Aim
• Identify remediable factors in the care received by patients
• Proposed by the JSC and JCCO as there was a belief that the standard of care was not uniform across the country

Expert group
• Medical/clinical and haematooncologists
• Palliative medicine physician
• Pharmacist
• Chemotherapy nurse
• Patient representative

Key areas defined
• The decision to treat
• Prescription and administration
• The safety of treatment
• End of life care
• Communication
• Clinical governance

Inclusion criteria
• Patients aged 16 years or over
• Solid tumours or haematological malignancies
• Received chemotherapy, monoclonal antibodies or immunotherapy during the study period
• Died within 30 days of receiving treatment

Data collection
• Questionnaire A
• Questionnaire B
• Casenotes
• Organisational questionnaire

Advisor groups
• All cases anonymised
• Clinical/medical/haematooncologists
• Palliative medicine physicians
• Pharmacists
• Chemotherapy nurse specialists
• Assessed all aspects of care

Overall assessment of care
• Good practice
• Room for improvement: clinical care
• Room for improvement: organisational care
• Room for improvement: clinical care & organisational care
• Less than satisfactory

Cases identified
• 47,050 treatment cases
• 55,710 deaths from any cause
• 1415 cases identified

Data returned

Recommendation
Cancer services managers and clinical directors must ensure that time is made available in consultants’ job plans for clinical audit. They must also ensure that the time allocated is used for the defined purpose.
(Cancer Services Managers and Clinical Directors)

Classification of hospitals

Hospital workload

Staffing

Emergency admissions facilities

General medical support

Other specialties onsite
• Critical care
– 204/291 Level 3
– 243/290 Level 2
• Palliative care
– 81/156 consultant palliative care sessions
• Resuscitation teams
– 11 hospitals did not have one onsite

Recommendation
Hospitals that treat patients with
SACT but do not have the facilities to manage patients who are acutely unwell should have a formal agreement with another hospital for the admission or transfer of such patients as appropriate.
(Medical directors)

• Aim
• Interpretation
• Limitations
• Results

Overall quality of care

Room for improvement
• Decision to treat
• Process of care
– Prescribing, dispensing and administration of SACT
• Communication
– Patient information, medical records
• SACT toxicity
– Admission, assessment and treatment
– Management of neutropenic sepsis
• End of life decisions

Advisors opinion on the decision to treat
Advisors’ opinion
Appropriate Decision
Inappropriate Decision
Reasons
- Poor performance status
- Abnormal of investigations
- End stage disease
- Lack of evidence of efficacy
513/546 cases
81%
19%
INCREASED
TOXICITY
DECREASED
BENEFIT

Decision to treat
PATIENT’S
DECISION
DISCUSSION OF
TREATMENT OPTIONS
ONCOLOGIST’S
ASSESSMENT
CLINICAL MANAGEMENT PLAN
MDT DISCUSSION

Multi-disciplinary team meetings
STANDARD
The management of all cancer patients should be discussed at regular MDT meetings.
Manual for Cancer Services: 2004
MDT discussion 58%
CURATIVE treatment intent
PALLIATIVE treatment intent
88%
51%
FIRST LINE SACT
PREVIOUS SACT
43%
73%

Tumour and patient characteristics
• Tumour type
• Tumour stage
• Previous SACT
• Medical complications of malignancy
• Patient’s age
• Patient’s performance status
• Patient’s co-morbidities

Solid tumours

Haematological malignancies

SACT regimens
• Carboplatin and Etoposide
• Capecitabine
• Gemcitabine and Carboplatin
• Oxaliplatin
• Carboplatin
• R-CHOP and CHOP

Performance score

Clinical management plan

Decision to treat
DECISION TO TREAT
ADVISOR
APPROPRIATE
81%
ONCOLOGIST
APPROPRIATE
82%
DECISION
JUSTIFIED
5%
ADVISOR
INAPPROPRIATE
19%
ONCOLOGIST
DIFFICULT DECISION
18%
QUESTIONABLE
7%
PATIENTS CHOICE
INAPPROPRIATE
DECISION
6%

Patient information 433/546 cases
Verbal – doctor
Verbal – nurse
Chemotherapy leaflet
Clinical trial information
BACUP booklet
Audio-visual information
Org Q Cases
>95% 66%
13%
>95%
>95%
56%
27%
4%
10%
<1%

Consent forms 310/546 cases
STANDARD
Written information should be provided on
• treatment intention and expected response rates
• acute and possible late side effects
• mortality rates
Obtaining Consent for Chemotherapy:
British Committee for Standards in Haematology Guidelines
DOCUMENTATION ON CONSENT FORM
Most common side effects
Most serious side effects
Mortality risk
75%
52%
9%

