Evaluation of automated manufacture of ready-to-administer injections to improve medicines safety in emergency intubation

Abstract

Abstract Introduction Within the clinical setting of emergency anaesthesia the lack of ready to administer preparations poses a high risk to patients. The CIVAS@IP5 Medicines hub were approached by Cardiff and Vale University Health Board in response to a quality improvement project to prepare ready to administer anaesthesia. To manufacture these medicines required the use of semi-automated technology and development of manufacturing techniques to meet the quantity and range of products required including Ketamine, Rocuronium and Fentanyl. These are some of the first products developed for manufacture using a Grifill 4.0 Semi-automated Medicines Pump within the UK. Aim To develop new ready-to-administer products or use in emergency intubation scenarios within critical clinical settings, manufactured using innovative and newly developed processes. The products would be presented with the Royal College of Anaesthetists label colour scheme and have extended shelf lives assigned to allow suitability of use. Methods The project required three separate stages of methodology. First within Cardiff and Vale UHB, a clinical agreement on standardised concentrations of Ketamine, Fentanyl and Rocuronium was required. Secondly, development within CIVAS@IP5 of a Semi-automated compounding process that had been fully process mapped, assessed via HAACP analysis. This process was then validated for microbiological integrity and efficiency using Gage R&R principles to prove repeatability and reproducibility of a quality product. The final stage involved collaborative development of the final presentation and facilitation of its use locally. Ethical approval was not required for this service development initiative and evaluation. Results The new methodology for semi-automated preparation of ready-to-administer injectable medicines gave the following capacity timings for the three agreed concentrations recommended by the Royal College of Anaesthetists. Fentanyl 250mcg in 5mL – 54 seconds per syringe (Batch size 200 syringes). Rocuronium 250mg in 10mL – 2 minutes per syringe (Batch size 50 syringes). Ketamine 100mg in 10mL – 1 minute 32 seconds per syringe (Batch size 40 syringes). These timings are compared to current documented preparations of 5 minutes 42 seconds for syringes made manually in pharmacy technical services settings. This meant Cardiff and Value UHB could be provided with their emergency intubation medication in a ready-to-use format within a pharmacy manufacturing capacity expenditure of 4 hours and 12 minutes per month when compared to the same manual preparation taking 26 hours. A literature search allowed extended shelf lives of up to 100 days to be applied to the products, and the labels designed in collaboration with anaesthetic colleagues in Cardiff and Vale UHB. The clinical impact is that for emergency intubation scenarios clinicians have ready-to-administer medications at the point of care. Discussion/Conclusion Use of semi-automation within Pharmacy Technical Services can greatly increase the production output of medicines allowing products where there is a current unmet demand to be prepared. The impact is an increased service capacity for the provision of well designed, clinically significant products to clinical areas improving efficiency, patient safety and clinical delivery of treatment in emergency situations.