PDIG Award 2008/9:
Purchasing for Safety –
GHP Procurement & Distribution Interest Group Autumn Symposium
12 November 2009
Dr Clare Crowley
Lead Medicines Safety Pharmacist
Oxford Radcliffe Hospitals NHS Trust
NPSA alert 20
Purchasing for safety
Regulatory compliance vs. fitness for purpose
NPSA Design for Patient Safety guides
National purchasing safeguards
Barriers to change
Current drivers for change
NAB work streams
NPSA Alert 20 Recommendations
1. Risk assess injectable medicine products & procedures in clinical
areas to identify high risks & develop an action plan to minimise
2. Ensure up-to-date protocols & procedures for prescribing,
preparing & administering injectable medicines in all clinical areas.
3. Ensure essential technical information is available and accessible to
healthcare staff in clinical areas at the point of use.
4. Implement a ‘purchasing for safety’ policy to promote procurement
of injectable medicine products with inherent safety features.
6. As part of the annual medicines management audit programme,
healthcare organisations should include an audit of medication
practice with injectable medicines.
Purchasing 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
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.
fitness for purpose
All licensed medicinal products satisfy detailed
regulatory criteria for quality, safety & efficacy
The regulatory process does not consider
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
Design for Patient Safety Series
A guide to the:
graphic design of
design of dispensed
Medication Error Potential Analysis
Considers and scores risks due to
– Labelling of primary and secondary packaging and
– Pack design
– Manipulations & calculations needed before
– Supporting technical information
Is being modified to accommodate unlicensed
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
Challenges 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? 10
Barriers to change
Lack of standardisation and rationalisation
Lack of evidence-based for preferred products
Stability / production issues.
Volume not commercially viable.
Users have never specified what they want ?
Suppliers influencing NHS practice through product
Unreliable supply chain 11
Number of presentations in use
critical care units
Intensive Care drugs
Graph 1: Number of presentations in use per medication in 154 UK
There were 372 presentations in use for the 20 substances in question.
Current drivers for change
Focus of productivity & lean working
Quality & Safety agenda
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 &
- Partnership with industry to develop licensed ready to
administer or ready to use medicines.
NAB work streams 2009 - 2010
(National Advisory Board for NHS Hospitals Medicines
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
Practice, not supply driven
Product rationalisation is critical, proving to be
Multiprofessional working essential to achieving
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.
Acknowledge the following for their input:
Colleagues within South Central