Recommendations
NCEPOD supports the Manual for
Cancer Services standard that initial clinical management plans for all cancer patients should be formulated within a MDT meeting.
(Clinical directors)

Recommendations
Giving palliative SACT to poor performance status patients grade
3 or 4 should be done so with caution and having been discussed at a MDT meeting.
(Consultants)

Recommendations
Consent must only be taken by a clinician sufficiently experienced to judge that the patient’s decision has been made after careful consideration of the potential risks and benefits of the treatment, and that treatment is in the patient’s best interest.
(Clinical directors)

Recommendations
All deaths within 30 days of SACT should be considered at a morbidity and mortality or a clinical governance meeting.
(Clinical directors and consultants)

Process of care
SACT
ADMINISTRATION
SACT PRESCRIPTIONS
PRE-TREATMENT ASSESSMENTS
STAFF - TRAINING AND ACCREDITATION

Authorisation to prescribe SACT
STANDARD
Chemotherapy must be initiated and prescribed only by clinicians who are appropriately accredited and/or experienced
Good Practice Guidance for Clinical Oncologists: RCR
List maintained
Yes
Unknown
Initiator
77%
24/285
Prescriber
71%
28/285

SACT initiators

SACT prescribers

SACT prescribing accreditation
• Independent prescribers n=32
– 6 at the consultant’s discretion
– 23 post formal assessment and accreditation
– 3 unknown

Initiator, prescriber, reviewer

Pre-treatment investigations

Pre-treatment assessments
STANDARDS
Toxicity should be recorded for each cycle using the
Common Toxicity Criteria
The outcomes of treatment should be monitored closely
Appropriate action should be taken if
- the side-effects are excessive
- the cancer progresses.
Chemotherapy Guidelines: COIN 2001
Casenotes available
267/278

Documentation of toxicity and tumour response
• Toxicity
– Record of assessment – 64%
– Toxicity checklist – 26/267
• Tumour response
– Record of assessment – 54%

Prescriptions
STANDARD
All prescriptions of cytotoxic chemotherapy should be computer generated at least when using regimens from the agreed list.
Manual for Cancer Services: 2004 n=426

Route of SACT administration

Recommendation
All independent and supplementary prescribers (specialist chemotherapy nurses and cancer pharmacists) and junior medical staff should be locally trained/accredited before being authorised to prescribe SACT.
(Cancer services managers and clinical directors)

Recommendation
Junior medical staff at FY1, FY2,
ST1 and ST2 grade should not be authorised to initiate SACT.
(Clinical directors)
Toxicity check lists should be developed to assist record keeping and aid the process of care in prescribing SACT.
(Cancer services managers and clinical directors)

Safety of SACT delivery
LIMIT SACT
TOXICITY
NURSE CHECKS
PHARMACY CHECKS
DOSE REDUCTIONS / TREATMENT DELAYS

Adjustments to SACT regimen

Prescription safety checks
STANDARD
All cytotoxic chemotherapy prescriptions should be checked and authorised by a pharmacist.
Manual for Cancer Services: 2004
Prescriptions checked Parenteral Oral
Yes
Unknown
97%
21/295
Prescriptions reviewed
Evidence that the prescription had been checked
73%
30/295
369
53%

SACT administration safety checks
STANDARD
Doctors or specialist nurses who administer chemotherapy must perform checks with a colleague to confirm patient identity, drug regimen, dosage, route of administration and frequency.
Good Practice for Clinical Oncologists: RCR 2003
POLICY – two nurses to check SACT
EVIDENCE – two nurses checked SACT
89% of organisations
71% cases

Recommendations
All SACT prescriptions should be checked by a pharmacist who has undergone specialist training, demonstrated their competence and are locally authorised/accredited for the task. This applies to oral as well as parenteral treatments.
(Clinical directors and pharmacists)

Recommendations
Pharmacists should sign the
SACT prescription to indicate that it has been verified and validated for the intended patient and that all the safety checks have been undertaken.
(Pharmacists)

Overall opinion on final cycle of SACT
• Inappropriate in 154/435 (35%)
– Inappropriate decision to initiate final COURSE of SACT
– Inappropriate timing or doses of final CYCLE of SACT
– Progressive disease

• Information for patients who become unwell
• Admission to hospital and management of sepsis
• Deaths after SACT and end of life care
• The need for regular audit

Information for unwell patients: standards
There should be written information for patients detailing how to seek advice if they become unwell with complications of chemotherapy
Manual for Cancer Services: Department of Health
2004
Patients should have access to appropriate advice and care at any time, day or night, should they suffer unexpected consequences of treatment
Good Practice Guide for Clinical Oncologists: Royal
College of Radiologists

