The recent second wave of the pandemic over the winter months has resulted in a significant increase in pressures on NHS services. This has been further compounded by the general impact of winter on clinical services with increased workload for both primary and secondary care with the rise in incidence of respiratory illnesses as well as the reduced staffing levels due to illness or self-isolation.

We recognise that as a result of the pandemic many women are likely to experience difficulties in obtaining their 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 COVID-19 related issues as well as the significant service provision demands that have resulted from primary care involvement in delivering the Covid-19 vaccination programme.

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 on HRT product availability.

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 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 obtaining their HRT preparations. This can be accessed through the following link: HRT Equivalent preparations 110421.

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

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

Any pharmacies who are having any difficulty in obtaining stock can contact Besins Healthcare information@besins-healthcare.com with the details of their wholesaler and pharmacy account details. 

Gedeon Richter

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

Evorel: UK Stock Update from Theramex:

Country Product Name Availability
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.

Intrarosa (Prasterone) 6.5 mg pessary. Available.

Zoely. Available.

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 

Further information

Patients who have any questions with regards to their treatment options should speak to their general practitioner. 

Note to 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. 

Novartis pharmaceuticals

Following temporary shortages on some of our Estradot range we can now provide the following stock update.

Estradot TTS-75 is now back in stock. Estradot TTS-37.5 has low stock levels and we are doing everything possible to minimise the impact from this. Any impact is likely to be for 2-3 weeks while we await our next delivery.

We understand shortages such as these can cause great uncertainty for patients and we are working hard to resolve this matter as quickly as possible. We encourage any patient affected by this shortage to speak with their doctor or pharmacist for information on available options.

Supplies of Estradot TTS-25, Estradot TTS-50 and Estradot TTS-100 are unaffected.

Estradot 37.5mg has been QA released and is now available to order.

If you are a healthcare professional and would like further information, please contact the Novartis Pharmaceuticals UK Medical Information Services by email; medinfo.uk@novartis.com or by phone; +44 1276 698370

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
  • For live updates on the Viatris HRT range, you can also visit mywayhub.co.uk/range
  • Viatris HRT stock can only be obtained through AAH, Alliance and Phoenix, if you need assistance from us please contact productenquiries@viatris.com.

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™ oral Range – all 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 

Elleste™ transdermal Range – all available

  • Elleste Solo™ MX patches 40mcg transdermal estradiol Available until estimated end of July 2021 (contact Viatris for more information)
  • Elleste Solo™ MX patches 80mcg transdermal estradiol Available until estimated end of April 2021 (contact Viatris for more information) 

Pfizer

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: customercare@novonordisk.com; or telephone 0845 600 5055, to guide them to their wholesale suppliers.

 Bayer

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

Qlaira out of stock from mid-April 2021 till end of October 2021 

Endo Pharmaceuticals

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

E-mail medinfoEU@endo.com

Aspen

Ovestin. Estriol topical vaginal cream. Available  

Marlborough

Oestriol 0.01%. Topical Estriol vaginal cream. Available 

Flynn Pharma Ltd

Blissel 50 micrograms estriol vaginal gel. Available 

Shionogi BV

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: medinfo@kyowakirin.com; or telephone 01896 664 000, to guide them to the process of obtaining emergency supplies until stocks back in supply. 

Lawley Pharmaceuticals

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.

 

Haitham Hamoda

Chairman, British Menopause Society