<p>Unlicensed “Special” Medicines: Understanding the Community Pharmacist Perspective</p>

Abstract

Objective: Community pharmacy staff are responsible for obtaining and supplying unlicensed "special" medicines to patients in primary care. Less well-defined parameters for safe and effective use of unlicensed compared to licensed medicines, along with issues around maintaining consistency between care settings or among manufacturers, have been associated with increased risks. This study aimed to explore the views and experiences of community pharmacy staff on accessing and supplying unlicensed "special" medicines to patients in Wales and the perceived impact of challenges faced on patient care. Methods: A qualitative, phenomenological approach was employed, involving semistructured interviews with pharmacists and pharmacy technicians working at one small chain of community pharmacies in Wales. The interview schedule focused on the personal experiences and perceptions of the participants on the processes involved in accessing and supplying unlicensed "special" medicines from a community pharmacy. Interviews were audio-recorded and transcribed verbatim. Results: A total of six participants completed the interview. Three main themes were constructed from inductive thematic analysis of the transcribed interviews: requirement for additional patient responsibilities; influences on the confidence felt by pharmacy staff when accessing and supplying unlicensed "special" medicines; and continuity of supply. Conclusion: This study gives a preliminary insight into the views and experiences of community pharmacy staff in Wales when accessing and supplying unlicensed "special" medicines. Further research is required to see if these views and experiences are representative of community pharmacy staff across the country.

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

“… 46 This study adds to the data for the difficulties HCPs face in conceptualising ULMs and how they are used in practice. Many of the schema script events we describe are also reflected by others 15 , 22 , 29 and we feel this adds to their likely transferability.…”

“…Potential pharmaceutical issues with ULMs have also been highlighted by others. 22 However, risk perception by individuals is influenced by an availability bias; most participants in this study could not describe a significant adverse consequence from using an ULM and this can create biases in the formation of schema. 38 This combined with the absence of robust data could lead to the conclusion that ULMs are safe to use.…”

“…This may be due to a greater emphasis on drug manufacturing and legislation as part of their core training, however our less experienced pharmacists were still less confident about these definitions and this is reflected in other work. 22 Another paper has also highlighted the potential for confusion surrounding the use of unlicensed and off-label use of medicines. 1 In the UK, the GMC has further complicated the issue by combining both off-label and ULM within the same guideline 1 despite the guidance note from the MHRA making clear differentiations in risk between these two categories.…”

“…11 , 36 All our participants highlighted issues around the transfer of care for ULMs and this has been reflected in work by others. 22 Primary care prescribers described having a lack of knowledge about ULMs and costs of ULMs were also cited as barriers in prescribing transfer. These issues have also been found in other work done on the transfer of paediatric patients from secondary to primary care.…”

“… 32 , 33 However, given the challenges that prescribers face around awareness of when they are using an ULM, applying this in practice is likely to be difficult. Whilst others have explored pharmacists' perceptions about informing patients about the status of ULM 22 or off-label use of medicines, 29 , 32 , 33 we are the first to include this debate from several actors' perspective. We feel that this is something that will need ongoing discussions between prescribers, pharmacists and patients.…”