the challenge: tendering for unlicensed medicines oct 30 th 2012
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The Challenge: Tendering for Unlicensed medicines Oct 30 th 2012. Tim Root Specialist Pharmacist Clinical Governance & Technical Services. The context. NHS re-disorganisation Cost pressures +++ More, more complex medicines vs less nursing time Regulatory & legal pressures - PowerPoint PPT PresentationTRANSCRIPT
East & South East England Specialist Pharmacy Services
East of England, London, South Central & South East Coast
The Challenge: Tendering for The Challenge: Tendering for Unlicensed medicinesUnlicensed medicines
Oct 30th 2012 Tim RootTim Root
Specialist PharmacistSpecialist PharmacistClinical Governance & Technical ServicesClinical Governance & Technical Services
East & South East England Specialist Pharmacy Services
East of England, London, South Central & South East Coast
The context• NHS re-disorganisation• Cost pressures +++• More, more complex medicines vs less nursing time • Regulatory & legal pressures• NHS preparative capacity stressed & at risk(?)• Demand increasing• Competition increasing
East & South East England Specialist Pharmacy Services
East of England, London, South Central & South East Coast
Issues• Licensed medicines carry a guarantee of Q,S,E
Nothing can be assumed about QSE of unlicensed medicines
• We have tried & tested systems & processes for tendering to buy medicines
They were developed for (products) licensed medicines Prices of licensed medicines are regulatedPrices of unlicensed medicines aren’tService is a critical
East & South East England Specialist Pharmacy Services
East of England, London, South Central & South East Coast
Experience• Overlabelled & repacked medicines• Dose banded cytotoxics• CIVAS• Other UMPs• Product specification• Mixed blessings• Procurement and clinical and QA expertise essential
at all stages
East & South East England Specialist Pharmacy Services
East of England, London, South Central & South East Coast
The good The not so good Labelling Inadequate risk awareness &
immature risk managementStability & shelf life Cost vs qualitySupplier understanding Lack of transparency e.g. Sub-
contractingPrice Risk to NHS servicesIncreased access to pharmacy-made products
Learning by experience rather than design
East & South East England Specialist Pharmacy Services
East of England, London, South Central & South East Coast
Summary• Quality & Safety
– is our responsibility – always comes first
• Licensed medicines are the gold standard– should always be the ultimate objective– but….. regulatory compliance isn’t the same as fitness for purpose
• We must develop coherent strategy– Do once and share– Including market management to secure essential NHS services
• Tendering is here to stay: we can make it work for everyone’s benefit!