The European Medicines Agency (EMA) has issued six key recommendations to tackle the issue of medication errors causing harm in the European Union (EU). These recommendations are described in the medication-errors workshop report. This workshop was held by the Agency from 28 February to 1 March 2013 to raise awareness of this important public-health issue. The Agency, in collaboration with the European Commission and the EU regulatory network, will now develop an action plan, which it will publish before the end of the year.
Medication errors are unintended errors in the prescribing, dispensing or administration of a medicine while in the control of a healthcare professional, patient or consumer. They are the single most common preventable cause of adverse events in medication practice. Since July 2012, the EU pharmacovigilance legislation has required reporting of all suspected adverse drug reactions resulting from medication errors to EudraVigilance, the EU database of adverse drug reactions. The European Union regulatory workshop on medication errors, which was attended by 240 participants representing various stakeholder groups, aimed to gather the available expertise in this area and to take stock of current best practice.
Six key recommendations resulted from the discussions. These are to progress:
- the harmonisation and further development of terminologies and definitions of medication errors at EU and international levels;
- the establishment of collaborative relationships between national patient safety authorities, national regulators, the EMA and the European Commission;
- the development of new methods to identify medication errors from a patient-safety and pharmacovigilance perspective through data pooling and analysis;
- the systematic assessment and prevention of the risk of medication errors during the life-cycle of a medicine, including prior to granting marketing authorisation through the EU risk-management planning process;
- active engagement and capacity building with patient and consumer groups and healthcare professionals to improve safe medication practices;
- support to research into safe medication practices.
These proposed actions will now be prioritised by the Agency in collaboration with the European Commission and the EU regulatory network by considering their potential benefit for public health and the resource implications in Member States and at EU level.