Ten more SSPs issued for HRT medicines

In response to significant ongoing disruption to the supply of some Hormone Replacement Therapy (HRT) medicines, the Department of Health and Social Care (DHSC) has issued a further ten new Serious Shortage Protocols (SSPs). Following the three HRT SSPs issued at the end of April 2022, the ten new SSPs, introduced with immediate effect, allow community pharmacists to consider different options to enable continued supply of HRT medicines to mitigate the ongoing supply disruptions affecting certain HRT medicines.

Depending on the prescribed quantity of the affected HRT medicines, the protocols allow pharmacists to either supply a reduced quantity of the same HRT medicine, or substitute with a specific alternative product, or provide a reduced quantity of a specific alternative product. For each SSP, DHSC has included specific patients counselling points which must be taken into account when deciding whether supply in accordance with an SSP is suitable for a patient. Pharmacists will need to call on their clinical expertise to determine which SSP is the most appropriate to use in each scenario and to counsel patients on any changes made to their treatment and what it means for their medicine regimen.

Pharmacy teams are advised to read the documentation in full for all SSPs published on the NHSBSA’s website and implement the protocols with immediate effect. DHSC have confirmed that the endorsement guidance for the new SSPs is currently being developed and will be added to the NHSBSA’s website shortly.


HRT SSPs

For five HRT medicines affected by ongoing supply disruptions, a total of 13 individual SSPs have been issued by DHSC 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.

Three of the SSPs restricting quantity to three months’ supply were issued on 29 April 2022 and a further ten SSPs were issued on 20 May 2022.

A summary breakdown of SSPs available for each HRT medicine is listed below.

Drug name SSP
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)
Premique® Low Dose 0.3mg/1.5mg modified-release tablet SSP 021
Ovestin® 1mg cream SSP 020 SSP 024 SSP 025
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

Pharmacists are 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.

Quantity restriction SSPs

Where a prescription has a duration of more than three months and supplies are available, five of the SSPs for HRT medicines enable community pharmacists in the UK to restrict the quantity supplied to an equivalent of three months’ supply.

No prescription charge is payable if a patient receives a smaller quantity of the medicine than the quantity originally ordered on the prescription if it was supplied in accordance with an SSP for reduced quantity. 

SSP number Brand name Generic name SSP Expiry Supporting Information Patient charge 
SSP019 Oestrogel® Pump-Pack 0.06% gel Estradiol 0.06% gel (750microgram per actuation) Friday 29 July 2022 SSP019 guide No
SSP020 Ovestin® 1mg cream Estriol 0.1% cream Friday 29 July 2022 SSP020 guide No
SSP021 Premique® Low Dose 0.3mg/1.5mg modified-release tablets Conjugated oestrogens 300microgram / Medroxyprogesterone 1.5mg modified-release tablet Friday 29 July 2022 SSP021 guide No
SSP026 Lenzetto® 1.53mg/dose transdermal spray Estradiol 1.53mg/dose transdermal spray Friday 19 August 2022 SSP026 guide No
SSP029 Sandrena®  0.5mg and 1mg gel sachets Estradiol 0.5mg and 1mg gel sachets Friday 19 August 2022 SSP029 guide No

Substitution SSPs

Where the prescribed duration of treatment is three months or less and supplies of the prescribed treatments are unavailable, three SSPs for HRT medicines enable community pharmacists in the UK to substitute with specific alternative estradiol patches to provide a reasonable estimate of the prescribed duration of treatment. The pharmacist will need to assess the clinical appropriateness of swapping a patient from a topical HRT gel/spray formulation to the closest patch formulation. Details of the alternative patches to supply can be found in Annex A of the relevant SSP.

One of the SSPs (SSP024) for Ovestin® 1mg cream (Estriol 0.1% cream) allows pharmacists to substitute to an alternative Estriol 0.01% cream. Provided the prescribed duration of treatment is three months or less, this SSP enables community pharmacists in the UK to provide the alternative Estriol 0.01% cream at a quantity that is equivalent of the number of days originally ordered on the prescription.

As there is no quantity restriction for the SSPs allowing substitution only, patients who pay for their prescriptions will continue to pay prescription charge(s) for all chargeable items including any HRT medicines supplied in accordance with such SSPs.

SSP number Brand name Generic name Substitute medicine SSP Expiry Supporting Information Patient charge 
SSP022 Oestrogel® Pump-Pack 0.06% gel Estradiol 0.06% gel (750microgram per actuation)

Estradiol patch

Once weekly patch (Progynova TS®, Femseven®) or
Twice weekly patch (Evorel®, Estraderm MX®)

Strength of estradiol patch to be determined according to the patient’s current dosing regime of Oestrogel® – refer to Annex A of SSP

Friday 19 August 2022 SSP022 guide Yes*
SSP024 Ovestin®  1mg cream Estriol 0.1% cream

Estriol 0.01% cream

For every 15g pack of Ovestin® 1mg cream or Estriol 0.1% cream, pharmacists must supply
2 x Estriol 0.01% cream (80g pack).

Total quantity to supply should be equivalent of the number of days originally ordered on the prescription.

