Supporting patients with unlicensed medicine use: Analysing the script schemas for prescribing, pharmaceutical assessment and supply

Unlicensed medicines (ULMs) are those which have not received authorisation from a regulator, as such they do not have the same reassurances around safety and efficacy as licensed medicines. This study aimed to explore the use of ULMs from the perspectives of prescribers, pharmacists and patients within the UK National Health Service (NHS) setting. Grounded theory was used as a framework, conducting 28 semi-structured qualitative interviews with prescribers, pharmacists and patients across both primary and secondary care settings. Participants were identified from their known use of ULMs where possible and a theoretical sampling approach was used to support recruitment of participants based on the emergent analysis. Analysis followed a constructivist inductive approach, using constant comparison to develop initial themes. This was followed by two focus groups, one with patients and one with professionals where initial analytic findings were presented to participants to further support the development of themes. All interviews were audio recorded and transcribed verbatim. Three sequential schema scripts were identified and used as a framework to explain our findings: ULM prescribing, pharmaceutical assessment of an ULM and ULM supply. Common and divergent events within these scripts were identified and analysed in an attempt to explain similarities and differences across primary and secondary care and between actors. The analysis identified issues around healthcare professional awareness of using ULMs, perceptions of ULM safety, challenges around what information should be provided to patients and by whom and adds to the debate around the place of ULMs in treatment pathways. This study highlights the need for a multidisciplinary conversation about how ULMs should be used in the NHS.