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10/05/2015 1 PDIG Award 2008/9: Purchasing for Safety – Injectable Medicines Dr Clare Crowley Lead Medicines Safety Pharmacist Oxford Radcliffe Hospitals.

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Presentation on theme: "10/05/2015 1 PDIG Award 2008/9: Purchasing for Safety – Injectable Medicines Dr Clare Crowley Lead Medicines Safety Pharmacist Oxford Radcliffe Hospitals."— Presentation transcript:

1 10/05/ PDIG Award 2008/9: Purchasing for Safety – Injectable Medicines Dr Clare Crowley Lead Medicines Safety Pharmacist Oxford Radcliffe Hospitals NHS Trust GHP Procurement & Distribution Interest Group Autumn Symposium 12 November 2009

2 10/05/ Session 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

3 10/05/ Risk assess injectable medicine products & procedures in clinical areas to identify high risks & develop an action plan to minimise them. 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. NPSA Alert 20 Recommendations NPSA Alert 20 Recommendations

4 10/05/ 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

5 10/05/ Are the following ‘safe’ purchases?  Dose required is 1/10,000 th 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.

6 10/05/ Regulatory compliance vs. fitness 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

7 10/05/ Design for Patient Safety Series A guide to the:  graphic design of medication packaging,  design of dispensed medicines,  labelling and packaging of injectable medicines.

8 10/05/ Medication 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

9 10/05/ Some 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

10 10/05/ 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?

11 10/05/ Barriers 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

12 10/05/ Intensive Care drugs There were 372 presentations in use for the 20 substances in question. Intensive Care drugs There were 372 presentations in use for the 20 substances in question.

13 10/05/ Current 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. –Practice inn–Practice inn

14 10/05/ NAB work streams (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

15 10/05/ Conclusions  Practice, 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.

16 10/05/ Acknowledge the following for their input:  Colleagues within South Central  Tim Root  Richard Bateman  Alison Ashman  Kevan Wind  David Cousins Any questions…?


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