1. London, Eastern and South East Specialist Pharmacy Services Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services Medicines – The QA Perspective Richard Bateman QA Specialist Pharmacist – London Guys and St Thomas’ Hospital NHS Trust Chair, NHS Pharmaceutical QA Committee

2. London, Eastern and South East Specialist Pharmacy Services Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services Role of Quality Assurance 1970’s – generics – product testing QC seen as linked to production activities 1980’s – QA concept, but largely still linked to technical services. QA applicable to all areas of practice End 1990’s onwards – concept in non-technical services. Procurement – move away from testing – concepts of safety in use and purchasing for safety Not just dispensing Integrate concepts with clinical staff, near patient processes AND patients.

3. London, Eastern and South East Specialist Pharmacy Services Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services Regulatory Compliance Licensed Products Released to market Pharmaceutical Risk Management Regulatory Compliance does not guarantee safety in use

4. London, Eastern and South East Specialist Pharmacy Services Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services Why are we concerned? Errors Compromise Patient Safety

5. London, Eastern and South East Specialist Pharmacy Services Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services Why do errors occur? We know the reasons Look alike Sound alike Multiple strengths So surely we must have done something about this?

6. London, Eastern and South East Specialist Pharmacy Services Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services National Aseptic Error Reporting Scheme Evaluate the type and frequency of occurrence of errors within aseptic processing activities “Error” – any occurrence that takes place at any stage of the product preparation process, up to and including storage and distribution, which has the potential to impact of the quality of the product in such a manner that it places the patient receiving the product at risk.

7. London, Eastern and South East Specialist Pharmacy Services Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services Objectives 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 Implement change!

8. London, Eastern and South East Specialist Pharmacy Services Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services Overview 0.1% error in released products 0.01% error in administered products Data relating to 4 million doses 95% errors no or minor risk

9. London, Eastern and South East Specialist Pharmacy Services Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services

10. Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services Contributory Factors Cytarabine – wrong strength selected Confusion with other drugs with multiple strengths Methotrexate, 5FU, Heparin Confusion with look alike / sound alike Vinblastine/ Vinorelbine

11. London, Eastern and South East Specialist Pharmacy Services Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services Examples Cisplatin / Carboplatin Epirubicin / Doxorubicin Docetaxel / Doxorubicin Amoxicillin / Flucloxacillin Cefalosporins Nb selection, labelling and worksheets

12. London, Eastern and South East Specialist Pharmacy Services Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services Examples Others – Vitlipid – Adult and Infant Additrace and Addiphos Nb Addiphos and Glycophos! Multiple phosphate sources in use Sodium Chloride, Potassium Chloride, Calcium Chloride (also different strengths)

13. London, Eastern and South East Specialist Pharmacy Services Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services Why do errors occur? We know the reasons Look alike Sound alike Multiple strengths So surely we must have done something about this?

14. London, Eastern and South East Specialist Pharmacy Services Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services

15. Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services

16. Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services

17. Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services NHS Production Unit Labelling Generally! No Colour Black/ White Single Label Font Size? Similar Appearance Bar Coding – patient safety, robotic dispensing

18. London, Eastern and South East Specialist Pharmacy Services Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services QA Assessment of Licensed Medicines Largely Focused on Risk Assessment Less focus on testing Medication Error Potential Safety in use National Co-ordinated Approach SCEP contracts Purchasing for Safety

19. London, Eastern and South East Specialist Pharmacy Services Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services Supply Chain Excellence Programme June 2004 Regional and Divisional contracts replaced with National Previously QA input on a local level Highlighted need for more uniform approach to QA assessment Improved relationships between QA pharmacists, PASA and NPSA (NPSA/MHRA dialogue) Contract Award Criteria established and link with QA Assessment process

