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

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The challenge tendering for unlicensed medicines oct 30 th 2012

The Challenge: Tendering for Unlicensed medicinesOct 30th 2012

Tim Root

Specialist Pharmacist

Clinical Governance & Technical Services


The context
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


Issues
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


Experience
Experience

Overlabelled & repacked medicines

Dose banded cytotoxics

CIVAS

Other UMPs

Product specification

Mixed blessings

Procurement and clinical and QA expertise essential at all stages


Summary
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!


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