CREATION, DEVELOPMENT AND PROSPECTS OF THE PHARMACOVIGILANCE SYSTEM

According to WHO and OECD, human protection from the undesirable effects of medicines is an indispensable condition for the sustainable development of the Ukrainian healthcare system. The safe use of medicines remains the main task in the treatment of diseases, which is the responsibility of the pharmacovigilance system. Pharmacovigilance is a scientific and practical activity related to the detection, assessment, understanding and prevention of adverse reactions or any other problems related to the safety and effectiveness of medicines. The purpose of the work is to analyze the reasons for the creation, functioning and development of the pharmacovigilance system in the world. At the end of the 19th century. The issue of the safe use of medicines became relevant, which was preceded by fatalities and poisonings after the use of medicines and vaccines. This led to the adoption of the Biological Control Act in 1902 in the USA, which became the basis for the introduction of the Purity of Drugs and Food Act in 1906 and the organization of the Drug Control and Drug Administration. Similar bodies were also created in other developed countries of the world to control medicines. The thalidomide tragedy significantly accelerated the development and implementation of European legislation on the circulation of medicines in the form of EU Directive 65/65 of January 26, 1965, which established the basic requirements for the registration of medicines. Today, the WHO Center for Pharmacovigilance is located in Uppsala, Sweden. About 180 countries are involved in the global pharmacovigilance system, providing information. There are some differences in the Rules of Good Practice between the European Union and the US: FDA – are advisory in nature, and the European Union Rules – are mandatory. The shortcomings of the European Union and US Rules are the assessment and interpretation of the drug circulation process, as well as the application of certain provisions in practice. In Ukraine, bringing the pharmacovigilance system into line with European standards is a priority and integral process that will improve the management process in the field of drug circulation and public health. Conclusion. International organizations should continue to deepen their understanding of the pharmacovigilance system and develop guidelines for the transition from focusing on identifying harm to spreading knowledge about safety among all stakeholders, including in Ukraine.