Drug Availability Update
Further to DrugAlert volume 695, HPS Pharmacies wish to give notice that Bayer is continuing to experience a supply interruption for Progynova® tablets as follows:
Estradiol valerate 1mg
Estradiol valerate 2mg
Normal supplies of each strength are expected to return by early May 2022.
The Therapeutic Goods Administration (TGA) has made a Serious Scarcity Substitution Instrument (SSSI) to help manage this long-term out of stock situation. The SSSI allows pharmacists to substitute the following products for Progynova®:
- Estrofem® (estradiol (as hemihydrate)) 1mg tablets
- Estrofem® (estradiol (as hemihydrate)) 2mg tablets
- Zumenon® (estradiol (as hemihydrate)) 2mg tablets
This SSSI expires on 1 May 2022, unless revoked earlier by the TGA. Points to consider during this time include:
- The pack size of estradiol-only tablets varies by brand. The quantity supplied to a patient under the SSSI must match the total dose prescribed;
- Zumenon® 2mg tablets are not scored; splitting the tablets to obtain a 1mg dose may be difficult for some patients;
- Occupational exposure to estradiol is hazardous. Personal protective equipment (e.g. gloves, mask) may be appropriate for carers when splitting tablets;
- Zumenon® is PBS-listed when prescribed but Estrofem® is not
Further information on the conditions of the SSSI can be found here.
Alternative estradiol valerate products may also be accessed via the Special Access Scheme (SAS), if necessary. Please note that SAS alternatives are subject to a longer lead-time and different pricing as they must be sourced internationally.
Retain this notice in a prominent position, including in other related business units until supplies return to normal. Report any problems identified with medicines, vaccines or medical devices to the TGA.
Should you require further information regarding this matter, please contact Bayer Australia on 1800 008 757 or your pharmacist at HPS Pharmacies.