Aim

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 haemato-

oncologists

• 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/haemato-oncologists

• 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 513/546 cases

Appropriate Decision 81%

Inappropriate Decision 19%

Reasons

- Poor performance status

- Abnormal of investigations

INCREASED TOXICITY

- End stage disease

- Lack of evidence of efficacy

DECREASED BENEFIT

Decision to treat

PATIENT’S DECISION

PATIENT’S DECISION

DISCUSSION OF TREATMENT OPTIONS

DISCUSSION OF TREATMENT OPTIONS

ONCOLOGIST’SASSESSMENT

ONCOLOGIST’SASSESSMENT

CLINICAL MANAGEMENT PLAN CLINICAL MANAGEMENT PLAN

MDT DISCUSSIONMDT 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 88%

PALLIATIVE treatment intent 51%

FIRST LINE SACT 43%

PREVIOUS SACT 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

ONCOLOGIST APPROPRIATE

82%

ONCOLOGIST DIFFICULT DECISION

18%

ADVISOR APPROPRIATE

81%

ADVISOR INAPPROPRIATE

19%

DECISION JUSTIFIED

5%

QUESTIONABLE 7%

PATIENTS CHOICE

INAPPROPRIATE DECISION

6%

Patient information 433/546 cases

Org Q Cases

Verbal – doctor >95% 66%

Verbal – nurse 13%

Chemotherapy leaflet >95% 27%

Clinical trial information 4%

BACUP booklet >95% 10%

Audio-visual information 56% <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

Most common side effects 75%

Most serious side effects 52%

Mortality risk 9%

DOCUMENTATION ON CONSENT FORM

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.


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

ADMINISTRATION

SACT PRESCRIPTIONS SACT PRESCRIPTIONS

PRE-TREATMENT ASSESSMENTSPRE-TREATMENT ASSESSMENTS

STAFF - TRAINING AND ACCREDITATION STAFF - TRAINING AND ACCREDITATION

Authorisation to prescribe SACT

List maintained Initiator Prescriber

Yes 77% 71%

Unknown 24/285 28/285

STANDARD

Chemotherapy must be initiated and prescribed only by clinicians who are appropriately accredited and/or experienced

Good Practice Guidance for Clinical Oncologists: RCR

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 treatmentshould 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 computergenerated 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.


Toxicity check lists should be developed to assist record keeping and aid the process of care in prescribing SACT.


Safety of SACT delivery

LIMIT SACT TOXICITY

LIMIT SACT TOXICITY

NURSE CHECKS NURSE CHECKS

PHARMACY CHECKS PHARMACY CHECKS

DOSE REDUCTIONS / TREATMENT DELAYS DOSE REDUCTIONS / TREATMENT DELAYS

Adjustments to SACT regimen

Prescription safety checks

Prescriptions checked Parenteral Oral

Yes 97% 73%

Unknown 21/295 30/295

Prescriptions reviewed 369

Evidence that the prescription had been checked

53%

STANDARD

All cytotoxic chemotherapy prescriptions should be checked and authorised by a pharmacist.

Manual for Cancer Services: 2004

SACT administration safety checks

STANDARD

Doctors or specialist nurses who administerchemotherapy 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

89%

of organisations

EVIDENCE – two nurses checked SACT

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





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

• 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

Emergency admission policies

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.


Every acute hospital should have writtenguidelines on the diagnosis andmanagement of neutropenic sepsis. Allmedical staff should be aware of theirexistence and a copy should be readilyavailable in all relevant clinical areasincluding Accident & Emergency.



Networks should agree, document anddisseminate guidelines for bothprophylaxis and management ofneutropenic sepsis …… These patients should be managed by a specialisthaemato-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






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)





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 SACTshould be considered at a morbidityand mortality or a clinicalgovernance meeting.

(Clinical directors and consultants)

Thank you

www.ncepod.org.uk

Documents

Aim