Drug Safety

, Volume 39, Issue 6, pp 491–500 | Cite as

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


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.


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



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.

Compliance with Ethical Standards


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

Conflict of interest

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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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

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