To help manage the ongoing supply disruptions, the health regulators have extended to 28 October 2022, serious shortage protocols (SSPs) for 12 of the 13 hormone replacement therapies (HRT).
“The only HRT SSP set to expire on 29 July 2022 is for SSP021 Premique low dose 0.3mg/1.5mg modified-release tablets. After 29 July, there will be no need to restrict quantities of Premique tablets as its supply situation has now stabilised,” said PSNC.
In addition, the dose equivalence advice and endorsement guidance for SSP024 and SSP025 have been updated.
SSP024 and SSP025 have been updated by DHSC to provide greater clarity to pharmacists on the dose equivalences to determine the appropriate quantity to supply.
Pharmacists are asked to refer to the latest SSP versions and endorsement guidance published on NHSBSA’s website.
They are also required to read and comply with the requirements outlined within the individual SSPs and supporting guidance as published on the NHSBSA website for the HRT products listed above.
The table below shows all HRT SSPs (except SSP021) with an extended expiry date to 28 October 2022.
|Restriction of the quantity supplied (for prescriptions ordering > 3 months)||Substitution with a specific alternative product (for prescriptions ordering < 3 months)||Substitution with a specific alternative product AND restriction of the quantity supplied (for prescriptions ordering > 3 months)|
|Ovestin® 1mg cream||SSP 020||SSP 024 (update to dose equivalence advice and endorsing guide – see latest versions)||SSP 025 (update to dose equivalence advice and endorsing guide – see latest versions)|
|Oestrogel® Pump-Pack 0.06% gel||SSP 019||SSP 022||SSP 023|
|Lenzetto® 1.53mg/dose transdermal spray||SSP 026||SSP 027||SSP 028|
|Sandrena® 0.5mg and 1mg gel sachets||SSP 029||SSP 030||SSP 031|
For four HRT medicines affected by ongoing supply disruptions, a total of 12 individual SSPs remain valid for use which allow either:
- Restriction of the quantity supplied – where a prescription has a duration of more than three months and supplies are available, an equivalent of three months’ supply will be permitted in accordance with the SSP for the prescribed medicine; or
- Substitution with a specific alternative product – where the prescribed duration of treatment is three months or less and supplies are unavailable, a pharmacist can supply a specific alternative product sufficient to provide a reasonable estimate of the prescribed duration of treatment, if deemed clinically appropriate; or
- Substitution with a specific alternative product AND restriction of the quantity supplied – where a prescription has a duration of more than three months and supplies are unavailable, the SSPs will allow pharmacists to provide three months’ supply of specific alternative product.