Access to Unlicensed Medicines in NHS Scotland

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Project in development

Given that licensed medicinal products do not meet the clinical needs of all patients in all situations, NHS Scotland requires to retain the capability to provide unlicensed medicines for patients in both acute and primary care. This capability requires a central NHS pharmaceutical manufacturing facility to provide those medicines that are not commercially available and without which patient care would be compromised. This facility will be able to provide those products which can be anticipated in advance of patient need.

The service will provide unlicensed medicines to all NHS Scotland bodies, taking into account anticipated changes in demand for the future lifespan of the new facility. The project will consider single site accommodation to unify the two existing units in Tayside and Greater Glasgow & Clyde, assessing any service gaps and opportunities to fill these.

The project will consider anticipated service knowledge advancements, and incorporate these into the new facility.

The services planned for a new facility will include:

  • manufacture of medicines that are not currently available as licensed products, but are critical for patient care within NHS Scotland – these include medicines used in Critical Care/Anaesthetics, Paediatrics and Neonates, Dermatology, Ophthalmology, Cancer Services;
  • support for Unscheduled Care and out-of-hours care services in line with the recent development of a Directors of Pharmacy National Formulary; support for Community Pharmacy services by providing extemporaneously prepared medicines for individual patients;
  • provision of medicines for emergency planning and during periods of product shortages;
  • manufacture of Clinical Trials Materials in support of NHS Scotland clinicians involved in R&D activities, Clinical Research Centres and the Scottish Academic Health Services Collaboration.
    The team have prepared a design statement which can be seen here.

For more information on the business case as the project develops see the project’s page at NHS Tayside

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