Medication errors are unintended mistakes in in the prescribing, dispensing and administration of a medicine that could cause harm to a patient. They are the most common preventable cause of undesired adverse events in medication practice and present a major public health burden.
The European Union (EU) pharmacovigilance legislation requires all adverse reactions resulting from medication errors at the EU level to be reported to EudraVigilance, the EU data processing network to collate and share pharmacovigilance information electronically.
The EU pharmacovigilance legislation has introduced a number of changes related to medication errors which affect the operation of pharmacovigilance systems in EU Member States:
- 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.
Responsibilities of EU Member States and role of the Pharmacovigilance Risk Assessment Committee (PRAC)
As part of their pharmacovigilance obligations marketing-authorisation holders and medicines regulatory authorities in EU Member States are responsible for the reporting of adverse reactions due to medication errors to EudraVigilance, the EU database for adverse reactions.
In this context, the Agency’s role is to facilitate the coordination between medicines regulatory authorities, national pharmacovigilance centres and national patient safety organisations in EU Member States. This is intended to enable the mutual exchange of information on adverse reactions resulting from medication errors and effective reporting to EudraVigilance.
The 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 regardless of whether it is associated with adverse reaction(s). 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 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, which resulted in six key recommendations:
- 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 for research into safe medication practices.
The full outcomes of the workshop are available in the report:
Action plan deliverables
In 2013 Heads of Medicines Agencies (HMA) had agreed on an action plan, and as part of which, the key deliverable of developing good practice guidance. This guidance has been jointly developed by the EU regulatory network and its governance structure for the implementation of the pharmacovigilance legislation, taking into account the recommendations of the 2013 workshop. The following draft good practice guidance are now launched for public consultation until 14 June 2015:
The good practice guide clarifies specific aspects related to recording, coding, reporting and the assessment of medication errors in the context of EU pharmacovigilance activities with the objective of improving reporting and learning from medication errors for the benefit of public health.
The good practice guide clarifies key principles of risk management planning in relation to medication errors and describes the main sources and categories of medication errors and how the risk of such errors can be minimised throughout the product life cycle.
- Risk minimisation strategy for high strength and fixed combination insulin products,addendum to the good practice guide on risk minimisation and prevention of medication errors
The guidance provides a strategy to minimise the potential risk of medication errors associated with the introduction of high strength insulins (i.e. higher than the EU-wide standard of 100 units/ml concentration) and fixed combinations of insulin with another non-insulin injectable blood glucose lowering agent.
Complementary guidance from the Agency
The following Good Pharmacovigilance Practices (GVP) Modules describe structures and processes relevant to medication errors:
- GVP Module V (rev. 1) on risk management
- GVP Module VI (rev. 1) on the management and reporting of adverse reactions to medicinal products
- GVP Module VII (rev. 1) on periodic safety update report
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 such use.
The report recommends a basic set of pharmaceutical care indicators and proposes their further development and implementation at international level:
- 2010 pharmacovigilance legislation
- Good pharmacovigilance practices
- Monitoring Medicines
- Creation of a better medication safety culture in Europe: Building up safe medication practices