Unlicensed “Special” Medicines: Using the Pillar Integration Model to Understand Stakeholder Perspectives Across Care Settings

Abstract

Background The use of unlicensed medicines has been associated with safety concerns, availability and accessibility issues, and lack of integrated care across care settings. Objective To understand the interaction between the views and experiences of those who prescribe, those who supply and those who receive unlicensed “special” medicines, so that factors affecting the patient journey and successful treatment can be identified and used to inform areas for change. Methods A qualitative, phenomenological approach was adopted, with semi-structured interviews with prescribers, community pharmacy staff and patients. A combination of stratified, purposive, snowball and convenience sampling was used to identify participants. Interviews were analysed using reflexive thematic analysis and the findings were integrated using an adapted model of the Pillar Integration Process. Results Three pillars were constructed after synthesising results from interviews with patients (n=4), prescribers (n=5) and pharmacy staff (n=6): the awareness of licensing status; perceptions of patient care and acceptability of unlicensed medicine use; and challenges associated with the accessibility of unlicensed medicines. The varying levels of awareness when unlicensed medicines are prescribed and the varying perceptions of responsibility and acceptability of the use of unlicensed medicines help to explain the challenges faced by participants across the patient journey, Challenges identified included understanding what unlicensed medicines are, awareness of the licensing status when unlicensed medicines are prescribed, managing care across care settings to ensure the patient is effectively treated and ensuring continuity of care for patients in the community. Conclusion The results highlight a clear need for more integrated care and support for prescribers to reduce the chances of delays between care settings, and more patient-centred care to ensure that any delays when accessing medicines do not lead to treatment disruption for the patient. The new national guidelines informed by findings of this study can support policy-makers across the globe.