EMA Releases Medication Error Guidelines

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The European Medicines Agency releases guidelines for addressing and reporting risks associated with medication errors.


The European Medicines Agency has released two draft guidelines addressing the reporting, assessment, and prevention of medicine errors. The agency defines medicine errors as “unintended mistakes in the prescribing, dispensing and administration of a medicine that could cause harm to a patient.” The EMA guidelines are part of the EMA/Heads of Medicines Agencies joint action plan, developed with the European Commission’s Patient Safety Quality of Care Working Group.

The first guide describes sources of medicine errors and provides suggestions for minimizing the risk of these errors throughout a drug’s lifecycle. The guideline states, “This good practice guide is one of the key deliverables of the agency’s medication error initiative and offers stand-alone guidance on risk minimization and prevention of medication errors, including population specific aspects in pediatric and elderly patients as well as the systematic assessment and prevention of the risk of medication errors throughout the product lifecycle.”


The second guideline describes good practices for recording, coding, reporting, and assessing suspected adverse reactions caused by medication errors, as well as medication errors that have not caused adverse reactions. The guideline requires the information to be provided periodically in safety update reports and risk management plans so the agency can use the data to evaluate the benefits and risks of drugs.

EMA also released a guideline specifically to address the risk of medication errors related to high-strength insulin. The guideline provides a strategy for proactively and harmoniously addressing risks associated with drugs containing insulin across the European Union.