Vnitr Lek 2022, 68(4):E10-E15 | DOI: 10.36290/vnl.2022.054

The position and importance of pharmacovigilance in the Czech Republic and in the world

Petra Zatovkaňuková, Jiří Slíva
Ústav farmakologie, 3. LF UK, Praha

Pharmacovigilance is an integral part of medicine. There is always a risk of side effects when using medication; these can be completely trivial, but there are side effects that can be life-threatening or fatal. Pharmacovigilance practices should prevent such side effects, or at least reduce their incidence, especially by developing preventive measures that are based on adverse drug reaction (ADR) data and the evaluations of these. This article deals with the general concept of pharmacovigilance and compares individual pharmacovigilance systems of several countries and regions.

Keywords: pharmacovigilance, adverse drug reaction, legislation, Czech Republic, China, Great Britain, Japan, Canada.

Published: June 22, 2022  Show citation

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Zatovkaňuková P, Slíva J. The position and importance of pharmacovigilance in the Czech Republic and in the world. Vnitr Lek. 2022;68(4):E10-15. doi: 10.36290/vnl.2022.054.
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    References

    1. info@aion.cz AC. 378/2007 Sb. Zákon o léčivech. Zákony pro lidi. Accessed January 18, 2022. https://www.zakonyprolidi.cz/cs/2007-378?text=farmakovigilance
    2. Informační zpravodaj Nežádoucí účinky léčiv 1/2014, Státní ústav pro kontrolu léčiv. Accessed January 18, 2022. https://www.sukl.cz/sukl/informacni‑zpravodaj‑nezadouci‑ucinky‑leciv-1-2014
    3. SÚKL. Informační zpravodaj Nežádoucí účinky léčiv 1/2011. 01252011;(1):https://www.sukl.cz/sukl/informacni‑zpravodaj‑nezadouci‑ucinky‑leciv-1-2011.
    4. SÚKL. Informační zpravodaj Nežádoucí účinky léčiv 1/2021. 2021;(1). https://www.sukl.cz/sukl/informacni‑zpravodaj‑nezadouci‑ucinky‑leciv-1-2021
    5. SÚKL. Informační zpravodaj Nežádoucí účinky léčiv 1/2014. 02102014;(1). https://www.sukl.cz/sukl/informacni‑zpravodaj‑nezadouci‑ucinky‑leciv-1-2014
    6. Zsifkovits J, Zuba M, Geißler W, et al. Costs of unsafe care and cost effectiveness of patient safety programmes. Published online 2016. https://ec.europa.eu/health/sites/default/files/systems_performance_assessment/docs/2016_costs_psp_en.pdf
    7. Routledge PA, O'Mahony MS, Woodhouse KW. Adverse drug reactions in elderly patients. Br J Clin Pharmacol. 2004;57(2):121-126. doi:10.1046/j.1365-2125.2003.01875.x Go to original source... Go to PubMed...
    8. Howard RL, Avery AJ, Slavenburg S, et al. Which drugs cause preventable admissions to hospital? A systematic review. Br J Clin Pharmacol. 2007;63(2):136-147. doi:10.1111/j.1365-2125.2006.02698.x Go to original source... Go to PubMed...
    9. Strengthening pharmacovigilance to reduce adverse effects of medicines. European Commission - European Commission. Published 2008. https://ec.europa.eu/commission/presscorner/detail/de/MEMO_08_782
    10. Canada H. Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals - Guidance document. Published August 11, 2020. Accessed January 18, 2022. https://www.canada.ca/en/health‑canada/services/drugs‑health‑products/medeffect‑canada/adverse‑reaction‑reporting/mandatory‑hospital‑reporting/drugs‑devices/guidance.html
    11. Canada H. Module 1: Overview of Vanessa's Law and mandatory hospital reporting requirements. Published February 12, 2020. Accessed January 18, 2022. https://www.canada.ca/en/health‑canada/services/drugs‑health‑products/medeffect‑canada/adverse‑reaction‑reporting/mandatory‑hospital‑reporting/education/module-1.html
    12. Canada H. Adverse reactions, medical device incidents and health product recalls in Canada: 2019 summary report. Published December 11, 2020. Accessed January 18, 2022. https://www.canada.ca/en/health‑canada/services/drugs‑health‑products/reports‑publications/medeffect‑canada/adverse‑reactions‑incidents‑recalls-2019-summary.html
    13. Canada H. Health Product InfoWatch: September 2021. Published September 29, 2021. Accessed January 16, 2022. https://www.canada.ca/en/health‑canada/services/drugs‑health‑products/medeffect‑canada/health‑product‑infowatch/september-2021.html
    14. Yamaguchi M, Inomata S, Harada S, et al. Establishment of the MID‑NET® medical information database network as a reliable and valuable database for drug safety assessments in Japan. Pharmacoepidemiol Drug Saf. 2019;28(10):1395-1404. doi:10.1002/pds.4879 Go to original source... Go to PubMed...
    15. Pharmaceuticals and Medical Devices Agency. MID‑NET (Medical Information Database NETwork). MHLW Pharmaceuticals and Medical Devices Safety Information (FY2021) | Pharmaceuticals and Medical Devices Agency. 2021;(382). https://www.pmda.go.jp/files/000241088.pdf#page=4
    16. Hitchen L. Adverse drug reactions result in 250000 UK admissions a year. BMJ. 2006;332(7550):1109. Go to original source... Go to PubMed...
    17. The Yellow Card scheme: guidance for healthcare professionals, patients and the public. GOV.UK. Accessed March 9, 2022. https://www.gov.uk/guidance/the‑yellow‑card‑scheme‑guidance‑for‑healthcare‑professionals
    18. Yellow Card: please help to reverse the decline in reporting of suspected adverse drug reactions. GOV.UK. Accessed March 9, 2022. https://www.gov.uk/drug‑safety‑update/yellow‑card‑please‑help‑to‑reverse‑the‑decline‑in‑reporting‑of‑suspected‑adverse‑drug‑reactions
    19. Zhao Y, Wang T, Li G, Sun S. Pharmacovigilance in China: development and challenges. Int J Clin Pharm. 2018;40(4):823-831. doi:10.1007/s11096-018-0693-x Go to original source... Go to PubMed...
    20. Sorgato A. New Drug Administration Law - New Rules and Liabilities -China. International Comparative Legal Guides International Business Reports. Accessed March 11, 2022. https://iclg.com/briefing/13934-new‑drug‑administration‑law‑new‑rules‑and‑liabilities‑china
    21. Annual Report for National Adverse Drug Reaction Monitoring (2019) Released. Accessed March 11, 2022. http://english.nmpa.gov.cn/2020-04/10/c_500154.htm

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