• Head of HRT Task Force and Industry Identify Immediate Action to Improve Short-Term Supply and Ensure Continuous Stability
  • Additional Serious Deficiency Protocols (SSPs) issued to provide flexibility for pharmacists to replace relevant products

Immediate action is still being taken to improve the supply of HRT products, helping those who need it to access vital medicines.

As the government works to regulate HRT supplies and takes steps to do so – such as the SSP for some products and the appointment of Madeleine McTernan as head of the HRT supply working group – access to HRT is improving by helping those who need it access vital medication.

The availability of Premique Low Dose has improved thanks to the SSP published on April 29 to limit the issuance of Oestrogel, Ovestin and Premique Low Dose to three months. Since the introduction of these measures, further deliveries of all three products have been made, and this week Premique Low Dose returned to good availability. Manufacturers of Oestrogel and Ovestin, as well as suppliers of alternative HRT products, are taking steps to increase supplies in the UK.

Following positive interactions with pharmacists, the government has released additional SSPs that allow pharmacists to safely offer women high-demand products – estrogel, Ovestin cream, Lenzetto transdermal spray and Sandrena gel sachets – with appropriate alternatives such as transdermal patches.

Giving women the opportunity to substitute foods is a safe and effective way to ensure that HRT remains available to all who need it and women can continue to manage their menopausal symptoms. Anyone who has questions or concerns about HRT should talk to their doctor or pharmacist. Clinical advice on these SSPs was taken from national experts including clinicians from the British Menopause Society and the Royal College of Obstetricians and Gynecologists.

SSPs, which limit prescriptions to a maximum of three months, will also be issued for substitutes, as a precaution to ensure that supplies of these substitutes are maintained.

The move comes after collaboration between HRT Supply Team Leader Madeleine McTernan and the Sector for Measures to Ensure Efficient Use of Current Stocks and increase supply, both in the short term and to ensure stability for the future.

The meetings also led to some vendors taking swift action to provide additional stocks of HRT products that are in short supply, leading to a good supply of Premique Low Dose, which was previously lacking.

Health and Social Welfare Minister Sajid Javid said:

We are working to make HRT available to all who need it, and I am pleased to see that suppliers continue to increase the supply of some products, indicating a collaborative approach.

Meetings with suppliers continue, and we are taking decisive action to address HRT supply problems and reduce any delays – this includes issuing additional SSPs so that women can receive the necessary medication.

HRT Supply Working Group Chair Madeleine McTernan said:

I am very encouraged by the constructive collaboration across the sector and the enthusiasm with which suppliers and pharmacists are committed to working with us to cope with this challenge.

It is important to focus on measures that ensure that we can make the most efficient use of stocks, as well as ensure increased supplies. ”

Women’s Health Minister Maria Caulfield said:

Improving supply stability is another key measure in increasing support for menopausal women and menopause to improve their quality of life.

Women’s health is a priority for this government – we work around the clock to ensure the stability of HRT supplies now and in the long run.

The NHSE guide explains that prescribers are not limited to formal lists and are not prevented from prescribing a wider range of products.

The British Menopause Society The HRT resource contains information on the selection of alternative HRT products. In addition, information on which drugs are most suitable for different populations and comorbidities can be found at DAYS website.

The NHS of England recommends that prescribing physicians check for HRT products before prescribing by reviewing NHS England Pharmacy Specialists website liaise with local pharmacies to identify available stocks and agree on suitable alternatives if necessary.

The MHRA reminded HRT manufacturers and suppliers of the steps they can take to alleviate supply shortages, and supplemented existing instructions by holding workshops with representatives of manufacturers, public pharmacies and wholesalers on 16 May to ensure that these provisions are understood. This includes confirmation that pharmacies have the ability to share medications if needed. MHRA is also working to consolidate its instructions so that they are available from a single web page and they will be available soon.

The vast majority of HRT products remain available, and alternatives are available for any products affected by supply problems.

Background information

  • On April 29, the Minister of Health and Social Services issued three SSPs [restrict dispensing for Oestrogel, Ovestin and Premique Low Dose to three months’ supply](Three-month limit for 3 HRT products for permanent access – GOV.UK (www.gov.uk)
  • SSPs were then issued allow public pharmacists, in consultation with patients, to supply certain alternatives to prescribed HRT products without the need to obtain permission from the prescribing physician. Clinical advice on these SSPs was taken from national experts including clinicians from the British Menopause Society and the Royal College of Obstetricians and Gynecologists. Additional SSPs were issued to limit the issuance of two replacement products, estradiol patches and estriol cream, limiting leave to three months to ensure stockpile maintenance
  • This is not to say that these products are not available, but to provide more flexibility for pharmacists and ensure that more people will be able to continue to access the medicines they need.
  • Foods that can be replaced if they are not available are estrogel, Ovestin cream, 1.53 mg Lenzetto transdermal spray and 0.5 mg and 1 mg Sandrena gel sachets.
  • Read more about Health Minister Madeleine McTernan and Minister Caulfield meeting with suppliers and manufacturers
  • MHRA Guide allows you to transfer medicines between pharmacies without the need to have a WDA license (wholesale / dealer license) provided: this happens from time to time; the amount of drugs supplied is small; delivery is carried out on a non-commercial basis; and delivery is not for further wholesale distribution.

https://www.gov.uk/government/news/further-action-taken-to-improve-supply-of-hrt

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