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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.

Duration

20 pages PDF.

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