Commissioning Chemotherapy Services Conference

Issues of consent in systemic therapy

Dr Janine MansiConsultant Medical Oncologist

28th November 2017

Introduction

• Background and context

• What we have done

• What we have achieved to date

• Future plans

Background and Context

• Consent for majority of systemic therapy is mandatory

• Pharmacists and specialist nurses will not dispense or give treatment unless the consent form has been signed

• Historically (and in some cases currently) a standard consent form is used for this function

Standard Consent Forms

• Hand written!

• Variable side-effects included (or not)

• Quality dependent on clinician taking consent

• Can just write – ‘see patient information sheet’

• No accurate or permanent record of what has been discussed

Standard Consent Form

Standard consent forms

Consent

• Consent is the principle that a person must give their permission before they receive any type of physical investigation, medical treatment, or personal care

• ‘…reflects the right of patients to determine what happens to their own bodies, and is a fundamental part of good practice.’1

Consent Issues

• Valid consent – voluntary, informed, capacity

• Legal and ethical principles

• Procedural, NHS and organisational practice guidelines

The Law and Ethics

The Bolam test (1957):

“If a doctor reaches the standard of a responsible body of medical opinion, he is not negligent”

The Law and Ethics

Montgomery Case 2015

Montgomery v Lanarkshire:

a woman with diabetes and a small stature delivered her son vaginally; he experienced shoulder dystocia, resulting in hypoxic insult with consequent cerebral palsy

The Law and EthicsAfter the Montgomery case, the Bolam test, which asks whether a doctor’s conduct would be supported by a responsible body of medical opinion, no longer applies to the issue of consent. The law now requires a doctor to take “reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments.”

The Law and Ethics

“a patient should be told whatever they want to know, not what the doctor thinks they should be told”

“the most important UK judgement on informed consent in 30 years”

“supports patient autonomy over medical paternalism”

Clinical Concerns and Ethical Arguments

Patients

• more stringent disclosure requirements would risk overwhelming patients

• may cause distress

• may make poor decisions

Doctors

• more lengthy explanations

• drain on healthcare resources

• defensive medicine

Clinical Concerns and Ethical Arguments

• The clinician’s role is to ensure that relevant information is presented to enable the patient to use it meaningfully

• Today’s patients can expect a more active and informed role in treatment decisions

• Legally, consent law has been clarified and aligns with current GMC guidance

• Ethically, it clarifies the existing shift towards a more cooperative approach in the consultation room

» Chan et al, BMJ 2017;357:2224

Consent for SACT – NCAG report7

• Recommendations relating to the whole of the chemotherapy pathway, including consent and information

Consent for SACT – NCAG report• ‘Consent should be obtained and recorded in detail

in terms of the aims of treatment and both the common and serious side effects of treatment’

• Main proposed actions– ‘Standardised consent forms are used which include details of

the toxicities discussed and which identify whether a patient has been provided with written information.’

– Chemotherapy service providers should ‘provide written information to patients about the chemotherapy they will be receiving, the likely side effects and whom they should contact if problems arise (including out of hours). Delivery of such information should be documented.’

– ‘A copy of the consent form should be given to the patient as well as one being filed in the patient’s case record.’

Consent for SACT – Peer review

• Manual for Cancer Services: Chemotherapy Measures 20148

Consent forms at GSTT/SEL• South East London – supported project for

development (AW)

• Guy’s and St. Thomas’ NHS Foundation Trust (GSTT) developed a library of >250 chemotherapy regimen-specific consent forms in 2010-2012

• Benefits

– High quality standardised information from clinician to patient

– Consistent, i.e. no omissions

– Tool for teaching and training

National project• Practice of consent for SACT varies in the UK

• Cancer Research UK (CRUK) awarded a grant to GSTT to host the project

• Project to develop a national library of SACT regimen-specific consent forms commenced in October 2015

• The UK Chemotherapy Board are the governing body for the project:

Created the webpage• To host the forms and associated documents:

www.cruk.org/sact_consent

Launch July 2016• Published and launched the guidance

document

• First regimen-specific forms for breast cancer, and the generic form in July 2016

– Emails to lead chemotherapy clinicians in the UK

– Communication to members of professional groups (ACP, RCP, RCR, RCPath, UKONS, BOPA)

– Cancer Research UK news report and tweets

National Guidance

• Recommends the use of regimen-specific forms• Guidance for the introduction of the forms• Guidance for the process of consent• Audit recommendations

SACT regimen-specific forms• By tumour group for oncology and

haematology SACT regimens

• Reference to SPC, PIL, CRUK and Macmillan drug information sheets

• Each form is independently checked by an oncology/haematology pharmacist, oncology/haematology consultant and member of the UK Chemotherapy Board

National Forms

• 5-page form• Standard template

Page 1• Hospital name

• Health professional details

• Patient details

• Regimen details

• Where treatment will be given

• The intended benefits

Page 2• Regimen-specific risks and side effects

• Separated into common, occasional and rare and other issues

•Includes a statement that the treatment may be life threatening or even result in death

Page 3• Space for other risks

• Statements confirming discussions

• Details of leaflets provided

• Clinician signature

• Interpreter signature (where appropriate)

