Shortage of Estradot (estradiol) 25 and 75

The Therapeutic Goods Administration (TGA) has previously published information about shortages of Estradot (estrodiol) hormone replacement therapy patches (multiple strengths). We are now extending the Serious Shortage Substitution Notice (SSSN) for Estradot 25 and issuing a new SSSN for Estradot 75.

Estradot hormone replacement therapy patches are used for short-term relief of symptoms associated with menopause.

Estradot 25

Supply of Estradot 25 or a suitable alternative remains less than required to meet Australian demand. As such, the TGA is extending the SSSN for Estradot 25, which was due to expire on 31 December 2020. The extended SSSN will apply until 30 June 2021.

Estradot 75

The TGA is also issuing a new SSSN for Estradot 75. This SSSN applies from 1 January 2021 until 30 June 2021.

Serious Shortage Substitution Notices

These notices specify substitutions that pharmacists are able to make for patients with a prescription for Estradot 25 or Estradot 75 patches. The notices allow those products to be replaced with the same strength of either Estraderm MX or Climara patches. Section 19A products are available for all Estradot strengths, but supply of Estradot 25 and 75 may not be sufficient to meet Australian demand.

The notices must be given effect under state or territory law before pharmacists can supply according to the specified substitution. The patient must consent to the substitution. The pharmacist does not require prior approval from the prescribing doctor. However, pharmacists should notify the prescriber of the substitution as soon as possible.

The TGA may lapse the notices prior to their end date if it becomes evident that supply of either the registered or the Section 19A products is adequate to meet demand in Australia.

The TGA continues to monitor the supply of these products and will consider additional management actions as required.

Information for consumers

Talk to your doctor or pharmacist if you have any questions regarding the above information.

The size and the frequency of application of transdermal patches vary between brands. If you have been prescribed Estradot 25 or Estradot 75 and you receive a substitute patch, your pharmacist will explain how often to apply the substitute patch. You can also find information about how often to apply your HRT patch on the label attached by the pharmacist, and in the Consumer Medicine Information (CMI) leaflet, which is available from your pharmacist or on the TGA website.

Information for prescribers

Prescribers should be alert to the current shortage of Estradot hormone replacement therapy transdermal patches when prescribing to your patients.

Information for pharmacists

Use your professional and clinical judgement to determine whether a patient is suitable for substitution under an applicable SSSN, and ensure the patient is fully informed and consents to the change.

Please refer patients to their doctor if substitution is not appropriate or where alternative treatments other than substitution may be more appropriate.

For patients who are switched:

• counsel them on the difference in patch size
• ensure they are aware that dosing intervals may be different and ensure that this is appropriate for them
• provide them a CMI leaflet and discuss possible adverse events.

SSSNs must be given effect under state or territory law before you can supply according to the specified substitution. States and territories may also apply specific conditions to the pharmacist substitution, such as recording and prescriber communication requirements.

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.