Tackling medication errors: European Medicines Agency workshop calls for coordinated EU approach

Press release 01/03/2013

Proposals to improve reporting and prevention of medication errors are made

A close collaboration between national patient safety authorities, national competent authorities, the European Medicines Agency, and the European Commission is necessary to tackle the issue of medication errors causing harm in Europe. This collaboration should engage patients and healthcare professionals. This was the conclusion of the workshop on medication errors organised by the Agency from 28 February to 1 March 2013.

This unique event at European Union (EU) level brought more than 150 people from all stakeholder groups together to determine a way forward for better reporting and prevention of medication errors.

The EU pharmacovigilance legislation provides a clear legal framework for sharing data on medication errors causing harm. Since July 2012, it has required reporting of all suspected adverse drug reactions resulting from medication errors to EudraVigilance, the EU database of adverse drug reactions.

Sharing and pooling of data on suspected adverse drug reactions at EU level has been demonstrated to result in earlier identification of emerging safety issues, and this can be leveraged to allow medication errors to be prevented through earlier detection of risks.

Based on the workshop's concrete suggestions for the development of harmonised practices across the EU and sharing of information, the Agency, through its Pharmacovigilance Risk Assessment Committee (PRAC), will issue a best-practice document and operational proposals for the reporting and prevention of medication errors in 2013.

About medication errors

Medication errors are the single most common preventable cause of adverse events in medication practice and a major public-health burden with an estimated annual cost between €4.5 billion and €21.8 billion (World Alliance for Patient Safety 2010). Medication errors refer to mistakes in the processes of prescribing, supplying, dispensing, preparing, administering or monitoring medicines in clinical practice.

In Europe, the medication-error rate in primary care is estimated at 7.5% at prescription and 0.08% at the dispensing stage, whereas in the hospital setting the rates vary between 0.3 and 9.1% and between 1.6 and 2.1% respectively.

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