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Enhancing Chemotherapy Preparation with Automation: Insights from the SafeChemo Project

This presentation by David Leonard, Executive Lead Pharmacist at Imperial College Healthcare NHS Trust, discusses the integration of automation in chemotherapy preparation at Charing Cross Hospital. Since the early 2000s, the Trust has leveraged systems like CytoCare to improve safety, efficiency, and reduce operational costs. The journey includes the validation process for new technologies and results from the SafeChemo Project, which aimed to revolutionize practices in chemotherapy production. Key outcomes and future steps will be addressed.

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Enhancing Chemotherapy Preparation with Automation: Insights from the SafeChemo Project

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  1. Using automation to prepare chemotherapy David Leonard Executive Lead Pharmacist Aseptics & Clinical Trials November 2009

  2. Imperial College Healthcare NHS Trust Charing Cross Hospital – Undergraduate Teaching & Research St Mary’s Hospital – Undergraduate teaching & Research Hammersmith Hospital – Postgraduate Teaching & Research Queen Charlottes and Chelsea – Postgraduate Women and Children

  3. The Trust • Income • >£650 million ‘healthcare’ per annum • >£150 million R&D and teaching • Activity • >170,000 inpatients pa • >690,000 outpatients pa • Staff • 9,700

  4. ICHNT Aseptic Units • MHRA licensed units at Charing Cross & Hammersmith • 27,000 doses of chemotherapy pa • 7,000 PN bags pa (neonatal & adult) • And increasingly…….clinical trial work including gene therapy

  5. The Imperial medicines automation experience • Dispensary automation since 2003….. • Rowa and Packpicker • CII safe • Ward based automation since 2002…. • ServeRx ward system • ServeRx night cabinet • Pyxis cabinets • Aseptic nothing since 90’s • Baxa pumps • Automix for neonatal PN

  6. CytoCare • The video

  7. What did we hope CytoCare would do for us? • Reduce repetitive strain injury • Improve safety • Improve efficiency • Reduce costs

  8. But first we needed to validate it! • We need to convince • Ourselves • & • the MHRA • that is was safe to use….. • Only then can we find out if it delivers our hopes…..

  9. SafeChemo Project • European Project started April 2007 & finished in March 2009 • 3 Pilot sites collaborating • 3 domains : • safety • efficiency • human aspects • www.safechemo.eu

  10. Early issues • Delivered in Dec 2006 • Uncapping & swabbing of vials • No check on bags • Replaced in May 2007 • Heat in main chamber

  11. Safety Validation results…... • Software GAMP compliant • Recognition of ingredients • Sterility of products (final product) & operator validation • Sterility of Partially used vials

  12. Validation results……(continued) • Physical monitoring • Cross product contamination • Precision • Internal Balance

  13. Precision of Preparation

  14. Microbiological Monitoring • Preliminary results • In unclassified room, CytoCare not cleaned • CytoCare under differing conditions • Air supply to CytoCare on or off • UV light on or off • After cleaning

  15. 1.3 Contact plates

  16. 1.3 Swabs

  17. MHRA view • Reviewed approach • Lots of comments & feedback • Approval to use in principle given Nov 2008

  18. Product phasing • Phase 1 : Solution into a syringe • Phase 2 : Solution into a bag • Phase 3 : Powder into a syringe • Phase 4 : Powder into a bag • Phase 5 : ?other containers

  19. “Go live” • 30 SOP’s • 5FU syringes • Simple • In solution • Cheap • Made in advance • High usage

  20. First live dose made!

  21. Aseptic Staff views

  22. Additional validation work • Sterility of bags as a final product - completed Jan 09 • Recognition work not transferable from product to product • Disinfection of line • Check database entries for each new drug

  23. Current Products • Nov 2008 : 5 FU syringes • Jan 2009 : 5 FU bags • February 2009 : 5FU for Hammersmith site • Apr 2009 : Carboplatin & Cisplatin bags

  24. Live results • 263 5FU syringes for patient use • 39 failures • Current failure rate = 14.8% • 424 bags • 42 failures • Current failure rate = 9.9%

  25. Reasons for failures • Aspiration • “Sleeping” • Recognition • Operator error • Bung in syringe • Barcodes • Gripper

  26. Additional considerations • Brief Nursing staff : • differences in labels • syringe sizes • graduations • What happens if recall • Train staff – also include troubleshooting

  27. Next steps • Install new software to improve operational use, to address: • maximum of 8 doses per cycle • Re-enter patients data for each dose & each drug • CytoCare weighs repeatedly • Methotrexate, Paclitaxel, Etoposide • Powders • Make more doses for other sites within the Trust

  28. Summary • Exciting piece of automation • Lots of highs & lows over the last 3 years • Validated & approved by MHRA in principle • Still believe it will : • reduce RSI & costs • improve safety & efficiency • Now using operationally & working on reducing failures, improving efficiency & increasing the range of products • But………..

  29. Questions?

  30. CytoCare

  31. Main chamber

  32. Waste bin & powder spinner

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