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Using automation to prepare chemotherapy

Using automation to prepare chemotherapy. David Leonard Executive Lead Pharmacist Aseptics & Clinical Trials November 2009. Imperial College Healthcare NHS Trust. Charing Cross Hospital – Undergraduate Teaching & Research. St Mary’s Hospital – Undergraduate teaching & Research.

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Using automation to prepare chemotherapy

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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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