Duty of Candour Drug Error — FRCA Final MCQ
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Correct answer: B — No reporting is needed if no harm occurred
The duty of candour (GMC, CQC, NHS) requires that all patient safety incidents are reported and disclosed to the patient, including 'near misses' and incidents causing no harm. An unlabelled syringe resulting in wrong drug administration is a patient safety incident that must be: (1) disclosed to the patient openly and honestly, (2) reported via the local incident reporting system (DATIX), (3) reviewed for learning opportunities. The AAGBI (now Association of Anaesthetists) recommends all syringes be labelled according to the international colour-coding standard (ISO 26825). This incident highlights a system failure.
Reference: GMC – 2020 – Duty of candour; CQC – 2023 – Regulation 20; AAGBI – 2019 – Syringe labelling guidelines