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update FYI
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British Menopause Society further update on HRT supply shortages (23rd September 2019)
24 September 2019
The British Menopause Society has produced this further update on the current availability of HRT products in response to the ongoing HRT shortages. The objective of this is to provide guidance to BMS members and clinical practitioners who may be experiencing difficulties with HRT supplies.
There continues to be availability issues with many HRT products, either 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 discussion with the manufacturers as well as the RCOG, FSRH and the Medicine 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 patient is 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.
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.
Utrogestan (micronised progesterone) 100 mg in continuous combined regimen and 200 mg in sequential regimens.
Orion HRT products
Sandrena 0.5 mg sachet Out of stock until late October / early November 2019.
Sandrena 1.0 mg sachet (x28 and x91 packs). Available.
Indivina 1mg oestradiol + 2.5mg medroxyprogesterone acetate Available.
Indivina 1mg oestradiol + 5mg medroxyprogesterone acetate Out of stock until December 2019.
Indivina 2mg oestradiol + 5mg medroxyprogesterone acetate Out of stock until December 2019.
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.
Evorel patches (Janssen)
Janssen have provided the following update on their Evorel patch products:
Janssen has issued the following update regarding their Evorel patch supplies:
There is an interruption of supply for Evorel®, Evorel® Sequi and Evorel® Conti that will result in shortages to patients. The product range will stockout at the end of October 2019. The company anticipates that pharmacies will be out of stock until mid-2020.
For further questions or additional information, please contact: Janssen Medical Information Department: email:
[email protected], telephone: 0800 731 8450 or 01494 567 444.
Estradot patches (Novartis pharmaceuticals):
Estradot oestradiol 25 / 37.5 / 50 / 75 / 100 micrograms Available. No supply shortages.
If difficulty obtaining supplies, the company has suggested contacting their customer care to guide them to the wholesale suppliers, on 08457 419 442; E-mail
[email protected]. Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR.
Merck Sharp & Dohme Limited
Livial (2.5 mg Tibolone) (x84 packs) Available.
Livial (2.5 mg Tibolone) (x28 packs) Out of stock until October 2019.
Mylan HRT products
Elleste Soloâ„¢ 1mg oestradiol. Shortage of supply.
Elleste Soloâ„¢ 2mg oestradiol. Available.
Elleste Duetâ„¢ 1mg oestradiol + 1mg norethisterone acetate. Shortage of supply.
Elleste Duetâ„¢ 2mg oestradiol + 1mg norethisterone acetate. Available.
Elleste Duetâ„¢ Conti 2mg oestradiol + 1mg norethisterone. Shortage of supplies.
Femoston® 1mg oestradiol + 10mg dydrogesterone. Shortage of supply.
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. Shortage of supplies.
Zumenon® 2mg oestradiol. Shortage of supplies.
Elleste Soloâ„¢ MX patches 40mcg transdermal oestradiol. Available.
Elleste Soloâ„¢ MX patches 80mcg transdermal oestradiol. Available.
Mylan have issued the following information to healthcare providers:
Earlier this year, Mylan was experiencing an interruption in the production of Ellesteâ„¢, which included; Elleste Soloâ„¢ (1mg & 2mg), Elleste Duetâ„¢ (1mg & 2mg) and Elleste Duetâ„¢ Conti (2mg).
At that time, Mylan anticipated a temporary interruption and for stock levels to resume during the middle of 2019. To minimise disruption to patients and to support pharmacies, societies and healthcare professionals (HCPs) across the country Mylan took several proactive steps, including:
sending two Ellesteâ„¢ stock constraint mailers to 50,000+ HCPs;
informing the British Menopause Society;
continuously communicating with the National Pharmacy Association; and
creating a MyWay Pharmacist leaflet for our salesforce to use when visiting pharmacists across the country.
In addition, Mylan created a new promotional page on its dedicated HCP website, called MyWay HRT Overview and Stock Availability. This page provides details of Mylan range of HRT products, stock availability and options to switch patients to alternative products where appropriate.
To ensure the stable supply of Ellesteâ„¢ Oral Tablets in the future, Mylan will be transferring the production of Ellesteâ„¢ to a Mylan owned and operated facility.
The site transfer is in progress and Myaln anticipate production to resume by second half of 2020. In the meantime, any stock of Ellesteâ„¢ Oral Tablets in the market, is available to order and prescribe. Once that supply has been depleted, the replenishment of Ellesteâ„¢ Oral Tablets will not be available until the site transfer process has been completed.
Mylan will continue to support pharmacies, societies and healthcare professionals by providing updates on 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 Soloâ„¢ 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/rangeMylan HRT stock can only be obtained through AAH, Alliance and Phoenix
If you have difficulty obtaining supplies please contact Mylan Customer Service on:
[email protected]Novo Nordisk HRT products
No shortage of supplies of any of their HRT products:
Kliovance 1mg oestradiol + 0.5mg norethisterone acetate.
Kliofem 2mg oestradiol + 1mg norethisterone acetate.
Novofem 1 mg oestradiol + 1 mg norethisterone acetate.
Trisequens 2mg/2mg/1mg oestradiol + 1mg norethisterone acetate.
Vagifem 10mcg topical vaginal oestrogen.
If difficulty obtaining supplies, the company suggested contacting their customer care on:
[email protected]; or telephone 0845 600 5055, to guide them to their wholesale suppliers.
Bayer
Progynova 1mg oestradiol tablets. Available.
Progynova 2 mg oestradiol tablets. Available.
Progynova TS oestradiol 50 patches. Out of stock next week until end of October 2019.
Progynova TS oestradiol 100 patches. Available.
Mirena IUS. Available.
Aspen
Ovestin. Oestriol topical vaginal cream. Available.
Theramax
Femseven mono oestradiol 50 / 75 / 100. Available.
Femseven conti. oestradiol / levonorgestrel Out of stock until end of 2020.
Femseven sequi. oestradiol / levonorgestrel Out of stock until early 2021.
Estraderm MX patches
No updates available regarding current availability of Estraderm patches.
Estraderm MX 50 patches.
Estraderm MX 75 patches.
Estraderm MX 100 patches.
Pfizer
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. Available.
Premarin conjugated equine oestrogen 0.625 mg and 1.25 mg. Available.
Estring oestradiol 7.5 micrograms/24 hours. Low stock until 11th October 2019.
Marlborough
Oestriol 0.01%. Topical vaginal cream. Available.
GPs and Pharmacists should be able to provide guidance on suitable alternatives.
Haitham Hamoda
Chairman, British Menopause Society
PMX