East South East England Specialist Pharmacy Services Risk

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East & South East England Specialist Pharmacy Services Risk Management and Learning from Errors

East & South East England Specialist Pharmacy Services Risk Management and Learning from Errors Richard Bateman QA Specialist Pharmacist, East and South East England Specialist Pharmacy Services

East & South East England Specialist Pharmacy Services Errors • • Occur Frequency Reasons

East & South East England Specialist Pharmacy Services Errors • • Occur Frequency Reasons Trends Benchmarking / Comparison Data Handling Corrective Action / Preventative Actions Learning?

East & South East England Specialist Pharmacy Services Learning from Errors • • Are

East & South East England Specialist Pharmacy Services Learning from Errors • • Are we good at this? Do we know where the problems are? Intrathecals? Potassium? Error / Exception Reporting systems Have you REALLY assessed your systems for existing risks Not just new products / systems

East & South East England Specialist Pharmacy Services Error Reporting • • Documentation RCA

East & South East England Specialist Pharmacy Services Error Reporting • • Documentation RCA What happened (Why? ) Fix it! (Stop it happening again? ) What Happened + Fix it = CA Why? + Stop it happening? = PA CAPA

East & South East England Specialist Pharmacy Services Error / Exception Reports • •

East & South East England Specialist Pharmacy Services Error / Exception Reports • • • Re-trained operator Reminded of principles of GMP Asked to be more careful Pay more attention Careful not to do again

East & South East England Specialist Pharmacy Services Conscious and Automatic Behaviour Knowledge Based

East & South East England Specialist Pharmacy Services Conscious and Automatic Behaviour Knowledge Based Improvisation in unfamiliar environment No rules available for handling situation Conscious Rule Based Set behaviour released when appropriate rule applied X goes wrong, so Y is the problem so do Z Skill Based Automatic routine needing less conscious attention Automatic

East & South East England Specialist Pharmacy Services Classification of Human Errors Human Failure

East & South East England Specialist Pharmacy Services Classification of Human Errors Human Failure Errors Slips Violations Mistakes Skill Based Routine Rule Based Knowledge Based Exceptional

East & South East England Specialist Pharmacy Services Human Factors • Human error cannot

East & South East England Specialist Pharmacy Services Human Factors • Human error cannot be eliminated • Errors rarely solely caused by technical failure / lack of knowledge • 80% accident causes due to breakdown in human interaction • Also need to focus on non technical skills

East & South East England Specialist Pharmacy Services Human Factors • • • Communication

East & South East England Specialist Pharmacy Services Human Factors • • • Communication Decision Making Situation awareness Leadership Teamwork Error management • How is behaviour influenced by: • The job • The individual • The organisation

East & South East England Specialist Pharmacy Services Human Factors Reading • http: //www.

East & South East England Specialist Pharmacy Services Human Factors Reading • http: //www. popularmechanics. com/technology/av iation/crashes/what-really-happened-aboard-airfrance-447 -6611877

East & South East England Specialist Pharmacy Services Risk Management • Assess continuously what

East & South East England Specialist Pharmacy Services Risk Management • Assess continuously what can go wrong • determine what risks are important to deal with • implement strategies to deal with those risks

East & South East England Specialist Pharmacy Services Aims • Risks continuously identified •

East & South East England Specialist Pharmacy Services Aims • Risks continuously identified • analyzed for relative importance • mitigated, tracked and controlled to effectively use resources. • Prevent problems before they occur. • Staff focus on what could affect product quality

East & South East England Specialist Pharmacy Services Aims • Shift from fire fighting

East & South East England Specialist Pharmacy Services Aims • Shift from fire fighting and crisis management • Proactive decision making to avoid problems before they occur • Insight into what can go wrong • Effective use of resources • The correct culture within the organisation

East & South East England Specialist Pharmacy Services National Aseptic Error reporting scheme •

East & South East England Specialist Pharmacy Services National Aseptic Error reporting scheme • Evaluate the type and frequency of occurrence of errors within aseptic processing activities • Attempt to quantify the number of incidents occurring in aseptic services units • Assign a “risk rating” (in terms of patient safety) to these incidents • Group incidents by identifying contributory factors

East & South East England Specialist Pharmacy Services National Aseptic Error reporting scheme •

East & South East England Specialist Pharmacy Services National Aseptic Error reporting scheme • • • 10 million + doses Summary Reports x 4 per year Processes where error occurred – not error rate in product supplied • Consistent – approx 1. 0% • Also with – error type and contributory factors

East & South East England Specialist Pharmacy Services Error Type • • Labelling (30

East & South East England Specialist Pharmacy Services Error Type • • Labelling (30 -35%) Transcription (15 -20%) Selection: drug, strength, diluent (12 -15%) Three categories – 70% Prioritise efforts National “Average” consistent Differences between units? Benchmarking, sharing best practice

East & South East England Specialist Pharmacy Services Potential Major and Critical Errors •

East & South East England Specialist Pharmacy Services Potential Major and Critical Errors • Labelling 22% • Selection 45% • Transcription 12%

East & South East England Specialist Pharmacy Services Error Type - Labelling • •

East & South East England Specialist Pharmacy Services Error Type - Labelling • • Unit 1 – 55% Unit 2 – 9% Unit 3 – 29% Reasons for variation? System? Checking? Process?

