OBJECTIVE: The aim of this study was to assess the situation regarding spontaneous adverse drug reaction reporting in the Czech Republic during a 5-year period (2005-2009). SETTING: Descriptive study was conducted using the data from the Czech State Institute for Drug Control pharmacovigilance database. METHODS: The data referring to all spontaneous adverse drug reaction reports received, by the pharmacovigilance department of the Czech State Institute for Drug Control during 2005-2009 were collected, analysed and compared with data from the Slovak Republic, Denmark, and the United Kingdom. MAIN OUTCOME MEASURES: The number of received spontaneous adverse drug reactions reports by year per 10,000 inhabitants, the seriousness and outcome of reactions, the reporting groups, and the top ten molecules which contributed to the highest number of reports. RESULTS: During the study period 2005-2009, the pharmacovigilance department of the State Institute for Drug Control received 7,708 spontaneous adverse drug reactions reports of which 73.6% were serious and 2.1% resulted in death. The number of spontaneous adverse drug reactions reports per 10,000 inhabitants ranged from 1.3 to 1.7, which was lower when compared with the number of reports from three other EU countries. The healthcare professionals contributed to 64.2% of the adverse drug reactions reports, whilst marketing authorization holders provided 35.5%, and finally patients with 0.3%. Vaccines, ketoprofen, amoxicillin, statins, and estradiol were amongst the top ten molecules that gave the highest number of spontaneous adverse drug reactions reports. CONCLUSIONS: Our assessment of adverse drug reactions spontaneous reports received by the Czech Institute for Drug Control during 2005-2009 showed that the reporting rate is relatively low and remains constant over the 5 year period. More emphasis on academic/professional training is needed to educate all potential reporters on the mechanism of reporting of adverse drug reactions and to also emphasize the importance of the whole pharmacovigilance process.

Department of Social and Clinical Pharmacy Faculty of Pharmacy Charles University Prague Heyrovského 1203 Hradec Králové 500 05 Czech Republic

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