The Department of Health and Social Care (DHSC) has issued a serious shortage protocol (SSP) for Utrogestan 100mg capsules, restricting the amount that a pharmacist can dispense to just two months’ supply with immediate effect.

DHSC said that Utrogestan, a progesterone hormone replacement therapy (HRT) drug, was expected to be in intermittent supply until late 2023, as manufacturer Besins was struggling to meet rising demand.

The SSP would ‘support access to available stock’ while Besins was ‘taking steps to increase supply’.

DHSC said that it was continuing to monitor the position of HRT supply ‘very closely’ and was working together with industry, the NHS and other key partners ‘to help ensure the continuity of supply of HRT medicines across the UK for everyone that needs them’.

Minister for the women’s health strategy Maria Caulfield described the issuing of the SSP as ‘decisive action’ that would mean more women would be able to access Utrogestan.

‘I want to reassure women that the vast majority of HRT products are in good supply,’ she said.

She added: ‘The overall supply of HRT products has improved considerably over the last year and I am encouraged by how industry is responding to the growth in demand and our continued calls for action to boost supply to meet it.

‘We continue working to help ensure continuity of supply – which is a key part of increasing support for menopausal and pre-menopausal women and improving their quality of life.’

Shortages of Utrogestan have been reported for several months.

In February, Ms Caulfield denied a national shortage of Utrogestan, amid widespread reports of supply delays and difficulties getting hold of the hormone treatment.

And last week, national newspaper i news reported that women were ‘risking their health’ by sharing medication after major online pharmacy Pharmcy2U told patients that it was currently struggling to fulfil all prescriptions of Utrogestan.

The Pharmaceutical Services Negotiating Committee (PSNC) issued guidance on the Utrogestan SSP today, saying that the SSP could not be used if a patient presents a prescription for an amount less than or equivalent to two months’ supply, and that no prescription charge would apply if a patient receives a smaller quantity of the medicine than the quantity originally ordered on the prescription if it was supplied in accordance with an SSP for reduced quantity.

PSNC added that the DHSC supply team were constantly monitoring the HRT supply situation, and the DHSC would issue SSPs for other HRT medicines if considered appropriate by ministers.

The negotiator also confirmed that contractors supplying Utrogestan 100mg capsules in accordance with the SSP would be reimbursed the Drug Tariff Part VIIIA reimbursement price for Utrogestan 100mg capsules, as well as being paid one Single Activity fee (currently £1.27) and one SSP fee (£5.35).

They added that until the end of May 2023, the reimbursement price will account for VAT payment, but from June 2023, this VAT allowance will no longer be paid as products supplied in accordance with an SSP would be considered VAT zero-rated.