Risk Management and Learning from Errors

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

2. Errors Occur Frequency Reasons Trends Benchmarking / Comparison Data Handling Corrective Action / Preventative Actions Learning?

3. 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

4. Error Reporting Documentation RCA What happened (Why?) Fix it! (Stop it happening again?) What Happened + Fix it = CA Why? + Stop it happening? = PA CAPA

5. Error / Exception Reports Re-trained operator Reminded of principles of GMP Asked to be more careful Pay more attention Careful not to do again

6. Knowledge Based Improvisation in unfamiliar environment No rules available for handling situation 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 Conscious and Automatic Behaviour Conscious Automatic

7. Human Failure Errors Violations Slips Mistakes Routine Exceptional Skill Based Rule Based Knowledge Based Classification of Human Errors

8. 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

9. Communication Decision Making Situation awareness Leadership Teamwork Error management How is behaviour influenced by: The job The individual The organisation Human Factors

10. Human Factors Reading • http://www.popularmechanics.com/technology/aviation/crashes/what-really-happened-aboard-air-france-447-6611877

11. Risk Management • Assess continuously what can go wrong • determine what risks are important to deal with • implement strategies to deal with those risks

12. 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

13. 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

14. 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

15. 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

16. 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

17. Potential Major and Critical Errors • Labelling 22% • Selection 45% • Transcription 12%

18. Error Type - Labelling Unit 1 – 55% Unit 2 – 9% Unit 3 – 29% Reasons for variation? System? Checking? Process?

19. Error Type - Transcription Unit 1 – 3% Unit 2 – 24% Unit 3 – 22% System? Training? Checks? Workload?

20. Error Type - Selection Unit 1 – 12% Unit 2 – 14% Unit 3 – 15% Less Variation Packaging Design?

21. 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

22. Error Type / Product Type Cytotoxics Labelling – 56% Selection – 10% TPN Labelling – 33% Selection – 20%

23. Contributory Factors Human Error +++ Workload / Staffing Distraction / Interruptions Computer System Inadequate training

24. Contributory Factors Local Variation – learn from trends? Unit A – Workload / Staffing 14% Unit B – Distractions / Interruptions 10% Unit C – Computer System – 8%

25. Error Classification - Examples Catastrophic Neonatal TPN Dextrose 50% instead of 20%

26. 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 and control the risks in your compounding process? Does the person releasing the product know how it is made and understand the risks?

27. Error Examples - Cytotoxics Cytarabine 100mg/ml and 100mg/5ml Reported x 12 SUI in Trust Verbal reports ++

28. 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 5FU syringes prepared in advance. Wrong drug supplied x 4. Other dose banded syringe selection errors Specials labelling standards?

29. NHS Production Unit Labelling Generally! No Colour Black/ White Single Label Font Size? Similar Appearance Bar Coding – patient safety, robotic dispensing

30. Error Examples - CIVAS Cephalosporin selection errors Amoxicillin / Flucloxacillin Selection – Product, worksheet, labels

31. 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

32. 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

33. Why do selection errors occur? We know the reasons Look alike Sound alike Multiple strengths So surely we must have done something about this?

34. Regulatory Compliance Licensed Products Released to market Pharmaceutical Risk Management Regulatory Compliance does not guarantee safety in use

38. 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!

39. 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.

40. 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!

41. 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

42. Where detected 1st 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!!!

43. Preparation type vs Cause Paediatric cytotoxics – Computer system, interuptions Adult PN – Poor storage, staffing and workload Paediatric PN – staffing and workload

44. 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

45. Selection Errors • Differentiation of ingredients and strengths • NB labelling – many are “Specials” • Dextrose – need to use multiple strengths? • Historical system configuration?

46. 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

47. 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?

48. Checking • Reconcilliation of containers and residues • Sharing of containers • Cost? • Information available at time of release? • Can a truly informed decision be made

49. 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!

50. 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