Scarcity substitution notice issued


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Pharmacists now able to substitute alternatives for menopause treatment after a scarcity notification was issued   

The Therapeutic Goods Administration (TGA) has advised of a shortage of all strengths of Progynova estradiol valerate tablets.

In response, the TGA has issued 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”.

This will allow pharmacists to instead dispense certain doses of Estrofem and Zumenon tablets “without prior approval from the prescriber so long as the permitted circumstances provided within the SSSI are met”.

The Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Estradiol Valerate) Instrument 2021(link is external) 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. Due to manufacturing issues the shortage is expected to continue until May 2022, the TGA said.

The TGA is able to revoke the SSSI before its end date if the serious scarcity is resolved, or safety concerns are identified.

“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,” the TGA said.

“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.

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