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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
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
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
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.
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
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
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
London, Eastern and South East Specialist Pharmacy Services
Why are we concerned?
• Errors
• Compromise Patient Safety
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
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?
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
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.
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
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!
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
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
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
London, Eastern and South East Specialist Pharmacy Services
Error T ype
14%
2%
5%
4%
4%
3%
34%
7%
2%
14%
9%2%
Incorrec t transcription
Calculation error
Incorrec t drug
Incorrec tdose/s trengthIncorrec tdiluent/Infus ion fluidIncorrec t final volum e
Labelling error
Incorrec t expiry date
Incorrec t container,eg infusor.bagO ther
Particulates
Not recorded
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
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
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
London, Eastern and South East Specialist Pharmacy Services
Examples
• Cisplatin / Carboplatin
• Epirubicin / Doxorubicin• Docetaxel / Doxorubicin• Amoxicillin / Flucloxacillin• Cefalosporins• Nb selection, labelling and worksheets
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
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)
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
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?
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
London, Eastern and South East Specialist Pharmacy Services
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
London, Eastern and South East Specialist Pharmacy Services
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
London, Eastern and South East Specialist Pharmacy Services
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
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
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
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
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
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
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
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”
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
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
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
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
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
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
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
London, Eastern and South East Specialist Pharmacy Services
Product Quality
• Licensed Products?
• Formulation• Blister packing• Stability• Ease of opening
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
London, Eastern and South East Specialist Pharmacy Services
Manufacturer Performance
• History
• Past problems• Reliability• Continuity• Audit reports• AIC/ PASA data• Recalls
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
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)
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
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
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
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
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
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
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
London, Eastern and South East Specialist Pharmacy Services
PRoMS
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
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?
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
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
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
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
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
London, Eastern and South East Specialist Pharmacy Services
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
London, Eastern and South East Specialist Pharmacy Services
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
London, Eastern and South East Specialist Pharmacy Services
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
London, Eastern and South East Specialist Pharmacy Services
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
London, Eastern and South East Specialist Pharmacy Services
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
London, Eastern and South East Specialist Pharmacy Services
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
London, Eastern and South East Specialist Pharmacy Services
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
London, Eastern and South East Specialist Pharmacy Services
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
London, Eastern and South East Specialist Pharmacy Services
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
London, Eastern and South East Specialist Pharmacy Services
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
London, Eastern and South East Specialist Pharmacy Services
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
London, Eastern and South East Specialist Pharmacy Services
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
London, Eastern and South East Specialist Pharmacy Services
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
London, Eastern and South East Specialist Pharmacy Services
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
London, Eastern and South East Specialist Pharmacy Services
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
London, Eastern and South East Specialist Pharmacy Services
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
London, Eastern and South East Specialist Pharmacy Services
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
London, Eastern and South East Specialist Pharmacy Services
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
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