1. Medication errors and patient safety Vic Vernenkar, D.O. Department of Surgery St. Barnabas Hospital

2. Quality in Healthcare Begins with ensuring patient safety

3. Patient safety Freedom from injury or illness resulting from the processes of healthcare

4. Healthcare errors Top worry of patient!

5. Healthcare errors  Failure to diagnose / incorrect diagnosis  Failure to utilise or act on diagnostic tests  Inappropriate use or outmoded diagnostic tests / treatments  Failure to monitor or provide follow-up  Wrong site surgery, medication errors  Transfusion mistakes

6. Healthcare errors  Nosocomial infections  Patients falls  Pressure sores  Phlebitis associated with intravenous lines  Restraint related strangulation  Preventable suicides  Failure to provide prophylaxis

7. How big is the problem?  USA errors by HCWs affect about 3-4% patients errors by HCWs affect about 3-4% patients mean of 7% ADEsmean of 7% ADEs >7,000 ADE deaths / year>7,000 ADE deaths / year 2 million nosocomial infections / year2 million nosocomial infections / year average ICU patient experiences almost 2 errors per dayaverage ICU patient experiences almost 2 errors per day each year, 44,000 - 98,000 deaths due to medical errors each year, 44,000 - 98,000 deaths due to medical errors annual cost of medical errors: US$29 billion annual cost of medical errors: US$29 billion

8. Medication errors  Prescribing errors  Administration errors includes failure to monitor drug levels and side effects of treatment includes failure to monitor drug levels and side effects of treatment

9. Medication errors  Rate of 3.99 per 1000 medication orders (Albany, NY, USA) a third had potential to cause adverse events a third had potential to cause adverse events  Common factors failure to take account of declining renal/hepatic function failure to take account of declining renal/hepatic function failure to check for possible allergic responses failure to check for possible allergic responses using wrong drug name or means of administration using wrong drug name or means of administration miscalculation of dosage miscalculation of dosage prescribing an unusual critical frequency of dose prescribing an unusual critical frequency of dose Lesar et al. Factors related to medication errors. JAMA 1997; 277: 312-7

10. Why did it happen?  Technology e.g. infusion pumps  Many care-givers  High acuity of illness / injury  Environment prone to distraction  Time-pressured, need to make quick decisions  High volume, unpredictable patient load

11. Key reasons  Patients are more at risk than non-patients  Medical interventions are, by their nature, high-risk procedures - small error margins  Medicine remains an inexact, hands-on endeavour

12. Errors are inevitable ………….but most are preventable

13. Facts  Often it is the best people who make the worst errors  About 90% of errors are not culpable  But some people knowingly adopt behaviors more likely to produce error - substance abuse, long working hours

14. Organisational accident model Organisational and corporate culture Contributory factors influencing clinical practice TaskDefence barriers Accident or incident Management decisions and organisational processes Error producing conditions Violation producing conditions Errors Violations James T Reason

15. Process review and change

16. Whose job is it? - Risk Manager?

17. Lessons from past  Problems often formally recognised when there is a major incident  Methodologies for organisational analysis not well developed  Short-term corrective action not well sustained  Problems in dealing with aftermath of service failure - grievance of victims and their families

18. Failure in standard of care Detect Analyse Take corrective action Sustain corrective action Deal with consequences Prevent similar problem Cycle of prevention

19. Recommendations  Leadership priority  Clear organisational commitment to patient safety (infrastructure and resources)  No-blame culture

20. Culture of safety  Integrated pattern of behaviour  Underlying philosophy and values  Continuos search to minimise hazards and patient harm

21.  Acknowledges high risk, error prone nature  Widespread shared acceptance of responsibility for risk reduction  Open communication about safety concerns, non-punitive environment  Reporting of errors and safety concerns Culture of safety

22.  Learns from errors  Accountability for patient safety  Organisational structure, processes, goals and rewards aligned with improving patient safety Culture of safety

23. Strategy 1: teams  Implement known safe practices  Design work so that it is easy to do it right and hard to do it wrong  Reduce reliance on memory  Less steps  Constraints  Protocols and checklists Clinical Pathways Care process models

24. Teams - lessons from the navy  Members monitor each other’s performance and stepped in to to help out. TRUST was an implicit part of this.  Giving and receiving feedback was norm for all team members. Understanding each other’s role is important part.  Communication was made real: senders checked their messages were received as intended.

