Clinician awareness and implementation of MHRA guidance on vitamin B12 monitoring in metformin users: a reflexive thematic analysis of primary care practice
Abstract
Abstract Background: Metformin is the first-line pharmacological treatment for type 2 diabetes mellitus (T2DM) but is associated with vitamin B 12 deficiency. In 2022, the Medicines and Healthcare products Regulatory Agency (MHRA) issued a Drug Safety Update recommending testing in symptomatic patients and consideration of periodic monitoring in those at risk. Quantitative studies have demonstrated only modest changes in monitoring following the alert, suggesting a gap between guidance and routine practice. This study aimed to explore clinician awareness of the MHRA update and examine how guidance on vitamin B12 monitoring is interpreted and implemented within primary care. Methods: A qualitative study using semi-structured interviews was conducted with clinicians involved in diabetes care in general practice in the South-West of England. Participants were recruited from respondents to a preceding survey who had expressed interest in follow-up interviews. Interviews were conducted remotely between October 2025 and January 2026 and transcribed verbatim. Data were analysed using reflexive thematic analysis following Braun and Clarke’s (2006) six-phase approach. Results: Eighteen clinicians participated, including general practitioners, nurses and pharmacy professionals. Four themes were identified: preventive monitoring under service pressure; navigating roles and responsibility in diabetes care; translating guidance into practice; and pragmatic decision-making under…
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