European Medicines Agency Urges Action on Medication Errors
To tackle medication errors throughout the European Union, stakeholders in healthcare are being called upon to work together to improve reporting and prevention strategies. Collaboration is needed among national patient safety authorities, national competent authorities, the European Medicines Agency (EMA), the European Commission, patients, and healthcare professionals, concluded participants of a workshop on medication errors organised by EMA from 28 February 2013 – 1 March 2013.
The EU pharmacovigilance legislation provides a clear legal framework for sharing data on medication errors causing harm, EMA reported in a statement. Since July 2012, the legislation has required reporting of all suspected adverse drug reactions resulting from medication errors to EudraVigilance, the EU database of adverse drug reactions, EMA stated.
"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," EMA stated.
Through its Pharmacovigilance Risk Assessment Committee (PRAC), EMA plans to issue a best practice document and operational proposals for the reporting and prevention of medication errors in 2013.
Medication errors include those made during prescribing, supplying, dispensing, preparing, administering, or monitoring medicinal products in clinical practice. EMA stated that "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 0.3–9.1% and 1.6–2.1% respectively."