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

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.

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Notes

  1. 1.

    MedDRA®, the Medical Dictionary for Regulatory Activities, is the international medical terminology developed under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The MedDRA® trademark is owned by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) on behalf of ICH.

  2. 2.

    ISO 14971—medical devices—application of risk management http://www.iso.org/iso/iso_catalogue/catalogue_ics/catalogue_detail_ics.htm?csnumber=38193.

  3. 3.

    IEC62366—medical devices—application of usability engineering to medical devices http://www.iso.org/iso/catalogue_detail.htm?csnumber=38594.

  4. 4.

    A safety signal is information on a new or known adverse event that is potentially caused by a medicine and that warrants further investigation. Signals are generated from several sources, such as spontaneous reports, clinical studies and the scientific literature.

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Acknowledgments

The authors thank the members of the PRAC for their active support throughout the development of the EU good practice guide on medication errors and the members of the European Commission’s Patient Safety and Quality of Care Expert Group for their useful contribution to the guidance.

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Correspondence to Thomas Goedecke.

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No sources of funding were used to assist in the preparation of this article.

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Thomas Goedecke, Kathryn Ord, Victoria Newbould, Sabine Brosch and Peter Arlett have no conflicts of interest that are directly relevant to the content of this article.

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The views expressed in this article are the personal views of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the EMA or one of its committees or working parties. Figures 1 and 4 are reproduced with the permission of the EMA.

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Goedecke, T., Ord, K., Newbould, V. et al. Medication Errors: New EU Good Practice Guide on Risk Minimisation and Error Prevention. Drug Saf 39, 491–500 (2016). https://doi.org/10.1007/s40264-016-0410-4

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Keywords

  • Medication Error
  • Medicinal Product
  • Risk Management Planning
  • Root Cause Analysis
  • National Competent Authority