Abstract

An unlicensed medicine (ULM) is a product which does not have a marketing authorisation from the MHRA. ULMs include Specials, food supplements and imported medicines. They have not
undergone the same regulatory processes as licensed medicines, including rigorous assessment of safety and efficacy. How and why prescribers choose to initiate these medicines, pharmacists
source them and patients use them has never been explored.
Aim and objectives

• To explore the use of unlicensed medicines across primary and secondary care from the
perspectives of prescribers, pharmacists and patients
– To conduct an analysis of guidance documentation designed to support the use of
unlicensed medicines
– To describe experiences of prescribing, dispensing and taking ULMs
– To explore perceptions of risks and benefits associated with ULMs
– To identify concerns around use of ULMs
– To discover any perceived improvements to ULM use in the NHS