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PDIG Award 2008/9:PDIG Award 2008/9:Purchasing for Safety – Purchasing for Safety –

Injectable MedicinesInjectable Medicines

Dr Clare Crowley Lead Medicines Safety Pharmacist

Oxford Radcliffe Hospitals NHS Trust

GHP Procurement & Distribution Interest Group Autumn Symposium GHP Procurement & Distribution Interest Group Autumn Symposium 12 November 200912 November 2009

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Session outlineSession outline

NPSA alert 20 Purchasing for safety Regulatory compliance vs. fitness for purpose NPSA Design for Patient Safety guides National purchasing safeguards Some solutions Barriers to change Current drivers for change NAB work streams Conclusions

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1.1. Risk assess injectable medicine products & procedures in clinical Risk assess injectable medicine products & procedures in clinical

areas to identify high risks & develop an action plan to minimise areas to identify high risks & develop an action plan to minimise them.them.

2.2. Ensure up-to-date protocols & procedures for prescribing, Ensure up-to-date protocols & procedures for prescribing, preparing & administering injectable medicines in all clinical areaspreparing & administering injectable medicines in all clinical areas ..

3.3. Ensure essential technical information is available and accessible to Ensure essential technical information is available and accessible to healthcare staff in clinical areas at the point of use.healthcare staff in clinical areas at the point of use.

4.4. Implement a ‘purchasing for safety’ policy to promote procurement Implement a ‘purchasing for safety’ policy to promote procurement of injectable medicine products with inherent safety features.of injectable medicine products with inherent safety features.

6.6. As part of the annual medicines management audit programme, As part of the annual medicines management audit programme, healthcare organisations should include an audit of medication healthcare organisations should include an audit of medication practice with injectable medicines.practice with injectable medicines.

NPSA Alert 20 RecommendationsNPSA Alert 20 Recommendations

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Purchasing for SafetyPurchasing for Safety The “systems” approach recognises that the chance

of mistakes and the impact of mistakes that are made can be reduced if systems, processes, the working environment and (medicinal) products.

Aim to buy products designed with safe use in mind Procurement decisions must be based on detailed

understanding of how healthcare staff and patients use and may misuse medicines

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Are the following ‘safe’ purchases?Are the following ‘safe’ purchases? Dose required is 1/10,000th of the vial size.

Manufacturer unable to provide advice on suitable flush solution.

Unlicensed product with no technical information provided or available on request.

Strength expressed in a different way from how it is used in practice.

Inadequate quality assurance information.

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Regulatory compliance Regulatory compliance vs.vs.

fitness for purposefitness for purpose All licensed medicinal products satisfy detailed

regulatory criteria for quality, safety & efficacy

The regulatory process does not consider medicines usage The gap is currently filled only if/when by addressed NPSA

and NHS procurement processes Locally, as part of the formulary process for new medicines

requests

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Design for Patient Safety SeriesDesign for Patient Safety SeriesA guide to the: graphic design of

medication packaging,

design of dispensed medicines,

labelling and packaging of injectable medicines.

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Medication Error Potential AnalysisMedication Error Potential Analysis

Considers and scores risks due to – Labelling of primary and secondary packaging and

dose units– Pack design– Manipulations & calculations needed before

administration– Supporting technical information

Is being modified to accommodate unlicensed medicines

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Some solutionsSome solutions….….

Change to an alternative product

Pre-filled ready to use syringe for ophthalmic use Injectables in solution instead of powder Ready to use vials instead of a concentrate Ready to administer epidural infusion solutions ‘Kits’- short expiry or rarely used products

Device based options e.g. reconstitution devices, point of care activated closed systems

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Challenges from Alert 20Challenges from Alert 20 Medicines not solely supplied by pharmacy. Scope of ‘injectable’? How do we find out all the different ways

injectables are used in practice? Specialist areas e.g. ophthalmic theatres. Where do you get information on specials? Keeping risk assessments up to date – new

practices, contract & SPC changes. New style of formulary in the future?

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Barriers to changeBarriers to change

Lack of standardisation and rationalisation Lack of evidence-based for preferred products Stability / production issues. Volume not commercially viable. Global market. Cost. Users have never specified what they want ?

Suppliers influencing NHS practice through product availability

Unreliable supply chain

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Intensive Care drugsIntensive Care drugs

There were 372 presentations in use for the 20 substances in question.There were 372 presentations in use for the 20 substances in question.

Graph 1: Number of presentations in use per medication in 154 UK critical care units

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6 6

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Current drivers for changeCurrent drivers for change Focus of productivity & lean working Quality & Safety agenda Technology

National Clinical Directors & the NHS Medical Board. Pharmacy in England Building on Strengths –

delivering the future [DH, 2008]. - Review of products prepared by NHS manufacturing &

preparation units- Partnership with industry to develop licensed ready to administer

or ready to use medicines.

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NAB work streams 2009 - 2010 NAB work streams 2009 - 2010 (National Advisory Board for NHS Hospitals Medicines (National Advisory Board for NHS Hospitals Medicines

Manufacturing & Preparative Services)Manufacturing & Preparative Services)

British Association of Dermatologists List Cytotoxics for dose banding Adult Intensive Care infusion rationalisation Concentrated IV potassium for adult critical care Potassium in adult haemofiltration Injectable monographs -> Medusa Epidurals for acute pain Heparin vial size IV infusion Other key high risk medicines

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ConclusionsConclusions Practice, not supply drivenPractice, not supply driven Product rationalisation is critical, proving to be

rate-limiting step. Multiprofessional working essential to achieving

patient outcomes. Need better cohesion between:

clinical, technical, purchasing staff NHS users and industry.

Remember that “safer” products are still unlikely to be foolproof and users will still need support.

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Acknowledge the following for their input:Colleagues within South CentralTim RootRichard BatemanAlison AshmanKevan WindDavid Cousins

Any questions…?