East & South East England Specialist Pharmacy Services Error Type - Transcription • •

East & South East England Specialist Pharmacy Services Error Type - Transcription • • Unit 1 – 3% Unit 2 – 24% Unit 3 – 22% System? Training? Checks? Workload?

East & South East England Specialist Pharmacy Services Error Type - Selection • •

East & South East England Specialist Pharmacy Services Error Type - Selection • • • Unit 1 – 12% Unit 2 – 14% Unit 3 – 15% Less Variation Packaging Design?

East & South East England Specialist Pharmacy Services Error Rates • • In Process

East & South East England Specialist Pharmacy Services Error Rates • • In Process – 1. 0% Released Product – 0. 02% Administered Product – 0. 005% How effective are systems? Compare with clinical areas? Most common error when released? Labelling, Transcription, Selection

East & South East England Specialist Pharmacy Services Error Type / Product Type •

East & South East England Specialist Pharmacy Services Error Type / Product Type • • • Cytotoxics Labelling – 56% Selection – 10% TPN Labelling – 33% Selection – 20%

East & South East England Specialist Pharmacy Services Contributory Factors • • • Human

East & South East England Specialist Pharmacy Services Contributory Factors • • • Human Error +++ Workload / Staffing Distraction / Interruptions Computer System Inadequate training

East & South East England Specialist Pharmacy Services Contributory Factors • • Local Variation

East & South East England Specialist Pharmacy Services Contributory Factors • • Local Variation – learn from trends? Unit A – Workload / Staffing 14% Unit B – Distractions / Interruptions 10% Unit C – Computer System – 8%

East & South East England Specialist Pharmacy Services Error Classification - Examples • •

East & South East England Specialist Pharmacy Services Error Classification - Examples • • • Catastrophic Neonatal TPN Dextrose 50% instead of 20%

East & South East England Specialist Pharmacy Services Neonatal TPN • Major • Strength

East & South East England Specialist Pharmacy Services Neonatal TPN • Major • Strength selection – dextrose, sodium chloride, calcium chloride, peditrace / additrace. • Sodium Chloride / Calcium Chloride • Potassium Chloride / Sodium Chloride • NB Selection on software? • Complex – number of ingredients? • Do you really understand control the risks in your compounding process? • Does the person releasing the product know how it is made and understand the risks?

East & South East England Specialist Pharmacy Services Error Examples - Cytotoxics • •

East & South East England Specialist Pharmacy Services Error Examples - Cytotoxics • • Cytarabine 100 mg/ml and 100 mg/5 ml Reported x 12 SUI in Trust Verbal reports ++

East & South East England Specialist Pharmacy Services Error Examples - Cytotoxics • •

East & South East England Specialist Pharmacy Services Error Examples - Cytotoxics • • Epirubicin / Doxorubicin confusion Cytotoxic syringes prepared in advance seen to be leaking past plunger – validation? , transport? Vinblastine / Vinorelbine confusion NB Vinorelbine incident! Wrong strength 5 FU x 3 Cyclophosphamide and 5 FU syringes prepared in advance. Wrong drug supplied x 4. Other dose banded syringe selection errors Specials labelling standards?

East & South East England Specialist Pharmacy Services NHS Production Unit Labelling • •

East & South East England Specialist Pharmacy Services NHS Production Unit Labelling • • Generally! No Colour Black/ White Single Label Font Size? Similar Appearance Bar Coding – patient safety, robotic dispensing

East & South East England Specialist Pharmacy Services Error Examples - CIVAS • •

East & South East England Specialist Pharmacy Services Error Examples - CIVAS • • • Cephalosporin selection errors Amoxicillin / Flucloxacillin Selection – Product, worksheet, labels

East & South East England Specialist Pharmacy Services Emerging trends • • • Some

East & South East England Specialist Pharmacy Services Emerging trends • • • Some errors seen over a long time period What about “new” products? Monoclonal selection errors – “…. mab” Infuser device selection errors Mitomycin Opthalmic preparation – concentration errors • Dose split between 2 containers – labelling errors

East & South East England Specialist Pharmacy Services NPSA alerts • • • Demand

East & South East England Specialist Pharmacy Services NPSA alerts • • • Demand for “new” products? These are likely to be HIGH risk Same principles apply – we CAN make mistakes as well! • Risk assessment • Checks and controls

East & South East England Specialist Pharmacy Services Why do selection errors occur? •

East & South East England Specialist Pharmacy Services Why do selection errors occur? • • • We know the reasons Look alike Sound alike Multiple strengths So surely we must have done something about this?

