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?
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
The target audience is primarily pharmacovigilance staff working at National Competent Authorities.
20 pages PDF.
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