Potential medication errors in the context of benefit risk balance and risk minimisation measures - Scientific guideline

This document focuses on the impact of potential medication errors on the benefit-risk balance of medicinal products introducing changes in relation to an authorised/established product containing the same active substance.

Keywords: Medication error, similar medicinal products, reference product, product confusion, error prevention

Current effective version

Position paper on potential medication errors in the context of benefit-risk balance and risk-minimisation measures

AdoptedLegal effective date: 01/06/2013Reference Number: EMA/CHMP/277591/2013Summary:

The aim of this position paper is to raise awareness for this issue, provide insight with regards to how the benefit-risk assessment of such products might be impacted and to discuss in general terms how the risk of medication errors could be adequately addressed.

Document history

Overview of comments received on 'position paper on potential medication errors in the context of benefit-risk balance and risk-minimisation measures'

Reference Number: EMA/CHMP/277592/2013

Position paper on potential medication errors in the context of benefit-risk balance and risk minimisation measures

Consultation dates: 01/06/2012 to 30/11/2012Draft: consultation closedReference Number: EMA/274183/2012Summary:

This position paper is intended to provide guidance on how potential medication errors should be addressed in the context of benefit-risk balance assessment and risk minimisation measures. Specifically, the paper focuses on potential medication errors caused by confusion of a newly introduced medicinal product with established medicines that contain the same active substance and are similar in appearance or name but different in some other attributes such as strength, dosing or route of administration.