Risk management of anticoagulation: Lessons from the Safer Patients Initiative

1. Risk management of anticoagulation: Lessons from the Safer Patients Initiative Kevin Gibbs Pharmacy Manager: Clinical Services

2. 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

3. Anticoagulants Jan ‘05 – Jun’06 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 Risk with anticoagulants:NRLS reports: Serious incidents

4. Risk with anticoagulants:Negligence 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.

5. Risk with anticoagulants:Adverse events reported to MDU 1977-2002

6. 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

7. Identification of riskFailure Modes and Effects Analysis (FMEA)

8. The Model for Improvement What are we trying to Accomplish? How will we know that a change is an improvement? What change can we make that will result in improvement? Act Plan Study Do Tools for improvement PDSA cycles

9. What PDSA cycles would you try out?

10. 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

11. Identification of adverse events (ADEs): Using a trigger tool Analysis of 20 random sets of notes per month

12. 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.pdf

13. Anticoagulation-related adverse drug events: UHBristol ADEs at interface included

14. Anticoagulation-related adverse drug events: All SPI Trusts

15. INRs above 4UHBristol in-patients

16. INRs above 5UHBristol in-patients

17. INRs above 6UHBristol in-patients

18. INRs above 8UHBristol in-patients

19. Further information: Institute for Healthcare ImprovementWebsite – Tools and resources www.ihi.org

20. Further reading & resources • Saferhealthcare.org • http://www.saferhealthcare.org.uk/ihi • World Alliance for Patient Safety • http://www.who.int/patientsafety/about/en/index.html • Institute for Healthcare Improvement • http://www.ihi.org/ihi • Institute for Safe Medication Practices • http://www.ismp.org/