Transcript NPSA Chemotherapy Project

NPSA Chemotherapy Project
Dermot Ball
Chemotherapy Project Pharmacist
[email protected]
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Structure & function of the NPSA
Chemotherapy Project
Oral chemotherapy Treatment Plan
BNF Chapter 8
Website
About the NPSA
Arms length body of the Department of Health
• NRES- National Research Ethics Service
provides safety and dignity of research participants by facilitating ethical
research
• NCAS- National Clinical Assessment Service
provides confidential services to help manage concerns with the
performance of practitioners
• NRLS- National Reporting and Learning Service
improves patient safety by enabling the NHS to learn from patient
safety incidents
The journey so far
An Organisation with a Memory (June 2000)
‘failures often have a familiar ring….strong
similarities to incidents which have
occurred before…almost exact replication’
Building a Safer NHS for Patients (May 2001)
‘A new independent body, the NPSA, will be
established within the NHS’
Safety First (Dec 2006)
‘NRLS should identify sources of risk and
harm…acted upon at a local and national level’
Size of the problem
• ‘First do no harm’ or ‘to help, or at least do no harm’
(Hippocrates 4th Century BC)
• Medical error accepted as part of practice
• A study in the USA estimated that 44,000 to 98,000
die each year from medical mistakes1
• NHS hospitals – harm in about 10% admissions – in
excess of 850,000 a year
• £2 billion a year in additional hospital stays
• £400 million a year in negligence claims
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Brennan et al. (1991) New England Journal of Medicine 324:377-384
Patient Safety Incident (PSI)
• A patient safety incident is an event or
circumstance which could have resulted, or
did result, in unnecessary harm to a patient.
• An adverse event is an incident which
results in harm to a patient.
Errors and violations
• An error may be defined as a failure to carry
out a planned action as intended or
application of an incorrect plan.
• A violation implies deliberate deviation from
an operating procedure, standard or rule.
Incident vs Error
• Cardiac arrest under general anaesthesia
• Related to violations
• About 75% of adverse events involve error
Contributing Factor
• A circumstance, action or influence which is
thought to play a part in the origin or
development of an incident, or to increase
the risk of an incident.
e.g. distraction/inattention, fatigue/exhaustion,
cognitive factors, communication,
protocols/procedures, resources/workload.
Part of clinical governance
• "A framework through which NHS organisations are
accountable for continually improving the quality of
their services and safeguarding high standards of
care by creating an environment in which
excellence in clinical care will flourish."
G Scally and L J Donaldson, 'Clinical governance and the drive for quality
improvement in the new NHS in England' BMJ (4 July 1998): 61-65
Part of quality
Effectiveness
Efficiency
Safety
Patient-centred
Appropriateness
Access
Nothing new
- 400 years ago -
- 300 years ago -
“Cure the disease
and kill the patient”
Francis Bacon
(1561-1626)
“Cur’d yesterday of my disease,
I died last night of my physician”
Matthew Prior
(1664-1721)
- 200 years ago -
“I do not want two diseases - one nature-made, one doctor made”
Napoleon Bonaparte
(1769-1821)
Patient Safety Is Important
Unsafe Care
Safer Care
significant source of patient
morbidity and mortality - major
cause of distress to patients
and families
not just a by-product of well
educated, well intentioned staff needs to be ‘hardwired’ into the
design and delivery of
systems of care…..
we need safe individuals and
safe systems
The Role of the NPSA and the
Reporting and Learning System
capture and analyse incidents
learn from mistakes
change practice & system factors to reduce risk
improve patient safety in the NHS
NPSA philosophy
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learn from things that go wrong
improve patient safety in frontline services
systems not individuals
learning not judgement
fairness not blame
openness not secrecy
develop and implement solutions to problems
Incident Reporting
• Adapted from the critical incident technique in
aviation
• Relies on good safety culture
• Inherent value is in the learning
• Near misses collected
• Should not be used for epidemiological analysis
• Under-reporting will always occur
Reporting Routes
FRONTLINE STAFF
Local
paper
form
Local
eform
RISK TEAM
Specifics e.g.
