Risk management of anticoagulation: Lessons from the Safer Patients Initiative

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Risk management of anticoagulation Lessons from
the Safer Patients Initiative

• Kevin Gibbs
• Pharmacy Manager Clinical Services

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Workshop aims

• 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

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Risk with anticoagulantsNRLS reports Serious
incidents

• Anticoagulants
• Jan 05 Jun06
• 8 serious harm
• 2 deaths
• 10.9 of reported serious incidents
• Main issues
• Communication
• Monitoring systems

• Opiates
• 13
• All incidents
• 54 serious harm
• 38 deaths

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Risk with anticoagulantsNegligence claim reports

• 600 reports harm or near harm 1990-2002
• 120 of these resulted in a death
• 77 of these from warfarin, 23 from heparin
• 88 of the warfarin reports resulted in death
• 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.
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Risk with anticoagulantsAdverse events reported
to MDU
1977-2002
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NPSA recommendations SOPs

• 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

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Identification of riskFailure Modes and Effects
Analysis (FMEA)
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Tools for improvement
PDSA cycles
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What PDSA cycles would you try out?
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Lessons learnt

• Rapid PDSA cycling
• Ward champions
• Clinician buy-in
• How to achieve reliability
• How do you spread?
• Measurement How we are doing?
• Sustaining this

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Identification of adverse events (ADEs) Using a
trigger tool
Trigger category Trigger Notes on finding or interpreting data
Medications or other treatments Vitamin K / phytomenadione / Konakion (oral or intravenous) Prescription chart once only, when required or regular sections
Protamine Prescription chart once only, when required or regular sections Required to reverse heparin. Possible haemorrhage.
Fresh frozen plasma Medical notes Required to reverse heparin. Possible haemorrhage.
Prothrombin complex concentrate e.g. Beriplex Medical notes Required to reverse warfarin Possible haemorrhage.
Blood transfusion Medical notes Possible haemorrhage
Chlorphenamine / Piriton (oral or intravenous) 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..
Laboratory results INR gt 5 Higher risk of haemorrhage with warfarin therapy
INR 0.5 units below the patients target range Higher risk of clotting
aPTT ratio gt7 Higher risk of haemorrhage with heparin infusion therapy
Platelet count lt 150 x 109/l Thrombocytopenia

• Analysis of 20 random sets of notes per month

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Classification of ADEs

• Categories recorded

• 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

http//www.nccmerp.org/pdf/algorColor2001-06-12.pd
f
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Anticoagulation-related adverse drug events
UHBristol
ADEs at interface included
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Anticoagulation-related adverse drug events All
SPI Trusts
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INRs above 4UHBristol in-patients
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INRs above 5UHBristol in-patients
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INRs above 6UHBristol in-patients
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INRs above 8UHBristol in-patients
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Further information Institute for Healthcare
ImprovementWebsite Tools and resources
www.ihi.org
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Further reading resources

• Saferhealthcare.org
• http//www.saferhealthcare.org.uk/ihi
• World Alliance for Patient Safety
• http//www.who.int/patientsafety/about/en/index.ht
  ml
• Institute for Healthcare Improvement
• http//www.ihi.org/ihi
• Institute for Safe Medication Practices
• http//www.ismp.org/