20. London, Eastern and South East Specialist Pharmacy Services Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services Supply Chain Excellence Programme NHS Pharmaceutical Quality Assurance Committee – formation of Procurement Subcommittee to manage process (Chair is Ian Beaumont, Quality Control North West) Yellow Cover Guidance Documents for NHS “Quality Assurance and Risk Assessment of Licenced Medicines for the NHS” NHSPQAC, June 2004. Also “Quality Assurance Policy for Contracting of Pharmaceuticals”

21. London, Eastern and South East Specialist Pharmacy Services Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services Assessment of Samples Assessment largely considers safety in use Need sample or accurate mock up Cannot be artwork alone Samples allocated to QA pharmacists across UK Nb timescales Overall Assessment, comments and images Collated QA representation at adjudication – refer to comments and images

22. London, Eastern and South East Specialist Pharmacy Services Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services Risk Assessment of Pharmaceutical Procurement Medication Error Potential Product Quality and Fitness for Purpose Manufacturer Performance Assessment

23. London, Eastern and South East Specialist Pharmacy Services Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services Medication Error Potential Presentation and Labelling Look Alike Sound Alike In use selection errors Pharmacy/ Clinical Areas/ Patients Company Livery PIs

24. London, Eastern and South East Specialist Pharmacy Services Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services Product Quality Licensed Products? Formulation Blister packing Stability Ease of opening

25. London, Eastern and South East Specialist Pharmacy Services Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services Manufacturer Performance History Past problems Reliability Continuity Audit reports AIC/ PASA data Recalls

26. London, Eastern and South East Specialist Pharmacy Services Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services Sources of Information Samples – but also AIC PASA PRoMs Safety Alerts QA information – networks and websites PharmaQC (development)

27. London, Eastern and South East Specialist Pharmacy Services Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services AIC Minor defects (analytical information) Reports to QA pharmacists Collated and shared nationally Search by supplier and or product PharmaQC in future? AIC(1)(1).AUG06.xls

28. London, Eastern and South East Specialist Pharmacy Services Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services PASA Information from previous adjudications QA related issues reported to PASA Formal system to pull together Monthly reports to NHSPQAC and Procurement Subcommittee Shared nationally with QA Pharmacists Use to inform assessment processes in future 20061002QC-SupplierIssuesSummary(2).xls

29. London, Eastern and South East Specialist Pharmacy Services Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services PRoMS Potential Risk of Medication Selection errors Started in London, South East and Eastern Procurement and QA staff Pharmacy, clinical areas, patients Summary reports – widely circulated – pharmacy staff and wider 200608PROMSsummaryReport.xls

30. London, Eastern and South East Specialist Pharmacy Services Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services PRoMS

31. London, Eastern and South East Specialist Pharmacy Services Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services Safety Alerts Need to award to High or Medium MEPA product Highlight issue to users Information and images Caution in use? Suggested precautionary measures?

32. London, Eastern and South East Specialist Pharmacy Services Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services Pharma QC In development (final stages) Manufacturers information and images (needs to be current / up to date) QA assessment – MEPA, comments, images AIC data PRoMS PASA reports Single point for all information sources Online access at adjudications and for procurement groups Ongoing assessment and monitoring

33. London, Eastern and South East Specialist Pharmacy Services Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services Risk Assessment Process Review following use in several rounds of contracts Practical Experience Simplified MEPA assessment process Identification of key Essential and Desirable Labelling and Packaging properties Only “new” products assessed Safety alerts if needed How to deal with existing lines

34. London, Eastern and South East Specialist Pharmacy Services Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services

35. Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services

36. Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services

37. Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services

38. Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services

39. Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services

40. Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services

41. Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services

42. Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services

43. Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services

44. Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services

45. Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services

46. Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services

47. Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services

48. Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services

49. Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services

50. Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services

51. Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services

52. Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training Medicines Information Procurement Quality Assurance Pharmaceutical Advice London, Eastern and South East Specialist Pharmacy Services Risk Management Pharmaceutical Risk Management vs Regulatory Compliance What are our concerns? Regulatory Compliance / GMP – Yes Risk to product – Yes But more than anything – Potential risk to patient