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

1. 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. 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. NPSA Alert 20 Recommendations • Risk assess injectable medicine products & procedures in clinical areas to identify high risks & develop an action plan to minimise them. • Ensure up-to-date protocols & procedures for prescribing, preparing & administering injectable medicines in all clinical areas. • Ensure essential technical information is available and accessible to healthcare staff in clinical areas at the point of use. • Implement a ‘purchasing for safety’ policy to promote procurement of injectable medicine products with inherent safety features. • As part of the annual medicines management audit programme, healthcare organisations should include an audit of medication practice with injectable medicines.

4. 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. 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.

6. 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. A guide to the: graphic design of medication packaging, design of dispensed medicines, labelling and packaging of injectable medicines. Design for Patient Safety Series

8. 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. 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. 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. 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. Intensive Care drugsThere were 372 presentations in use for the 20 substances in question.

13. 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

14. 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

15. 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. Acknowledge the following for their input: • Colleagues within South Central • Tim Root • Richard Bateman • Alison Ashman • Kevan Wind • David Cousins Any questions…?