Summary
Medication errors present a major public health burden and there is a need to optimise risk minimisation and prevention of medication errors through the existing regulatory framework. The European Medicines Agency (EMA) in collaboration with the EU regulatory network was mandated to develop regulatory guidance for medication errors, taking into account the recommendations of a stakeholder workshop held in London in 2013. This guidance is intended to support the implementation of the new legal provisions regarding the reporting, evaluation and prevention of medication errors and is intended mainly for the pharmaceutical industry and national competent authorities. Healthcare professionals (HCP) are expected to consult national clinical guidance on reducing the risk of medication errors.
Content
This good practice guide is one of the key deliverables of the Agency’s medication error initiative and offers guidance on risk minimisation and prevention of medication errors. The guidance includes population-specific aspects in paediatric and elderly patients, as well as guidance on the systematic assessment and prevention of the risk of medication errors throughout the product life-cycle.
The key recommendations:
- The potential for medication errors should be considered at all stages of the product life-cycle but particularly during product development.
- To minimise the risk of medication errors - careful consideration should be given to the name and pharmaceutical design of a medicinal product (including its type of dosage form, appearance and other formulation characteristics, packaging and labelling) in order to minimise the risk of mix-ups between different products; the product information should inform HCPs, patients and caregivers of the most appropriate use of the product.
- Where medication errors result in adverse outcomes, corrective actions should be taken.
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