Skip to main content
SpringerLink
Log in

Diverse pharmacovigilance jurisdiction—The right way for global drug safety?

  • Review
  • Published:
European Journal of Clinical Pharmacology Aims and scope Submit manuscript

Abstract

Purpose

The purpose of this narrative review is to provide a comparison of several countries with different legislation and approaches to pharmacovigilance and to point out how these impact the number of adverse drug reactions (ADRs) that are reported to national competent authorities.

Methods

Legislative and statistical data regarding ADR reporting from various national competent authorities’ websites, databases, and pharmacovigilance centers were used. In combination with the WHO pharmacovigilance quantitative indicator that was applied to evaluate the effectiveness of particular national pharmacovigilance systems in our scope.

Results

The study compared pharmacovigilance systems in six countries, focusing on ADR reporting from 2010 onwards. All countries required MAHs to report ADRs, while healthcare professionals’ obligations varied. Per-capita ADR reports increased in all countries with available data, with the United States having a significantly higher reporting rate, possibly due to FDA campaigns. Despite starting later, China’s per-capita reporting rate surpassed that of the Czech Republic and Japan. The study highlighted various measures taken by countries to enhance ADR reporting systems since the inception of their programs, contributing to the overall increase in reporting rates.

Conclusions

ADR reporting is a global priority, with efforts made by different countries to strengthen their pharmacovigilance systems. Some success can be seen in gradually improving per-capita ADR reporting rates. The varying reporting rates and measures taken by each country may serve as a basis for further research and exchange of best practices to improve drug safety monitoring worldwide.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3
Fig. 4
Fig. 5
Fig. 6
Fig. 7
Fig. 8
Fig. 9

Similar content being viewed by others

Availability of data and materials

Availability upon request from the main author.

References

  1. Zsifkovits J, Zuba M, Geißler W et al (2016) Costs of unsafe care and cost effectiveness of patient safety programmes. https://jasmin.goeg.at/70/1/Behandlungsfehler%20und%20Kosteneffektivit%C3%A4t%20von%20Patientensicherheitsprogrammen.pdf

  2. Routledge PA, O’Mahony MS, Woodhouse KW (2004) Adverse drug reactions in elderly patients. Br J Clin Pharmacol 57:121–126. https://doi.org/10.1046/j.1365-2125.2003.01875.x

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  3. Howard RL, Avery AJ, Slavenburg S et al (2007) Which drugs cause preventable admissions to hospital? A systematic review. Br J Clin Pharmacol 63:136–147. https://doi.org/10.1111/j.1365-2125.2006.02698.x

    Article  CAS  PubMed  Google Scholar 

  4. European Commission (2008) Strengthening pharmacovigilance to reduce adverse effects of medicines. In: European Commission. https://ec.europa.eu/commission/presscorner/detail/de/MEMO_08_782

  5. WHO pharmacovigilance indicators: a practical manual for the assessment of pharmacovigilance systems. World Health Organization, Geneva. https://apps.who.int/iris/handle/10665/186642

  6. Canada Vigilance Program. https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/canada-vigilance-program.html. Accessed 25 Jul 2023

  7. Canada H (2008) Canada Vigilance Program. https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/canada-vigilance-program.html. Accessed 21 May 2023

  8. Canada H (2020) Module 1: overview of Vanessa’s Law and mandatory hospital reporting requirements. https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting/mandatory-hospital-reporting/education/module-1.html. Accessed 18 Jan 2022

  9. Canada H (2020) Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals - guidance document. https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting/mandatory-hospital-reporting/drugs-devices/guidance.html. Accessed 18 Jan 2022

  10. Canada H (2020) Adverse reactions, medical device incidents and health product recalls in Canada: 2019 summary report. https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/adverse-reactions-incidents-recalls-2019-summary.html. Accessed 18 Jan 2022

  11. Canada H (2021) Health product InfoWatch: September 2021. https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/health-product-infowatch/september-2021.html. Accessed 16 Jan 2022

  12. (2022) Health product InfoWatch: November 2022. https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/health-product-infowatch/november-2022.html. Accessed 25 Jul 2023

  13. Zhao Y, Wang T, Li G, Sun S (2018) Pharmacovigilance in China: development and challenges. Int J Clin Pharm 40:823–831. https://doi.org/10.1007/s11096-018-0693-x

    Article  PubMed  Google Scholar 

  14. Sorgato A New drug administration law – new rules and liabilities -China. In: International comparative legal guides international business reports. https://iclg.com/briefing/13934-new-drug-administration-law-new-rules-and-liabilities-china. Accessed 11 Mar 2022

  15. Top national pharma markets by market share (2021) In: Statista. https://www.statista.com/statistics/245473/market-share-of-the-leading-10-global-pharmaceutical-markets/. Accessed 11 Jun 2023

  16. Annual report for national adverse drug reaction monitoring (2019) Released. http://english.nmpa.gov.cn/2020-04/10/c_500154.htm. Accessed 11 Mar 2022

  17. History and present. In: State Institute for Drug Control. https://www.sukl.eu/sukl/history-and-present. Accessed 10 Jun 2023

  18. AC- 378/2007 Sb. Zákon o léčivech. In: Zákony pro lidi. https://www.zakonyprolidi.cz/cs/2007-378?text=farmakovigilance

  19. SÚKL zahajuje kampaň o bezpečnosti léčivých přípravků. In: Státní ústav pro kontrolu léčiv. https://www.sukl.cz/sukl/sukl-zahajuje-kampan-o-bezpecnosti-lecivych-pripravku. Accessed 20 Jun 2023

  20. Informační zpravodaj Nežádoucí účinky léčiv 1/2014, Státní ústav pro kontrolu léčiv. https://www.sukl.cz/sukl/informacni-zpravodaj-nezadouci-ucinky-leciv-1-2014. Accessed 18 Jan 2022