East & South East England Specialist Pharmacy Services Regulatory Compliance • • Licensed Products

East & South East England Specialist Pharmacy Services Regulatory Compliance • • Licensed Products Released to market Pharmaceutical Risk Management Regulatory Compliance does not guarantee safety in use

East & South East England Specialist Pharmacy Services

East & South East England Specialist Pharmacy Services

East & South East England Specialist Pharmacy Services

East & South East England Specialist Pharmacy Services

East & South East England Specialist Pharmacy Services

East & South East England Specialist Pharmacy Services

East & South East England Specialist Pharmacy Services Actions? • • Purchasing for safety

East & South East England Specialist Pharmacy Services Actions? • • Purchasing for safety PQA scoring Contracting decisions Awareness of issues Safe Medication Bulletins Pharma QC website Work with Pharma companies to improve and understand real life in use issues!

East & South East England Specialist Pharmacy Services Clear Information? • After reconstitution: Chemical

East & South East England Specialist Pharmacy Services Clear Information? • After reconstitution: Chemical and physical in-use stability has been demonstrated for 21 days at 25°C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution / dilution (etc) has taken place in controlled and validated aseptic conditions. Solutions should not be refrigerated, as crystallisation may occur. Reconstituted solution should be used immediately or may be stored for 6 hours.

East & South East England Specialist Pharmacy Services Statistically significant associations? • Are there

East & South East England Specialist Pharmacy Services Statistically significant associations? • Are there statistically significant association between types and severity of errors and reporting categories within the scheme? • Highlights only selected – much more detail in paper!

East & South East England Specialist Pharmacy Services Product Type • Adult cytotoxics –

East & South East England Specialist Pharmacy Services Product Type • Adult cytotoxics – labelling, expiry date and incorrect diluent • Paediatric cytotoxics – labelling error • Adult PN – Calculation error, ingredient selection • Paediatric PN – Transcription, calculation and selection

East & South East England Specialist Pharmacy Services Where detected • • • 1

East & South East England Specialist Pharmacy Services Where detected • • • 1 st assembly check – adult cyto and PN Final check – Paediatric cytotoxics In clinical area before administration – adult cytotoxics • In clinical area during or after administration – PAEDIATRIC PN!!!

East & South East England Specialist Pharmacy Services Preparation type vs Cause • Paediatric

East & South East England Specialist Pharmacy Services Preparation type vs Cause • Paediatric cytotoxics – Computer system, interuptions • Adult PN – Poor storage, staffing and workload • Paediatric PN – staffing and workload

East & South East England Specialist Pharmacy Services Product Type vs Potential Outcome •

East & South East England Specialist Pharmacy Services Product Type vs Potential Outcome • Major / Critical – Paediatric PN (v v high significance – most 1 -2 but this one nearly 6!!) • Moderate – Paediatric PN • Minor – Paediatric PN and cytotoxics • No potential outcome – adult cytotoxic and PN

East & South East England Specialist Pharmacy Services Selection Errors • • Differentiation of

East & South East England Specialist Pharmacy Services Selection Errors • • Differentiation of ingredients and strengths NB labelling – many are “Specials” Dextrose – need to use multiple strengths? Historical system configuration?

East & South East England Specialist Pharmacy Services PN Incident • Automix • Order

East & South East England Specialist Pharmacy Services PN Incident • Automix • Order of additions vs worksheet (configuration can be changed) • Data output / records vs current expectations • Macro additions but also consider micro • Overtyping • Time in use

East & South East England Specialist Pharmacy Services Checking • • Automaticity What is

East & South East England Specialist Pharmacy Services Checking • • Automaticity What is the check Why is it there Pharmacists – understanding of process What can go wrong Bag weighing process What does it mean?

East & South East England Specialist Pharmacy Services Checking • • • Reconcilliation of

East & South East England Specialist Pharmacy Services Checking • • • Reconcilliation of containers and residues Sharing of containers Cost? Information available at time of release? Can a truly informed decision be made

East & South East England Specialist Pharmacy Services Other issues • • Bag testing

East & South East England Specialist Pharmacy Services Other issues • • Bag testing – what? limits? Not single answer – overall assurance level New technology – validation? Costs, expertise Consider whole process risk Checking – accreditation frameworks Validity, numbers and statistics!

East & South East England Specialist Pharmacy Services Summary • • • Report errors

East & South East England Specialist Pharmacy Services Summary • • • Report errors Learn and change practice Value of pooled data – benchmarking, make trends visible • Understand why errors occur and stop them happening again • Reduce risk to patients