Monitoring of Adverse Events and Reporting

Abstract

Monitoring adverse events is recognized as one of the major safety measures of current pharmacotherapeutics. Although the concept of a formal system for adverse drug reaction (ADR) monitoring has existed for many years and some countries have more than 30 years of experience with such systems, monitoring is still far from perfect.

Since the early 1990s, when the political systems of the central European countries changed and their economies began moving toward a free market system, the approach to drug safety had to be changed. At present, in Poland and Hungary ADR monitoring systems are undergoing major changes. In the Slovak and Czech republics the system was previously well organized and continues to be effective. In Poland, a number of new initiatives, and a new pharmaceutical law that obliges the industry to monitor and report ADRs, changed the approach to drug safety. There is a considerable effort to adopt proven concepts, for example, a decentralized monitoring system similar to the one created in France, and adopting the CIOMS II format for drug safety summary. It is expected that within a few years, monitoring of adverse events from clinical trials and spontaneous reporting will become fully efficient.