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P16 Audit on outsourcing investigational medicinal product (IMP) production
  1. Gethin Jenkins
  1. Birmingham Women’s and Children’s NHS Foundation Trust


Aim In autumn 2020 there was a National report for the Department of Health and Social Care by Lord Carter of Coles on ‘Transforming NHS Pharmacy Aseptic Services in England’. His report highly emphasized the importance of moving towards standardisation of aseptic units across England to create high quality, effective and efficient services as part of the National aseptic transformation work.1 Aseptic services provide foundation for much of the National Health Service (NHS) contribution to clinical trials, supporting advances in medicines and contributing to the United Kingdom (UK) economy.1 At this hospital there is no onsite aseptic unit. Therefore, the trust relies on using outsourced products. An audit was carried out to identify the resilience of certain third-party companies used at this hospital, for the outsourcing of IMP production by identifying late deliveries of IMP, which resulted in delayed treatment.

Method Retrospective data was collected ranging from six to twelve months for three different clinical trials, from two different manufacturing units. Manufacturing unit 1 was 63 miles away from the hospital. Whereas manufacturing unit 2, was only 5.9 miles. Data was collected by checking temperature data loggers, as an indicator of what time the IMP arrived at the hospital clinical trials unit (CTU). Any IMP that arrived the CTU after 1300h was defined as ‘delayed treatment’, as this resulted in patient/parent and nursing staff having to stay past their intended finish time for IMP.

Results A total of 33 items were received from manufacturing unit 1, over a one-year period. 71.86% were classed ‘late’, resulting in delayed treatment. A total of 23 items were received from manufacturing unit 2, over a 6-month period. 30% were classed as ‘late’ (majority were due to late prescribing at site), resulting in delayed treatment.

Conclusion Results highlight that logistically, the closer the manufacturing unit the better. This does not necessarily guarantee better resilience. There are several issues with delayed treatment such as patient safety concerns, unnecessary stress for patients and patients/parents staying later than expected. All which could impact negatively on the studies (patient withdrawal). Delayed treatment relies on staff staying late, which is a cost implication to the trust. Scoping potential for an offsite manufacturing unit or increasing use of local aseptic unit as part of National aseptic transformation work, could reduce the impact on delayed treatment and improve both patient safety and experience. As this would rely less on manufacturing units further away from the hospital. This would also align with Lord Carter of Coles recommendations about transforming aseptic services in England.1 Clear set Key Performance Indicator’s (KPI’s) should be agreed with the third-party companies and monitored regularly, allowing us to deliver a high quality, effective and efficient service to our patients. Also ensuring prescribing in a timely manner at the hospital would also improve patient experience.


  1. Coles C. Transforming NHS pharmacy aseptic services in England. A national report for the Department of Health and Social Care by Lord Carter of Coles 2020;1:3–51.

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