Friday 19 August 2022 SSP024 guide Yes*
SSP027 Lenzetto® 1.53mg/dose transdermal spray Estradiol 1.53mg/dose transdermal spray

Estradiol patch

Once weekly patch (Progynova TS®, Femseven®) or
Twice weekly patch (Evorel®, Estraderm MX®)

Strength of estradiol patch to be determined according to the patient’s current dosing regime of Lenzetto® – refer to Annex A of SSP

Friday 19 August 2022 SSP027 guide Yes*
SSP030 Sandrena®  0.5mg and 1mg gel sachets Estradiol 0.5mg and 1mg gel sachets

Estradiol patch

Once weekly patch (Progynova TS®, Femseven®) or
Twice weekly patch (Evorel®, Estraderm MX®)

Strength of estradiol patch to be determined according to the patient’s current dosing regime of Sandrena gel® – refer to Annex A of SSP

Friday 19 August 2022 SSP030 guide Yes*

*where a patient does not hold a valid exemption.

Substitution AND quantity restriction SSPs

Where the prescribed duration of treatment is longer than three months and supplies of the prescribed treatment are unavailable, three of the SSPs for HRT medicines enable community pharmacists in the UK to provide three months’ supply of specific alternative estradiol patches. Due to the nature of the substitution, as it is not possible to provide an equivalent dose, the quantity of the patches to supply should be reasonable estimate to provide three months’ supply.

The pharmacist will need to assess the clinical appropriateness of swapping a patient from a topical HRT gel/spray formulation to the closest patch formulation. Details of the alternative patches to supply can be found in Annex A of the relevant SSP.

One of the SSPs (SSP025) for Ovestin® 1mg cream (Estriol 0.1% cream) allows pharmacists to substitute to an alternative Estriol 0.01% cream. If the prescribed duration of treatment is longer than three months, this SSP enables community pharmacists in the UK to provide the alternative Estriol 0.01% cream at a quantity limited to three months’ supply.

No prescription charge is payable if a patient receives a smaller quantity of the medicine than the quantity originally ordered on the prescription if it was supplied in accordance with an SSP for substitution AND reduced quantity

SSP number Brand name Generic name Substitute medicine SSP Expiry Supporting Information Patient charge 
SSP023 Oestrogel® Pump-Pack 0.06% gel Estradiol 0.06% gel (750microgram per actuation)

Estradiol patch

Once weekly patch (Progynova TS®, Femseven®) or
Twice weekly patch (Evorel®, Estraderm MX®)

Strength of estradiol patch to be determined according to the patient’s current dosing regime of Oestrogel® – refer to Annex A of SSP

Friday 19 August 2022 SSP023 guide No
SSP025 Ovestin®  1mg cream Estriol 0.1% cream

Estriol 0.01% cream

For every 15g pack of Ovestin® 1mg cream or
Estriol 0.1% cream, pharmacists must supply
2 x Estriol 0.01% cream (80g pack).

The total quantity supplied under this SSP to be limited to three months’ supply.

Friday 19 August 2022 SSP025 guide No
SSP028 Lenzetto® 1.53mg/dose transdermal spray Estradiol 1.53mg/dose transdermal spray

Estradiol patch

Once weekly patch (Progynova TS®, Femseven®) or
Twice weekly patch (Evorel®, Estraderm MX®)

Strength of estradiol patch to be determined according to the patient’s current dosing regime of Lenzetto® – refer to Annex A of SSP

Friday 19 August 2022 SSP028 guide No
SSP031 Sandrena®  0.5mg and 1mg gel sachets Estradiol 0.5mg and 1mg gel sachets

Estradiol patch

Once weekly patch (Progynova TS®, Femseven®) or
Twice weekly patch (Evorel®, Estraderm MX®)

Strength of estradiol patch to be determined according to the patient’s current dosing regime of Sandrena® gel – refer to Annex A of SSP

Friday 19 August 2022 SSP031 guide No


Support on implementation

Only one SSP can be used against an individual prescription. Therefore, in each scenario, the pharmacist will need to consider both the pharmacy’s stock levels of different HRT medicines and the patient’s circumstances and before determining which of the SSPs is most appropriate to use. Depending on the SSP used, the change in supply may require additional counselling to ensure that the patient is confident to take their medication.

PSNC is also liaising with system suppliers to ensure that they will be able to implement these SSPs and provide support to pharmacy teams on how best to utilise the SSP functionality available on their systems.


Endorsement Guidance

Due to the number of different HRT SSPs available for each affected HRT medicine, pharmacists must ensure that they follow the correct endorsements requirements as per the supporting guidance published for each SSP on the dedicated page of the NHSBSA’s website. Incorrect endorsements will affect pharmacy payments.

PSNC has put together some helpful reminders and top tips on the correct SSP endorsement and submission requirements which can be found here.


Reimbursement

Reimbursement is for the medicine supplied in accordance with the SSP and not the originally prescribed medicine i.e. in this instance contractors will be reimbursed for the HRT products. The reimbursement price will account for VAT payment. Supply in accordance with the SSP will result in the following fees being paid to the contractor:

  • One Single Activity fee (currently £1.27)
  • One SSP fee (£5.35)

Useful resources

PSNC Briefing 023/19: Serious Shortage Protocols – A guide for community pharmacy teams

Serious Shortage Protocols (SSPs) webpage