The current peak in COVID-19 cases has resulted in a significant increase in demand on NHS services. This has been further compounded by the general winter pressures and increased workload for both primary and secondary care with the increased incidence of flu and respiratory illnesses as well as the reduced staffing levels due to illness or self-isolation. As a result of these pressures, and as we saw in the earlier months of the pandemic, a number of non-urgent services including menopause services have been restricted to divert staff to support the critical care and emergency services.
We recognise that as a result of the current coronavirus situation many women are likely to experience difficulties in obtaining HRT supplies. We also appreciate that continuing HRT intake is likely to help many women control their often difficult menopausal symptoms, particularly relevant given the additional stress some women may be under in view of the strains of the current situation on society. In addition, General Practitioners’ surgeries have also been put under additional pressure, with consultations and advice prioritised to dealing with serious and potentially life-threatening medical issues.
The British Menopause Society has issued this further update on the current availability of HRT products to provide guidance to BMS members and clinical practitioners in response to the ongoing HRT shortages.
We recommend that Healthcare Professionals and prescribers follow the joint guidance issued by the BMS, RCOG, RCGP and FSRH which recommends that General Practitioners and healthcare providers consider advising women about menopause issues through telephone and virtual consultations where at all possible to reduce face to face engagement, and with easy access to repeat prescriptions of HRT supplies (especially to women who have been on HRT and have not been experiencing any problems with their intake). This will help to avoid the need for many women to visit their GP surgery to discuss these issues and assist with obtaining repeat prescriptions. This can be accessed through the following link: https://thebms.org.uk/wp-content/uploads/2020/06/Framework-for-restoration-of-menopause-services-2020.pdf
The BMS has produced a document on alternative HRT preparations to provide guidance to BMS members and clinical practitioners who may be experiencing difficulties with HRT supplies. This can be accessed through the following link: https://thebms.org.uk/wp-content/uploads/2019/11/HRT-alternatives-04.11.2019.pdf
Prescribers should consider equivalent preparations to that which their patients are using. If an exact match is not possible, prescribers can seek guidance available on the BMS document on alternative HRT preparations and the practical prescribing chart on the BMS website and Menopause Matters website, to clarify equivalent doses. Consideration could also be given to prescribing estrogen and progestogen separately to make the closest match or find a suitable alternative. Different brands for the same medication may vary in appearance or excipients. However, they would provide equivalent amounts of hormones when used in similar doses.
Signposting could also be provided to resources on the BMS website as well as Women’s Health Concern (WHC) website, Menopause Matters and the Primary Care Women’s Health Forum (PCWHF).
BMS members can post prescribing queries on the BMS forum if any clarifications are required.
The information on stock availability and supplies below was obtained from the pharmaceutical companies manufacturing these products. We are not in a position to comment on availability at wholesale suppliers’ level and appreciate that availability from wholesale suppliers may lag behind and thus sometimes vary from the information provided by the manufacturers.
Besins Healthcare (UK) HRT products
No shortage of supplies of Besins HRT products:
Oestrogel systemic estradiol gel. Available
Utrogestan (micronised progesterone) 100 mg in continuous combined regimen and 200 mg in sequential regimens. Available
Testogel 50 mg, gel sachet. Available
Off-label use for female testosterone replacement (5 mg a day).
Imvaggis vaginal 0.03 mg estriol vaginal pessary. Available
Lenzetto 1.53 mg/spray, transdermal estradiol spray. Available
Lenzetto is an estradiol metered-dose transdermal spray. The Medicines and Healthcare Products Regulatory Agency granted a marketing authorisation valid throughout the European Union for Lenzetto on 13 August 2015. Gedeon Richter UK launched Lenzetto in the UK on 1st April 2020.
Vagirux 10 micrograms vaginal tablets. Available
Gedeon Richter UK launched Vagirux in the UK in October 2020. This is delivered through a reusable applicator (applicator can be used up to 24 times).
Lenzetto and Vagirux are available to order via AAH
Orion HRT products
Sandrena 0.5 mg estradiol sachet (28x packs). Limited stock available
Sandrena 1.0 mg estradiol sachet (91x packs). Available
Sandrena 1.0 mg estradiol sachet (28x packs). Out of stock
Indivina 1mg estradiol + 2.5mg medroxyprogesterone acetate. Available
Indivina 1mg estradiol + 5mg medroxyprogesterone acetate. Available
Indivina 2mg estradiol + 5mg medroxyprogesterone acetate. Available
Tridestra 2mg estradiol + 20mg medroxyprogesterone acetate. Available
If difficulty obtaining supplies, the company has suggested contacting their customer care on 01635520300 to guide them to the wholesale suppliers.
