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Risk management of anticoagulation: Lessons from the Safer Patients Initiative Kevin Gibbs Pharmacy Manager: Clinical Services 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 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% Main issues Communication Monitoring systems All incidents 54 serious harm 38 deaths Risk with anticoagulants: Negligence claim reports 600 reports harm or near harm 19902002 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. Risk with anticoagulants: Adverse events reported to MDU 1977-2002 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 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 Rapid PDSA cycling Ward champions Clinician buy-in How to achieve reliability How do you ‘spread’? Measurement – How we are doing? 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 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 Saferhealthcare.org World Alliance for Patient Safety http://www.who.int/patientsafety/about/en/ index.html Institute for Healthcare Improvement http://www.saferhealthcare.org.uk/ihi http://www.ihi.org/ihi Institute for Safe Medication Practices http://www.ismp.org/
