A multi-method study of unlicensed medicine risk assessment: a cross-sectional survey of pharmacy procurement leads and policy analysis across NHS trusts in England.

introductionMedicines which lack a marketing authorisation, referred to as unlicensed medicines, are used across healthcare systems internationally. Their use carries recognised quality and safety risks, yet no published evidence describes how healthcare institutions assess and mitigate these risks at a system level.

aimThis study aimed to explore the processes and variation in risk assessment for unlicensed medicines across NHS trust hospital pharmacies in England.

methodA multi-method design was used. An online questionnaire was distributed to pharmacy procurement leads across NHS trusts in England (n = 37). Concurrently, unlicensed medicines policies from 40 NHS trusts were analysed using a structured coding framework developed through iterative refinement. The questionnaire collected data on unlicensed medicines risk assessment volume, scope, and governance; policies were analysed to identify organisational intended practice. Datasets were independently analysed and compared at code level across eighteen shared elements to examine variations between practice and policy.

resultsApproximately three quarters of questionnaire respondents (73%; 27/37) reported completing both quality and clinical risk assessments for all unlicensed medicines procured, and most trusts (92%; 34/37) had an unlicensed medicine policy; however, only 65% (24/37) reported clearly defined governance oversight, and 57% (21/37) cited formal approval of unlicensed medicine use. Practices were heterogeneous: risk assessments frequently focused on product identity (e.g., 86%; 32/37, considered country of manufacture) but rarely examined processes of manufacturing or sterilisation. A minority (16%; 6/40) used a formal risk scoring system, and review cycles were inconsistent, with 41% of policies (16/40) not mandating review periods. Policies typically mandated risk assessment and recording on a register but varied in technical detail and rarely indicated that quality checks were required upon receipt. Comparison of findings revealed probable duplication of effort in risk assessment for commonly procured unlicensed medicines and divergence between policy emphasis and practitioner focus.

conclusionNHS trusts routinely risk assess unlicensed medicines yet do so independently, with variation in risk assessment content, limited use of structured scoring, and gaps in post-receipt- verification. A national minimum dataset for risk assessment and a shared repository of completed assessments could reduce duplication, improve consistency, and strengthen patient safety.