SACT dataset: Obstacles, progress and the way forward Paul Buckle Senior Project Manager, Chemotherapy Intelligence Unit, PHE Marcus Warner Chair, SACT.

SACT dataset: Obstacles, progress and the way forward Paul Buckle Senior Project Manager, Chemotherapy Intelligence Unit, PHE Marcus Warner Chair, SACT Dataset User Group and Specialist e-prescribing Pharmacist, CIS/Mosaiq BOPA Symposium 19 th October 2013

Cancer chemotherapy has been provided in the NHS for decades Accurate, timely and complete data collection is now seen as a priority and this can be assisted by e-prescribing systems The introduction of the Systemic Anti-Cancer Therapy (SACT) Information Standard (ISB 1533) As of 1 st October 2013, the collection and submission of SACT data is specifically incorporated in the England NHS Standard Contract Background

All organisations providing cancer chemotherapy services in or funded by the NHS in England and includes: all cancer patients, adult AND paediatric acute inpatient, daycase outpatient settings and delivery in the community; Includes oral chemotherapy Covers chemotherapy treatment for: all solid tumours haematological malignancies and includes those in clinical trials SACT dataset applies to:

SACT dataset Consists of 6 sections across 42 data items: –Demographics & Consultant –Clinical Status –Programme & Regimen –Cycle –Drug Details –Outcome

SACT programme – two year implementation period As at 30 th August 2013: 91% of trusts submitting data (136/149 Trusts) 140,195 patient records 267,750 regimens recorded

Who? SACT Programme Manager SACT Project Manager SACT Systems Developer SACT Senior Public Health Data Clerk SACT Senior Public Health Data Clerk SACT Snr. PH Analyst SACT Trainer/Liaison Disease Registration National Director for Disease Registration Public Health England CKO Chief Knowledge Officer SACT Programme Board NCIN (PHE) Directors Pharmacist Support Dr Ken Lloyd and Sue Forsey Principal developers of the SACT CIU Core Team CCIG Chemotherapy Clinical Information Group NCIN Clinical Information Specialists

1.Linking to outcomes 2.Identify variations 3.Is a balance being struck? What is the value of detailed chemotherapy treatment data?

Ineffective drug? or insufficient dose of effective drug? Allows additional scrutiny of clinical decisions

toxicity benefit Optimal choice of clinical management for desired outcome Optimal choice of clinical management for desired outcome age Clinical status Regimen & delivery Regimen & delivery young : oldstage : performance status : co-morbidity - curative treatment - disease control - symptom control recording regimen and detail correctly is critical - stopped early - dose modified - treatment delayed SACT Dataset

process review and update (continuous) mandatoryprovider approval correct regimen grouping regimen profile confirm outlier scrutiny data quality analysis SACT data and reporting quality assurance processes mandatory provider approval correct regimen grouping regimen profile confirm outlier scrutiny process review and update (continuous) correct regimen grouping

Top Regimens by Diagnostic Group Lower GI Example: English NHS hospital trustAll submitting trusts aggregated Data received for April 2012 – December 2012. Patients aged 16 and over.

SACT Reports

An introduction to Regimen Mapping

SACT Regimen names received by the CIU Wide variation in regimen naming In excess of 20,000 different regimen names submitted Some intelligible others unintelligible – Dr No’s regimen – Breast regimen #5 Need common nomenclature for analysis DH Chemotherapy Regimens List (OPCS 4.6) 1 Mapped manually to 2,000 comparable regimens 1. Available at https://www.uktcregistration.nss.cfh.nhs.uk/trud3/user/guest/group/0/home

SACT Regimen Mapping the future Local regimen names need to be mapped against DH Chemotherapy Regimens List Trusts do not need to change local names Cancer pharmacists are key to this We have devised a three stage process: StageAimObjective 1Trust level feedback and mapping Bulk of trust regimens mapped, a one-off exercise 2On-going and future mappingContinued mapping for new and ad-hoc treatments undertaken on a monthly basis 3Acceptance of stage 1 and 2 mappings Ensure that regimen mapping allows for effective analysis

Regimen Name (Dataset short version)Regimen name (Long version) Component Drug name Bevacizumab+temoz+RT (weeks 1 to 6) Bevacizumab + Temozolomide +RT weeks 1 to 6 (Glioblastoma new)Bevacizumab Bevacizumab+temoz+RT (weeks 1 to 6) Bevacizumab + Temozolomide +RT weeks 1 to 6 (Glioblastoma new)Temozolomide Bevacizumab+temoz+RT(we eks7 to 9) Bevacizumab + Temozolomide +RT weeks 7 to 9 (Glioblastoma new)Bevacizumab Bevacizumab+temoz+RT(we eks7 to 9) Bevacizumab + Temozolomide +RT weeks 7 to 9 (Glioblastoma new)Temozolomide Bexarotene BGEM Carmustine BGEM Etoposide BGEM Gemcitabine BGEM Melphalan BIP Bleomycin BIP Cisplatin BIP Ifosfamide DH Chemotherapy Regimen List

