Using automation to prepare chemotherapy

David LeonardExecutive Lead Pharmacist Aseptics &

Clinical TrialsNovember 2009

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

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…..

• European Project started April 2007 & finished in March 2009

• 3 Pilot sites collaborating• 3 domains :

– safety– efficiency– human aspects

• www.safechemo.eu

SafeChemo Project

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 w eights for 2ml 0.9% Sodium Chloride into 3ml syringes (Target w eight 2.00g +/-5%)

0.7

0.8

0.9

1

1.1

1.2

1.3

1.4

1.5

1.6

1.7

1.8

1.9

2

2.1

2.2

2.3

1 6 11 16 21 26 31 36 41 46 51

Fill Number

Wei

ght (

g)

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

Goods entry zonecontact plates

0

1

2

3

4

5

6

Expt 1- No Air. No UV

Expt 2- Air on. No UV

Expt 3- Air onovernight, off

when monitoring.No UV

Expt 4 - Air onovernight and

when monitoring.No UV

Expt 5 - UVovernight, no air

during monitoring

Expt 6- UVovernight, air onwhen monitoring

Expt 7 UVovernight, air on

during monitoring,Cytocare cleaned

Left Side Entry Right Side Entry Left Wall Entry Right Wall Entry Top of Door Under Door

Working zonecontact plates

0

2

4

6

8

10

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, air on when

monitoring

Expt 7 UV overnight, air on during

monitoring, Cytocare cleaned

Base Rear Left Base Rear Right Base Front Left Base Front Right Balance

Syringe Holder Robot Arm - Flat Grey P art Needle Holder (L side) Left Wall (below vial holder) Right Wall (below gap)

Carousel zonecontact plates

0

1

2

3

4

5

6

7

8

9

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, air on

when monitoring

Expt 7 UV overnight, air on

during monitoring, Cytocare

cleaned

Base Rear Left Base Rear Right Base Front Left Base Front Right

Rear Wall Top Left Right Wall – Top Left Rear Wall Bottom Left Rear Wall Bottom Right

Left Side – Raised Shelf Rear Left Side – Raised Shelf Front Top Centre of Carousel Carousel Cylinder – Left Side

Carousel Cylinder – Right Side

1.3 Swabs

Goods entry and carouselswabs

0

10

20

30

40

50

60

70

E xpt 1- No Air . No UV E xpt 2- Air on. No UV E xpt 3- Air on over night, off

when monitor ing. No UV

E xpt 4 - Air on over night and

when monitor ing. No UV

E xpt 5 - UV over night, no ai r

dur ing monitor ing

E xpt 6- UV over night, ai r on

when monitor ing

E xpt 7 UV over night, air on

dur ing monitor ing, Cytocar e

cleaned

Inside Front Lip of Door - TSA Inside Front Lip of Door - SDA P erforated Door Handle - TSAP erforated Door Handle - SDA P erforated Door Rear - TSA P erforated Door Rear - SDACarousel Vial Stand 1 - TSA Carousel Vial Stand 1 - SDA Carousel Vial Stand 2 - TSACarousel Vial Stand 2 - SDA Carousel Vial Stand 3 - TSA Carousel Vial Stand 3 - SDA

Carousel Syringe Holder - TSA Carousel Syringe Holder - SDA Carousel Top - TSACarousel Top - SDA Carousel IV Bag Holder - TSA Carousel IV Bag Holder - SDACable (From Door) - TSA Cable (From Door) - SDA

Working zone swabs

0

2

4

6

8

10

12

14

16

Expt 1- No Air. No UV

Expt 2- Air on. No UV

Expt 3- Air onovernight, off whenmonitoring. No UV

Expt 4 - Air onovernight and whenmonitoring. No UV

Expt 5 - UVovernight, no air

during monitoring

Expt 6- UV overnight,air on whenmonitoring

Expt 7 UV overnight,air on duringmonitoring,

Cytocare cleaned

No. o

f colo

nies

Balance - TSA Balance - SDA Vial Holder Upper Right - TSA Vial Holder Upper Right - SDA

Robot Arm P incers - TSA Robot Arm P incers - SDA Robot Arm Grey Rotating P art - TSA Robot Arm Grey Rotating P art - 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 Mixer Disc - TSA Rotating Mixer Disc - SDA

Rotating Mixer Disk Underside - TSA Rotating Mixer 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