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Unlicensed medicines uses: A UK guideline analysis using the AGREE II tool

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Publication details

JournalThe International journal of pharmacy practice
DateAccepted/In press - 19 Dec 2017
DateE-pub ahead of print (current) - 30 Jan 2018
Early online date30/01/18
Original languageEnglish


Objectives There is widespread use of unlicensed medicines within primary
and secondary care but little information is available around how these medicines
are used. This analysis examines and evaluates the content and quality of
relevant guidance documentation currently in use within the UK.
Methods Guidance documents were identified through a literature search as
well as email requests to pharmacy organisations throughout the UK. Unlicensed
medicine documentation suitable for inclusion in the analysis underwent
thematic analysis and quality assessment using the AGREE II tool.
Key findings Thematic analysis of 52 guidelines revealed four parent themes:
(1) Professional responsibility (2) Usage practicalities (3) Risk versus benefit
(4) Controlling use. There was variability in scores across the AGREE II
domains with areas covering Scope and Purpose and Clarity of Presentation
scoring well. Conversely, an area needing attention was Rigour of Development.
Conclusion Healthcare organisations would benefit from agreeing a ‘core content’
for the development of unlicensed medicines guidelines to ensure consistency
and the presence of robust operating systems to deliver safe, effective
treatment to all NHS patients. 6

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