The Royal Marsden

1

Nursing and Service Aspects of Extracorporeal Photopheresis ( ECP)

Janet Baker (Sister-Haem-Onc Daycare/Outpts/Apheresis)Royal Marsden NHS Foundation Trust

EBMT NAP UK 5/10/2012

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Background

Opportunity to deliver ECP at RMH

Commercially sponsored clinical trial: ECP for 1st line Chronic GvHD

Provision of CellEx™ Photopheresis system

Charity funded programme for Acute GvHD

Development of an ECP service

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Discussion Points

Clinical Governance Issues

Management, Organisation, and Personnel

Training and Supervision

Premises-Space-Storage

Key Documentation

Quality Assurance/ Standards

Patient Management

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Clinical Governance Issues

Service Objectives / Outcome Service Agreements/ Maintenance

New Equipment User Group Drug and Therapeutics Committee-Approval

for 8-Methoxypsoralen (Uvadex™)

Risk Assessment Incident Reporting System

Procurement Finance Reporting- updates to Charity Fund

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Management, Organisation, and Personnel ? Extension / Integration of Apheresis service

Inpatient / outpatient service

Designated leads/ Keyworkers: Nursing and Medical

Accountability / Responsibility

Skill mix / Experience: Apheresis + Transplant

Resources: Nursing Staff and Time

Institutional / Department support

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Training Requirements

Technical Competency Certificate from Company Trainer – ‘water treatment’ and patient treatments

Theoretical component- workbook

Arranged observational visit to Nottingham -ECP

Strasbourg- Company HQ, and clinical observational visit

On- the – job training / learning….ongoing

Instruction Manual

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Premises – Space - Storage

CellEx™

Location of procedure – Inpt/ Outpt/ Apheresis

Therapeutic environment

Service is portable

Storage of kits

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Key Documentation Standard Operating Procedure ( SOP) for ECP

Patient Consent Form Patient Information Leaflet

Photopheresis Procedure record Prescription/ Proforma -Uvadex™ / Heparin GvHD monitoring/ assessment form FACT-BMT Quality of Life questionnaire

Reporting forms for System failures/Incidents Maintenance and Cleaning records

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Quality Assurance / Standards

SOP policy for ECP and associated policies JACIE accredited centre

JACIE 5th edn standards B7.2 acknowledge: - “Inspectors are encountering ECP processes during inspection-if part of therapy for GvHD- must comply with JACIE standards-performed according to policies for safe administration of ECP”

UK Photopheresis Society (UKPS) advocates ECP accreditation in UK / Europe by external assessment

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Patient Management

Patient selection / Eligibility for treatment – SOP ‘ to ECP or not to ECP?’

Further consensus guidelines for acute GvHD needed

Scheduling –treatment efficacy -Acute –twice weekly-8 wks

- Chronic- per trial / 2x week every 2 weeks

- logistics and practicalities

Clinical pre-assessment criteria-blood values (Fbc, Coag, U&es, Lfts, lipids) / Weight

Baseline GvHD assessment and I/S medication review

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Patient Consent / Information

Commitment / Compliance Repeat hospital visits Inpt/ Outpt Realistic aims and timeframes- not ‘quick fix’ Support / Reassurance Low fat diet- ( lipids) UVA protection skin / eyes - dark glasses Contraception – (Uvadex ™) Good oral hydration Acute/ Chronic GvHD pts… different needs

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Side –effect profile

Fatigue Hypotension / dizziness/ syncope - ECV Increased sensitivity to sunlight- skin / eyes Pain, anxiety, bruising – peripheral

cannulation Infection- central access lines Bleeding/ bruising – anticoagulation

Metallic taste in mouth , ‘sparkly’ sensation in eyes during re-infusion

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Venous access - vein assessment

Peripheral Access– Kimal needle size 16/17 - 17/18 g cannula Return - 18/ 20 g cannula

Central Line –Double lumen - LTS line(long term

silicone,tunnelled) - 12 French ( 5.5 mm per lumen) - > 3 French per lumen - provide flow rates > 15 ml/ min

CellEx™ - Single or Double lumen procedure

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Transfusion Requirements pre ECP

Institutional Parameters

Hct > 27 %

Platelets > 25,ooo

Blood results < 48 hours pre procedure

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Anticoagualtion

System licensed for Heparin not Citrate

? Anticoagulant not anti-platelet clumping activity

10,ooo units Heparin in 500 mls / AC ratio 10:1

Adjust for high/ low platelet counts

Watch for Platelet Clumping Assess for bleeding, bruising - haematuria Patient anti-coag history- INR

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Technical problems

CellEx™ Alarms

Problem solving

Technical support - Hotline / UK trainer

Kits - Reimbursement if problems

Smart Cards- send for analysis

Reporting / Documenting System and kit problems

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Assessment, Monitoring, Evaluation

Efficacy v toxicity of treatment - ECP good safety profile

GvHD assessments - who should complete these?

Record Clinical Outcomes - ? National ECP database

Quality of Life information

Financial Outcomes - Commissioners / Reimbursement and future funding

Evidence -based and cost- effective service

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Our experience so far…….

3 AGvHD patients treated- 1 in treatment

CGvHD Trial - 1 pt enrolled- not randomised to ECP

? Future after funding/ trial complete

Challenging / time-consuming

Great opportunity for us and our patients

Collaboration and networking with other ECP centres

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Acknowledgement / Thanks

Regina De Jesus - Joint ECP Key- worker - Sister, Transplant Unit,

RMH

Nurses on Bud Flanagan Ambulatory Care ( BFAC)

ECP experts, esp - Emma Luke at Nottingham - Tracy Maher and Maggie

Foster at Rotherham

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Thank You for listening.

– Questions?

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References

FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing, and Administration. 5th edition. JACIE