London, Eastern and South East Specialist Pharmacy Services Clinical Pharmacy Clinical Governance & Technical Services Community Care Education & Training.

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



Medicines – The QA Perspective

Richard Bateman

QA Specialist Pharmacist – London

Guys and St Thomas’ Hospital NHS Trust

Chair, NHS Pharmaceutical QA Committee





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.





Regulatory Compliance

• Licensed Products

• Released to market• Pharmaceutical Risk Management• Regulatory Compliance does not guarantee

safety in use





Why are we concerned?

• Errors

• Compromise Patient Safety





Why do errors occur?

• We know the reasons

• Look alike• Sound alike• Multiple strengths• So surely we must have done something about

this?





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.





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!





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





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





Contributory Factors

• Cytarabine – wrong strength selected Confusion with other drugs with multiple strengths

• Methotrexate, 5FU, Heparin• Confusion with look alike / sound alike• Vinblastine/ Vinorelbine





Examples

• Cisplatin / Carboplatin

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





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)





Why do errors occur?

• We know the reasons

• Look alike• Sound alike• Multiple strengths• So surely we must have done something about

this?

















NHS Production Unit Labelling

• Generally!

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





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





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





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”





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





Risk Assessment of Pharmaceutical Procurement

• Medication Error Potential

• Product Quality and Fitness for Purpose• Manufacturer Performance Assessment





Medication Error Potential

• Presentation and Labelling

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





Product Quality

• Licensed Products?

• Formulation• Blister packing• Stability• Ease of opening





Manufacturer Performance

• History

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





Sources of Information

• Samples – but also

• AIC• PASA• PRoMs• Safety Alerts• QA information – networks and websites• PharmaQC (development)





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





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





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





PRoMS





Safety Alerts

• Need to award to High or Medium MEPA product

• Highlight issue to users• Information and images• Caution in use?• Suggested precautionary measures?





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





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













































































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