Doctors Continue to Prescribe Buccal Hydrocortisone Despite MHRA Safety Alert

Dawn O'Shea

December 01, 2020

Doctors continue to prescribe buccal hydrocortisone (buccal-HC) to children with adrenal insufficiency (AI) despite a Medicines and Healthcare products Regulatory Agency (MHRA) safety alert recommending against the off-label use of mucoadhesive buccal-HC tablets because of insufficient cortisol absorption and risk of life-threatening adrenal crisis.

The British Society of Paediatric Endocrinology and Diabetes (BSPED) has evaluated the extent of buccal-HC use in the UK since the MHRA safety alert using an online survey to: (a) investigate hydrocortisone prescribing practices between June 2019 and February 2020 and (b) ascertain experience of buccal-HC. The survey was circulated to all UK tertiary paediatric endocrine centres and BSPED members.

Responses were received from 14 out of the 22 tertiary paediatric endocrine units in the UK (64%), as well as six district general hospitals.

All hospitals used 10 mg hydrocortisone tablets while also using other preparations. More than half (55%) used approved Alkindi hydrocortisone granules, whereas 60 per cent used non-proprietary oral hydrocortisone solutions. More than a third (35%) of hospitals used buccal-HC.

Of all respondents, 65 per cent reported either present or prior experience of buccal-HC. Those hospitals reporting use of buccal-HC cited patient choice and ease of drug administration by families as reasons to continue usage despite the recent MHRA safety alert.

There were 33 episodes of adrenal crises reported by 13 hospitals over the preceding year. Only one patient in one episode (3%) had been receiving buccal-HC at the time of adrenal crisis.

Presenting the findings in Archives of Disease in Childhood, the authors said: “Our survey demonstrates widespread clinical use of buccal-HC for the treatment of childhood AI despite the recent MHRA safety alert. While overwhelming safety concerns were not identified in our survey, it would be advisable to adhere to MHRA guidance and re-engage with those patients and families who prefer to remain on buccal-HC for regular treatment, to discuss switching to licenced preparations for future prescriptions.”

Shaunak M, Banerjee I, Davies JH. Hydrocortisone muco-adhesive buccal tablets continue to be used for the treatment of adrenal insufficiency in children in the UK. Arch Dis Child. 2020 Nov 17 [Epub ahead of print]. doi: 10.1136/archdischild-2020-319865. PMID: 33203652 View abstract

This article originally appeared on Univadis, part of the Medscape Professional Network.

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