The British Menopause Society has produced this further update on the current availability of HRT products.
The objective of this is to provide guidance to BMS members and clinical practitioners in response to the ongoing HRT shortages.
There continues to be availability issues with many HRT products related to manufacturing shortages or supply issues. The BMS has been informed that these are temporary shortages, which pharmaceutical companies and their suppliers are addressing. The BMS has been in ongoing discussions with the manufacturers as well as the RCOG, FSRH and the Medicines Supply Team at the Department of Health and Social Care to explore this ongoing issue and to provide up to date information on HRT product availability.
In the meantime, prescribers can continue to consider equivalent preparations that provide a similar dose to that which their patients are using. If an exact match is not possible, prescribers can seek guidance available on 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.
The BMS has produced a document on alternative HRT preparations and equivalent alternatives in response to the ongoing HRT shortages to provide guidance to BMS members and clinical practitioners who may be experiencing difficulties with HRT supplies.
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 producing these products.
Besins Healthcare (UK) HRT products
No shortage of supplies of their HRT products:
Oestrogel systemic oestradiol gel. Available.
Utrogestan (micronised progesterone) 100 mg in continuous combined regimen and 200 mg in sequential regimens. Available.
Testogel 50 mg, gel sachet. Available.
Orion HRT products
Sandrena 0.5 mg sachet. Out of stock until end of December 2019.
Sandrena 1.0 mg sachet (91 packs). Available.
Sandrena 1.0 mg sachet (x28). Out of stock until end of December 2019 / early January.
Indivina 1mg oestradiol + 2.5mg medroxyprogesterone acetate. Out of stock until end of January 2020.
Indivina 1mg oestradiol + 5mg medroxyprogesterone acetate. Out of stock until end of December 2019.
Indivina 2mg oestradiol + 5mg medroxyprogesterone acetate. Out of stock until end of January 2020.
Tridestra 2mg oestradiol + 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
Theramex acquired the Evorel line of products from Janssen Pharmaceutical Companies of Johnson & Johnson on 23rd October 2019.
Theramex have issued the following update on Evorel patch availability:
Since Theramex acquired the product on 23rd October 2019, the company has been working to accelerate supply and bring the product back to market much earlier than originally planned. To do so, Theramex have included an additional manufacturer to fast-track the process and ensure that supply is resumed as quickly as possible. Theramex estimate, with the new timelines in place that Evorel Mono, Conti & Sequi ranges will be back in stock in the UK from February 2020 onwards.
Theramex also holds the marketing authorisation for FemSeven Mono, FemSeven Conti and FemSeven Sequi in the UK. Theramex acquired these products from Teva Pharmaceutical Industry Ltd on 1st February 2018.
Theramex have issued the following update on FemSeven patch availability: FemSeven Conti and Sequi products have been out of stock in the UK since Q4 2018 and FemSeven Mono since Sep-tember 2019. Theramex estimate that FemSeven Mono & Conti will be back in stock Q4 2020, and FemSeven Sequi in Q1 2021.
For the latest information on stock and timelines.
Estradot patches (Novartis pharmaceuticals):
Estradot oestradiol 25 / 37.5 / 50 / 75 / 100 micrograms. Available, No supply shortages.
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.
Estraderm MX patches (Norgine)
Estraderm MX 25 patches. Shortage of supplies until the second week of December 2019.
Estraderm MX 50 patches. Shortage of supplies until the second week of December 2019.
Estraderm MX 75 patches. Shortage of supplies until the second week of December 2019.
Estraderm MX 100 patches. Shortage of supplies until the second week of December 2019.
Mylan HRT products
Supply information as of 19th November 2019:
Elleste Solo™ 1mg oestradio.l Available.
Elleste Solo™ 2mg oestradiol. Available.
Elleste Duet™ 1mg oestradiol + 1mg norethisterone acetate. Available.
Elleste Duet™ 2mg oestradiol + 1mg norethisterone acetate. Shortage of supplies.
Elleste Duet™ Conti 2mg oestradiol + 1mg norethisterone. Shortage of supplies.
