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Medication errors and patient safety Vic Vernenkar, D.O. Department of Surgery St. Barnabas Hospital Quality in Healthcare Begins with ensuring patient safety Patient safety Freedom from injury or illness resulting from the processes of healthcare Healthcare errors Top worry of patient! 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 Healthcare errors Nosocomial infections Patients falls Pressure sores Phlebitis associated with intravenous lines Restraint related strangulation Preventable suicides Failure to provide prophylaxis How big is the problem? USA errors by HCWs affect about 3-4% patients • • • • mean of 7% ADEs >7,000 ADE deaths / year 2 million nosocomial infections / year average ICU patient experiences almost 2 errors per day each year, 44,000 - 98,000 deaths due to medical errors annual cost of medical errors: US$29 billion Medication errors Prescribing errors Administration errors includes failure to monitor drug levels and side effects of treatment Medication errors Rate of 3.99 per 1000 medication orders (Albany, NY, USA) a third had potential to cause adverse events Common factors failure to take account of declining renal/hepatic function failure to check for possible allergic responses using wrong drug name or means of administration miscalculation of dosage prescribing an unusual critical frequency of dose Lesar et al. Factors related to medication errors. JAMA 1997; 277: 312-7 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 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 Errors are inevitable ………….but most are preventable 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 Organisational accident model Organisational and corporate culture Management decisions and organisational processes James T Reason Contributory factors influencing clinical practice Task Defence barriers Accident or incident Error producing conditions Errors Violation producing conditions Violations Process review and change Whose job is it? - Risk Manager? 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 Cycle of prevention Failure in standard of care Prevent similar problem Detect Deal with consequences Sustain corrective action Take corrective action Analyse Recommendations Leadership priority Clear organisational commitment to patient safety (infrastructure and resources) No-blame culture Culture of safety Integrated pattern of behaviour Underlying Continuos philosophy and values search to minimise hazards and patient harm Culture of safety 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 Learns from errors Accountability for patient safety Organisational structure, processes, goals and rewards aligned with improving patient safety 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 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. Teamwork and team leadership Good organisational culture of welcoming openness and monitoring changes that result Good teams do not develop on their own team leadership is essential development is vital across organisation Hospital team activities Improving information access Standardising and simplifying medication procedures teams worked on high risk and high error-potential drugs Restricting physical access to potentially lethal drugs hospital teams redesigned medication administration records chemotherapy drugs, concentrated KCl, NaCl Educating clinical staff about medications 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 Strategy 2: education Recognise effect of fatigue on performance Education and training for safety Teamwork Reduce known sources of confusion Awareness Education Training and supervision Training in organisational aspects of care medical training focuses on diagnosis and management of individuals Training in skills of risk management understanding of inevitability of human error factors associated with errors, mistakes and near misses appropriate checking behaviour, safe handover team work Strategy 3: accountability Acknowledge error Apologise Provide remedial care Conduct root cause analysis Fix system or process problems Risk management system Sentinel event team Clinical incident reporting system Success depends on change in culture staff must be convinced of importance of patient safety board has to agree on “no-blame” culture systematic and strategic approach to risk management reporting system must produce reports that are timely and informative Main Incident Page – Reporting Person Risk Management System (RMS) Fall Report Fall Report Sharp Report Reporting Nurse Fall Report Sharp Report Nurse Manager Sharp Report Sharp Report Follow-up Doctor Supervisor / Manager Sharp Report CMB / Administrator Sharp Report Sharp Report Sharp Report Doctor Management Fall Report Reporting Doctor Reporting Person CEO/CMB Assist. Director Nursing Sharp Report Injured Staff Fall Report Medication Medication Error Report Error Report Pharmacy Manager Head of Department / Division Chairman Dept Of Quality Management Medication Error Report Infection Control (Sharp only) Medication errors Sharps injury Clinical incident: morbidity mrotality surgical incident Patient falls RMS Risk Management System Cat I CMB and DQM informed within 6 H SET Root cause analysis by appointed team Cat I or Cat II? Cat II Report with investigation findings and recommendations to Division Chairman Report to CMB, CEO, and DQM Recommendations reported to SET HOD/Managers monitor to assure compliance with corrective actions and report back to RM Yes Recommendations implemented? No Operations informed to implement recommendations DQM presents findings, recommendations, summary analysis, and follow-up to RM, QC, reports number of events quarterly per department to QC as part of BSC Complaints Sentinel Event Team CEO CMB Administrator, Director, Nursing QM Administrator, Medical Board Sentinel Event Team Incident reporting, complaints Category I SET discussion Appoints team to investigate Root cause analysis Reviewing the process What happen? How did it happen? Why did it happen? What can we do differently? 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? 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 Key findings in IOM report: • Errors occur because of system failures • Preventing errors means designing safer systems of care Committee on Quality of Health Care in America. To Err is Human. Institute of Medicine, 2000. IOM report Avoid reliance on memory Use constraints or forcing functions Avoid reliance on vigilance Simplify key processes Standardise work processes Institutional practice Clinical risk management system Plan Process People Culture LEADERS