Theramex HRT products (update January 2021)
Evorel: UK Stock Update from Theramex:
|UK||1. Evorel 25
2. Evorel 50
3. Evorel 75
4. Evorel 100
5. Evorel Conti
6. Evorel Sequi
|1. Available – Fully in stock
2. Available – Fully in stock
3. Available – Fully in stock
4. Available – Fully in stock
5. Available – Fully in stock
6. Available – Fully in stock
Theramex focus their attention on building a stable supply chain to replenish the market and build a solid inventory of product and will continue to provide regular updates via their website and the UK Health Authorities.
UK FemSeven patches (estradiol +/- levonorgestrel) Stock Update
FemSeven Conti® (estradiol/levonorgestrel) is now available via Alliance Healthcare
Theramex holds the marketing authorisation for FemSeven 50, 75 and 100® (estradiol), FemSeven Conti® (estradiol/levonorgestrel) and FemSeven Sequi® (estradiol/levonorgestrel) in the UK and Europe since acquiring these products from Teva Pharmaceuticals Ltd on 1st February 2018.
Non-patient-safety related quality issues were brought to Thermex’s attention resulting in the gradual withdrawal of the FemSeven® portfolio from the market.
Theramex have since been working to fix these issues and they have indicated that the entire FemSeven® portfolio of products will be returning in 2021 commencing with FemSeven Conti® which is available now from Alliance Healthcare.
Theramex anticipate that the rest of the FemSeven® portfolio will be available by mid-2021 and will continue to keep health care professionals informed of any changes. Theramex would like to thank both patients and prescribers for their continued patience.
FemSeven Conti Available
FemSeven Sequi Out of stock. Anticipated to be available by mid-2021
FemSeven Mono Out of stock. Anticipated to be available by mid-2021
Patients who have any questions with regards to their treatment options should speak to their general practitioner.
Note to pharmacists
In order to ensure the widest possible reach of the available stock, Alliance Healthcare have applied monthly quotas to the volume of stock available to individual pharmacists.
For pharmacists and healthcare professionals who wish to place orders for the Evorel range of products, please contact Alliance Healthcare via your usual channels.
For pharmacists and healthcare professionals who wish to place orders for FemSeven Conti®, please contact Alliance Healthcare via your usual channels.
If you require additional stock above this quota, in order to fulfil prescriptions, please contact Alliance Healthcare Customer Service by telephone 0330 100 0448 or email firstname.lastname@example.org.
Novartis pharmaceuticals – Estradot patches
Estradot estradiol 25 / 37.5 / 50 / 75 / 100 micrograms. Available – No supply shortages
Novartis have provided the following information regarding Estradot supplies:
‘Due to global supply issues on generic HRT variants; Novartis is not able to backfill the generic shortages with Estradot, as the demand now being placed on the brand is beyond Novartis’ supply capacity. Novartis are working with the plant to increase supply but this cannot be achieved in the short term.
Novartis are supplying as much stock as possible into their two Wholesaler’s AAH & Alliance, which is above the normal expected demand for the brand.
Novartis are unable to accept direct supply orders at this time as all stock available is being supplied to the two wholesalers.’
All Estradot stock is being distributed through AAH & Alliance, please ask your pharmacist to contact their preferred wholesaler to source a supply. Please call Novartis Customer Care on 08457 419 442 or e-mail email@example.com if you need any further assistance.
Norgine UK – Estraderm MX patches
Estraderm MX estradiol 25 patches. Available
Estraderm MX estradiol 50 patches. Available
Estraderm MX estradiol 75 patches. Available
Estraderm MX estradiol 100 patches. Available
Viatris HRT products
Viatris is a new global healthcare company formed in 2020 through the combination of Mylan and Upjohn, a legacy division of Pfizer.
Viatris have provided the following information about the Elleste™ Oral Range (estradiol +/- norethisterone):
Viatris remains committed to the continuation of the Elleste™ Oral Range and are working closely with their supply chain team to ensure a steady supply.
The Elleste™ Oral Range had undergone a manufacturing site transfer from a third party to a Viatris owned and operated facility and the site transfer is now complete.
Viatris anticipate a steady supply of Elleste™ Oral Tablets, which includes: Elleste Solo™ 1 & 2mg, Elleste Duet™ 1 & 2mg and Elleste Duet™ Conti 2mg.
