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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

Using automation to prepare chemotherapy

David Leonard

Executive Lead Pharmacist Aseptics & Clinical Trials

November 2009

imperial college healthcare nhs trust
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

the trust
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
ichnt aseptic units
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
the imperial medicines automation experience
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
cytocare
CytoCare
  • The video
what did we hope cytocare would do for us
What did we hope CytoCare would do for us?
  • Reduce repetitive strain injury
  • Improve safety
  • Improve efficiency
  • Reduce costs
but first we needed to validate it
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…..
safechemo project
SafeChemo Project
  • European Project started April 2007 & finished in March 2009
  • 3 Pilot sites collaborating
  • 3 domains :
    • safety
    • efficiency
    • human aspects
  • www.safechemo.eu
early issues
Early issues
  • Delivered in Dec 2006
    • Uncapping & swabbing of vials
    • No check on bags
  • Replaced in May 2007
    • Heat in main chamber
safety validation results
Safety Validation results…...
  • Software GAMP compliant
  • Recognition of ingredients
  • Sterility of products (final product) & operator validation
  • Sterility of Partially used vials
validation results continued
Validation results……(continued)
  • Physical monitoring
  • Cross product contamination
  • Precision
  • Internal Balance
microbiological monitoring
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
mhra view
MHRA view
  • Reviewed approach
  • Lots of comments & feedback
  • Approval to use in principle given Nov 2008
product phasing
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
go live
“Go live”
  • 30 SOP’s
  • 5FU syringes
  • Simple
  • In solution
  • Cheap
  • Made in advance
  • High usage
additional validation work
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
current products
Current Products
  • Nov 2008 : 5 FU syringes
  • Jan 2009 : 5 FU bags
  • February 2009 : 5FU for Hammersmith site
  • Apr 2009 : Carboplatin & Cisplatin bags
live results
Live results
  • 263 5FU syringes for patient use
  • 39 failures
  • Current failure rate = 14.8%
  • 424 bags
  • 42 failures
  • Current failure rate = 9.9%
reasons for failures
Reasons for failures
  • Aspiration
  • “Sleeping”
  • Recognition
  • Operator error
  • Bung in syringe
  • Barcodes
  • Gripper
additional considerations
Additional considerations
  • Brief Nursing staff :
    • differences in labels
    • syringe sizes
    • graduations
  • What happens if recall
  • Train staff – also include troubleshooting
next steps
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
summary
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………..