A medication error is an unintended failure in the drug treatment process that leads to, or has the potential to lead to, harm to the patient. Mistakes in the prescribing, dispensing, storing, preparation and administration of a medicine are the most common preventable cause of undesired adverse events in medication practice and present a major public health burden. European Union (EU) legislation requires information on medication errors to be collected and reported through national pharmacovigilance systems. In addition, the European Medicines Agency (EMA) plays a coordinating role and has published a set of good practice guidance.
The EU regulatory network and its governance structure have developed specific guidance to support stakeholders, including the pharmaceutical industry and regulatory authorities in Member States involved in the reporting, evaluation and prevention of medication errors. This guide is complementary to the guideline on GVP and other existing guidelines published by the Agency.
The Heads of Medicines Agencies (HMA) endorsed the final two-part guide in November 2015, taking into account comments from a two-month public consultation.
The first part of the guide clarifies specific aspects related to recording, coding, reporting and 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:
- Good practice guide on recording, coding, reporting and assessment of medication errors
- Overview of comments on draft guide
The second part of the 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:
- Good practice guide on risk minimisation and prevention of medication errors
- Overview of comments on draft guide
The addendum to the guide provides a strategy to minimise the potential risk of medication errors associated with high strength insulin products (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:
- Risk minimisation strategy for high strength and fixed combination insulin products, developed as an addendum to the good practice guide on risk minimisation and prevention of medication errors
- Overview of comments on draft addendum
The guide takes into account the recommendations of a stakeholder workshop on medication errors held in 2013 and is a key deliverable of the resulting action plan agreed by the HMA.
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. These oblige:
- marketing-authorisation holders and national competent authorities to report adverse reactions, including those resulting from medication errors, toEudraVigilance, the EU database for adverse reactions. This obligation is stated in Module VI of the guideline onGood pharmacovigilance practices. The term 'adverse reaction' covers noxious and unintended effects resulting not only from the authorised use of a medicinal product at normal doses, but also from uses outside the terms of the marketing authorisation, including medication errors.
- EU Member States to operate a pharmacovigilance system to collect data for the safety 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, including overdose, misuse, abuse and medication errors, as well as suspected adverse reactions associated with occupational exposure.
- Member States to 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 authorities, bodies, organisations or institutions responsible for patient safety within that Member State. Both patients and healthcare professionals may report suspected adverse reactions to both national competent authorities and marketing-authorisation holders.
EMA's role is to coordinate the EU pharmacovigilance network and to support pharmacovigilance through standards, systems (including EudraVigilance) and services.
EMA's Pharmacovigilance Risk Assessment Committee (PRAC) is responsible for the coordinating the assessment and monitoring of safety issues and all aspects of risk management planning. The PRAC's responsibilities in relation to medication errors include:
- assessing potential medication errors at all stages of a medicine's product life-cycle in risk management plans (RMP), including errors during product development;
- providing recommendations for regulatory action on safety issues arising from errors associated with the use of medicines authorised in the EU;
- monitoring the effectiveness of specific measures to prevent or minimise the risk of medication errors, as described in the RMP;
- including data on any medication errors in the reporting period in each periodic safety update report regardless of whether it is associated with adverse reaction(s). This information feeds into the continuous evaluation of the benefits and risks of a medicine.
In addition, EMA's Name Review Group routinely assesses whether the (invented) name of a medicine as proposed by the manufacturer could create a public-health concern or potential safety risk, including medication errors.
EMA applies a consistent approach to communicating to patients and healthcare professionals on any additional measures recommended by the PRAC to reduce the risk of medication errors with a specific medicine. These communications are accessible via the European public assessment report page of concerned medicines and the following dedicated webpage:
For more information on how EMA streamlines its communication on medication errors, see:
The following 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
- GVP Module XVI (Rev. 1) on risk minimisation measures: selection of tools and effectiveness indicators
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:
- Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action is a project of the European Commission to support operations of pharmacovigilance in Europe following new requirements introduced by the European pharmacovigilance legislation. One of the SCOPE deliverables is best practice in signal management across the EU network, building on work done to improve signal detection from medication errors and misuse/abuse of medicines.
- The World Health Organization has developed guidance for pharmacovigilance centres for medication-error reporting as part of the EU-funded project Monitoring Medicines.