Adverse Drug Reaction Monitoring Program in Georgia

Nikoloz Gongadze,* Zaza Chapichadze,* Bondo Kobulia,** Levan Schalamberidze,* Irina Jashi,** Tamar Tchelidze**

Background: Due to the fact that the information about the adverse drug reactions (ADR) registered during pre-marketing period is incomplete and according the recommendations and guidelines of the WHO, the drug monitoring program and the system of pharmacovigilance was established in Georgia according the order of the minister of health in 1997 to monitor the safety of medicinal products and detect adverse drug reactions. Methods: According the international standards the special system of active search and spontaneous ADR reporting was elaborated and implemented in Georgia. The special CIOMS methods were implemented to analyze the reports about the adverse drug reaction and report to the international database center in Uppsala (Sweden). Results: The significance of the international system of adverse drug monitoring is very high and it will rise together with the overall use of drugs, complicity and increase of treatment duration. The system of spontaneous adverse drug reporting is of highest importance due to its economic efficacy and scientific significance especially in countries with limited resources.

Keywords:   adverse drug reaction, drug monitoring, spontaneous ADR reporting, pharmacovigilance