On 14 April 2015, the European Medicines Agency (“EMA”) published three draft guidance documents concerning medication errors for consultation.
The new European Union (“EU”) laws and regulations governing pharmacovigilance activities require reports of suspected adverse reactions arising from an error associated with the use of a medicinal product to be reported to EudraVigilance. To support the implementation of the new requirements, the EMA in collaboration with the national competent authorities of the EU Member States was mandated to develop draft guidance documents concerning the reporting of such medication errors.
The draft guidance documents are as follows:
- Good practice guide on recording, coding, reporting and assessment of medication errors;
- Good practice guide on risk minimisation and prevention of medication errors;
- 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.
Good practice guide on recording, coding, reporting and assessment of medication errors
This good practice guide clarifies specific aspects related to recording, coding, reporting and the assessment of medication errors. The guide outlines the obligations imposed on the competent authorities in the EU Member States, marketing authorisation holders and the EMA.
The guide also provides guidance in relation to the assessment of medication errors. This includes recommendations for marketing authorisation holders concerning the recording, coding, reporting and assessment of medication errors brought to their attention and which are not associated with adverse reactions.
Good practice guide on risk minimisation and prevention of medication errors
This good practice guide clarifies the key principles of risk management planning in relation to medication errors. The guide also describes the main sources and categories of medication errors, including population specific aspects in paediatric and elderly patients. Moreover, the draft document also provides guidance in relation to the minimisation of the risk of such errors 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 purpose of this guidance document is to minimise the potential risk of medication errors associated with the introduction of high strength insulin and fixed combinations of insulin with another non-insulin injectable blood glucose lowering agent. High strength insulin is considered to be an amount higher than the EU-wide standard of 100 units/ml concentration.
Interested stakeholders can submit their comments on the draft guidance documents to the following address: medicationerrors2013@ema.europa.eu. The consultation ends on 16 June 2015.