Viatris supply information as of 6th January:
Femoston Range – all available
Femoston® 1mg estradiol + 10mg dydrogesterone. Available
Femoston® 2mg estradiol + 10mg dydrogesterone. Available
Femoston®-conti 1mg estradiol + 5mg dydrogesterone. Available
Femoston®-conti low dose 0.5mg estradiol + 2.5mg dydrogesterone. Available
Zumenon Range – all available
Zumenon® 1mg estradiol. Available
Zumenon® 2mg estradiol. Available
Elleste™ Range – all available
Elleste Solo™ MX patches 40mcg transdermal estradiol Available
Elleste Solo™ MX patches 80mcg transdermal estradiol Available
Elleste Solo™ 1mg estradiol Available
Elleste Solo™ 2mg estradiol Available
Elleste Duet™ 1mg estradiol + 1mg norethisterone acetate. Available
Elleste Duet™ 2mg estradiol + 1mg norethisterone acetate. Available
Elleste Duet™ Conti 2mg estradiol + 1mg norethisterone acetate. Available
Viatris HRT stock can only be obtained through AAH, Alliance and Phoenix.
If you have difficulty obtaining supplies please contact Viatris Customer Service on: firstname.lastname@example.org
Viatris has a dedicated website for healthcare professionals, which has up-to-date information about current supply of their HRTs & useful webinars.
The overview of stock availability can be accessed on: https://mywayhub.co.uk/en-gb/range
PRODUCT RECALL (as referred to in the previous BMS HRT update): Duavive. Conjugated equine estrogen 0.45 mg + 20 mg bazedoxifene
In 2018 Pfizer communicated that it planned to discontinue Duavive in the UK. Pfizer have continued to supply Duavive to patients since then but now all remaining supplies have been exhausted.
Doctors and/or Healthcare Professionals are best equipped to advise on alternative options. Impacted patients should follow local GP surgery guidance on the best way to contact them during this time.’’
Please see information on the availability of Pfizer’s other HRT products below:
Premique low dose. Conjugated equine estrogen 0.3 mg + medroxyprogesterone acetate 1.5 mg. Available
Premarin conjugated equine estrogen 0.625 mg and 1.25 mg. Available
Estring estradiol 7.5 micrograms/24 hours. Available
Provera 5 mg tablets. Available
Provera 10 mg tablets. Available
Novo Nordisk HRT products
No shortage of supplies of any of their HRT products:
Kliovance 1mg estradiol + 0.5mg norethisterone acetate. Available
Kliofem 2mg estradiol + 1mg norethisterone acetate. Available
Novofem 1 mg estradiol + 1 mg norethisterone acetate. Available
Trisequens 2mg/2mg/1mg estradiol + 1mg norethisterone acetate. Available
Vagifem 10mcg topical vaginal estrogen. Available
If difficulty obtaining supplies, the company suggested contacting their customer care on: email@example.com; or telephone 0845 600 5055, to guide them to their wholesale suppliers.
Progynova 1mg estradiol tablets. Available
Progynova 2 mg estradiol tablets. Available
Progynova TS estradiol 50 patches. Available
Progynova TS estradiol 100 patches. Available
Mirena IUS. Available
Testim testosterone gel. 50 mg tube. Available
Off-label use for female testosterone replacement (5 mg a day).
Medical Information Direct Line 0800 069 8421
http://www.endo.com +353 1 268 2000
Ovestin. Estriol topical vaginal cream. Available
Oestriol 0.01%. Topical Estriol vaginal cream. Available
Flynn Pharma Ltd
Blissel 50 micrograms estriol vaginal gel. Available
Senshio (ospemifene) 60mg 28 tablet pack – Available. No supply shortage
Shionogi UK has decided to discontinue commercial support behind Senshio (ospemifene). However, Shionogi Europe will continue to support existing and upcoming formulary applications through the EU Med Affairs and Senshio remains available to prescribe in the UK for patients who need it.
Any supply issues, medical information enquiries or questions regarding formulary applications should be addressed to the company on 020 3053 4197.
Kyowa Kirin Ltd
Tostran 2% Gel. Available
Off-label use for female testosterone replacement (10 mg per measure to take 2-3 times a week).
If difficulty obtaining supplies, the company suggested contacting their customer care on: firstname.lastname@example.org; or telephone 01896 664 000, to guide them to the process of obtaining emergency supplies until stocks back in supply.
AndroFeme 1 testosterone 1% cream (Specials unlicensed supply). Available
AndroFeme 1 remains available in the UK with no shortages anticipated and the UK ‘specials’ status remains.
On 23rd November 2020 Australia’s regulatory granted AndroFeme 1 full marketing authorisation and registration on the Australian Register of Therapeutic Goods.
The approved indication for the management of hypoactive sexual desire dysfunction (HSDD) in postmenopausal women.
There will be some minor text and colour scheme changes to the tube and carton appearance, but no changes to the formulation. These changes will not be implemented until June/July 2021.
Merck Sharp & Dohme Limited
Livial (2.5 mg Tibolone) (x84 packs). Available
Livial (2.5 mg Tibolone) (x28 packs). Available
GPs and Pharmacists should be able to provide guidance on suitable alternatives.
Chairman, British Menopause Society