Substitution instrument to address shortage of PROGYNOVA estradiol valerate tablets (multiple strengths)

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 Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Estradiol Valerate) Instrument 2021 has been made to:

• Declare PROGYNOVA estradiol valerate 1 mg tablet (AUST R: 10708) and PROGYNOVA estradiol valerate 2 mg tablet (AUST R: 323720) as scarce medicines; and
• Specify ESTROFEM estradiol (as hemihydrate) 1 mg tablet (AUST R: 188520), ESTROFEM estradiol (as hemihydrate) 2 mg tablet (AUST R: 188521) and ZUMENON estradiol (as hemihydrate) 2 mg tablet (AUST R: 75888) as substitutable medicines that pharmacists are permitted to dispense in substitution for the scarce medicines and specify the circumstances in which that substitution is permitted

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 about SSSIs see Substituting scarce medicines and Serious Scarcity Substitution Instruments (SSSIs).

Information for pharmacists

The SSSI allows you to substitute the specified substitutable medicines without prior approval from the prescriber so long as the permitted circumstances provided within the SSSI are met. See both the specific permitted circumstances (in Schedule 1) and general permitted circumstances (in Schedule 2) of the SSSI for estradiol valerate.

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

You must refer patients back to their prescriber if substitution is not appropriate or where alternative treatments may be more appropriate.

For patients who are dispensed the substitutable medicine:

• Ensure correct total dose is provided
• Calculate the number of tablets required to provide the prescribed dose noting that tablets may need to be cut in half (i.e. using Zumenon 2mg tablets to obtain a 1mg dose). Patients should be advised to ensure that the dose is taken in full at the prescribed time.
• Provide the Consumer Medicine Information (CMI) leaflet and discuss possible adverse events

When cutting tablets is required:

• As Zumenon 2mg tablets are unscored, assess patient’s ability to cut the tablets to obtain the correct dose
• Estradiol hemihydrate is classified as occupational hazard and may cause harm or pose a risk of harm through low dose exposure such as when a person is cutting the tablets. When instructions are provided for cutting tablets, consider the advice to use personal protective equipment such as gloves and a mask
• The Australian Pharmaceutical Formulary and Handbook (APF25) recommends cautionary advisory labels 21 and A for estradiol tablets, because unintended exposure to estradiol poses a risk of harm. Advise patients, carers and healthcare workers how to avoid unintended exposure to estradiol if Zumenon tablets need to be cut. Use professional judgement to decide whether to omit label A if tablets need to be cut. Consult APF25 for further information

Information for prescribers

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.

Excipients (inactive ingredients) vary between brands. Let your pharmacist know if you are allergic or intolerant to certain ingredients. You can also find information about excipients in the Consumer Medicine Information (CMI) leaflet, which is available from your pharmacist or on the TGA website.