1. East & South East England Specialist Pharmacy Services East of England, London, South Central & South East Coast The Challenge: Tendering for Unlicensed medicines The Challenge: Tendering for Unlicensed medicines Oct 30 th 2012 Tim Root Specialist Pharmacist Clinical Governance & Technical Services

2. 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

3. 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 regulated Prices of unlicensed medicines aren’t Service is a critical

4. 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

5. East & South East England Specialist Pharmacy Services East of England, London, South Central & South East Coast The goodThe not so good LabellingInadequate risk awareness & immature risk management Stability & shelf lifeCost vs quality Supplier understandingLack of transparency e.g. Sub- contracting PriceRisk to NHS services Increased access to pharmacy- made products Learning by experience rather than design

6. 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!