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EU Initiative to Tackle Medication Errors – Proposals and Challenges

Published online by Cambridge University Press:  20 January 2017

Els Janssens
Els Janssens*
Affiliation:
European Medicines Agency
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Type
Reports
Information
European Journal of Risk Regulation , Volume 4 , Issue 3 , September 2013 , pp. 388 - 391
Copyright
Copyright © Cambridge University Press 2013

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References

1 EMA press release of 1 march 2013 (EMA/130601/2013).

2 EMA medication errors workshop report -<http://www.ema.europa.eu/docs/en_GB/document_library/Report/2013/05/WC500143163.pdf>.

3 Lisby, M., Nielsen, L.P., Brock, B. and Mainz, J., “How are medication errors defined? A systematic literature review of definitions and characteristics”, 22(6) International Journal for quality in healthcare (2010), pp. 507–518 CrossRefGoogle ScholarPubMed (Advance Access Publication: 17 October 2010), as quoted by Jeffrey Aronson and Robin Ferner in their presentation “Do we have a common understanding of medication errors?” during EMA workshop on medication errors on 28 February 2013.

4 Ferner, R. and Aronson, J., “Clarification of terminology in medication errors – Definitions and classification”, 29(11) Drug Safety (2006), 1011–1022 CrossRefGoogle ScholarPubMed.

5 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 (Official Journal L 348, 31/12/2010, p. 74-99).

6 Position paper on potential medication errors in the context of benefit risk balance and risk minimisation measures, 30 May 2013 (EMA/277591/2013).

7 Council Recommendation of 9 June 2009 on patient safety, including the prevention and control of healthcare associated infections (2009/C 151/01).

8 Report from the Commission to the Council on the basis of Member States’ reports on the implementation of the Council Recommendation (2009/C 151/01) on patient safety, including the prevention and control of healthcare associated infections (COM(2012) 658 final)

9 Directive 2001/83/EC and Regulation (EC) No 726/2004

10 Report from the Commission to the Council on the basis of Member States’ reports on the implementation of the Council Recommendation (2009/C 151/01) on patient safety, including the prevention and control of healthcare associated infections (COM(2012) 658 final)

11 Wachter, R and Pronovost, P., “Balancing “No Blame” with accountability in patient safety”, 361(14) The New England Journal of Medicine (2009), pp. 1401–1406 CrossRefGoogle ScholarPubMed