TrustSubmitted Regimen NameCategoryAction Your NHS trust nameCalcium + Cholecalciferol (Adcal D3) tabletsRequires mapping by trustMapped to NOT CHEMO category Your NHS trust nameCAPMatched DH Chemotherapy Regimen ListNo action Your NHS trust nameCAP:Cyclophos.-Dox-Cisplatin Malignant ThymoRequires mapping by trustMapped by trust Your NHS trust nameCapeciatabineMatched DH Chemotherapy Regimen ListNo action Your NHS trust nameCapecitabine Advanced Breast Ca. 3wklyRequires mapping by trustMapped by trust Your NHS trust nameCapecitabine (21 day) + OxaliplatinMatched DH Chemotherapy Regimen ListNo action Your NHS trust nameCapecitabine + LapatinibMatched DH Chemotherapy Regimen ListNo action Your NHS trust nameCapecitabine + RTRequires mapping by trustMapped by trust Your NHS trust nameCetuximab + FOLFIRIMatched DH Chemotherapy Regimen ListNo action Your NHS trust nameCetuximab + FOLFIRI © Cetuximab + Oxaliplatin +Requires mapping by trustMapped by trust Your NHS trust name Cetuximab + Irinotecan (Cycle 1) © Cetuximab + IrinotecanRequires mapping by trustMapped by trust Your NHS trust nameTNT Group B DocetaxelRequires mapping by trustMapped to NCRN Trial Name Your NHS trust nameTNT Group B Docetaxel V1Requires mapping by trustMapped to NCRN Trial Name Stage 1: Trust level feedback and mapping Objective: Bulk of regimens mapped - one-off exercise SACT Regimen Mapping DescriptionMeaningActionPriority Matched DH chemotherapy regimen list on upload Submitted regimen matched the DH chemotherapy regimen list on upload No action requiredLow Mapping by TrustThe regimen did not match the DH chemotherapy regimen list on upload but is EITHER a known DH chemotherapy regimen OR is a recognised treatment not listed on DH chemotherapy regimen list Please map to DH chemotherapy regimen list OR lists component drugs in alphabetical order separated by a ‘+’ High Mapping by trust to NCRN trial name The regimen did not match the DH chemotherapy regimen list but is a known trial regimen Please map to recognised trial name on NCRN list Medium Mapping to Not Chemo category The regimen did not match the DH chemotherapy regimen list on upload and it is not considered to be chemotherapy (Anti-emetics, steroids and other supplementary medicines are not consider to be chemotherapy) Please map to ‘NOT CHEMO’Medium Where unable to map to DH Chemotherapy Regimen List, then submit: -BNF approved drug name (not trade name) -In alphabetical order -Interspaced by ‘+’

Stage 2: On-going and future regimen mapping Objective: Continued mapping for new and ad-hoc treatments undertaken on a monthly basis. SACT Regimen Mapping

Stage 3: Acceptance of mappings (CIU) Objective: Ensure that regimen mapping allows for effective analysis CIU team will accept and group the mapped regimens to enable effective clinical analysis. CIU can continue to develop the more specific types of analysis that the clinical community are requesting: – Effective comparison of treatments and corresponding outcomes – More detailed/more complex reports – Dosage and age distributions – Establishing a base for more effective commissioning SACT Regimen Mapping

What do you get from this work?

SACT – PRELIMINARY ANALYSIS

Individual Trust SACT analysis (UHL)

SACT – PRELIMINARY ANALYSIS

How you can help? Cancer pharmacists’ expertise to map Identify who will lead on this locally Register on SACT portal Request “Regimen Mapping” Access Log on and map monthly Reminder emails sent out Reminder on login to users Help Desk support SACT Regimen Mapping

www.chemodataset.nhs.uk www.chemodataset.nhs.uk ciu@sph.nhs.uk Helpdesk 01865 334 770

Interesting you should ask…

Reporting and analysis of sequential regimens in SACT October 2013

Day One 1 st Cycle FEC Fluorouracil (5FU) Epirubicin Cyclophosphamide + 2 or 3 cycles of FEC T + 3 weeks rest period (no chemo) DOCETAXEL Taxotere® It takes about an hour to give these three drugs, all on the same day + 2 or 3 cycles of T More T? + 3 weeks rest period (no chemo) Based on information from MacmillanMacmillan More FEC or T?

