Transcript Risk management of anticoagulation: Lessons from the Safer

Risk management of
anticoagulation: Lessons from the
Safer Patients Initiative
Kevin Gibbs
Pharmacy Manager: Clinical Services
Workshop aims
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To use failure modes and effects analysis
(FMEA) to identify areas of risk
Describe how we used PDSA cycles in practice
to test change of a new anticoagulant chart
Design a PDSA cycle
Share the lessons that learnt on reliability and
of spreading of tests of improvement
How to use performance indicators
Risk with anticoagulants:
NRLS reports: Serious incidents
Anticoagulants
Jan ‘05 – Jun’06
8 serious harm
 2 deaths
= 10.9% of reported
serious incidents
Opiates
 13%
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Main issues
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Communication
Monitoring systems
All incidents
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54 serious harm
38 deaths
Risk with anticoagulants:
Negligence claim reports
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600 reports harm or near harm 19902002
120 of these resulted in a death
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77% of these from warfarin, 23% from
heparin
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88% of the warfarin reports resulted in death
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76% in primary care
Inadequate laboratory monitoring
Clinically significant drug interactions, usually
involving NSAIDs
Cousins D, Harris W. Risk assessment of anticoagulant therapy. NPSA Jan 2006.
Risk with anticoagulants:
Adverse events reported to MDU
1977-2002
NPSA recommendations: SOPs
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How to risk assess patients
Information commenced for patients before
discharge
Initiation including low initial dosing for AF
Monitoring and dose adjustment
Safe systems for documenting results
Effective communication systems, e.g. on
discharge
Annual clinical review
How to safely discontinue anticoagulation
Identification of risk
Failure Modes and Effects Analysis (FMEA)
Tools for
improvement
The Model for
Improvement
What are we trying to
Accomplish?
How will we know that a
change is an improvement?
PDSA
cycles
What change can we make that
will result in improvement?
Act
Plan
Study
Do
What PDSA cycles would you
try out?
Lessons learnt
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Rapid PDSA cycling
Ward champions
Clinician buy-in
How to achieve reliability
How do you ‘spread’?
Measurement – How we are doing?
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Sustaining this
Identification of adverse events
(ADEs): Using a trigger tool
Trigger category
Medications or other
treatments
Trigger
Vitamin K / phytomenadione /
Konakion®
(oral or intravenous)
Protamine
Analysis of 20
random sets
of notes per
month
Notes on finding or interpreting data
Prescription chart: once only, when
required or regular sections
Prescription chart: once only, when
required or regular sections
Required to reverse heparin. Possible
haemorrhage.
Fresh frozen plasma
Prothrombin complex concentrate
e.g. Beriplex
Blood transfusion
Chlorphenamine /
Piriton®
(oral or intravenous)
Laboratory results
Medical notes
Required to reverse heparin. Possible
haemorrhage.
Medical notes
Required to reverse warfarin Possible
haemorrhage.
Medical notes
Possible haemorrhage
Prescription chart: once only, when
required or regular sections Antihistamine.
Possible rash or sensitivity reaction
Adrenaline injection
Prescription chart: once only, when
required or regular sections Antihistamine.
Possible allergic reaction or anaphylaxis..
INR > 5
Higher risk of haemorrhage with warfarin
therapy
Higher risk of clotting
INR 0.5+ units below the patients
target range
aPTT ratio >7
Platelet count < 150 x 109/l
Higher risk of haemorrhage with heparin
infusion therapy
Thrombocytopenia
Classification of ADEs
Categories recorded
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http://www.nccmerp.org/pdf/algorColor2001-06-12.pdf
E: Temporary harm to the
patient and required
intervention
F: Temporary harm to the
patient and required initial
or prolonged hospitalization
G: Permanent patient harm
H: Intervention required to
sustain life
I: Patient death
Anticoagulation-related adverse drug
events: UHBristol
ADEs at
interface
included
Anticoagulation-related adverse drug
events: All SPI Trusts
INRs above 4
UHBristol in-patients
INRs above 5
UHBristol in-patients
INRs above 6
UHBristol in-patients
INRs above 8
UHBristol in-patients
Further information: Institute for Healthcare Improvement
Website – Tools and resources
www.ihi.org
Further reading & resources
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Saferhealthcare.org
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World Alliance for Patient Safety
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http://www.who.int/patientsafety/about/en/
index.html
Institute for Healthcare Improvement
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http://www.saferhealthcare.org.uk/ihi
http://www.ihi.org/ihi
Institute for Safe Medication Practices
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http://www.ismp.org/