25. Teamwork and team leadership  Good teams do not develop on their own organisational culture of welcoming openness and monitoring changes that result organisational culture of welcoming openness and monitoring changes that result  Good team leadership is essential development is vital across organisation development is vital across organisation

26. Hospital team activities  Improving information access hospital teams redesigned medication administration records hospital teams redesigned medication administration records  Standardising and simplifying medication procedures teams worked on high risk and high error-potential drugs teams worked on high risk and high error-potential drugs  Restricting physical access to potentially lethal drugs chemotherapy drugs, concentrated KCl, NaCl chemotherapy drugs, concentrated KCl, NaCl  Educating clinical staff about medications to assess knowledge deficiencies, drug knowledge, awareness for potential for error to assess knowledge deficiencies, drug knowledge, awareness for potential for error Silver et al. Reducing medication errors in hospitals: a peer review organisation collaboration. J Qual Improvement 2000; 26: 332-40

27.  Recognise effect of fatigue on performance  Education and training for safety  Teamwork  Reduce known sources of confusion Strategy 2: education AwarenessEducation

28. Training and supervision  Training in organisational aspects of care medical training focuses on diagnosis and management of individuals medical training focuses on diagnosis and management of individuals  Training in skills of risk management understanding of inevitability of human error understanding of inevitability of human error factors associated with errors, mistakes and near misses factors associated with errors, mistakes and near misses appropriate checking behaviour, safe handover appropriate checking behaviour, safe handover team work team work

29. Strategy 3: accountability  Acknowledge error  Apologise  Provide remedial care  Conduct root cause analysis  Fix system or process problems Risk management system Sentinel event team

30. Clinical incident reporting system  Success depends on change in culture staff must be convinced of importance of patient safety staff must be convinced of importance of patient safety board has to agree on “no-blame” culture board has to agree on “no-blame” culture systematic and strategic approach to risk management systematic and strategic approach to risk management reporting system must produce reports that are timely and informative reporting system must produce reports that are timely and informative

31. Main Incident Page – Reporting Person

32. Risk Management System (RMS) Reporting Nurse Injured Staff Reporting Doctor Nurse ManagerFollow-up Doctor Head of Department / Division Chairman Assist. Director Nursing Dept Of Quality Management Infection Control (Sharp only) Fall Report CEO/CMB CMB / Administrator Sharp Report Doctor Management Sharp Report Supervisor / Manager Sharp Report Reporting Person Fall Report Pharmacy Manager Medication Error Report Medication Error Report Medication Error Report Sharp Report Sharp Report Sharp Report Fall Report Sharp Report

33. Risk Management System

34. Sentinel Event Team  CEO  CMB  Administrator, Nursing  Director, QM  Administrator, Medical Board

35. Sentinel Event Team Incident reporting, complaints Category I SET discussion Appoints team to investigate

36. Root cause analysis  Reviewing the process What happen? What happen? How did it happen? How did it happen? Why did it happen? Why did it happen? What can we do differently? What can we do differently?

37. MOH requirement  Report within 7 days of knowing  Submit full report within 60 days  De-identify  Objective: how can we improve what happen, how did it happen, why did it happen, can we do differently? what happen, how did it happen, why did it happen, can we do differently?

38. Impact “As evidence in support of the value of the changes made to our processes, we observed no further fatal ADEs…..” John Rex et al. Systematic root cause analysis of adverse drug events in a tertiary referral hospital. J Qual Improvement 2000; 26: 563-75

39. Key findings in IOM report: Key findings in IOM report: Errors occur because of system failures Preventing errors means designing safer systems of care To Err is Human.Institute of Medicine, 2000.Committee on Quality of Health Care in America.

40. IOM report  Avoid reliance on memory  Use constraints or forcing functions  Avoid reliance on vigilance  Simplify key processes  Standardise work processes

41. Institutional practice  C linical risk management system P lan P lan P rocess P rocess P eople P eople  C ulture LEADERS LEADERS