Femoston® 1mg oestradiol + 10mg dydrogesterone. Available.
Femoston® 2mg oestradiol + 10mg dydrogesterone. Available.
Femoston® conti 1mg oestradiol + 5mg dydrogesterone. Available.
Femoston® conti low dose 0.5mg 0estradiol + 2.5mg dydrogesterone. Available.
Zumenon® 1mg oestradiol. Available.
Zumenon® 2mg oestradiol. Available.
Elleste Solo™ MX patches 40mcg transdermal oestradiol Available.
Elleste Solo™ MX patches 80mcg transdermal oestradiol Available.
Mylan have issued the following information to healthcare providers:
Earlier this year, Mylan informed third-party manufacturing partners it was experiencing an interruption in the production of Elleste™, which included; Elleste Solo™ (1mg & 2mg), Elleste Duet™ (1mg & 2mg) and Elleste Duet™ Conti (2mg). At that time, Mylan anticipated a temporary interruption and for stock levels to resume during the middle of 2019.
To ensure the stable supply of Elleste™ Oral Tablets in the future, Mylan will be transferring the production of Elleste™ to a Mylan owned and operated facility. The site transfer is in progress and we anticipate production to resume by second half of 2020.
In the meantime, any stock of Elleste™ Oral Tablets in the market, is available to order and prescribe. Once that supply has been depleted, the replenishment of Elleste™ Oral Tablets will not be available until the site transfer process has been completed. Mylan understands the challenges this situation poses to women and is working closely with their manufacturing partners to expedite deliveries when possible.
Mylan will continue to support pharmacies, societies and healthcare professionals by providing updates to our materials and communications including updates to stock availability, timing for resolution and information about Mylan’s other HRT products.
Please note that this does not affect the transdermal patches; Elleste Solo™ MX (40 and 80mcg).
Mylan has a dedicated website for healthcare professionals, which has LIVE information about current supply of their HRT. The overview of stock availability page can be accessed on: https://mywayhub.co.uk/en-gb/range
Mylan HRT stock can only be obtained through AAH, Alliance and Phoenix.
If you have difficulty obtaining supplies please contact Mylan Customer Service on: firstname.lastname@example.org
Novo Nordisk HRT products
No shortage of supplies of any of their HRT products:
Kliovance 1mg oestradiol + 0.5mg norethisterone acetate. Available.
Kliofem 2mg oestradiol + 1mg norethisterone acetate. Available.
Novofem 1 mg oestradiol + 1 mg norethisterone acetate. Available.
Trisequens 2mg/2mg/1mg oestradiol + 1mg norethisterone acetate. Available.
Vagifem 10mcg topical vaginal oestrogen. 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 oestradiol tablets. Shortage of supply until end of December 2019.
Progynova 2 mg oestradiol tablets. Available.
Progynova TS oestradiol 50 patches. Available.
Progynova TS oestradiol 100 patches. Available.
Mirena IUS. Available.
Ovestin. Oestriol topical vaginal cream. Available.
Merck Sharp & Dohme Limited
Livial (2.5 mg Tibolone) (x84 packs). Available.
Livial (2.5 mg Tibolone) (x28 packs). Available.
Oestriol 0.01%. Topical vaginal cream. Available.
Kyowa Kirin Ltd
Tostran 2% Gel. Out of stock until first week of December.
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.
Premique low dose. Conjugated equine estrogen 0.3 mg + medroxyprogesterone acetate 1.5 mg. Available.
Duavive. Conjugated equine estrogen 0.45 mg + 20 mg bazedoxifene. Discontinued August 2018. Stocks expected to be available until end of 2019 / early 2020.
Premarin conjugated equine oestrogen 0.625 mg and 1.25 mg. Available.
Estring oestradiol 7.5 micrograms/24 hours. Available.
Provera 5 mg tablets. Available.
Provera 10 mg tablets. Available.
GPs and Pharmacists should be able to provide guidance on suitable alternatives.
Chairman, British Menopause Society