North of England Parenteral Risk Assessment Projects 20042006

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North of England Parenteral Risk Assessment
Projects 2004-2006

• Linda Hardy
• Project Manager Reducing Risk with Parenteral
  Therapies
• Leeds Teaching Hospitals

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Modernisation of NHS Manufacturing in England

• Why?
• Ageing facilities / poor local investment
  strategies
• Unplanned closure of NHS Units (MHRA
  intervention) due to lack of investment
• Department of Health Risk assessment
• All 125 licence holders surveyed
• Data returned to DOH central returns office
• Workforce Facilities
• Facilities Products
• Capacity

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• National Modernisation Board
• Four Local Review Groups
• North
• South
• Central
• London

• Four Pillars of
• Modernisation Process
• Rationalisation
• Clinical Governance
• Protecting NHS intellectual property
• Improved links to commercial sector

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Modernisation of NHS Manufacturing in England

• How can the modernised production service
  contribute to the reduction of risk?
• Development of batch aseptic production.
• Development of terminally sterilised
  intermediates/concentrates/diluents.
• Development of terminally sterilised products in
  final containers e.g. vials/bags/syringes.
• Co-ordinated service with improved communication
  (Pro-File database)

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Risk Assessment Project Key Questions

• What high risk products are being made in
  clinical areas?
• What do aseptic and manufacturing services do?
• Which high risk products are suitable for
  transfer to a pharmacy environment?
• Which products are currently made in pharmacy but
  could be suitable for transfer back to a clinical
  environment?

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Phase One Eight High Risk Categories Cytotoxics,
Adult PN, Paed PN, Potassium, ITEpidurals,
Cardioplegia, Eye Injections, Eye dropsEye
Irrigations
Clinical areas and Preparation in Pharmacy 82
participation rate
Phase Two Top 50 High High/Medium
Risk Miscellaneous Drugs
Clinical areas only 72 participation rate

• Phase Three
• Preparation in Pharmacy
• Licensed
• Section 10

Pharmacy only 69 participation rate
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• Phase One Results
• Doses Prepared in Clinical Areas per annum
• Cytotoxics 1,192
• Adult TPN 3,615
• Paediatric TPN 537
• Intrathecal/Epidural 61,892
• Potassium Solutions 108,197
• Intraocular injections 15,136
• Eye drops/Eye Irrigations 20,380
• Cardioplegia 2,933
• Total 213,882
• Adjusted total 235,270

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Risk Assessment Project Data Collection Phase Two

• Data on preparation in clinical areas only.
• List of 48 high high/medium risk products.
• List based on previous work in 7 trusts
• Study Days held to agree final list.
• Final list appears in Hosp. Pharm.
• Hardy L Mellor L Hospital Pharmacist.
  20071458-64

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Risk Assessment Project Results - Doses
prepared in Clinical Areas per annum
Phase One Results Eight Categories 235,000 doses
Phase Two Results 48 named drugs 992,000 doses
Total 1,227,000 doses
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Risk Assessment Project Results Doses Prepared
in Pharmacy per annum
Phase One PN Adult Paediatric 129,000 doses
Phase Three Doses prepared in Pharmacy 2,140,000
doses
Total 2,269,000 doses
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Risk Reduction

• Clinical Reviews switch to lower risk
  alternatives.
• e.g. IV to oral switching.
• Collaboration between trusts
• e.g. North West model hub and
  spoke.
• Improved communication of product availability
• Pro-File database
• Increased use of dose-banding
• Chemotherapy

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Product Variability

• Potassium Containing Solutions
• 52 different KCL infusions
• 7 different Phosphate Infusions
• 7 different dialysis/haemofiltration
  solutions
• Intrathecal Solutions
• 27 reports/20 different preparations
• Epidural Solutions
• 45 reports/40 different solutions

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Implementation Project

• Three work streams
• 1 Support Chief Pharmacists in implementation of
  local risk reduction strategies.
• Preparation of list of products for
  prioritisation by manufacturing and preparation
  units.
• 3 Achieve risk reduction in a number of specific
  high risk issues arising from the risk assessment
  project.

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Chief Pharmacist Feedback

• Did the risk assessment exercise result in the
  identification of any high risk activities which
  were previously unknown to you?
• 10/21 Yes
• Intracameral cefuroxime
• Proactive audit (of strong potassium chloride
  injection) as part of risk assessment
  demonstrated several areas of non-compliance
  with national local recommendations.
• Diamorphine 1mg in 1ml for spinal anaesthesia
  now prepared in Aseptic Unit

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Workstream Two - Preparation of list of products
for prioritisation by manufacturing and
preparation units.

• Multidisciplinary Review
• Royal College Anaesthetists
• NPSA
• Intensive Care Society Project
• Manufacturing and Technical Groups
• PMU leads
• QC North West

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Workstream Three - Achieve risk reduction in a
number of specific high risk issues arising from
the Risk Assessment Project

• Cytotoxic dose banding
• Intrathecal and Epidural
• Potassium Containing Solutions
• Cardioplegia
• Paediatrics
• Eye Injections/Eye irrigations

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Intrathecals and Epidurals

• 50 of doses given to patients in the North of
  England were being prepared in clinical areas.
• High risk of error due to complexity of
  solutions.
• High degree of variation within and between
  trusts has made standardisation of solutions
  difficult.
• Provision of 24 hour service for individualised
  aseptic preparation.
• Key task for project identify the preferred
  products for centralised production.
• Terminally sterilised products preferred.

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Intrathecals and Epidurals

• Royal College of Anaesthetists Specials Working
  Group 2004.
• Project Data sent to President of RCA for comment
  and to seek any preferred product lists.
• RCA recommendations
• Bupivacaine 0.1 0.125 Epidural
• Fentanyl 2mcg/ml in Bupivacaine 0.1 0.125
• Midazolam 1mg/ml in 50ml IV syringe
• Morphine Sulphate 1mg/ml, 2mg/ml and 30mg/ml

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Intravenous drugs administered at doses less than
one tenth of a vial

• Drug of doses of that drug
• Furosemide 83
• Cefotaxime 52
• Benzylpenicillin 14
• Diamorphine 23
• Ranitidine 100
• Gentamicin 8
• Dexamethasone 76
• Indometacin 69
• Insulin 100
• Atracurium 41

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Intravenous drugs administered at doses less than
one hundredth of a vial (Chappell Newman Arch
Dis Childhood Fetal,Neonatal Ed. Nov 2004)

• Drug of doses of that drug
• Diamorphine 12
• Insulin 10
• Potassium Canrenoate 100
• Midazolam 18

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Paediatrics Parenteral Risk Group

• Purpose
• Finalise list of paediatric products for
  potential centralised preparation.
• Recommend a mechanism for continuation of
  collaboration between technical and
  multidisciplinary clinical groups.
• Membership
• Medical Anaesthetist, NNU consultant.
• Pharmacy Paed Chiefs, QA/Product development,
  Paed Aseptic Specialists.
• Nursing Paed Matron.

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Intraocular Injections

• Intracameral Cefuroxime.
• European Society of Cataract Refractive
  Surgeons.
• ESCRS study of prophylaxis of postoperative
  endophthalmitis after cataract surgery. Barry P
  et al. J Cataract Refract Surg 2006 (32)407-410

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Summary

• Large scale project over two years with 80
  engagement in target area.
• Most Trusts have performed risk assessments and
  many have found areas of practice which they are
  now addressing.
• Modernised Manufacturing and Preparation Services
  have identified list of priority products which
  can be accessed by trusts when taking action
  following March 2007 NPSA Alerts.
• Good communication links have been established
  with clinical groups.