Skip to main Content

Medication Errors

The purpose of this document is to promote the importance of a uniform approach regarding coding of medication errors (MEs) during the assessment of an Individual Case Safety Report (ICSR), to raise awareness about the importance of inter-institutional collaboration and exchange of information regarding MEs. Also, the intention is to start a discussion regarding healthcare professionals (HCPs) liability in the context of ADR reporting of cases of MEs.

This document is not intended to be a duplicate of the European Medicines Agency’s guide regarding MEs, although some recommendations are the same.

What does this document cover?

1. Introduction

2. Medication errors

 - Coding of medication errors

 - Exemption from liability for HCPs when reporting cases of medication errors

 - Collaboration with other institutions which deal with medication errors

3. Conclusions

Target audience

The target audience is primarily pharmacovigilance staff working at National Competent Authorities.


20 pages PDF.

Click here to access this document. 

Our Progress