NPSA Chemotherapy Project

Dermot Ball

Chemotherapy Project Pharmacist

dermot.ball@npsa.nhs.uk

• Structure & function of the NPSA• Chemotherapy Project• Oral chemotherapy Treatment Plan• BNF Chapter 8• Website

About the NPSAArms length body of the Department of Health

• NRES- National Research Ethics Serviceprovides 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 Serviceimproves 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

1 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

Safety

Efficiency Effectiveness

Appropriateness

Access

Patient-centred

Part of quality

Nothing new- 400 years ago -- 400 years ago -

“Cure the disease “Cure the disease and kill the patient”and kill the patient”

Francis BaconFrancis Bacon(1561-1626)(1561-1626)

- 300 years ago -- 300 years ago -

“Cur’d yesterday of my disease, “Cur’d yesterday of my disease, I died last night of my physician”I died last night of my physician”

Matthew PriorMatthew Prior (1664-1721) (1664-1721)

-- 200 years ago -200 years ago -

“I do not want two diseases - one nature-made, one doctor made”“I do not want two diseases - one nature-made, one doctor made”Napoleon Napoleon

BonaparteBonaparte(1769-1821)(1769-1821)

Safer Carenot just a by-product of well

educated, well intentioned staff -

needs to be ‘hardwired’ into the design and delivery of

systems of care…..

Unsafe Care significant source of patient

morbidity and mortality - major cause of distress to patients

and families

Patient Safety Is Important

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

• 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

Local

paper

form

Specifics e.g.

HSE, MHRA

SHAs or WAG

(SUIs)Local

eform

NPSA

eform

RLS

RISK TEAMFRONTLINE STAFF

Patient

Reporting to NPSA

Data C

leansing

RLS

Database

Analysis tools

Reports & Analysis

99% upload from

local trust reporting system

eform

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

0

50,000

100,000

150,000

200,000

250,000

300,000

Oct -Dec2003

Jan -Mar2004

Apr -Jun2004

Jul -Sep2004

Oct -Dec2004

Jan -Mar2005

Apr -Jun2005

Jul -Sep2005

Oct -Dec2005

Jan -Mar2006

Apr -Jun2006

Jul -Sep2006

Oct -Dec2006

Jan -Mar2007

Apr -Jun2007

Jul -Sep2007

Oct -Dec2007

0%

10%

20%

30%

40%

50%

60%

70%

80%Incidents submitted

Average proportion of trusts reporting per month

Average proportion of trusts reporting per month

Number of incidents reported

3 million incidents Jan 2009

Outputs

SafetySolutions

Case Review

Filtered on severity, themes

QDSDMG DH

SHAWAG

FOI Parliamentary Questions

6 monthly Extranet feedback reports

Standard report

Ad hoc report

NRLS

Database

RLS

Database

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

4Full-

scope

20Issues followed up

with mini-scope e.g. RLS search, basic literature

search

50Incidents & issues considered by

the Weekly Response Group

2000Systematic review of RLS death & severe incidents

Systematic review of STEIS reportsAd hoc incident / issue reports e.g. coroners, clinicians

1

Acting on Urgent Risks

• Fast-track urgent issues identifies immediate action

• System to track activity with deadline

• Evaluation shows support for one-pager

• Oral chemotherapy

• Vinca Alkaloids

Outputs – to improve patient safety guidance

Adapted from REASON, 2005

People

Environment

Workspace

Task

Equipment

Staff

The ‘system’

Factors within the healthcare system that could potentially lead to harm

Staff act as harm absorbers

Organisation

Patients

Cancer Projects

• Radiotherapy• Chemotherapy• Early Diagnosis

Chemotherapy Project

• 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

• 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

Chemotherapy Project

• Taxanes – 436 reports• Cisplatin – 404 reports• Etoposide – 396 reports• Capecitabine – 368 reports• Cyclophosphamide – 359 reports• 35 named drugs

Chemotherapy Project

• Quantitative data - limitations• Qualitative data - limitations• Eight emerging themes• Trends• 20 recommendations• Links to NCEPOD, NCAG

Chemotherapy Project

• 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

• 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.

• 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.

• 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.

• 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.

• A patient had received two prior cycles of PECC for relapsed NHL• 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

• 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?

Treatment Plan• Open to interpretation!

• Is it a Protocol – no

• Is it a Patient Diary – no

• Is it something in between – probably!

Treatment Plan

• 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 Capecitabine for a maximum of FOUR cycles

CYCLE No 1

Days of Treatment……14.First day……12 Sept 08……Last day… 25 Sept 08……...

Treatment Authorised By B Brown

Date 10 Sept 08

Next Review/Blood Test on 1 Oct 08.

Date 12 Sept 13 Sept 14 Sept 15 Sept 16 Sept 17 Sept 18 Sept 19 Septetc

Daily Dose

2150mg 2150mg 2150mg 2150mg 2150mg 2150mg 2150mg 2150mg etc

CYCLE No 2

Days of Treatment……First day…………Last day… ……...

Treatment Authorised By

Date

Next Review/Blood Test on

Date

Daily Dose

<Rows Repeated>

ORAL CHEMOTHERAPY TREATMENT PLANDate of issue 10 September 2008

Patient Name;

John Smith

NHS/Hospital Number

123456789/A

Address

12 Acacia GardensAnytownBerksAY1 2BC

Telephone

0123 456 7890

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;

St.Elsewhere’s Hospital

Your Consultant is;Dr. Brown………………………………

Contact Details;

Phone 0123 456 0987

Email drbrown@Trust.nhs.uk

Your chemotherapy regimen is called;

CAPOXYou will be receiving TWO

different chemotherapy drug (s). Some of the drugs will be in the form of tablets or capsules and

they are calledCapecitabine (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?