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. Conscious and Automatic Behaviour
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
Automatic

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

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

10. Human Factors Reading

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 Reduce risk to patients 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