Adverse drug reaction reporting in the Czech Republic 2005–2009
- 196 Downloads
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.
KeywordsAdverse drug reactions Czech Republic Pharmacovigilance Spontaneous reporting Under-reporting
This paper was supported by scientific grant SVV-2010-261-004 (Charles University in Prague).
Conflicts of Interest
- 3.Volume 9A of the rules governing medicinal products in the European Union: pharmacovigilance for medicinal products for human use (version September 2008). [Online]. 2008; Available from: URL:http://ec.europa.eu/enterprise/sectors/pharmaceuticals/documents/eudralex/vol-9/index_en.htm. Accessed 13 Mar 2010.
- 4.Act on pharmaceuticals 378, 2007 (Zákon č.378/2007Sb.o léčivech.) [Online]. Available from: http://aplikace.mvcr.cz/archiv2008/sbirka/2007/sb115-07.pdf. Accessed 3 Nov 2010. [Czech].
- 7.Vlček J, Dalecká R, Koblihová H, Kučera Z, Macek K, Matoulková P, et al. Základy farmakoepidemiologie, farmakoekonomiky a farmakoinformatiky (Basic pharmacoepidemiology, pharmaeconomics and pharmacoinformatics). 2nd ed. Prague: Remedia; 2005. p. 6–41. ISBN 80-903555-0-1 [Czech].Google Scholar
- 8.Health care workers as of 31.12.2009. Available from: URL: http://www.uzis.cz/. Accessed 30 Oct 2010 [Czech].
- 16.Hospitalisations in hospitals in the Czech Republic in 2008. [Online]. 2010; Prague: Institute of Health Information and Statistics of the Czech Republic. Available from: URL:http://www.uzis.cz. ISBN 978-80-7280-851-9. Accessed 7 Mar 2010 [Czech].
- 23.State Institute for Drug Control. Annual Report 2004 State Institute for Drug Control. [Online]; Available from: URL:http://www.sukl.cz/vyrocni-zprava-o-cinnosti-sukl. Accessed 18 Aug 2009. [Czech/English].
- 24.Beneš M, Mladá J. Bezpečnost léčivých přípravků v České republice aneb 5 minut pro bezpečnější farmakoterapii. (Safety of human medicinal products in CZ alias 5 minutes for safer pharmacotherapy) [Online]. 2010; Available from: URL:http://www.sukl.cz/sukl-zahajuje-kampan-o-bezpecnosti-lecivych-pripravku. Accessed 17 Feb 2010. [Czech].
- 25.Pelcová D. Nejčastější otravy a jejich terapie (The most frequent intoxications and their treatment) Prague: Galén; 2009. ISBN 9788072626038 [Czech].Google Scholar
- 26.Directive 2010/84/EU of the European Parliament and of the council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the community code relating to medicinal products for human use. OJ L 348/74 31.12.2010.Google Scholar