instructions for medical use, if necessary. Data from VigiBase are used as additional information in the analysis of the safety information of medicinal products in the territory of Ukraine.
We remind you that since 2002 Ukraine has been a full member of the WHO Programme for International Drug Monitoring (PIDM)
This program is a global collaboration for the development of pharmacovigilance in countries around the world.
The program was created in 1968 in order to ensure the collection of data on harm caused by the use of medicinal products from as many sources as possible.
Participation in the program gives the Center the opportunity to be aware of current global data on the safety of medicinal products/vaccines that may not be apparent from local data alone.
