About the shortage of transdermal HRT patches

Pharmaceutical companies Sandoz and Juno Pharmaceuticals have notified us of shortages of their estradiol and combination estradiol/norethisterone (norethindrone) transdermal patch products. These medicines are used as hormone replacement therapy (HRT) in the management of perimenopause and menopause.

The shortages, which are due to manufacturing issues and an unexpected increase in demand, are affecting multiple brands as follows:

Up-to-date information about these shortages is also published on the Medicine Shortages Reports Database, which can be searched by a medicine’s trade name (brand) or active ingredient, or by clicking on the therapeutic class tab and searching for ‘Genito urinary system and sex hormones’ using ‘CTRL + F’ on the database web page. 

The Climara brand of HRT transdermal patches was discontinued at the end of 2023, which has contributed to the supply constraints of alternative products.

Supply of some Australian-registered HRT patch products will remain very limited until the end of 2026. We have approved the supply of overseas-registered alternatives for most strengths of Estradot transdermal patches under section 19A of the Therapeutic Goods Act 1989 to reduce the impact of these shortages. Go to the Section 19A approvals database for up-to-date information about these alternative products (search by the active ingredient, ‘estradiol’).

To help manage the shortage of estradiol-containing transdermal patches, we have also implemented a Serious Scarcity Substitution Instrument (SSSI). It allows a pharmacist to dispense an alternative brand or strength, if appropriate, without a new prescription from the prescriber. See below for information about the SSSI for patients, pharmacists and prescribers.

Information for patients

We understand the importance of a reliable supply of these medicines for the patients who use them. We also appreciate the concern and frustration these shortages have caused.

Your pharmacist can tell you about the best way to get your medicines during these shortages. To help with supply, we have approved access to several overseas-registered versions of HRT patches. Your pharmacist can order these alternative products by contacting the approval holders, whose contact details are available on the Section 19A approvals database. These overseas-registered alternatives are subsidised on the Pharmaceutical Benefits Scheme (PBS).

Unfortunately, as the limited global supply continues to fluctuate, we cannot predict with certainty which Australian-registered HRT patch products might be available at any time. We understand it can be frustrating when you are unable to get your preferred brand of a medicine, but using other brands, including overseas-registered products, may be unavoidable at times during these shortages.

We have also approved substitutions your pharmacist can make without needing a new prescription. This may mean you will need to switch between different brands of transdermal patches when the medicine prescribed for you is unavailable.

If your prescribed medicine is unavailable, the pharmacist will give you either of the following:

• a different brand of medicine that releases the same amount of estradiol per day
• multiple packs of lower-strength patches that release the same amount of estradiol per day.

If your pharmacist offers you a substitute medicine, they should explain any differences between the products, including if you need to apply multiple patches.

You can find information about how often to apply your HRT patch (or patches) on the label attached by the pharmacist. You can also find this information in the Consumer Medicine Information (CMI) leaflet that is available from your pharmacist or on our website.

Please note that:

• certain medicines a pharmacist can substitute may cost you more ─ the pharmacist will tell you about this
• you may still need a new prescription from your doctor in some cases
• you should not cut patches that contain estradiol to make an equivalent dose as this may affect how the medicine is absorbed through the skin
• if you have had a bad reaction to patches or sticky bandages in the past, you should tell your pharmacist. Different brands of patches have different ingredients, including those that help stick the patch to your skin.

If you are having difficulty getting your regular medicines, speak to your doctor about alternative options for your situation. Other forms of HRT are available, including oral tablets, topical gels and vaginal pessaries.

Information for prescribers

Please consider these shortages when initiating new patients on HRT transdermal patches. Limiting initiations in this shortage period will help preserve available supply for existing patients.

Please refer to this webpage and the Medicine Shortage Reports database for up-to-date information about return-to-supply dates for different brands and strengths.

We have approved the supply of overseas-registered estradiol-containing transdermal patch products in multiple strengths. Pharmacists can order these alternative products and supply them using existing prescriptions. More details are available on our Section 19A approvals database. These overseas-registered alternative HRT products are subsidised on the Pharmaceutical Benefits Scheme (PBS).

Patients and pharmacists may contact you for advice about prescriptions for estradiol-containing transdermal patch products and to authorise alternative strengths or substitute medicines. We acknowledge the difficulties involved in supporting your patients, and the burden these shortages have caused.

With the SSSI in place (see above), a pharmacist may substitute a prescribed estradiol transdermal patch for your patient with either of the following:

• an alternative brand of estradiol transdermal patch of the same strength
• 2 packs of half the prescribed strength to make the same equivalent daily dose.

If your patient or their carer contacts you about this, they may need instructions on how to apply an unfamiliar patch or multiple patches.

