Buying and Selling Specials in 2012 What the NHS customer wants How the contracting process helps them to get it Jane Page Principal Pharmacist Medicines Procurement University Hospitals of Leicester

NHS Customer…

The view from here UHL - large NHS Trust (not yet an FT) - no pharmacy production unit East Midlands - other large Trusts with production units - no “Regional” production unit - modernisation money went into QA

Unlicensed Medicines Seemingly undiminished need Over 10% of drug catalogue unlicensed A big headache for procurement staff

What does the NHS Customer want? The NHS customer – THE PATIENT wants Safe medicine Effective medicine Available when needed Low cost (it’s taxpayers’ money)

How do we ensure SAFETY ? Chief Pharmacist responsibility Trust Unlicensed Medicines Policy Risk Assessment Clinical risk – evidence for use, risk of harm, side effects, therapeutic window Pharmaceutical risk – source of supply, production process, product specification and QA Bond and release process on receipt

How does the procurement process ensure delivery of safe medicines on time? Choice of supplier – appropriately licensed, QA audited, performance record Product specifications Certificates of Analysis.....but are we getting the best price?

How easy is all this? ProFile is really useful Manufacturers’ information more readily available BUT More and more companies knocking on the door Competitive pricing Need for quality assurance

Contracting Stops the doorbell ringing Stable source of supply Improves quality assurance Ensures value for money Meets EU and public sector procurement rules Any qualified provider

Contracting Process Service to supply unlicensed medicines Includes examples of products required and potential volumes EM contracts for unlicensed medicines are framework contracts with a number of suppliers awarded to the framework. Each supplier is awarded specified products and volumes, with any new products required subject to mini-competition

Contracting Process Advertisement – we find out how many potential suppliers there are PQQ – checks suppliers are qualified to tender ITT – detailed specification of service required. Allows suppliers to tell us in detail what they can deliver Evaluation of supplier offers Adjudication – side by side comparison of offers Award Implementation Contract Management and KPIs

What are we looking for? Quality Management System Evidence of control of raw materials, production process, QC, finished products, staff training, documentation Products which meet specification Labelling in accordance with NPSA guidance Flexibility to change labels to meet our needs Certificates of Analysis

Evaluation ITT – answer questions fully and include relevant documentation as evidence Products – samples should be correctly labelled and packaged as for hospital delivery Documentation – product specification, stability data, Cof A Presentation – make it relevant Contingency plans Price – evaluated last

Categories Dose banded chemotherapy “ready to use” injectables Infusions for home delivery Imported medicines (unlicensed) Specials (UK compounded unlicensed medicines)

Thank you and any questions?