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.

Please note that Pfizer is recalling Duavive from the UK market. This is further detailed where the Pfizer HRT products are referred to in this document.

We recognise that many women are likely to experience difficulties in obtaining HRT supplies due to the current coronavirus situation. 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.

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 in response to the ongoing HRT shortages 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

Imvaggis vaginal 0.03 mg estriol vaginal pessary. Available

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.

Lenzetto is available to order via AAH

Orion HRT products

Sandrena 0.5 mg estradiol sachet. Available

Sandrena 1.0 mg estradiol sachet (91x packs). Available

Sandrena 1.0 mg estradiol sachet (28x packs). Out of stock till week ending 19th June. Supplies expected to be available from week starting 22nd June 2020.

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 June 2020)

Evorel: UK Stock Update from Theramex:

In February 2020 Theramex restarted the supply of the Evorel portfolio of products. Since then Theramex have supplied a total of over half a million packs of Evorel 25, Evorel 50, Evorel 75 and Evorel Conti to the UK market.

Theramex have now relaunched Evorel Sequi (available from June 1st). Evorel 25, Evorel 50, Evorel 75 and Evorel 100 are all currently available.

Theramex will be restocking Evorel Conti in mid-June. It is possible that there will be intermittent supply shortages throughout the month due to high demand. There will also be a period of supply shortage for Evorel 75 from the middle to the end of June. Theramex hope to stabilise stock levels for both products by July. Theramex are committed to resolving these issues and being able to maintain a steady state of supply and fill backorders across the UK.

Country Product Name Dates of Availability UK Evorel 25 Evorel 50 Evorel 75 Evorel 100 Evorel Conti 6. Evorel Sequi Available Available Supply shortage expected for the final two weeks of June Available Available mid-June 2020. Possible intermittent supply shortages throughout June Available

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.

FemSeven Mono. Out of stock until Quarter 4 2020

FemSeven Conti. Out of stock until Quarter 4 2020

FemSeven Sequi. Out of stock until Quarter 1 2021

Further information

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

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 – 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 novartis.customercare@novartis.com if you need any further assistance.

Norgine UK – Estraderm MX patches

Estraderm MX estradiol 25 patches. Shortages in supply until mid-July

Estraderm MX estradiol 50 patches. Shortages in supply until mid-July

Estraderm MX estradiol 75 patches. Shortages in supply until mid-July

Estraderm MX estradiol 100 patches. Shortages in supply until mid-July

Mylan HRT products

Supply information as of 16th June 2020:

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® 1mg estradiol. Available

Zumenon® 2mg estradiol. Available

Elleste Solo™ MX patches 40mcg transdermal estradiol Available

Elleste Solo™ MX patches 80mcg transdermal estradiol Available

Mylan HRT stock can only be obtained through AAH, Alliance and Phoenix.

If you have difficulty obtaining supplies please contact Mylan Customer Service on: productenquiries@mylan.com

Elleste™ Oral Range

Elleste Solo™ 1mg estradiol Limited quantity expected from 19th June 2020, then expected full return Q4 2020

Elleste Solo™ 2mg estradiol Expected return Q4 2020

Elleste Duet™ 1mg estradiol + 1mg norethisterone acetate. Expected return Q4 2020

Elleste Duet™ 2mg estradiol + 1mg norethisterone acetate. Expected return Q4 2020

Elleste Duet™ Conti 2mg estradiol + 1mg norethisterone acetate. Expected return Q4 2020

Mylan 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 page can be accessed on: https://mywayhub.co.uk/en-gb/range

Pfizer

PRODUCT RECALL: Duavive. Conjugated equine estrogen 0.45 mg + 20 mg bazedoxifene

Pfizer have issued the update below regarding the recall of Duavive from the UK Market:

‘’Pfizer Limited is recalling the following batches of Duavive (conjugated estrogens/bazedoxifene) Modified Release Tablets. This is because of an issue relating to the foil pouch in which Duavive is supplied. Batches in scope of this recall:

Pfizer Limited, in conjunction with the Defective Medicines Report Centre (DMRC) of the Medicines and Healthcare products Regulatory Agency (MHRA), have agreed to this recall at the wholesaler level. The MHRA have issued a Class 3 Recall Drug Alert to relevant healthcare professionals (Reference MDR 142- 05/20).

Pfizer’s assessment of the issue concluded that the use of the impacted product has a probability of delayed therapeutic effect of bazedoxifene, however, the probability of endometrial hyperplasia due to delay in the dissolution of bazedoxifene is unlikely.

The potential risk to the patient arising from the current issue is considered to be low.

No adverse safety information was identified from the search of the Pfizer post-marketing safety database relating to this issue. Pfizer’s assessment of the issue concluded that the use of the impacted product has an unlikely probability of being associated with adverse events and the potential risk to patients is considered to be negligible.

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

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

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

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