Grade 3 and Grade 4 toxicity
220/514 (43%) cases

Information for unwell patients: findings
• 96% of hospitals provided information to patients about what to do if they become unwell
• 43% of patients who died within 30 days of SACT suffered grade 3 or 4 treatment related toxicity

Patient delay in reporting side effects

Examples of good practice in patient education
• Nurse and/or pharmacist led education clinics
• Follow up call from hospital to patient
• Dedicated phone line for patients to call

• Information for patients who become unwell
• Admission to hospital and management of sepsis
• Deaths after SACT and end of life care
• The need for regular audit

Hospital admissions after SACT
If a patient becomes unwell after receiving SACT due to side effects, progression of disease, or worsening co-morbidity they must be able to get appropriate advice and if necessary admission under the care of an appropriate specialist.

Emergency admission policies

Emergency admission policies
• 85% of patients admitted to hospital within last 30 days of life
• Of those 18% (nearly 1 in 5) were not admitted to the hospital in which they received SACT

Specialty of first admission during last 30 days of life

Time to review by oncologist

Appropriateness of specialty for patient’s condition
• May depend on the reason patient is unwell
• Time to specialist review - may exclude telephone review
• Additional training?
• Shift in care of emergency admissions?

Recommendation
In planning the provision of oncology services outside of cancer centres, commissioners should take into account the need for specialist advice to be readily available when patients are admitted acutely.
(Cancer services managers)

Management of neutropenic sepsis: standards
Intravenous antibiotics should be commenced within 30 minutes in
100% of patients who have received recent chemotherapy and who are shocked.
Chemotherapy Guidelines: COIN 2001

Management of neutropenic sepsis: standards
Every acute hospital should have written guidelines on the diagnosis and management of neutropenic sepsis. All medical staff should be aware of their existence and a copy should be readily available in all relevant clinical areas including Accident & Emergency.
Chemotherapy Guidelines: COIN 2001

Management of neutropenic sepsis: standards
Networks should agree, document and disseminate guidelines for both prophylaxis and management of neutropenic sepsis …… These patients should be managed by a specialist haemato-oncology MDT.
Improving outcomes in haematological cancer:
NICE 2003

Neutropenic sepsis policy

Recommendation
Emergency admissions services must have the resources to manage SACT toxicity
These should include:-
–A clinical care pathway for suspected neutropenic sepsis
–A local policy for the management of neutropenic sepsis
–Appropriately trained staff familiar with the neutropenic sepsis policy
–The policy should be easily accessible in all emergency departments
–Availability of appropriate antibiotics within the emergency department
(Cancer services managers and clinical directors)

• Information for patients who become unwell
• Admission to hospital and management of sepsis
• Deaths after SACT and end of life care
• The need for regular audit

Where patients died

Effect of treatment on outcome

Why patients died

Deaths after SACT and end of life care
“how we care for the dying is an indicator of how we care for all sick and vulnerable people”
(Ivan Lewis care service minister, Department of Health 2008)

Do Not Attempt Resuscitation
(DNAR)
• Hospital trusts are required to have resuscitation policies in place to support people’s choices about future care and treatment

DNAR

End of life care pathways
• Developed for cancer patients
• Only found in notes of 57 patients

End of life care pathways
• Help those with advanced, progressive, incurable illness to live as well as possible until they die
• Enable the supportive and palliative care needs of both patient and family to be identified and met throughout the last phase of life and into bereavement
• Includes management of pain and other symptoms and provision of psychological, social, spiritual and practical support
(National Council for Palliative Care 2006)

Recommendation
A pro-active rather than reactive approach should be adopted to ensure that palliative care treatments or referrals are initiated early and appropriately: Oncologists should enquire at an appropriate time, about any advance decisions the patient might wish to make should they lose the capacity to make their own decisions in the future.
(Consultants)

• Information for patients who become unwell
• Admission to hospital and management of sepsis
• Deaths after SACT and end of life care
• The need for regular audit

Audit
• Neutropenic sepsis in solid tumours was audited in 45% (101/224) hospitals
• Neutropenic sepsis in haematological malignancies was audited in 51% (100/196)

Audit
• Solid tumours: 24% of hospitals
• Haematological malignancies: 14% of hospitals
• The deaths of only 16% of patients in this study were discussed

Which cases were discussed

The need for regular audit
• Most hospitals held regular audit/clinical governance meetings
• About half discussed adherence to
NICE guidelines but only a quarter discussed chemotherapy toxicity

Recommendations
Regular clinical audit should be undertaken on the management of all cases of neutropenic sepsis following the administration of
SACT.
(Clinical directors)

Recommendations
All deaths within 30 days of SACT should be considered at a morbidity and mortality or a clinical governance meeting.
(Clinical directors and consultants)

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