1. Managing Medicines Safely Human Factors Vivienne van Someren & Chloe Benn

2. Acknowledgements The concepts and graphics used in this presentation are based on those developed for the Advanced Resuscitation of the Newborn Infant Course of the Resuscitation Council (UK) by Dr John Madar and others. The copyright belongs to the Resuscitation Council. I have adapted their material and used examples relevant to Medicines Safety Vivienne van Someren

3. Aims To be aware of the human factors which may influence the effective management of medicines for children.

4. Effective Resource Management SYSTEMS PROCESS PROCEDURES HUMAN FACTORS

5. Systems Planning Prevents Problems

6. Systems BNF C Licensing – MHRA Research Governance

7. Processes Systematic approach E prescribing Drug chart design Procurement Specialist training? Dose banding

8. Procedures Appropriate skills, well rehearsed Right equipment, right place, right time Contingencies for failure

9. Procedures NPSA gentamicin bundle Medicines reconciliation Do not disturb medicines rounds

10. Well rehearsed procedures and situations

11. Human Factors Situation awareness Decision making Team working & leadership Task management

12. Situation Awareness Global Overview Clear Vision - Systems Check Goals - Direction of travel Time - Progress Resources - Help Deviation - Fixation errors

13. Decision making Leadership role Clear communication What Who When Why

14. Errors Slips and Trips Cognitive errors ? Examples from your experience

15. Cognitive Errors Ignorance Fixation Assumption Arrogance –(confidence/competence mismatch) Misinterpretation Miscomprehension

16. Your experience? Cognitive errors

17. Cognitive Errors Ignorance Fixation Assumption Arrogance –(confidence/competence mismatch) Misinterpretation Miscomprehension

18. Team Working For the collective good Clear goals / strategies Work together Accept leadership / roles Suspend hierarchies Respect others Actively contribute Discipline Rehearsal

19. Task Management Delegation Collaboration Coordination

20. Communication Effective communication is vital at all stages Common language Inclusive - within team, between teams Dynamic Structured (SBAR) ‘closed loop’ Moderated (through team leader) Polite

21. SBAR A paediatrician has written a newborn baby up for abacavir, 3TC and kaletra. The BNF C says these drugs are not licensed in the newborn period and does not give any doses. You need to ring the paediatrician to discuss

22. SBAR Situation Who you are and what the call is about

23. SBAR Situation I am the pharmacist for the maternity unit and I am phoning to discuss the prescription for antiretrovirals for Baby A

24. SBAR Situation I am the pharmacist for the maternity unit and I am phoning to discuss the prescription for antiretrovirals for Baby A Background

25. SBAR Situation I am the pharmacist for the maternity unit and I am phoning to discuss the prescription for antiretrovirals for Baby A Background I see the mother is HIV positive and on treatment and that you have prescribed ABC, 3TC and Kaletra for the baby.

26. SBAR Situation I am the pharmacist for the maternity unit and I am phoning to discuss the prescription for antiretrovirals for Baby A Background I see the mother is HIV positive and on treatment and that you have prescribed ABC, 3TC and Kaletra for the baby. Assessment

27. SBAR Situation I am the pharmacist for the maternity unit and I am phoning to discuss the prescription for antiretrovirals for Baby A Background I see the mother is HIV positive and on treatment and that you have prescribed ABC, 3TC and Kaletra for the baby. Assessment I am worried because we usually use zidovudine, because these drugs are not licensed for use in the newborn and because the doses are not given in the BNF C

28. SBAR Situation I am the pharmacist for the maternity unit and I am phoning to discuss the prescription for antiretrovirals for Baby A Background I see the mother is HIV positive and on treatment and that you have prescribed ABC, 3TC and Kaletra for the baby. Assessment I am worried because these drugs are not licensed for use in the newborn and the doses are not given in the BNF C Recommendation

29. SBAR Situation I am the pharmacist for the maternity unit and I am phoning to discuss the prescription for antiretrovirals for Baby A Background I see the mother is HIV positive and on treatment and that you have prescribed ABC, 3TC and Kaletra for the baby. Assessment I am worried because we usually use Zidovudine, because these drugs are not licensed for use in the newborn and because the doses are not given in the BNF C Recommendation Can you tell me why the baby needs triple therapy? Can you direct me to the guideline you are using for selection of drug and dosage?