  21. Informační zpravodaj Nežádoucí účinky léčiv 1/2011, Státní ústav pro kontrolu léčiv. https://www.sukl.cz/sukl/informacni-zpravodaj-nezadouci-ucinky-leciv-1-2011. Accessed 18 Jan 2022

  22. SÚKL (2021) Informační zpravodaj Nežádoucí účinky léčiv 1/2021. In: Státní ústav pro kontrolu léčiv. https://www.sukl.cz/sukl/informacni-zpravodaj-nezadouci-ucinky-leciv-1-2021

  23. Japan Pharmaceutical Manufacturers Association (JPMA); Pharmaceutical Regulations in Japan 2020 - Chapter 2. Pharmaceutical laws and regulations. https://www.jpma.or.jp/english/about/parj/eki4g6000000784o-att/2020e_ch02.pdf

  24. Kitabayashi A, Inoue Y (2022) Factors that lead to stagnation in direct patient reporting of adverse drug reactions: an opinion survey of the general public and physicians in Japan. Ther Innov Regul Sci 56:616–624. https://doi.org/10.1007/s43441-022-00397-x

    Article  PubMed  PubMed Central  Google Scholar 

  25. Act on securing quality, efficacy and safety of products including pharmaceuticals and medical devices - English - Japanese Law Translation. https://www.japaneselawtranslation.go.jp/en/laws/view/3213/en#je_ch11at9. Accessed 27 Jul 2023

  26. Yamaguchi M, Inomata S, Harada S et al (2019) Establishment of the MID-NET® medical information database network as a reliable and valuable database for drug safety assessments in Japan. Pharmacoepidemiol Drug Saf 28:1395–1404. https://doi.org/10.1002/pds.4879

    Article  PubMed  PubMed Central  Google Scholar 

  27. Pharmaceuticals and Medical Devices Agency MHLW Pharmaceuticals and Medical Devices Safety Information (FY2021) | Pharmaceuticals and Medical Devices Agency. https://www.pmda.go.jp/english/safety/info-services/drugs/medical-safety-information/0019.html. Accessed 21 Feb 2022

  28. Steering Committee for the Review of Access to Yellow Card Data; Report of an independent review of access to the yellow card scheme. https://sante.gouv.fr/IMG/pdf/Report_of_an_Independent_Review_of_Access_to_the_Yellow_Card_Scheme.pdf

  29. Hitchen L (2006) Adverse drug reactions result in 250 000 UK admissions a year. BMJ 332:1109

    Article  PubMed  PubMed Central  Google Scholar 

  30. The Yellow Card scheme: guidance for healthcare professionals, patients and the public. In: GOV.UK. https://www.gov.uk/guidance/the-yellow-card-scheme-guidance-for-healthcare-professionals. Accessed 9 Mar 2022

  31. Information | Making medicines and medical devices safer. https://yellowcard.mhra.gov.uk/information. Accessed 27 Jul 2023

  32. Yellow Card: please help to reverse the decline in reporting of suspected adverse drug reactions. In: GOV.UK. https://www.gov.uk/drug-safety-update/yellow-card-please-help-to-reverse-the-decline-in-reporting-of-suspected-adverse-drug-reactions. Accessed 9 Mar 2022

  33. Freedom of Information request on the number of yellow card reports received from 2017–2021 (FOI 21/1055). In: GOV.UK. https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-11-october-2021/freedom-of-information-request-on-the-number-of-yellow-card-reports-received-from-2017-2021-foi-211055. Accessed 18 Jul 2023

  34. Commissioner O of the (2023) A brief history of the center for drug evaluation and research. In: FDA. https://www.fda.gov/about-fda/fda-history-exhibits/brief-history-center-drug-evaluation-and-research

  35. Khaleel MA, Khan AH, Ghadzi SMS et al (2022) A standardized dataset of a spontaneous adverse event reporting system. Healthcare (Basel) 10:420. https://doi.org/10.3390/healthcare10030420

    Article  PubMed  Google Scholar 

  36. Commissioner O of the (2023) Reporting serious problems to FDA. In: FDA. https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda. Accessed 26 Jul 2023

  37. Commissioner O of the (2023) Reporting serious problems to FDA. In: FDA. https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda. Accessed 18 Jul 2023

  38. Top 10 pharmaceutical markets by value (USD). https://www.abpi.org.uk/facts-figures-and-industry-data/global-pharmaceutical-market/top-10-pharmaceutical-markets-by-value-usd/. Accessed 27 Jul 2023

Download references

Acknowledgements

We would like to thank to personnel at Health Canada for providing available statistical information.

Funding

No funding was received to assist with the preparation of this manuscript.

Author information

Authors and Affiliations

  1. Department of Pharmacology, Third Faculty of Medicine, Charles University, Ruská 87, 100 00, Prague 10, Czech Republic

    Petra Zatovkaňuková & Jiří Slíva

Authors
  1. Petra Zatovkaňuková
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Jiří Slíva
    View author publications

    You can also search for this author in PubMed Google Scholar

Contributions

Both authors contributed to the idea for the article. Petra Zatovkanukova performed the literature search, data analysis and prepared the original draft. Jiri Sliva critically revised the draft and proposed ideas for improvement of the work.

Corresponding author

Correspondence to Petra Zatovkaňuková.

Ethics declarations

Ethical approval

Not applicable.

Competing interests

The authors declare no competing interests.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Zatovkaňuková, P., Slíva, J. Diverse pharmacovigilance jurisdiction—The right way for global drug safety?. Eur J Clin Pharmacol 80, 305–315 (2024). https://doi.org/10.1007/s00228-023-03608-y

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00228-023-03608-y

Keywords

Search

Navigation