HSE, MHRA
SHAs or WAG
(SUIs)
RLS
Patient
NPSA
eform
Reporting to NPSA
Analysis
tools
eform
Data Cleansing
99% upload
from
local trust
reporting system
RLS
Database
Reports &
Analysis
Currently most reporting comes from the acute sector
Reported incident types
Chart 1: Number of incidents reported and organisations reporting by quarter, October
2003 to December 2007
Average proportion of trusts
reporting per month
Number of incidents
reported
300,000
80%
Incidents submitted
Average proportion of trusts reporting per month
70%
250,000
60%
3 million
incidents
Jan 2009
200,000
150,000
50%
40%
30%
100,000
20%
50,000
10%
0
0%
Oct Dec
2003
Jan Mar
2004
Apr Jun
2004
Jul Sep
2004
Oct Dec
2004
Jan Mar
2005
Apr Jun
2005
Jul Sep
2005
Oct Dec
2005
Jan Mar
2006
Apr Jun
2006
Jul Sep
2006
Oct Dec
2006
Jan Mar
2007
Apr Jun
2007
Jul Sep
2007
Oct Dec
2007
Outputs
NRLS
RLS
Database
6 monthly Standard Ad hoc
Extranet report
report
feedback
reports
QDS
DMG
Safety
Case Review
Solutions
FOI
Filtered on
severity, themes
DH
Parliamentary
SHA Questions
WAG
Quarterly Reports
• Trends in reporting and
profile of reports
• Clinical topics in each issue
such as:
• Chemotherapy Project
• Available on website
Thematic Analysis
• 424/576 deaths reported to the NRLS in
2005/06 occurred in acute hospitals
• 3 key themes:
o Diagnostic errors (n = 71)
o Clinical deterioration not recognised or
not acted upon (n = 64)
o Problems with resuscitation after
cardiopulmonary arrest (n = 43 in
acute/general hospitals)
In-depth Analysis on Topics and Issues
2000
Systematic review of RLS death & severe incidents
Systematic review of STEIS reports
Ad hoc incident / issue reports e.g. coroners, clinicians
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Incidents & issues considered by
the Weekly Response Group
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Issues followed up
with mini-scope
e.g. RLS search,
basic literature
search
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Fullscope
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Acting on Urgent Risks
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Fast-track urgent issues
identifies immediate action
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System to track activity with
deadline
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Evaluation shows support for
one-pager
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Oral chemotherapy
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Vinca Alkaloids
Outputs – to improve patient
safety guidance
Adapted from REASON, 2005
Organisation
Environment
Factors within
the healthcare
system that
could potentially
lead to harm
Workspace
The ‘system’
Task
Equipment
People
    Staff     
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Patients
Staff act
as harm
absorbers
Cancer Projects
• Radiotherapy
• Chemotherapy
• Early Diagnosis
Chemotherapy Project
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Between Nov 2003 and June 2008
219,000 patient safety reports (medication)
4829 (2.2%) anti-cancer medicines
Manual validation 25/272
8 Deaths, 9 Severe Harm, 8 Moderate Harm
6 deaths associated with ORAL CHEMOTHERAPY
>95% resulted in Low Harm or No Harm
Chemotherapy Project
• 43% of errors associated with administration
• 33% of errors associated with wrong dose,
frequency or quantity of medication
• 18% of errors associated with delayed or
omitted treatment
Chemotherapy Project
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Taxanes – 436 reports
Cisplatin – 404 reports
Etoposide – 396 reports
Capecitabine – 368 reports
Cyclophosphamide – 359 reports
35 named drugs
Chemotherapy Project
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Quantitative data - limitations
Qualitative data - limitations
Eight emerging themes
Trends
20 recommendations
Links to NCEPOD, NCAG
Chemotherapy Project
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Data often incomplete
No specific research question
Exaggeration of degree of ACTUAL harm
Potential harm not easy to assess
Large amounts of ‘noise’
• Side effects, ADR, extravasation, protocols
followed correctly
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An F2 doctor was electronically prescribing chemotherapy whilst his
consultant, oncology pharmacist and System Administrator were away
on annual leave.
The patient’s serum creatinine was not automatically entered on the
system, so the doctor attempted to do it manually.
The level was entered incorrectly and a low creatinine clearance was
subsequently produced.
This resulted in a low dose of carboplatin being calculated, which the
doctor amended manually by changing the AUC to 30.1 resulting in a
500% dose increase.
Three weeks later a second unsupervised F2 doctor, again working
without Consultant supervision prescribed further carboplatin for the
same patient. The dose of 4875mg was queried by the pharmacist and
reduced(!)
• A patient had been changed from OxMdG to capecitabine and
oxaliplatin. The nurse selected the OxyCap regimen from the
computer, and they received their first cycle. On returning for
their second cycle it was realised they should have received
XelOx. On the computer OxyCap referred to an arm of FOCUS 2
which delivered a 30% dose reduction of the two drugs.
• A patient was receiving ifosfamide and Mesna and three doses of
Mesna were omitted resulting in the patient experiencing
haemorrhagic cystitis.
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A 69 year-old patient with relapsed multiple myeloma received four
times the intended dose of idarubicin. He was admitted with neutropenic
sepsis from which he did not recover and he died 11 days after
commencing the idarubicin.
