Abstract

Problem
An unlicensed medicine (ULM) is a product which does not have a marketing authorisation from the MHRA. ULMs include Specials, food supplements and imported medicines. There has never been an evaluation of the quality of ULM guidelines or analysis of their content.

Approach
A search of published guideline documentation was conducted using peer-reviewed electronic databases. Search terms included ‘unlicensed medicine’ or ‘specials’ combined with; guideline, policy, framework, standardized operating procedure, standard operating procedure or recommendation. Internal documentation was acquired using a ‘call for guidance’ which was distributed both locally and nationally across healthcare settings.

The quality of the guidelines was assessed using the AGREE II tool alongside a thematic analysis of the content.

Findings
A total of 52 guidance documents were included in the analysis. The quality of the guidance documentation was good for the domains ‘Scope and Purpose’ (70.6%) and ‘Clarity of Presentation’ (70.4%). However, the ‘Rigour of Development’ domain (12.1%) and the ‘Editorial Independence’ domain (2.6%) scored poorly. Rigour of development reflected the fact that ULM guidance lacked references to an evidence base. The editorial independence score was due to lack of clarity around competing interests from the guideline authors. Some documents provided tools for the implementation of the recommendations but many did not, resulting in a low ‘Applicability’ score (23.9%). The ‘Stakeholder development’ score (30%) revealed lack of multidisciplinary and specialist input and little involvement of patients.

Thematic analysis of the guidance documents revealed four parent themes across the documentation. The ‘Professional Responsibility’ theme highlighted the need for healthcare professionals to be aware of when they were using ULM and their responsibilities when using them. The ‘Usage Practicalities’ theme included the stages of use from prescribing to administration. ‘Risk versus benefit’ in using ULMs was a strong theme throughout the guidance documentation. This included evidence to support use of ULMs and the place of ULMs in treatment. ‘Controlling the use’ of ULMs described the strategies employed to regulate costs and restrict access to ULM.

Consequences
There is a lack of transparency around who writes guidance on ULM and on what foundations they base their recommendations. This is likely to reflect a wider issue around lack of evidence for ULM which has also been found in guidance documentation in paediatrics. There is a large deficit in stakeholder and patient involvement in ULM guidance development.

In addition, there is also a lack of consistency in content across ULM guidelines and there is a need to agree a ‘core content’. There was little documentation from community pharmacy or the primary care sector. It is not clear if this is due to a lack of guidance or a lack of submission to the project for analysis.