Australia 

Patch Shortages

There are a number of MHTs that are currently unavailable. Please note that the TGA has approved some unregistered products under Section 19A and some substitute doses are currently in supply in Australia. Pharmacists are encouraged to contact suppliers Medsurge Healthcare Pty Ltd on 1300 788 261 for orders of Estramon and Sandoz on 1800 726 369 for orders of Estradiol Transdermal System.

Oestradiol patches

Combined patches

All doses of Climara have been deleted from the market and there will be a reduction in supply until supply is exhausted.

The AMS Guide to MHT Doses (Australia only) provides a guideline to approximately equivalent doses of the different MHT/HRT products in Australia.

Australia 

Patch Shortages

There are a number of MHTs that are currently unavailable. Please note that the TGA has approved some unregistered products under Section 19A and some substitute doses are currently in supply in Australia.

Pharmacists are encouraged to contact suppliers Medsurge Healthcare Pty Ltd on 1300 788 261 for orders of Estramon and Sandoz on 1800 726 369 for orders of Estradiol Transdermal System.

Oestradiol patches

Combined patches

All doses of Climara have been deleted from the market and there will be a reduction in supply until supply is exhausted.

The AMS Guide to MHT Doses (Australia only) provides a guideline to approximately equivalent doses of the different MHT/HRT products in Australia.

The Australasian Menopause Society (AMS) provides education to health professionals to improve the healthcare of women at perimenopause and after menopause.

The AMS welcomes discussion of menopause and efforts to improve access to appropriate care. However, we have recently become aware of spurious claims being made about menopause and hormone therapy by some health professionals on social media and in opinion pieces. These claims are presented as mainstream expert opinion, but some of them do not accord with current evidence-based guidelines.

The concerning content includes:

• Promotion of menopausal hormone therapy (MHT) for treatment of a wide variety of symptoms that may not be related to menopause.

• Promotion of MHT for primary prevention of cardiovascular disease and dementia prevention for women at the usual age of menopause. This is not supported by evidence or current guidelines.

• Not using agreed definitions of the perimenopause, leading to patient treatment with MHT outside of accepted indications. Perimenopause is defined as beginning when menstrual cycle changes occur as per the STRAW +10 criteria.

• Promoting testosterone as a routine component of MHT and promoting testosterone for non-specific symptoms such as fatigue or ‘brain fog’, or to improve general wellbeing. The only evidence-based indication for testosterone currently is hypoactive sexual desire dysfunction in postmenopausal women. Evidence for testosterone to treat any other symptom or for disease prevention is lacking.

• Minimising risks of MHT and making overly simplified statements regarding the highly emotive area of MHT use and breast cancer risk. Much more research is needed before it can be said that any of the available forms of MHT are risk free with regards to breast cancer.

• Suggesting that breast cancer survivors can routinely be prescribed MHT. There are very occasional circumstances when women with breast cancer may be prescribed MHT but it should be a careful decision involving multidisciplinary discussion.

MHT is the most effective treatment for menopausal symptoms and has a role in preventing osteoporosis and fracture. It can be offered to women who are medically eligible, along with an individualised discussion of the benefits and risks. AMS promotes a balanced, evidence-based discussion of the benefits and risks of hormone therapy.

On 13 June 2024 the Australian Commission on Safety and Quality in Health Care released national trend data in a new report suggesting that women may be turning from hysterectomy to less invasive treatments for heavy menstrual bleeding, a condition that affects one in four Australian women.

It has also released an updated Heavy Menstrual Bleeding Clinical Care Standard (2024) to ensure that women with this condition can make an informed choice about the most appropriate treatment for their individual situation.

Together these resources aim to improve care for women with heavy menstrual bleeding, which can have a substantial impact on a woman's quality of life.

Hysterectomy is one option for treating heavy menstrual bleeding, but there are a number of associated risks. Less invasive treatments are available, including oral medicines, the hormonal IUD and procedures like endometrial ablation. 

