How Specials Can Deliver Value to the NHS | страница 20

CASE STUDY 7
Non-availability of licensed/fragile supply
chain in high-risk disease areas

Background
Procurement and consultant pharmacists, clinical experts,
government agencies and pharmaceutical industry representatives
collaborated to develop a set of recommendations to combat the effect
of medicine shortages on patients with tuberculosis (TB).32 The US has
documented supply issues for second line tuberculosis medicines over many
years33 which can lead to adverse patient outcomes.
Based on the finding of a report published in 2011 which evaluated the impact of
anti-TB medicine shortages on patient care, the project had two main terms of reference:
1. to improve the supply chain for anti-TB medicines and
2.  promote the development of standardised oral formulations of anti-TB medicines for use
to
in children and people with swallowing difficulties.
One of the key recommendations was that the management of medicine shortages should be extended to
cover unlicensed imports and UK-manufactured Specials. Said the project group, “More and more unlicensed
medicines are becoming critical to many different diseases, and we need to give them much more attention
than we currently are in terms of the supply chain.”
The project was described as a case study on how teams could work together to help maximise the stability of a very
fragile supply chain in a very high-risk area.

Non-availability of licensed/fragile supply chain in high-risk disease areas
LOWEST RISK/PREFERRED CHOICE

UK-licensed medicine

Limited availability of licensed drugs
for treatment of TB due to medicine
shortages and lack of investment by
major pharmaceuticals

Off-label use of UK-licensed medicine

Imported product licensed in
(approved) country of origin

UK-manufactured Special
in MHRA-licensed facilities
An extemporaneously dispensed medicine
An imported product not licensed in the country of origin
Crushing or splitting licensed tablets or capsules
A non-UK-made unlicensed medicine or food supplement

HIGHEST RISK/LAST CHOICE
20

Adapted from RPS practical guidelines on supplying Specials
Hierarchy may alter in particular patient groups; for example, neonates

Imported and UK-manufactured
Specials ensure availability of
critical treatments