Hydrocortisone
The question
To ask the Secretary of State for Health and Social Care, with the withdrawal of liquid hydrocortisone what steps is his department is taking to source a suitable alternative liquid hydrocortisone product for use in the UK.
Answered by Preet Kaur Gill
The Department is aware of the discontinuation of hydrocortisone sodium phosphate 100 milligram/1 millilitre solution for injection, and we continue to work with industry to find a longer-term solution.
Hydrocortisone sodium succinate 100 milligram powder remains available for patients. We have issued comprehensive management guidance to healthcare professionals on how to manage patients while supply is disrupted. The guidance highlighted the differences between the two hydrocortisone injections. It also included resources for patients and healthcare professionals on how to administer the alternative hydrocortisone injection.
We also understand that The Addison’s Self Help Group has also published information on this discontinuation to keep patients informed, along with resources for patients on how to administer the alternative hydrocortisone.
Act-O-Vial currently is not available as a licenced medicine in the United Kingdom and the decision to market a product in the UK lies with the manufacturer of the product. However, we are working closely with the manufacturer, specialist importers, and the Medicines and Healthcare products Regulatory Agency (MHRA) to understand the options available for supplies to be made available to UK patients. Currently, specialist importers are able to source unlicensed supplies for patients. We have updated our communications to healthcare professionals to advise them of this option. Furthermore, the MHRA recognises the concerns raised about the withdrawal of the previously marketed liquid hydrocortisone injection. We have not had any conversations with the Office for Life Sciences about this product.
Following a review of the current regulatory position, the MHRA can confirm that any marketing authorisation application for a liquid hydrocortisone injection product submitted to the MHRA will be rapidly progressed.
Should a company choose to submit an application for such a product, the MHRA would prioritise its assessment, recognising the clear clinical importance. However, decisions regarding the development, manufacture, and marketing of medicines rest solely with the companies that hold, or seek to hold, the relevant product licences. The MHRA cannot compel companies to supply a medicine.
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