Drug Safety

, Volume 39, Issue 6, pp 491–500

Medication Errors: New EU Good Practice Guide on Risk Minimisation and Error Prevention

  • Thomas Goedecke
  • Kathryn Ord
  • Victoria Newbould
  • Sabine Brosch
  • Peter Arlett
Leading Article

Abstract

A medication error is an unintended failure in the drug treatment process that leads to, or has the potential to lead to, harm to the patient. Reducing the risk of medication errors is a shared responsibility between patients, healthcare professionals, regulators and the pharmaceutical industry at all levels of healthcare delivery. In 2015, the EU regulatory network released a two-part good practice guide on medication errors to support both the pharmaceutical industry and regulators in the implementation of the changes introduced with the EU pharmacovigilance legislation. These changes included a modification of the ‘adverse reaction’ definition to include events associated with medication errors, and the requirement for national competent authorities responsible for pharmacovigilance in EU Member States to collaborate and exchange information on medication errors resulting in harm with national patient safety organisations. To facilitate reporting and learning from medication errors, a clear distinction has been made in the guidance between medication errors resulting in adverse reactions, medication errors without harm, intercepted medication errors and potential errors. This distinction is supported by an enhanced MedDRA® terminology that allows for coding all stages of the medication use process where the error occurred in addition to any clinical consequences. To better understand the causes and contributing factors, individual case safety reports involving an error should be followed-up with the primary reporter to gather information relevant for the conduct of root cause analysis where this may be appropriate. Such reports should also be summarised in periodic safety update reports and addressed in risk management plans. Any risk minimisation and prevention strategy for medication errors should consider all stages of a medicinal product’s life-cycle, particularly the main sources and types of medication errors during product development. This article describes the key concepts of the EU good practice guidance for defining, classifying, coding, reporting, evaluating and preventing medication errors. This guidance should contribute to the safe and effective use of medicines for the benefit of patients and public health.

