TGA warns of a serious shortage of HRT patches, and their planned replacements, as well as some oral contraceptives
Australia is facing a shortage of estradiol patches which will last well into 2021. A combination oral cotraceptive will also be in short supply till the end of the year, the Therapeutic Goods Administration (TGA) has warned.
The TGA said it 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.
The problem is being exacerbated by a delay in the arrival of five overseas registered products which had been authorised for use by patients currently using the Estradot patches.
“The TGA has… become aware of a delay in the availability of some strengths of the overseas-registered product,” it said.
“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, and 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 and 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.
“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,” the TGA says.
“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 notices will apply from 26 August 2020 until 31 December 2020.
Meanwhile, a warning has also been issued of a shortage of oral contraceptive pills containing the combination ethinylestradiol and norethisterone.
The affected products are:
- Brevinor – norethisterone 0.5 mg and ethinylestradiol 35 micrograms
- Norimin – norethisterone 0.5 mg and ethinylestradiol 35 micrograms
- Brevinor-1 – norethisterone 1 mg and ethinylestradiol 35 micrograms
- Norimin-1 – norethisterone 1 mg and ethinylestradiol 35 micrograms.
All four products are sponsored by Pfizer Australia who said the shortage is due to manufacturing issues and is expected to continue until mid-October 2020 and early December 2020, depending on the product.
“There are currently no exact alternatives for these products,” the TGA said.
“If your patient has been prescribed Brevinor, Brevinor-1, Norimin or Norimin-1, you may wish to consider an alternative combined oral contraceptive pill or methods of contraception”.
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