How Specials Can Deliver Value to the NHS | Page 18
CASE STUDY 6
Child where licensed product was
not suitable
Background
A two-year-old child was diagnosed with reflux and was
prescribed a proton-pump inhibitor, with instructions provided to
the parents to dissolve the tablet in 5ml of water prior to administration,
as per the instructions on the patient information leaflet. The child’s
parents followed the instructions and tried to dissolve the tablets. Every time
the parents tried to give the child the medicine they spat it out. The parents
persevered, but the child refused to take the medicine. The child continued to
suffer from pain, particularly at night, which caused distress to the child and the
parents. In desperation, after two weeks of interrupted sleep, the parents returned to
the prescriber. The prescriber then prescribed the proton-pump inhibitor as a suspension.
The child took the medicine and their symptoms improved, especially at night.
For many other patients the licensed proton-pump inhibitor soluble tablets are the most suitable
option. For this child, the proton-pump inhibitor suspension manufactured as an unlicensed Special
was the most appropriate option, as it was palatable and easy for the parents to administer. In addition,
the child successfully took the dose and no longer spat out the medication.
Child with reflux
LOWEST RISK/PREFERRED CHOICE
UK-licensed medicine
Licensed liquid formulation prepared
by dissolving tablets. Bitter taste
resulted in child’s refusal to take
medication resulting in increased pain,
particularly at night time.
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
Adapted from RPS practical guidelines on supplying Specials
Hierarchy may alter in particular patient groups; for example, neonates
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Liquid suspension formulated
and symptoms relieved