Page 4• Patient statement and confirmation of consent

• Further information for patients

• Whether copy accepted by patient or not

Page 5• Guidance for health professionals

Published forms• Breast – July 2016• Generic – July 2016 • Head and neck cancers – October 2016• Melanoma – November 2016• Generic immunotherapy – December 2016• Gynaecological cancers – January 2017• Lung cancers – March 2017• Supportive medicines – April 2017• Colorectal cancer – May 2017• Urology/Bladder cancer – July 2017• Thyroid cancer – September 2017• Oesophago-gastric and GIST – October 2017

Communication and Queries• Communication

– Email updates when new forms published

– Emails to lead chemotherapy clinicians in the UK, UK Chemotherapy Board members, and project mailing list

• Queries

– Database of all user queries and our responses

– FAQ document published October 2016

– Used to inform development of forms and project

Evaluation – Website analytics (1)

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Visits to consent form page by Country

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England

N. Ireland

Scotland

Wales

Unknown

Other

Evaluation – Website analytics (2)

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Downloads from consent form webpage (www.cruk.org/sact_consent)

Guidance document

Generic SACT form

Genericimmunotherapy formFAQ document

Breast forms

Head & neck forms

Melanoma forms

Gynaecological cancerformsCML forms

Lung forms

Supportive medicinesformsColorectal forms

Urology forms

Thyroid forms

Total

January 2017: Evaluation – Survey (1)• Aims and objectives

– To evaluate the uptake of the national forms in England, N. Ireland, Scotland and Wales

– To obtain feedback on the forms

– To obtain feedback on the challenges related to introducing the forms

– To use feedback to inform future developments of the project

Evaluation – Survey (2)• Method

– Survey built using SurveyMonkey®, piloted and emailed to lead chemotherapy clinicians within NHS hospitals/Trusts in the UK in January 2017

– Results analysed after 2 weeks

• Results

– 87 responses

– 87% of responses from hospitals/Trusts in England

– 92% aware of national consent forms

– 74% aware of guidance on consent for SACT

Evaluation – Survey (3)• Results (cont….)

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Dept. of Healthconsent form 1

Local hospital/Truststandard consent

form

Locally developedgeneric SACT consent

form

Locally developedSACT regimen-

specific consentforms

National generic SACTconsent form

National SACTregimen-specificconsent forms

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Method used to consent adult patients to treatment with SACT in the hospital/Trust

Prior tolaunch ofnationalforms

Followinglaunch ofnationalforms

Evaluation – Survey (4)• Results (cont…)

– 30 hospitals/Trusts using forms; 17 plan to use

– Reasons for not using forms included:o Prefer existing method o Resistance from key stakeholders

o Forms not approved in hospital/Trust

o Too much paper to give to patients

o Time and motivation to implement

o Awaiting regional steer on use of national forms

o Use of electronic systems and processes

o Queries regarding legality of forms

o Forms not available for all tumour groups

Evaluation – Survey (5)• Conclusions

– Results give an indication of the awareness and uptake of forms

– Responses give insight into the benefits and challenges of using the forms

– Comments positive overall

– Constructive feedback

Evaluation – Survey (6)• Recommendations

– Continue to publish forms

– Outline options for local processes

– Issue reminder regards national guidance document

– Continue to send regular updates and comms

– Legal review of the forms

– Develop and publish paediatric forms

– Scope feasibility of electronic forms

– Repeat survey in 1 year

Iterative process

• Responding to comments

• Hearing about other practices

• Extravasation

• Peripheral neuropathy

• Haemato-oncology

Next steps• Forms for the remaining tumour groups will be

published in 2017-2018

• A national steering group is being set up

• Project evaluation – repeat survey Jan/Feb ‘18

• Year 3

– Continued maintenance and update of form library

– Paediatric, TYA and Sarcoma

– Scope electronic forms

– Welsh translation of generic forms

References• Reference guide to consent for examination or treatment: Second edition,

Department of Health, 2009.

• Consent: patients and doctors making decisions together, General Medical Council, 2008.

• Sokol D. Update on the UK law on consent. BMJ 2015; 350:h1481.

• Guidance on consent, General Pharmaceutical Council, 2012.

• The code for nurses and midwives, Nursing and Midwifery Council, 2015.

• Health and Social Care Act 2008 (Regulated Activities) Regulations Care Quality Commission, 2014.

• Chemotherapy Services in England: Ensuring quality and safety, National Chemotherapy Advisory Group, August 2009.

• Manual for Cancer Services Chemotherapy Measures: Version 1.0, National Peer Review Programme, NHS England, April 2014.

• Consent form 1, Department of Health, 2009.

Acknowledgements• Acknowledgements:

– Rena Chauhan – highly specialist pharmacist

– Victoria Fashina – highly specialist pharmacist (June 2017)

– Jacky Turner – previous lead pharmacist (to 2015)

– Nisha Shaunak – Lead Oncology Pharmacist and Specialised Cancer Commissioning Pharmacist, NHS England (London region)

– Colleagues at GSTT and Cancer Research UK

– Members of the UK Chemotherapy Board

– Tumour–specific leads from the CSGs who will help drive the project forward (Steering Group)