Serious shortage protocol issued to restrict dispensing of HRT drug Utrogestan 

Community pharmacists are now able to restrict supply of Utrogestan 100mg capsules (progesterone; Besins) in line with a government protocol issued to mitigate a shortage of the HRT.

On 19 May 2023, the Department of Health and Social Care (DHSC) issued a serious shortage protocol (SSP) for Utrogestan 100mg capsules, which will enable pharmacists to dispense a maximum of two months’ supply per prescription.

In a statement issued alongside the SSP, the DHSC said the HRT “is expected to be in intermittent supply until late 2023”.

“Deliveries are frequently being made by the manufacturer, Besins, but it has struggled to meet rising demand. The manufacturer is taking steps to increase supply, but in the meantime the SSP will support access to available stock,” the statement said.

Data published by NHS Business Services Authority on 6 October 2022, showed a 35% increase in prescribing of HRT in England between 2020/2021 and 2021/2022, and a 30.5% increase in the number of patients prescribed HRT during the same period.

According to the data, Utrogestan 100mg capsules were the third most commonly prescribed HRT item in 2021/2022, with 458,396 items prescribed — more than double the number prescribed in 2020/2021 (223,513 items).

In its statement, the DHSC said the restriction in supply “will ensure more women can continue to access the medication they need”.

In the statement, Maria Caulfield, minister for women’s health strategy, said she wanted “to reassure women that the vast majority of HRT products are in good supply”.

“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,” she said.

“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.”

Since April 2022, the government has issued 22 SSPs for HRT products to mitigate the impact of ongoing supply problems.

In April 2023, the government launched a prepayment scheme for HRT prescriptions, allowing patients to pay £19.30 for a 12-month supply of HRT.

A spokesperson for Besins Healthcare UK said: “The demand for Utrogestan 100mg has increased by double over the last 12 months, and five-fold since March 2021. This significant rise in UK demand, coupled with a rise in global demand, has required an enormous increase in our manufacturing capacity. This has been achieved in the short term by adding additional production lines, increasing shifts and increasing inventory of component parts such as packaging. In the longer term, recognising that demand will continue to rise, we are significantly increasing the quantity of Utrogestan 100mg available to the market by investing in the construction of a new manufacturing facility in Muel, Spain. Ground was broken in May 2022, and full production is set to commence later this year once the site has been appropriately registered with the regulatory authorities. Utrogestan 100mg capsules will be the first product to be manufactured in the new factory. We anticipate product will be available to the market in late 2023 or early 2024.”

The spokesperson added that there were “good supplies of Utrogestan 100mg in the last two weeks (weeks commencing 8th and 15th May 2023)”. 

“We are expecting a further delivery this week (week commencing 22nd May 2023). These supplies will need to work their way through the supply chain which means pharmacies may experience short interruptions in availability locally,” they said.