Medicines The QA Perspective

1
Medicines The QA Perspective

• Richard Bateman
• QA Specialist Pharmacist London
• Guys and St Thomas Hospital NHS Trust
• Chair, NHS Pharmaceutical QA Committee

2
Role of Quality Assurance

• 1970s generics product testing
• QC seen as linked to production activities
• 1980s QA concept, but largely still linked to
  technical services.
• QA applicable to all areas of practice
• End 1990s 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
Regulatory Compliance

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

4
Why are we concerned?

• Errors
• Compromise Patient Safety

5
Why do errors occur?

• We know the reasons
• Look alike
• Sound alike
• Multiple strengths
• So surely we must have done something about this?

6
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
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
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
(No Transcript)
10
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
Examples

• Cisplatin / Carboplatin
• Epirubicin / Doxorubicin
• Docetaxel / Doxorubicin
• Amoxicillin / Flucloxacillin
• Cefalosporins
• Nb selection, labelling and worksheets

12
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
Why do errors occur?

• We know the reasons
• Look alike
• Sound alike
• Multiple strengths
• So surely we must have done something about this?

14
(No Transcript)
15
(No Transcript)
16
(No Transcript)
17
NHS Production Unit Labelling

• Generally!
• No Colour
• Black/ White
• Single Label
• Font Size?
• Similar Appearance
• Bar Coding patient safety, robotic dispensing

18
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
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
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
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
Risk Assessment of Pharmaceutical Procurement

• Medication Error Potential
• Product Quality and Fitness for Purpose
• Manufacturer Performance Assessment

23
Medication Error Potential

• Presentation and Labelling
• Look Alike
• Sound Alike
• In use selection errors
• Pharmacy/ Clinical Areas/ Patients
• Company Livery
• PIs

24
Product Quality

• Licensed Products?
• Formulation
• Blister packing
• Stability
• Ease of opening

25
Manufacturer Performance

• History
• Past problems
• Reliability
• Continuity
• Audit reports
• AIC/ PASA data
• Recalls

26
Sources of Information

• Samples but also
• AIC
• PASA
• PRoMs
• Safety Alerts
• QA information networks and websites
• PharmaQC (development)

27
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
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
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
PRoMS
31
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
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
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
(No Transcript)
35
(No Transcript)
36
(No Transcript)
37
(No Transcript)
38
(No Transcript)
39
(No Transcript)
40
(No Transcript)
41
(No Transcript)
42
(No Transcript)
43
(No Transcript)
44
(No Transcript)
45
(No Transcript)
46
(No Transcript)
47
(No Transcript)
48
(No Transcript)
49
(No Transcript)
50
(No Transcript)
51
(No Transcript)
52
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