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Practical Implementation in Six Member States

  • Michael Kaeding
  • Julia Schmälter
  • Christoph Klika
Open Access
Chapter

Abstract

This chapter represents the core of this study and presents the main findings. The aim of this chapter is threefold. First, it offers in-depth explanations of the adverse drug reaction (ADR) reporting systems, and it describes relevant tasks and actors involved in all six countries under consideration (the United Kingdom, Finland, Poland, France, Portugal and Germany).

Keywords

Healthcare Professional Competent Authority Batch Number Awareness Raising Pharmacovigilance System 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

References

  1. ANSM (2016). Annual Report 2015. Last accessed on 04.11.2016: ansm.sante.fr/content/download/97375/1237039/…/ANSM-RA-15_EN_oct2016.pdfGoogle Scholar
  2. AkdÄ (2016). Tätigkeitsbericht 2015. Last accessed on 02.12.2016: www.akdae.de/Kommission/Organisation/Aufgaben/Taetigkeitsbericht.pdf
  3. Bronder, E., Stammschulte, T. (2013). Nebenwirkungen von Arzneimitteln: Meldung an die Arzneimittelkommission der deutschen Ärzteschaft, Erfassung in einer Datenbank und Bewertung. Ärzteblatt Thüringen, Ausgabe 12/2013: 670-672.Google Scholar
  4. Caron, J., Gautier, S., Mallaret, M. (2014). Spontaneous Reporting: France. Andrews, E., Moore, N. (eds) (2014). Mann’s Pharmacovigilance. Wiley-Blackwell.Google Scholar
  5. Casassus, B. (2016). Drug Scandals in France: Have the Lessons Been Learnt? The Lancet 2016/388: 550-552.Google Scholar
  6. Duarte, M., Ferreira, P., Soares, M., Cavaco, A., Martins, A. P. (2015). Community Pharmacists’ Attitudes towards Adverse Drug Reaction Reporting and their Knowledge of the New Pharmacovigilance Legislation in the Southern Region of Portugal: A Mixed Methods Study. Drugs and Therapy Perspectives 31 (9): 316-322.Google Scholar
  7. EMA (2013). Medication Errors Workshop – Workshop Report. EMA/144458/2013 Patient Health Protection 06.05.2013.Google Scholar
  8. Fimea (2010). Guideline 2/2010 – Reporting of Adverse Drug Reactions. Last accessed on 22.05.2016: https://www.fimea.fi/documents/542809/844142/17296_Ohje_2_2010_Haittavaikutusten_ilmoittaminen_EN.pdf.
  9. Fimea Administrative Guidelines 2/2013 (2013). Reporting of Adverse Drug Reactions, 3428/03.01.01/2012. Last accessed on 22.05.2016: https://www.fimea.fi/…/23514_Ohje_2_2013_EN.pdf
  10. Finnish Communicable Diseases Act (583/1986). Last accessed on 22.05.2016: www.finlex.fi/fi/laki/kaannokset/1986/en19860583.pdf
  11. Foy, M. (2015). eHealth – The Road towards More Efficient and Integrated Care Solutions for Patients. Presentation for MHRA.Google Scholar
  12. Hagemann, U., Paeschke, N. (2014). How Pharmacovigilance Is Organised in Germany. In: Andrews, E., Moore, N. (eds) (2014). Mann’s Pharmacovigilance. Wiley-Blackwell Oxford.Google Scholar
  13. Inácio, P., Airaksinen, M., Cavaco, A. (2015). Language Does Not Come “in Boxes”: Assessing Discrepancies between Adverse Drug Reactions Spontaneous Reporting and MedDRA® Codes in European Portuguese. Research in Social and Administrative Pharmacy 11: 664-674.Google Scholar
  14. INFARMED (2011). Boletim de Farmacovigilânica. Boletim de Farmacovigilância 15 (2).Google Scholar
  15. INFARMED (2016). Boletim de Farmacovigilânica. Boletim de Farmacovigilância 20 (2).Google Scholar
  16. Marques, J. I. O., Polonia, J. M. J., Figueiras, A. G., Santos, C. M., Herdeiro, M. F. (2016). Nurses’ Attitudes and Spontaneous Adverse Drug Reaction Reporting: A Case-Control Study in Portugal. Journal of Nursing Management 24: 409-416.Google Scholar
  17. Matos, C., Van Hunsel, F., Joaquim, J. (2015). Are Consumers Ready to Take Part in the Pharmacovigilance System? A Portuguese Preliminary Study Concerning ADR Reporting. European Journal of Clinical Pharmacology 71: 883-890.Google Scholar
  18. Mendes, D., Alves, C., Batel-Marques, F. (2014). Safety Profiles of Adalimumab, Etanercept and Infliximab: A Pharmacovigilance Study Using a Measure of Disproportionality in a Database of Spontaneously Reported Adverse Events. Journal of Clinical Pharmacy and Therapeutics 39: 307-313.Google Scholar
  19. Mullard, A. (2011). Mediator Scandal Rocks French Medical Community. The Lancet 2011/377: 890-892.Google Scholar
  20. Ribeiro-Vaz, I., Santos, C., Cruz-Correira, R. (2016). Promoting Adverse Drug Reaction Reporting: Comparison of Different Approaches. Revista Saúde Pública 50 (14): 1-9.Google Scholar
  21. Santos, A. (n.d.). Direct Patient Reporting in the European Union: A Snapshot of Reporting Systems in Seven Member States. Health Action International. Last accessed on 02.12.2016: http://haiweb.org/publication/direct-patient-reporting-in-the-eu-a-snapshot-of-reporting-systems-in-seven-member-states/
  22. THL (2016). National Institute for Health and Welfare – Vaccinations. Last accessed on 04.10.2016: https://www.thl.fi/fi/web/thlfi-en/statistics/information-on-statistics/quality-descriptions/vaccinations
  23. URPL (2015). Jak zgłaszać działania niepożądane (How to Report Side Effects). On Youtube posted by URPLWMiPB on 10.02.2015. Last accessed on 25.09.2016: https://www.youtube.com/watch?v=mE_EbeE7ado&feature=youtu.be
  24. URPL (2014). Zgłaszanie działań niepożądanych (Reporting Adverse Events). On Youtube posted by URPLWMiPB on 14.02.2014. Last accessed on 25.09.2016: https://www.youtube.com/watch?v=g2H8BOq0UOc
  25. Yellow Card Centre Wales (n.d.). Annual Report Year 2013-2014. Last accessed 13.09.2016: http://www.yellowcardwales.org/pdfs/YCCW%20Annual%20Report%202013-14-%20Final.pdf

Copyright information

© The Author(s) 2017

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Authors and Affiliations

  • Michael Kaeding
    • 1
  • Julia Schmälter
    • 1
  • Christoph Klika
    • 1
  1. 1.Institut für PolitikwissenschaftUniversität Duisburg-Essen Institut für PolitikwissenschaftDuisburgGermany

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