Key findings

The Women’s Health Focus Report found a 20% decrease nationally in the rate of hysterectomy between 2014-15 and 2021-22, and a 10% increase in the rate of the less invasive option of endometrial ablation (2013-16 and 2019-22).* 

However, the data indicate inconsistencies in care across the country. Rates for both procedures were consistently higher in regional areas than in major cities and remote areas. In 2021-22, the hysterectomy rate for First Nations women was 9% higher than for other Australian women.

Use the Report’s interactive maps and graphs to view hospitalisation rates and trends in your state or territory, PHN and local area. If substantial variation exists, investigate whether appropriate care is being delivered in line with the Standard. 

Download the Standard and implementation resources to learn more about best practice care and local improvement opportunities for women with heavy menstrual bleeding.

Australia 

Patch Shortages

There are a number of MHTs that are currently unavailable. Please note that the TGA has approved some unregistered products under Section 19A and some substitute doses are currently in supply in Australia.

Pharmacists are encouraged to contact suppliers Medsurge Healthcare Pty Ltd on 1300 788 261 for orders of Estramon and Sandoz on 1800 726 369 for orders of Estradiol Transdermal System.

Oestradiol patches

Combined patches

All doses of Climara have been deleted from the market and there will be a reduction in supply until supply is exhausted.

The AMS Guide to MHT Doses (Australia only) provides a guideline to approximately equivalent doses of the different MHT/HRT products in Australia.

Pharmac have recently announced that restrictions on the prescription of Utrogestan® will be removed from 1 December 2022. This will mean that women will be able to access fully funded Utrogestan® for a range of uses, including for menopausal hormone therapy.

The Australasian Menopause Society provided a letter of support to Pharmac in June 2022 supporting the funding of Utrogestan® for MHT as the endometrial protection agent when women require oestrogen for the treatment of menopausal symptoms in the perimenopausal time and also as part of hormone replacement therapy for premature ovarian insufficiency. Being a bioidentical progesterone, international opinion says that it is the safest progesterone to use with the lowest side effect profile. it is considered best practice to use this progesterone as it has a more favourable effect on lipid profiles and potentially less likely to impact on breast cancer risk. It has the additional advantage of having a soporific effect.

More information about the announcement can be found here.

Content updated 26 September 2022

The theme of International Women’s Day for 2022 is ‘Breaking the bias’. Researchers at Monash Centre for Health Research and Implementation, Monash University, have chosen this day to ‘break the silence’ on early menopause, to launch their new evidenced based App for women Ask Early Menopause. Developed by women for women, and with multidisciplinary early menopause expert input, the App includes women’s stories, evidence-based information, animation and a personalised dashboard to help women manage early menopause and premature ovarian insufficiency. Development of the App was undertaken as part of the CRE in Women’s Health in Reproductive Life (CRE-WHiRL) and builds on previous work from the NHMRC partnership project, Healthtalk Australia Early Menopause Digital Resource where AMS was a project partner.

The App is to be launched by guest speaker, Professor Beverley Vollenhoven AM, former AMS board member, at an online event on March 7 2022, which will include expert speakers and a Q&A session. We hope that you and the women with early menopause you care for can join us.

Clinical A/Prof Amanda Vincent
Head of Early Menopause research, Monash Centre for Health Research and Implementation, Monash University
Endocrinologist, Menopause Clinic, Monash Health
AMS Past President

Breaking the Silence on Early Menopause594.87 KB 

13 September 2021: 

Back in May, Sandoz, the supplier of Estradot and Estalis applied to delist these medications from the Pharmaceuticals Benefits Scheme (PBS) as they were not financially viable. The AMS in collaboration with the Royal Australian and New Zealand College of Obstetricians and Gynaeocologists (RANZCOG) and the Endocrine Society of Australia (ESA) wrote to Minister Hunt expressing our concern about access to Estradot and Estalis and the potential health outcomes if these medications were to be delisted from the PBS.

