How Specials Can Deliver Value to the NHS | Page 14

CASE STUDY 4
Dose consistency for an
anti-rejection drug

Background
An adult was prescribed an immunosuppressant in hospital to
help prevent organ rejection following a kidney transplant. Whilst the
immunosuppressant capsule is a licensed product, none are bio equivalent.
In hospital, the drug dose and formulation was monitored carefully and titrated
to a target level to reduce the risk of organ rejection.
On discharge from hospital the adult was given a non-bio equivalent formulation
post-hospital discharge in the form of a capsule which was crushed (as no licensed liquid
formulation is available). As a result of this, the target level was not maintained and the
patient was subsequently re-admitted to hospital and had to be re-stabilised. There have been
other instances where patients have had to go back onto renal dialysis as a result of receiving a
crushed capsule instead of a Special being prescribed and used. The MHRA has directed that all oral
licensed immunosuppressants should be prescribed and dispensed by brand name only15.

Dose consistency for an anti-rejection drug
LOWEST RISK/PREFERRED CHOICE

UK-licensed medicine

Adult prescribed an immunosuppressant
in hospital to help prevent organ rejection
following a kidney transplant

Off-label use of UK-licensed medicine
Imported product licensed in (approved) country of origin

UK-manufactured Special
in MHRA-licensed facilities

Liquid Special from single source
of supply stabilised patient

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
14

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

On discharge from hospital the patient was
given a non-bio equivalent formulation
post-hospital discharge in the form of a
capsule which was crushed (as no licensed
form is available). Inconsistent dose resulted
in hospitalisation and potential renal dialysis.
Cost for one year £23,712.