title: 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.
authors.affiliation: Pharmacovigilance Department, Inspections and Human Medicines Pharmacovigilance Division, European Medicines Agency (EMA), 30 Churchill Place, London, E14 5EU, UK. thomas.goedecke@ema.europa.eu.
authors.forename: Thomas
authors.initials: T
authors.lastname: Goedecke
authors.affiliation: Benefit Risk Management Group, Vigilance and Risk Management of Medicines, Medicines and Healthcare products Regulatory Agency (MHRA), 151 Buckingham Palace Road, London, SW1W 9SZ, UK.
authors.forename: Kathryn
authors.initials: K
authors.lastname: Ord
authors.affiliation: Pharmacovigilance Department, Inspections and Human Medicines Pharmacovigilance Division, European Medicines Agency (EMA), 30 Churchill Place, London, E14 5EU, UK.
authors.forename: Victoria
authors.initials: V
authors.lastname: Newbould
authors.affiliation: Pharmacovigilance Department, Inspections and Human Medicines Pharmacovigilance Division, European Medicines Agency (EMA), 30 Churchill Place, London, E14 5EU, UK.
authors.forename: Sabine
authors.initials: S
authors.lastname: Brosch
authors.affiliation: Pharmacovigilance Department, Inspections and Human Medicines Pharmacovigilance Division, European Medicines Agency (EMA), 30 Churchill Place, London, E14 5EU, UK.
authors.forename: Peter
authors.initials: P
authors.lastname: Arlett
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000331:legislation & jurisprudence*; D064420:Drug-Related Side Effects and Adverse Reactions; D005060:Europe; D006801:Humans; D008508:Medication Errors / Q000331:legislation & jurisprudence / Q000517:prevention & control* / Q000706:statistics & numerical data; D017410:Practice Guidelines as Topic