Please also note that:

• not all Australian-registered or section 19A-approved estradiol transdermal patch medicines are PBS-subsidised under the SSSI. Your patient may prefer a new prescription for a medicine that is subsidised on the PBS
• pharmacists will advise patients to contact you if their prescribed medicine is unavailable and substitutable alternatives are either inappropriate or unavailable.

Information for pharmacists

We understand the difficulties the shortage of HRT products has caused you and the patients who rely on them.

We have approved the supply of overseas-registered estradiol-containing transdermal patch products in multiple strengths. You can order these alternative products and supply them to patients using existing prescriptions.

Please call the approval holder, Sandoz, on 1800 726 369 for details about ordering these products. More details are available on our Section 19A approvals database. These overseas-registered alternative HRT products are also subsidised on the Pharmaceutical Benefits Scheme (PBS).

Using the SSSI that is in place allows you to substitute estradiol transdermal patch products without prior approval from the prescriber, if the permitted circumstances are met. See both the Specific permitted circumstances in Schedule 1 and General permitted circumstances in Schedule 2 of the SSSI.

You are encouraged to use your professional and clinical judgement to determine whether substitution is suitable for a patient. Refer patients to the prescriber if:

• substitution is inappropriate
• an appropriate substitutable medicine is not available
• alternative treatments other than substitution may be more appropriate.

If you determine that substitution is suitable, please consider the following:

• For a patient who requires an estradiol transdermal patch product that is declared as a scarce medicine, you may substitute a medicine of the same strength, or 2 packs of medicines which are half the strength of the prescribed medicine (provided the 2 packs are of the same brand) to create an equivalent dose.
• The SSSI sets out that a prescription for a scarce medicine be dispensed in the following order of preference, where possible:
  1. The prescribed formulation and strength.
  2. An alternative medicine of the same strength as the prescribed medicine.
  3. A medicine that is half the strength of the prescribed medicine, where the patient can apply 2 patches at the same time to create the prescribed dose. The 2 substitute medicines must be the same strength and brand when making this substitution.

PBS considerations

If dispensing a PBS prescription under preference 3 above, you must give the patient enough of the substitute patches to maintain the same duration of treatment as the prescribed patches. In this case, the required quantity will exceed the PBS-listed maximum quantity. In this circumstance, pharmacists may use the authority prescription number ‘00000246’ and disregard the PBS Online warning (reason code 151).

Example: Mrs Smith is a healthcare card holder and has a PBS prescription for estradiol 50 mcg patches in a quantity of 8. Her pharmacist does not have any estradiol 50 mcg patches in stock. The pharmacist can therefore dispense two 8-packs of the currently available estradiol 25 mcg patches to Mrs Smith for the same co-payment of $7.70. The pharmacist should then advise Mrs Smith about applying multiple patches to create her dose and highlight any differences between the products.

Dispensing certain estradiol transdermal patch medicines under this SSSI can affect PBS subsidisation. Please consider the following information, and discuss with your patients, when making the following substitutions:

• Estraderm MX 75 mcg transdermal patches are not PBS-listed. If you are presented with a PBS prescription for a scarce estradiol transdermal patch and dispense Estraderm MX 75 mcg transdermal patches as a substitutable medicine, the patient will not receive a PBS subsidy. Dispensing a PBS prescription as private may also affect how future repeats are dispensed under the PBS.
• The overseas-registered Estramon transdermal patches (25 mcg, 50 mcg, 75 mcg and 100 mcg) are not currently PBS-subsidised when dispensed under the SSSI, due to differences in pack size. They contain 24 patches compared to the Australian-registered Estradot or Estraderm, which contain 8 patches. A patient will need a new prescription for Estramon to be PBS-subsidised.

Please see the PBS website for more information.

In all cases, when obtaining informed consent from the patient, make sure they understand the substitution. You may need to use educational resources or translation services, or engage support from a carer. Explain that a substitute patch may look different and contain different adhesives, which can cause skin reactions in some people.

Inform the prescriber by email, fax or phone as soon as is practical after you make the substitution.

General information

Please note that the dates given for these shortages may change and we encourage you to check the medicine shortage reports database for updates about the supply of HRT transdermal patch products.

Please also keep in mind that we can work with pharmaceutical companies to communicate information about medicine shortages to health professionals and patients, but we cannot compel companies to increase supply or apply to have their products subsidised on the PBS.

While we can suggest approaches to manage the supply of medicines during shortages, we do not have the power to regulate the clinical decisions of health professionals.

We will continue to monitor the supply of estradiol-containing and combination estradiol/norethisterone (norethindrone)-containing transdermal patch products and work with the suppliers and relevant health professionals to update this advice if needed.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.