Medication errors are unintentional errors in the prescribing, dispensing, administration or monitoring of a medicine while under the control of a healthcare professional, patient or consumer. They are the most common single preventable cause of adverse events in medication practice.
Since July 2012, the new European Union (EU) pharmacovigilance legislation has required all adverse drug reactions resulting from medication errors at the European Union (EU) level to be reported EudraVigilance, the EU database of adverse drug reactions.
Responsibilities of the Agency and role of the PRAC
The European Medicines Agency is responsible for facilitating the reporting of adverse drug reactions due to medication errors to EudraVigilance. This database is designed to receive, process, store and make available information submitted electronically and support its analysis.
The Agency also has a role in facilitating coordination between medicines regulatory authorities in Member States, national pharmacovigilance centres and national patient-safety authorities. This is intended to enable the mutual exchange of information on adverse reactions resulting from medication errors and effective reporting to EudraVigilance.
The Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) provides recommendations for regulatory action on safety issues arising due to errors associated with the use of medicines authorised in the EU. This includes all aspects of risk management and monitoring the effectiveness of specific measures to prevent or minimise the risk of medication errors, as contained in the risk-management plan (RMP) for a medicine. Accordingly, each periodic safety update report (PSUR) assessed by the PRAC contains data on any medication errors that occurred with a medicine during the reporting period; this information feeds into the continuous evaluation of the benefits and risks of each medicinal product.
In addition, the potential for medication errors associated with the name of a medicine is routinely assessed by the EMA’s Name Review Group, whose mandate includes the assessment of medicinal product names from a safety and public health point of view prior to marketing authorisation.
The new EU pharmacovigilance legislation has introduced a number of changes related to medication errors:
- The definition of the term ‘adverse reaction’ now covers noxious and unintended effects resulting not only from the authorised use of a medicinal product at normal doses, but also from medication errors and uses outside the terms of the marketing authorisation, including the misuse and abuse of the medicine. This is described in the guideline on good pharmacovigilance practices.
- EU Member States should operate a pharmacovigilance system to collect information that is useful for the monitoring of medicines. This includes information on suspected adverse reactions arising from use of a medicine within the terms of the marketing authorisation as well as from use outside these terms: this includes overdose, misuse, abuse and medication errors, as well as suspected adverse reactions associated with occupational exposure.
- Member States should ensure that reports of suspected adverse reactions arising from an error associated with the use of a medicine that are brought to their attention are made available to the EudraVigilance database and to any authorities, bodies, organisations or institutions responsible for patient safety within that Member State. Patients and healthcare professionals will be able to report these suspected adverse reactions directly via standard web-based forms.
The Agency organised a workshop on medication errors in February 2013 to raise awareness of the new legal provisions amongst the stakeholders involved in the reporting, evaluation and prevention of medication errors.
Discussions took place to:
- clarify what constitutes a medication error and the new legal requirements for reporting cases at EU level;
- get a better understanding of how medication errors are managed at national level;
- share best practice for the prevention of medication errors;
- make proposals to streamline efforts and resources between national competent authorities, pharmacovigilance centres and patient-safety organisations and improve cooperation at national and international level.
The workshop resulted in six key recommendations. 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 Agency 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.
The full outcomes of the workshop are available in the report:
Heads of Medicines Agencies (HMA) agreed on 28 November 2013 to the following deliverables being developed through existing development fora:
Guidance from the Agency
Module VI of the GVP guideline describes the structures and processes for medication-error reporting:
The Agency’s Committee for Medicinal Products for Human Use (CHMP) published a position paper in June 2013 on the potential for medication errors in the context of benefit-risk balance and risk-minimisation measures. The paper focuses on medication errors caused by confusion of a newly introduced medicinal product with an existing one:
- Position paper on potential medication errors in the context of benefit-risk balance and risk-minimisation measures
Resources from other organisations
In 2012, the European Directorate for the Quality of Medicines and Healthcare (EDQM) published a report summarising the evidence for:
- inappropriate and unsafe use of medicines;
- non-adherence to good prescribing practices;
- non-compliance with therapeutic plans;
- lack of documentation and monitoring of therapeutic plans;
- preventable adverse drug reactions arising from this use
The report recommends a basic set of pharmaceutical care indicators and proposes their further development and implementation at an international level:
- Pharmaceutical care: Policies and practices for a safer, more responsible and cost-effective health system
Source: World Alliance for Patient Safety, 2010
- 2010 pharmacovigilance legislation
- Good pharmacovigilance practices
- Monitoring Medicines
- Creation of a better medication safety culture in Europe: Building up safe medication practices
- Medication errors - Follow-up actions from workshop: Implementation plan 2014-2015 (16/04/2014)
- Guideline on good pharmacovigilance practices: Module VI – Management and reporting of adverse reactions to medicinal products (25/06/2012)
- Position paper on potential medication errors in the context of benefit-risk balance and risk minimisation measures (01/06/2012)