Brussels, 28/05/2013 (Agence Europe) - Last week, the European Medicines Agency (EMA) issued six key recommendations to tackle the issue of medication errors causing harm in the European Union. EMA also announced that, in collaboration with the European Commission, it would now be developing an action plan to be published before the end of the year. These recommendations were drawn up during the medication-errors workshop held by EMA from 28 February to 1 March 2013, which sought to raise awareness of this important public-health issue. The recommendations seek to improve notification of medical errors and prevention in this field.
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. The EMA recommendations are as follows: 1) harmonisation and further development of terminologies and definitions of medication errors at EU and international levels; 2) establishment of collaborative relationships between national patient safety authorities, national regulators, the EMA and the European Commission; 3) development of new methods to identify medication errors from a patient-safety and pharmacovigilance perspective through data pooling and analysis; 4) 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; 5) active engagement and capacity building with patient and consumer groups and healthcare professionals to improve safe medication practices; 6) support to research into safe medication practices.
For many years, 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. Since July 2012, EU pharmacovigilance legislation has required reporting of all suspected adverse drug reactions resulting from medication errors to EudraVigilance. (IL/transl.fl)