References

  1. 1.
    World Health Organization. Reporting and learning systems for medication errors: the role of pharmacovigilance centres. 2014. Available from: http://www.who.int/medicines/areas/quality_safety/safety_efficacy/emp_mes/en. Accessed 27 Nov 2015.
  2. 2.
    Howard R, Avery A, Slavenburg S, Royal S, Pipe G, Lucassen P, Pirmohamed M. Which drugs cause preventable admissions to hospital? A systematic review. Br J Clin Pharmacol. 2007;63(2):136–47.CrossRefPubMedPubMedCentralGoogle Scholar
  3. 3.
    Dean B, Schachter M, Vincent C, Barber N. Prescribing errors in hospital inpatients: their incidence and clinical significance. Qual Saf Health Care. 2002;11(4):340–4.CrossRefPubMedPubMedCentralGoogle Scholar
  4. 4.
    Shah S, Aslam M, Avery A. A survey of prescription errors in general practice. Pharm J. 2001;267:860–2.Google Scholar
  5. 5.
    Recio Blázquez M, López Ruiz M, Arias Fernández L, Zamora Barrios M. Analysis of medication errors detected in the dispensing process by the unit dose system in a Spanish hospital. Eur J Hosp Pharm. 2004;1:20–5.Google Scholar
  6. 6.
    Beso A, Franklin B, Barber N. The frequency and potential causes of dispending errors in a hospital pharmacy. Pharm World Sci. 2005;27(3):182–90.CrossRefPubMedGoogle Scholar
  7. 7.
    Chua S, Wong I, Edmondson H, Allen C, Chow J, Peacham J, et al. A feasibility study for recording of dispensing errors and near misses in four UK primary care pharmacies. Drug Saf. 2003;26(11):803–13.CrossRefPubMedGoogle Scholar
  8. 8.
    Union European. 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. 2010;53(L348):74–99.Google Scholar
  9. 9.
    Union European. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. OJ. 2001;44(L311):67–128.Google Scholar
  10. 10.
    European Medicines Agency. Medication-errors workshop report (EMA/144458/2013). 2013. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Report/2013/05/WC500143163.pdf. Accessed 27 Nov 2015.
  11. 11.
    European Medicines Agency. Medication errors—follow-up actions from workshop (EMA/20791/2014). 2014. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014/04/WC500165496.pdf. Accessed 27 Nov 2015.
  12. 12.
    European Commission. Patient Safety Policy: EU Patient Safety and Quality of Care Expert Group. 2016. Available from: http://ec.europa.eu/health/patient_safety/policy/index_en.htm. Accessed 27 Jan 2016.
  13. 13.
    Reporting and learning subgroup of the European Commission Patient Safety Quality of Care Working Group. Key findings and recommendations on reporting and learning systems for patient safety incidents across Europe. 2014. Available from: http://ec.europa.eu/health/patient_safety/docs/guidelines_psqcwg_reporting_learningsystems_en.pdf. Accessed 27 Nov 2015.
  14. 14.
    Pharmacovigilance Risk Assessment Committee. Good practice guide on recording, coding, reporting and assessment of medication errors (EMA/762563/2014). 2015. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2015/11/WC500196979.pdf. Accessed 27 Nov 2015.
  15. 15.
    Pharmacovigilance Risk Assessment Committee. Good practice guide on risk minimisation and prevention of medication errors (EMA/606103/2014). 2015. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2015/11/WC500196981.pdf. Accessed 27 Jan 2016.
  16. 16.
    European Medicines Agency. Good pharmacovigilance practices. 2016. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000345.jsp&mid=WC0b01ac058058f32c. Accessed 27 Jan 2016.
  17. 17.
    Cousins D, Gerrett D, Richards N, Jadeja M. Initiatives to identify and mitigate medication errors in England. Drug Saf. 2015;38(4):349–57.CrossRefPubMedGoogle Scholar
  18. 18.
    International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Medical Dictionary for Regulatory Activities (MedDRA). 2016. Available from: http://www.meddra.org. Accessed 27 Jan 2016.
  19. 19.
    Council for International Organisations of Medical Sciences. CIOMS Working Group on Standardised MedDRA Queries (SMQs). 2016. Available from: http://www.cioms.ch/index.php/2012-06-10-08-47-53/working-groups/meddra-smqs. Accessed 27 Jan 2016.
  20. 20.
    US Food and Drug Administration Center for Drug Evaluation and Research (CDER). Safety considerations for product design to minimize medication errors. 2012. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM331810.pdf. Accessed 27 Jan 2016.
  21. 21.
    US Food and Drug Administration Center for Drug Evaluation and Research (CDER). Safety considerations for container labels and carton labeling design to minimize medication errors. 2012. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM349009.pdf. Accessed 27 Jan 2016.
  22. 22.
    Pirmohamed M, James S, Meakin S, Green C, Scott A, Walley T, et al. Adverse drug reactions as cause of admissions to hospital: prospective analysis of 18,820 patients. BMJ. 2004;329(7456):15–9.CrossRefPubMedPubMedCentralGoogle Scholar
  23. 23.
    Manias E, Kinney S, Cranswick N, Williams A. Medication errors in hospitalised children. J Paediatr Child Health. 2014;50(1):71–7.CrossRefPubMedGoogle Scholar
  24. 24.
    Bolt R, Yates J, Mahon J, Bakri I. Evidence of frequent dosing errors in paediatrics and intervention to reduce such prescribing errors. J Clin Pharm Ther. 2014;39(1):78–83.CrossRefPubMedGoogle Scholar
  25. 25.
    Padden Elliot J, McConaha J, Bunk E, Hilton L, Modany A, Bucker I. Influence of viscosity and consumer use on accuracy of oral medication dosing devices. J Pharm Tech. 2014;30(4):111–7.Google Scholar
  26. 26.
    Pharmacovigilance Risk Assessment Committee. Risk minimisation strategy for high-strength and fixed-combination insulin products. Addendum to the good practice guide on risk minimisation and prevention of medication errors (EMA/686009/2014). 2015. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2015/11/WC500196980.pdf. Accessed 18 Dec 2015.
  27. 27.
    Committee for Medicinal Products for Human Use. Guideline on the acceptability of names for human medicinal products processed through the centralised procedure (EMA/CHMP/287710/2014 - Rev. 6). 2014. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2014/06/WC500167844.pdf. Accessed 27 Nov 2015.
  28. 28.
    Committee for Human Medicinal Products. Mandate, objectives and rules of procedure for the Name Review Group (NRG) (EMA/411943/2014). 2014. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014/07/WC500169642.pdf. Accessed 27 Nov 2015.
  29. 29.
    European Medicines Agency. Recommendations on medication errors. 2016. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000398.jsp&mid=WC0b01ac058098f1c0. Accessed 27 Jan 2016.
  30. 30.
    Medicines and Healthcare products Regulatory Agency. The strengthening collaboration for operating pharmacovigilance in Europe (SCOPE) joint action. 2016. Available from: http://www.scopejointaction.eu. Accessed 27 Nov 2015.
  31. 31.
    NHS England. Patient Safety Alert (NHS/PSA/D/2014/005): Improving medication error incident reporting and learning. 2014. Available from: http://www.england.nhs.uk/wp-content/uploads/2014/03/psa-med-error.pdf. Accessed 28 Jan 2016.

Copyright information

© European Union 2016

Authors and Affiliations

  • Thomas Goedecke
    • 1
  • Kathryn Ord
    • 2
  • Victoria Newbould
    • 1
  • Sabine Brosch
    • 1
  • Peter Arlett
    • 1
  1. 1.Pharmacovigilance Department, Inspections and Human Medicines Pharmacovigilance DivisionEuropean Medicines Agency (EMA)LondonUK
  2. 2.Benefit Risk Management Group, Vigilance and Risk Management of MedicinesMedicines and Healthcare products Regulatory Agency (MHRA)LondonUK

Personalised recommendations