European Union regulatory workshop on medication errors
Presentations given at the workshop held at the European Medicines Agency are now available
- Date : 18 Mar 2013
- Topic : Anticancer agents & Biologic therapy
The European Union (EU) Regulatory workshop on Medication Errors was organised by the European Union regulatory network with an aim to raise awareness of this important public-health issue, discussing the new legal requirements for reporting medication errors and developing best practice among stakeholders. The presentations given at this EU regulatory workshop held at the European Medicines Agency (EMA) on 28 February–1 March 2013 are now available on the EMA website and can be found here.
The recording of the workshop will be available before the end of this month and the link will be published on EMA website.
This two-day workshop was organised by the EMA. Medication errors with medicinal products are a major public-health burden and generally refer to mistakes in the processes of prescribing, dispensing, administering or monitoring medicinal products in clinical practice.
In Europe, the medication-error rate in ambulatory 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.
At national level, various systems are in place to allow for medication-error detection, reporting and prevention, and the collaboration between organisations such as patient-safety institutions, pharmacovigilance centres and poison-control centres in one Member State can inform other Member States and inform work at EU level.
Since July 2012, the EU pharmacovigilance legislation explicitly foresees reporting of suspected adverse reactions associated with medication errors and liaison with national patient-safety organisations to improve public health [Directive 2001/83/EC Articles 1(11), 101(1) and 107a(5)]. The aim of this workshop was to facilitate the implementation of these new legal provisions at EU level.
Medication errors are the most common single preventable cause of adverse events in medication practice. Acknowledging medication errors as a major public-health burden, the new pharmacovigilance legislation explicitly foresees reporting of suspected adverse reactions associated with medication errors.
This workshop was an excellent opportunity to bring together the available expertise with stakeholders from all areas of healthcare, including regulatory and public bodies, national patient-safety organisations, healthcare-professional and patient-consumer organisations, academia, learned societies and the pharmaceutical industry.
The workshop's objective was to develop and share best practices for the prevention of medication errors through raised awareness among the stakeholders involved in the reporting, evaluation and prevention of medication errors, and through greater clarity on what constitutes a medication error. A better understanding of how medication errors are managed at national level will enable the EU regulatory network to improve stakeholder cooperation at national and international level. A focused dialogue between regulators and stakeholders is crucial to set the scene for safer medication practice with a reduced public-health burden from medication errors.
The session topics covered medication errors in the product lifecycle and special populations, reporting, analysis of medication errors resulting in harm, regulatory tools for managing the risk of medication errors, implementation of preventive measures, and the way forward.
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