Abstract

Problem
An unlicensed medicine (ULM) is a product which does not have a marketing authorisation from the MHRA. They include Specials, food supplements and imported medicines. Areas that have not been explored include:
• How and why prescribers choose to initiate them
• How and where pharmacists source them
• Patient use and awareness of ULM
• Perceptions of use

Approach
Semi-structured face-to-face interviews were conducted with prescribers (n=11), pharmacists (n=10) and patients (n=7) sampled from both primary and secondary care in the North East of England. Interviews were audio recorded and transcribed verbatim. Grounded theory analysis led to the development of themes and informed the selection of subsequent participants.

Findings
Several themes were identified across the data by healthcare professionals and patients in primary and secondary care, including:
• Healthcare professionals’ awareness of when they were using an ULM and their definition of an ULM
• Perceptions of safety of ULMs was elicited, including the lack of safety and efficacy data compared to licensed products and the perceived under-reporting of adverse effects
• Provision of information and whether patients were likely to be informed about the unlicensed status of their medicines, who the person to inform them should be and what information patients would want
• The place of unlicensed medicine use in the clinical management of a patient, including whether licensed alternatives were tried first
• Trust as an important aspect in the use of unlicensed medicines, this was apparent throughout the interviews and between all actors

Lack of education and training for healthcare professionals around what an ULM is and the associated implications with their use, coupled with a lack of information seems to perpetuate problems identified in the use of ULM. Cost implications associated with ULM was a strong theme among primary care participants, however, many secondary care participants lacked an awareness of the associated costs which could lead to under-utilisation of viable alternatives.Costly and burdensome regulatory processes for medicines licensing were often cited for the use of ULMs and seemed to legitimise their routine use in practice.

Consequences
The lack of marketing authorisation creates many issues in the use of ULMs, including a lack of access to information and reduced intelligence around their safety and efficacy. Despite this they are generally perceived as safe. The regulatory implications of using ULMs and the potential variability between products, does not seem to be well understood. Consideration of how the patient will use the medication and the provision of suitable written information seems to be inconsistently considered. There is a need for training and the development of mutually agreed standards on the use of ULMs to be created to inform a more consistent approach to their use by both healthcare professionals and patients.