Pilot Study Assessing the Safety and Ease of Use of a Closed System to Administer Single Agent Infusional Chemotherapy Within an Oncology Day Unit

• This study assessed the impact of introducing a needle free closed system for the administration of two single chemotherapy infusion regimens (oxaliplatin and irinotecan).
• The results of the evaluation questionnaires, completed by nurses administering chemotherapy, showed that the needle free system was positively received,nurses stated that they would like to use the product in their clinical practice in future.
• A meeting of stakeholders will now be arranged to consider whether the type of needle free closed system piloted should be adopted for routine use within our Trust.
• If adopted, commercial suppliers will be contacted to investigate the potential for outsourcing of infusions which are compatible with a needle free,no spike administration system.

Introduction
It is widely accepted that hazardous drugs present an occupational risk to all staff involved in their handling and that there is a pressing need to reduce the risk of exposure for nurses in clinical areas (1) In the light of this, the first edition of a Yellow Cover Document, “Guidance on Handling of Injectable Cytotoxic Drugs in Clinical Areas in NHS Hospitals in the UK “,was recently published (July 2018).
A closed system corresponding to the one recommended in this document was developed by pharmacy and nursing staff at our trust in collaboration with Spirit Medical. The system piloted was compared to the standard system (nurses must routinely spike chemotherapy infusion bags , adding a closed system device to the giving port which enables connection of the infusion bag to a closed system giving set). The piloted system removed the requirement for nurses to spike infusion bags containing Hazardous drugs.

Methods
All staff received training in advance of the introduction of the new system.Laminated posters featuring information about the pilot study were displayed in pharmacy and the ward area during the study period.
Single agent Oxaliplatin and single agent Irinotecan infusions, usually outsourced, were prepared in house using bags fitted with a needle free addition port. Infusion ports were capped following the addition of the drug ,with a sterile removable luer lock cap, then sealed with a tamper evident seal before dispatch to the day unit.
Nursing staff connected the needle free port of the infusion to the closed system giving set using luer to luer tubing which had been primed using a needle free flush bag.The closed system set featured two administration ports ,one for chemotherapy and one for an anti-emetic infusion if required. After one hundred infusions were administered using the new system ,nurses were asked to complete a questionnaire evaluating the new closed system.

Results
Ease of Use:Nurses were asked about ease of use, quality of connections, ease of swabbing needle free hubs and ease of priming. The majority of nurses responded that the system met or exceeded their expectation, nobody disliked the system.
Safety :No chemotherapy leaks were experienced during use.
In comparison with spiking, the majority of nurses reported feeling the safety of the system to be much better than spiking.
All nurses who used the system regularly said they would like to use it in their practice.

Conclusion
The closed system piloted in this trust was generally well recieved by nurses .Nurses felt that it offered them a safety advantage and indicated when asked that they would like to use it in their routine practice.The results of this pilot study will help to inform a future review meeting of stakeholders who will be making a final decision on the introduction of this system in our trust. If adopted the potential to obtain commercial supplies of compatible infusions will be investigated.

References
1. Perceived adverse effects from handling systemic anti-cancer therapy agents; Alison Simons, Samantha Toland; British Journal of Nursing, 2017, (Oncology Supplement) Vol 26, No 16
2. Guidance on Handling of Injectable Cytotoxic Drugs in Clinical Areas inNHS Hospitals in the UK Edition 1

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