- HRT Supply Task Force Leader and Industry Identify Immediate Actions to Improve Short-Term Supply and Ensure Ongoing Stability
- Other Severe Shortage Protocols (SSPs) published to give pharmacists the ability to substitute appropriate products
Urgent steps continue to be taken to improve the supply of HRT products, helping those in need to access lifesaving medicines.
Since the government has worked to resolve the supply of HRT and has put in place measures to do so – such as SSPs for certain products and the appointment of Madelaine McTernan as head of the supply working group in HRT – access to HRT is improving, helping those in need to access it. vital medicine.
The availability of Premique Low Dose has improved with SSPs released on April 29 to limit the distribution of Estrogel, Ovestin and Premique Low Dose to three months supply. Since the implementation of these measures, new deliveries of all three products have been made, with Premique Low Dose returning to good availability this week. Manufacturers of Oestrogel and Ovestin, as well as suppliers of alternative HRT products, are taking steps to increase supply in the UK.
Following a positive dialogue with pharmacists, the government has released further SSPs to give pharmacists the ability to safely offer high-demand substitute products to women – Oestrogel, Ovestin cream, Lenzetto transdermal spray and Sandrena gel sachets – with suitable alternatives, such as transdermal patches, which are well stocked.
Giving women the option to switch products is a safe and effective way to ensure that HRT continues to be available to everyone who needs it and that women can continue to manage their menopausal symptoms. Anyone with questions or concerns about HRT should talk to their GP or pharmacist. Clinical advice for these SSPs has been drawn from national experts, including clinicians from the British Menopause Society and the Royal College of Obstetricians and Gynecologists.
SSPs limiting prescriptions to a maximum of three months supply will also be issued for substitute products, as a precautionary measure to ensure continued supply of such substitutes.
The move follows engagement between HRT Supply Task Force Leader Madelaine McTernan and the industry on measures to ensure the efficient use of current stock as well as increase supply, both at short term and to provide stability for the future.
The meetings also allowed some suppliers to take quick action to secure additional stock of HRT products that are experiencing shortages, resulting in a good supply of Premique Low Dose that was previously experiencing shortages.
Health and Social Care Secretary Sajid Javid said:
We are working hard to ensure that HRT is available to everyone who needs it and I am pleased to see that vendors continue to increase the supply of certain products, which is a testament to the collaborative approach taken.
Meetings with suppliers are ongoing and we are taking decisive action to manage HRT supply issues and reduce delays – this includes issuing additional PHCs so women can access the medicines they need.
Madelaine McTernan, HRT Supply Task Force Leader, said:
I am very encouraged by the constructive engagement across the sector and the enthusiasm with which providers and pharmacists seek to work with us to meet this challenge.
It is essential to focus both on measures that ensure that we can use stocks in the most efficient way while guaranteeing the increase in supply”.
Women’s Health Minister Maria Caulfield said:
Improving supply stability is another key measure to increase support for postmenopausal and permenopausal women to improve their quality of life.
Women’s health is a priority for this government – we are working around the clock to ensure stable HRT supply now and for the long term.
The NHSE guidelines make it clear that prescribers are not restricted by formulary lists and are not prevented from prescribing a wider range of products.
The British Menopause Society’s resource on HRT supply provides information on choosing alternative HRT products. Additionally, information on the most appropriate formulations for different populations and comorbidities is available on the NICE website.
NHS England encourages prescribers to check the availability of HRT products before prescribing, consulting the NHS England Specialist Pharmacy Service website liaising with local pharmacies to identify available stocks and agree suitable alternatives if necessary.
The MHRA has reminded manufacturers and suppliers of HRT of steps they can take to alleviate supply shortages and has supplemented existing guidance on this by holding workshops on May 16 with representatives from manufacturers, community pharmacies and wholesalers to ensure these provisions are understood. This includes confirming that pharmacies have the ability to share medications where appropriate. The MHRA is also working to consolidate its guidelines so that they are available from a single webpage, which will be available soon.
The vast majority of HRT products remain available and alternatives are available for any products affected by supply issues.
- On April 29, the Secretary of Health and Social Care issued three SSPs for [restrict dispensing for Oestrogel, Ovestin and Premique Low Dose to three months’ supply](Three month limit for 3 HRT products to ensure continued access – GOV.UK (www.gov.uk)
Other SSPs have been issued to allow community pharmacists, in consultation with patients, to provide specified alternatives to prescribed HRT products without needing to seek permission from the clinician who prescribed the drug. Clinical advice for these SSPs has been drawn from national experts, including clinicians from the British Menopause Society and the Royal College of Obstetricians and Gynecologists. Further SSPs have been issued to limit distribution to three months supply for the two substitute products, estradiol patches and estriol cream, to ensure continued supply.
- This does not mean that these products are out of stock, but will provide greater flexibility for pharmacists and ensure that more people can continue to access the medicines they need.
- Products that can be substituted in case of unavailability are Oestrogel, Ovestin cream, Lenzetto transdermal spray 1.53 mg and Sandrena gel sachets 0.5 mg and 1 mg.
- More details on Health Secretary Madelaine McTernan and Minister Caulfield’s meeting with suppliers and manufacturers
MHRA guidelines allow the transfer of drugs between pharmacies without the need for a WDA (wholesaler/dealer) license provided: it occurs occasionally; the amount of drugs provided is low; the supply is made on a non-profit basis; and the supply is not intended for subsequent wholesale distribution.