Following further discussions, Sandoz agreed to apply to the Pharmaceutical Benefits Advisory Committee (PBAC) for a price increase instead of delisting Estradot and Estalis from the PBS. Again, in collaboration with RANZCOG and ESA, AMS wrote a joint letter of support to PBAC for a price increase, rather than them being delisted from the PBS.

AMS is now happy to advise that the PBAC has agreed to the price increase for Estradot and Estalis from 1 October. This price increase means that these medications will remain on the PBS and support continuous and sustainable supply to the Australian market. While many women will need to pay more for these medications from 1 October, importantly, women on a healthcare card will only need to pay the concession price. A letter from Sandoz is attached for further information.

HCP Letter Estradot Estalis Sep 2021

12 August 2021: 

Information for Doctors

The Therapeutic Goods Administration (TGA) is advising health professionals and consumers of a current shortage for all strengths of PROGYNOVA estradiol valerate tablets. Due to manufacturing issues the shortage is expected to continue until May 2022.

PROGYNOVA tablets are used for short-term relief of symptoms associated with menopause.

The TGA has made a Serious Scarcity Substitution Instrument (SSSI) to assist patients in accessing their medicine from their pharmacist without delay, ensure treatments are not interrupted and relieve workload pressure on prescribers and pharmacists.

The SSSI is in force from 13 August 2021 until 1 May 2022. The TGA may, however, revoke the SSSI before its end date if the serious scarcity is resolved, or safety concerns are identified.

For more information see Substitution instrument to address shortage of PROGYNOVA estradiol valerate tablets (multiple strengths)

You should be alert to the current shortage of Progynova tablets when prescribing to your patients. Consider prescribing available estradiol-only tablets such as Estrofem and Zumenon tablet.

Zumenon is PBS-listed when prescribed but Estrofem is not.

Information for patients

Talk to your doctor or pharmacist if you have any questions regarding this substitution.

The pack size of estradiol-only tablets varies between brands. However, your pharmacist will supply the correct total dose that your doctor has prescribed.

If you have been prescribed Progynova 1mg or 2mg tablets and you receive a substitute medicine, your pharmacist will explain to you how to take your tablets.

If you are provided 2 mg tablets as a substitute for your usual 1 mg tablets, ask your pharmacist for advice on how to cut the tablets. If someone else is cutting the tablets for you, they may need to consider using personal protective equipment such as gloves and a mask to avoid unintended exposure to estradiol. Low dose of unintended exposure may cause harm or pose a risk of harm.

There has been a recent shortage of a number of menopausal hormone therapy (MHT) preparations and some of these have now been or soon will be resolved:

Oral MHT

Duavive – supply due to be resolved by end January 2022

Progynova 2mg – supply due to be resolved by end of April 2022

Femonston Conti – supply shortage expected between 25 June and 9 July

Transdermal MHT

Estradot 100 – supply due to be resolved by 31 August

Estradot 75 – supply due to be resolved by 31 August

Estradot 50 – supply due to be resolved by 1 July

Estradot 37.5 – supply due to be resolved by 31 August

Estradot 25 – supply due to be resolved by 1 July

Estalis Conti 50/140 – supply resolved

Estalis Conti 50/250 – supply resolved

Estalis Sequi 50/140 – supply resolved

Estalis Sequi 50/250 – supply resolved

Estraderm MX 50 – supply resolved

Estraderm MX 100 - supply resolved

Non-Hormonal Options

There is also an expected shortage of supply of non-hormonal treatment options:

Gabapentin-APOTEX 100mg – supply shortage expected between 20 August- 15 October

Gabapentin 300mg- supply shortage expected between 18 June- 16 July

APX-Gabapentin 300mg- supply shortage expected between 16 July- 6 August

Gabapentin-APOTEX 300mg – to be discontinued from 18 July

Combined oral contraceptive pill

There is also an expected shortage of combined oral contraceptive pill:

Qliara – supply due to be resolved by 1 June 2022

Please note that dates for supply have been sourced from either the pharmaceutical supplier or the TGA website and may change at any time.