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

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

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

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………..

30. Questions?

31. CytoCare

32. Main chamber

33. Waste bin & powder spinner