International Journal of Clinical Pharmacy

, Volume 33, Issue 4, pp 683–689 | Cite as

Adverse drug reaction reporting in the Czech Republic 2005–2009

  • Eva Kopečná
  • Veronika Deščíková
  • Jiří Vlček
  • Jana Mladá
Research Article


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.


Adverse 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

None declared.


  1. 1.
    Tisoňová J, Szalayová A, Kriška M, Gibala P, Foltán V. Factors influencing the spontaneous reporting of adverse drug reactions—the experience of the Slovak Republic. Pharmacoepidemiol Drug Saf. 2004;13:333–7.PubMedCrossRefGoogle Scholar
  2. 2.
    Perlík F, Slanař O, Šmíd M, Petráček J. Attitude of Czech physicians to adverse drug reaction reporting. Eur J Clin Pharmacol. 2002;58:367–9.PubMedCrossRefGoogle Scholar
  3. 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: Accessed 13 Mar 2010.
  4. 4.
    Act on pharmaceuticals 378, 2007 (Zákon č.378/2007Sb.o léčivech.) [Online]. Available from: Accessed 3 Nov 2010. [Czech].
  5. 5.
    Osborne CA. Adverse drug reactions: investigating to reporting. J Can Acad Child Adolesc Psychiatry. 2010;19:46–7.PubMedGoogle Scholar
  6. 6.
    Hazell L, Shakir SA. Under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2006;29:385–96.PubMedCrossRefGoogle Scholar
  7. 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. 8.
    Health care workers as of 31.12.2009. Available from: URL: Accessed 30 Oct 2010 [Czech].
  9. 9.
    Ulfvarson J, Mejyr S, Bergman U. Nurses are increasingly involved in pharmacovigilance in Sweden. Pharmacoepidemiol Drug Saf. 2007;16:532–7.PubMedCrossRefGoogle Scholar
  10. 10.
    Blenkinsopp A, Wilkie P, Wang M, Routledge PA. Patient reporting of suspected adverse drug reactions: a review of published literature and international experience. Br J Clin Pharmacol. 2007;63:148–56.PubMedCrossRefGoogle Scholar
  11. 11.
    de Langen J, van Hunsel F, Passier A, den Berg L, van Grootheest K. Adverse drug reaction reporting by patients in the Netherlands: three years of experience. Drug Saf. 2008;31:515–24.PubMedCrossRefGoogle Scholar
  12. 12.
    Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA. 1998;279:1200–5.PubMedCrossRefGoogle Scholar
  13. 13.
    Patel H, Bell D, Molokhia M, Srishanmuganathan J, Patel M, Car J, Majeed A. Trends in hospital admissions for adverse drug reactions in England: analysis of national hospital episode statistics 1998–2005. BMC Clin Pharmacol. 2007;7:9.PubMedCrossRefGoogle Scholar
  14. 14.
    Brvar M, Fokter N, Bunc M, Mozina M. The frequency of adverse drug reaction related admissions according to method of detection, admission urgency and medical department speciality. BMC Clin Pharmacol. 2009;9:8.PubMedCrossRefGoogle Scholar
  15. 15.
    van der Hooft CS, Dieleman JP, Siemes C, Aarnoudse AJ, Verhamme KM, Stricker BH, et al. Adverse drug reaction-related hospitalisations:a population-based cohort study. Pharmacoepidemiol Drug Saf. 2008;17:365–71.PubMedCrossRefGoogle Scholar
  16. 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: ISBN 978-80-7280-851-9. Accessed 7 Mar 2010 [Czech].
  17. 17.
    Pirmohamed M, James S, Meakin S, Green C, Scott AK, Walley TJ, et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18,820 patients. BMJ. 2004;329:15–9.PubMedCrossRefGoogle Scholar
  18. 18.
    Chyka PA. How many deaths occur annually from adverse drug reactions in the United States? Am J Med. 2000;109:122–30.PubMedCrossRefGoogle Scholar
  19. 19.
    Wester K, Jönsson A, Spigset O, Hägg S. Spontaneously reported fatal suspected adverse drug reactions: a 10-year survey from Sweden. Pharmacoepidemiol Drug Saf. 2007;16:173–80.PubMedCrossRefGoogle Scholar
  20. 20.
    Zhang M, Holman J, Preen DB, Brameld K. Repeat adverse drug reactions causing hospitalization in older Australians: a population-based longitudinal study 1980–2003. Br J Clin Pharmacol. 2007;63:163–70.PubMedCrossRefGoogle Scholar
  21. 21.
    Mannesse CK, Derkx FH, de Ridder MA, Man in’t Veld AJ, van der Cammen TJ. Adverse drug reactions in elderly patients as contributing factors for hospital admission: cross-sectional study. BMJ. 1997;315:1057–8.PubMedGoogle Scholar
  22. 22.
    Kimland E, Rane A, Ufer M, Panagiotidis G. Paediatric adverse drug reactions reported in Sweden from 1987 to 2001. Pharmacoepidemiol Drug Saf. 2005;14:493–9.PubMedCrossRefGoogle Scholar
  23. 23.
    State Institute for Drug Control. Annual Report 2004 State Institute for Drug Control. [Online]; Available from: URL: Accessed 18 Aug 2009. [Czech/English].
  24. 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: Accessed 17 Feb 2010. [Czech].
  25. 25.
    Pelcová D. Nejčastější otravy a jejich terapie (The most frequent intoxications and their treatment) Prague: Galén; 2009. ISBN 9788072626038 [Czech].Google Scholar
  26. 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

Copyright information

© Springer Science+Business Media B.V. 2011

Authors and Affiliations

  • Eva Kopečná
    • 1
  • Veronika Deščíková
    • 1
    • 2
  • Jiří Vlček
    • 1
  • Jana Mladá
    • 2
  1. 1.Department of Social and Clinical Pharmacy, Faculty of PharmacyCharles University in PragueHradec KrálovéCzech Republic
  2. 2.Pharmacovigilance DepartmentState Institute for Drug ControlPrague 10Czech Republic

Personalised recommendations