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A questionnaire based study into the variation in the volume, completion and content of Unlicensed Medicines Risk Assessments in NHS Trusts in England

Trial Status: Open

The majority of medicines used in the National Health Service (NHS) are licensed medicines, meaning that they have
gone through a rigorous process to determine safety, efficacy and quality and thus are permitted to be used under
specific circumstances. However, there are instances where no appropriate licensed medicine is available for use to
treat a specific patient. In these situations, a doctor may decide to use a medicine that has not been licensed for use
in humans (an unlicensed medicine). The risks associated with using unlicensed medicines have been well
documented: increased risk of adverse events, potentially poorer quality formulation and absence of regulated
manufacturing and supply standards. Therefore, there is a requirement for NHS organisations to risk assess the need
and quality of unlicensed medicines to reduce harm to patients, staff and the organisation. This study aims to
investigate the identification and management of the risks associated with unlicensed medicines by NHS trusts in
England through the unlicensed medicines risk assessment process.
The results from this study may provide an overview of the national practice around how unlicensed medicines are
managed within NHS trusts and potentially lead to a series of improvements that can optimise the process