30. ‘Swiss Cheese’ INSTITUTIONAL SYSTEMS FAILURE PROCESS & PROCEDURES FAILURE HUMAN FACTORS TEAM WORKING FAILURE HOLES LINE UP… INDIVIDUAL FAILINGS COMBINE TO LEAD TO UNTOWARD EVENT HAZARDS UNTOWARD EVENT

31. ‘Swiss Cheese’ MANUFACTURER FAILS TO MAKE PAEDIATRIC FORMULATION HOSPITAL DECIDES TO DILUTE ADULT FORMULATION TECHNICIAN ASSUMES THEY ARE DEALING WITH USUAL PAEDIATRIC FORMULATION HOLES LINE UP… INDIVIDUAL FAILINGS COMBINE TO LEAD TO UNTOWARD EVENT HAZARDS Baby gets overdose

32. Gentamicin care bundle

33. Background to alert development PSA Neonatal Nurses Association

34. Why do we need an alert? Used in 89 per cent of neonatal units Over 500 patient safety incidents reported to NPSA in 2008/2009 Side effects include vestibular and auditory damage, and nephrotoxicity Narrow therapeutic range necessitates regular monitoring of blood serum concentrations

35. Factors influencing prescribing and administration Dosing regimens vary across the country There is no consensus on guidelines for dosing with some units using British National Formulary guidance and others using local variations Mechanisms for measuring levels are not agreed and are not a priority in some units – the monitoring needs of neonates are not given parity with other patients. The availability of specialist pharmacist advice in units is very variable

36. Development of the care bundle Very little published evidence of the use of care bundles in neonates COSMIC study to identify interventions which can be used to reduce errors e.g. electronic prescribing system, double checking, smart pump and Centralised Intravenous Additive Service (CIVAS) can potentially reduce dosing errors

37. Reporting and Learning data A review of the top five medications involved in neonatal incidents reported to the NPSA RLS was carried out. The stage of the process when the incident took place, the incident type and the degree of harm caused was reviewed

38. Root causes of incidents Poor prescribing practice Lack of clearly assigned responsibility relating to blood levels Lack of clearly assigned responsibility during the preparation, checking and administration phase Poor communication between medical and nursing staff Interruptions, particularly during the preparation and administration phase

39. Proposed measures to reduce errors Dose calculator Standardisation of dose and frequency Clinical Pharmacy input Training, education and communication Role clarification Taking of blood levels Specific gentamicin prescription chart

40. Agreed Care Bundle components

41. A policy of no interruptions during drug preparation and administration A disposable, coloured apron Aprons conform to local infection control requirements Parents were informed of the significance of this policy by staff All staff had to “sign up” to avoiding interrupting those involved in the preparation, checking and administering of gentamicin

42. Use 24 hour clock when prescribing During this pilot, staff were taught to avoid using 24h00 or 00h00 when prescribing, as the risk of the dose being administered a day too early or too late was increased. 24 hour clocks were purchased by participating units

43. Use of a drug checking prompt provided a checklist of key information included a reminder that drug levels should be monitored and the dose adjusted

44. Dose to be given within 1 hour either side of the prescribed dosing time This intervention prompted awareness of the need to ensure that blood levels were done and acted upon and maximised the opportunity to ensure that therapeutic blood levels were achieved

45. What does the alert say?

46. Any Questions?

47. Summary Understanding the Human Factors which operate to interfere with medicines safety is vital There are systems, processes and procedures which help prevent errors – use them.