This incident was originally reported to NHSE. Further details have subsequently been provided by the trust.

Following delivery, five units of oxytocin were administered intravenously (IV), during an emergency Caesarean section. The uterus remained poorly contracted and there was excessive bleeding. In response the obstetrician requested  a further 5 units of IV oxytocin and tranexamic acid in line with guidance for managing post-partum haemorrhage.

The anaesthetist slowly injected the solution from a 5ml ampoule [thought to be TXA] IV. Approximately 2 minutes later the patient became restless, her breathing became shallow, and she became unresponsive. The patient required intubation and ventilation.

Following the completion of the surgery and after a head CT scan the patient was transferred to ICU. She was extubated later that day and transferred back to the maternity ward. Review of the case suggested that an ampoule of rocuronium had probably been replaced in the box of tranexamic acid in the drug cupboard following a previous theatre case.

The Operating Department staff informed members of the investigation team that prior to this, it was common practice that when tidying up after procedures, unused ampoules of medication were put away back in their boxes or on their own in the drug cupboard or fridge. The rationale behind this was to reduce medicines wastage and costs.

Commentary

This case highlights the dangers involved in ‘tidying ampoules away’ by replacing them into their boxes. the Association of Anaesthetist’s guidelines on handling injectable medications in anaesthesia states clearly ‘do not replace single ‘stray’ ampoules into boxes if discovered; they should be thrown away’.¹

SALG recognises that both rocuronium and tranexamic acid (TXA) are commonly used during emergencies and that time-critical situations can make errors such as this one more likely. This is one of the reasons why SALG is working to ensure priority is given  to the production, licensing and procurement of such ‘emergency’ drugs, in clearly labelled pre-filled syringes. 

Rocuronium has in fact recently become available in pre-filled syringe format, in a colourway that conforms to the ISO 26825: 2008 user applied labels colourway for muscle relaxants (see below). SALG encourages hospitals, in line with the Royal Pharmaceutical Society’s  guidance on the safe and secure handling of medicines² and the Association’s guidelines already mentioned above, to ensure where possible, that rocuronium is  available in a ready-to-administer preparation in a storage arrangement that allows for immediate access in the event of a clinical emergency. The pre-filled syringe has a 3-year shelf life when refrigerated, and 12 weeks stability once removed from the fridge.

1. Kinsella, SM. et al. Handling Injectable Medications in Anaesthesia. Association of Anaesthetists. June, 2023
2. Royal Pharmaceutical Society. Professional guidance on the safe and secure handling of medicines. January, 2024