Shortage of Estradot (estradiol) hormone replacement therapy patches (multiple strengths)

The Therapeutic Goods Administration (TGA) has been notified of a current shortage for all strengths of Estradot (estradiol) hormone replacement therapy (HRT) transdermal patches due to manufacturing issues. The shortage is expected to continue until July 2021.

Estradot HRT patches are used for short-term relief of symptoms associated with menopause.

In order to reduce the impact of this shortage on patients the TGA has authorised the supply of five overseas-registered products under Section 19A of the Therapeutic Goods Act 1989. These products are similar in strength to the Australian registered Estradot patches that are in shortage.

The TGA has since become aware of a delay in the availability of some strengths of the overseas-registered product. In response, we are issuing Serious Shortage Substitution Notices for Estradot 25 and Estradot 100 patches. The notices specify substitutions that pharmacists are able to make for patients with a prescription for Estradot 25 or Estradot 100 patches. The notices allow Estradot patches to be replaced with the same strength of either Estraderm MX or Climara patches.

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 notices apply from 26 August 2020 until 31 December 2020. The TGA may lapse the notices prior to this date, if it becomes evident that either the registered or the Section 19A products become available to meet demand in Australia.

Overseas-registered Estradot 50 and 75 patches are supplied under Section 19A by Novartis Pharmaceuticals Australia Pty Ltd (Novartis). Novartis can be contacted on 1800 671 203 for further information on supply.

The TGA has also approved supply of overseas-registered Estradot 37.5 patches under section 19A, but has been informed by Novartis that availability of this strength has been delayed. Enquiries about the availability of this strength can be directed to Novartis. There is no equivalent strength of other brands of estradiol HRT patch. People who are prescribed Estradot 37.5 patches should speak to their doctor regarding other suitable alternatives.

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 100 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 leaflet, which is available from your pharmacist or on the TGA website. Talk to your doctor or pharmacist if you have any concerns.

Information for prescribers

Prescribers should be alert to the current shortage of Estradot HRT 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 the Serious Shortage Medicine Substitution Notice 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 Consumer Medicine Information (CMI) leaflet and discuss possible adverse events.

The Serious Shortage Substitution Notices 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.