Transcript Using automation to prepare individual doses of 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
Hammersmith Hospital
– Postgraduate
Teaching & Research
Queen Charlottes and
Chelsea – Postgraduate
Women and Children
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
• 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
• 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
• The video
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!
• 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
• European Project started April 2007 & finished
in March 2009
• 3 Pilot sites collaborating
• 3 domains :
– safety
– efficiency
– human aspects
• www.safechemo.eu
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…...
• Software GAMP
compliant
• Recognition of
ingredients
• Sterility of products
(final product) &
operator validation
• Sterility of Partially
used vials
•
Validation results……(continued)
• Physical monitoring
•
• Cross product contamination
• Precision
• Internal Balance
Precision of Preparation
Fill weights for 2ml 0.9%SodiumChloride into 3ml syringes (Target weight 2.00g +/-5%)
Weight (g)
2.3
2.2
2.1
2
1.9
1.8
1.7
1.6
1.5
1.4
1.3
1.2
1.1
1
0.9
0.8
0.7
1
6
11
16
21
26
Fill Number
31
36
41
46
51
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
1.3 Contact plates
1.3 Swabs
Working zone
swabs
16
14
No. of colonies
12
10
8
6
4
2
0
Expt 1- No Air.
No UV
Expt 2- Air on.
No UV
Expt 3- Air on
overnight, off when
monitoring. No UV
Expt 4 - Air on
overnight and when
monitoring. No UV
Expt 5 - UV
overnight, no air
during monitoring
Expt 6- UV overnight, Expt 7 UV overnight,
air on when
air on during
monitoring
monitoring,
Cytocare cleaned
Balance - TSA
Balance - SDA
Vial Holder Upper Right - TSA
Vial Holder Upper Right - SDA
Robot Arm Pincers - TSA
Robot Arm Pincers - SDA
Robot Arm Grey Rotating Part - TSA
Robot Arm Grey Rotating Part - SDA
Syringe Holder Top Centre - TSA
Syringe Holder Top Centre - SDA
Syringe Holder Bottom Left - TSA
Syringe Holder Bottom Left - SDA
Vial Holder Left Side - TSA
Vial Holder Left Side - SDA
Rotating M ixer Disc - TSA
Rotating M ixer Disc - SDA
Rotating M ixer Disk Underside - TSA
Rotating M ixer Disk Underside - SDA
MHRA view
• Reviewed approach
• Lots of comments & feedback
• Approval to use in principle given Nov 2008
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”
•
•
•
•
•
•
•
30 SOP’s
5FU syringes
Simple
In solution
Cheap
Made in advance
High usage
First live dose made!
Aseptic Staff views
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
•
•
•
•
Nov 2008 : 5 FU syringes
Jan 2009 : 5 FU bags
February 2009 : 5FU for Hammersmith site
Apr 2009 : Carboplatin & Cisplatin bags
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
•
•
•
•
•
•
•
Aspiration
“Sleeping”
Recognition
Operator error
Bung in syringe
Barcodes
Gripper
Additional considerations
• Brief Nursing staff :
– differences in labels
– syringe sizes
– graduations
• What happens if recall
• Train staff – also include troubleshooting
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
•
•
•
•
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………..
Questions?
CytoCare
Main chamber
Waste bin & powder spinner