FEC DOCETAXEL 1 st April 2013January 2013July 2013 onwards… C C C C C C C C C C C C FebMarAprMayJunJulJanAugSep

Trust Patient Regimen Programme Number Regimen Number Start Date of Regimen Start Date of Cycle Cycle Number Drug Name Drug Administration Date ABC1FEC1101/01/2012 1FLUOROURACIL01/01/2012 ABC1FEC1101/01/2012 1EPIRUBICIN01/01/2012 ABC1FEC1101/01/2012 1CYCLOPHOSPHAMIDE01/01/2012 ABC1FEC1101/01/201229/01/20122FLUOROURACIL29/01/2012 ABC1FEC1101/01/201229/01/20122EPIRUBICIN29/01/2012 ABC1FEC1101/01/201229/01/20122CYCLOPHOSPHAMIDE29/01/2012 ABC1FEC1101/01/201226/02/20123FLUOROURACIL26/02/2012 ABC1FEC1101/01/201226/02/20123EPIRUBICIN26/02/2012 ABC1FEC1101/01/201226/02/20123CYCLOPHOSPHAMIDE26/02/2012 ABC1DOCETAXEL1225/03/2012 1DOCETAXEL25/03/2012 ABC1DOCETAXEL1225/03/201222/04/20122DOCETAXEL22/04/2012 ABC1DOCETAXEL1225/03/201220/05/20123DOCETAXEL20/05/2012

Trust Patient Regimen Programme Number Regimen Number Start Date of Regimen Start Date of Cycle Cycle Number Drug Name Drug Administration Date ABC1 FEC + DOCETAXEL 1101/01/2012 1FLUOROURACIL01/01/2012 ABC1 FEC + DOCETAXEL 1101/01/2012 1EPIRUBICIN01/01/2012 ABC1 FEC + DOCETAXEL 1101/01/2012 1CYCLOPHOSPHAMIDE01/01/2012 ABC1 FEC + DOCETAXEL 1101/01/201229/01/20122FLUOROURACIL29/01/2012 ABC1 FEC + DOCETAXEL 1101/01/201229/01/20122EPIRUBICIN29/01/2012 ABC1 FEC + DOCETAXEL 1101/01/201229/01/20122CYCLOPHOSPHAMIDE29/01/2012 ABC1 FEC + DOCETAXEL 1101/01/201226/02/20123FLUOROURACIL26/02/2012 ABC1 FEC + DOCETAXEL 1101/01/201226/02/20123EPIRUBICIN26/02/2012 ABC1 FEC + DOCETAXEL 1101/01/201226/02/20123CYCLOPHOSPHAMIDE26/02/2012 ABC1 FEC + DOCETAXEL 1101/01/201225/03/20124DOCETAXEL25/03/2012 ABC1 FEC + DOCETAXEL 1101/01/201222/04/20125DOCETAXEL22/04/2012 ABC1 FEC + DOCETAXEL 1101/01/201220/05/20126DOCETAXEL20/05/2012

TRASTUZUMAB (Herceptin ® ) “A monoclonal antibody that interferes with the HER2 receptor” Three-weekly regimen (21 days) Initial loading dose of 8mg/kg body weight, followed by 6mg/kg body weight every three weeks for 1 year Weekly regimen (7 days) Initial loading dose of 4mg/kg body weight, followed by 2mg/kg body weight every week for 1 year Licensed to be given concurrently with Paclitaxel Source: NICE Technology Appraisal guidance 107, August 2006

Regimen nomenclature Regimens reported in different ways: FEC DOCETAXEL TRASTUZUMAB FEC + DOCETAXEL TRASTUZUMAB FEC + DOCETAXEL + TRASTUZUMAB Need for re-packaging regimens to standardise analysis and reporting

Other factors Time-lag e.g. reporting ‘FEC + DOCETAXEL + TRASTUZUMAB’ as one block, but only delivering ‘FEC’ element within activity window reported. Alternatively, opposite problem at other end of programme – long tail of ‘TRASTUZUMAB’ use reported as ‘FEC + DOCETAXEL + TRASTUZUMAB’ when ‘FEC’ and ‘DOCETAXEL’ elements no longer delivered.

FEC DOCETAXEL TRASTUZUMAB FEC + DOCETAXEL TRASTUZUMAB FEC + DOCETAXEL + TRASTUZUMAB FEC DOCETAXEL 1 st April 2013January 2013July 2013 onwards… C C C C C C C C C C C C TRASTUZUMAB C C C C C C C C C C C C

Other regimens Also, concurrent regimens e.g. ‘CARBOPLATIN + PACLITAXEL’ (Breast, Gynae, Lung) ‘CISPLATIN + PACLITAXEL’ (Gynae) … FEC DOCETAXEL TRASTUZUMAB EC BEVACIZUMAB AC PERTUZUMAB or + / -

Six of the top ten breast regimens are variations of ‘FEC’, ‘DOCETAXEL’ AND ‘TRASTUZUMAB’

What is required? Consistent recording of key data items: – Regimen Name – Programme Number – Cycle Start Date – Drug Name – Drug Administration Date

Drug Name and Administration Date Not all systems currently report this level of detail. However, where this is sourced from an e-prescribing system this should be reasonably reliable.

Cycle Start Date Not mandatory (Cycle Number is instead), so not consistently reported Are some hospital trusts’ systems only reporting first cycle? (Somerset)

For breast patients (C50) Programme number… 27% of breast patients receive more than one uniquely named regimen per programme… …vs 18% for all other patients Source: SACT dataset, accessed 3 rd September 2013