Abstrakt
Data collected in spontaneous reporting systems in 26 European countries were analysed. In 2007, 2008 and 2009, the average value of reports per year per million inhabitants based on the safety databases of countries was 208, 236, 286, respectively; in comparison, that of Eudra-Vigilance was 311, 453 and 435, respectively.
Twelve countries reached a significant level for signal detection of ADRs in 2009. The population-based reporting ratio (PBRR) was correlated to the total expenditure on health (rho=0.499, p=0.023, n=21), public expenditure on health (rho=0.477, p=0.035, n=20), density of physicians (rho=0.336, p=0.136, n=21) and expenditure on pharmaceuticals (rho=0.365, p=0.114, n=20).
Strategies of regulatory authorities to increase reporting were determined.