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In the process of completing an SAE form following the sudden death of
a patient, it was noticed that he had received four cycles of capecitabine
at 1250mg/m2. As the patient was >70 yrs the QUASAR TT protocol
indicates that his maximum dose should have been 1000mg/m2.
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A chemotherapy trial patient was admitted due to acute breathlessness.
Scans had shown pulmonary fibrosis, pulmonary emboli and a pleural
effusion. He died in ITU 6 days later of pulmonary fibrosis secondary to
receiving an overdose of bleomycin - on seven separate occasions.
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A patient had received two prior cycles of PECC for relapsed NHL
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Prednisolone 40mg daily for 7/7 days
Etoposide 400mg daily for 3/7 days
Chlorambucil 40mg daily 4/7
CCNU 200mg daily 1/7
For his third cycle the prescription was misread and he received
• Etoposide 400mg daily for 8 days
• CCNU 200mg daily for 7 days
• Prednisolone & Chlorambucil were correctly supplied
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The patient’s concerns regarding the extra medication were ignored
He was admitted 10 days after starting 3rd cycle with toxicity
He died 30 days after admission as a result of the excessive doses
BNF Chapter Eight
• “A little knowledge is a dangerous thing”
• Long standing concern regarding the advice it offers
and how it’s interpreted
• Doesn’t fully reflect the complexities of current
chemotherapy, especially oral treatments
• Lack of consistency re; dosing information
• Status of BNF “brand” may provide a false sense of
security for non-specialists
• Cancer professionals use other sources
BNF Chapter Eight
“Be very afraid……”
Main focus is introductory section
Standardisation of drug monographs?
BNF acknowledge that some changes may
be required
• Draft chapter for consultation
• BNF editorial policy
• Oncology Pharma input?
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Treatment Plan
• Open to interpretation!
• Is it a Protocol – no
• Is it a Patient Diary – no
• Is it something in between – probably!
Treatment Plan
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Not designed as patient information
Not part of the Information Prescription project
Target audience is primarily non-specialists
Patient is the ‘conduit’
Potentially valuable during any health care intervention;
• Admission
• Discharge
• Dispensing
• Reviewing
The information on this side of the card is designed specifically for health professionals who may need to know about your treatment. It is NOT a prescription and
cannot be used to obtain extra supplies of your tablets.
Treatment Plan for Oral Chemotherapy for < John Smith >DOB < 11/12/1940 > who is taking oral
FOUR cycles
CYCLE No 1
Days of Treatment……14.
First day……12 Sept 08……
Last day…
25 Sept 08……...
Capecitabine
Treatment Authorised
By B Brown
Date 10 Sept 08
for a maximum of
Next Review/Blood
Test on
1 Oct 08.
Date
12 Sept
13 Sept
14 Sept
15 Sept
16 Sept
17 Sept
18 Sept
19 Sept
e
t
c
Daily
Dose
2150mg
2150mg
2150mg
2150mg
2150mg
2150mg
2150mg
2150mg
e
t
c
CYCLE No 2
Date
Daily Dose
<Rows Repeated>
Days of Treatment……
First day…………
Last day…
……...
Treatment Authorised
By
Date
Next Review/Blood
Test on
ORAL CHEMOTHERAPY
TREATMENT PLAN
Date of issue
10 September 2008
John Smith
This card contains detailed
information regarding your
chemotherapy. You should carry it
with you at all times and show it to any
doctor, nurse, pharmacist or other
health professional who is giving you
care or advice.
You are being treated at;
NHS/Hospital Number
St.Elsewhere’s Hospital
123456789/A
Your Consultant is;
Dr. Brown
………………………………
Patient Name;
Address
12 Acacia Gardens
Anytown
Berks
AY1 2BC
Contact Details;
Phone 0123 456 0987
Email [email protected]
Telephone
0123 456 7890
Your chemotherapy regimen is
called;
CAPOX
You will be receiving TWO
different chemotherapy drug (s).
Some of the drugs will be in the
form of tablets or capsules and
they are called
Capecitabine (Xeloda)
and the strength of the tablet (s)
are
150mg and 500 mg.
You may take the tablets every
day without stopping or you may
take the tablets for
14 day (s) at a time and then
have break of 7 days.
Look at the label on your
tablets for exactly how you
should take them.
You may also be receiving
chemotherapy injections in the
hospital clinic.
Web-based support
• Cancer Network websites as a resource for
(oral) chemotherapy safety?
• 30 Networks, ~ 5 have readily accessible
information on chemotherapy protocols
• Web site quality extremely variable!
• NPSA to develop a standard template with
North of England Cancer Network
• To be continued…….
Summary
• Patient Safety is part of NHS care
• Incident reporting is the key to learning
• Admitting failure is the sign of a mature
organisation
• Learning needs to take place at local and
national level
• Cancer patients can benefit from patient
safety initiatives
Any Questions?