SSP075 – Monomil® XL 60mg tablets

Update 15/11/2024 – The Department of Health and Social Care (DHSC) has provided an update on the Serious Shortage Protocol (SSP) for Monomax® 60XL tablets (SSP074). This SSP has now expired.

There are no further changes to SSP075. Please see an updated table below:

Update 18/10/2024 – The Department of Health and Social Care (DHSC) has provided an update on the Serious Shortage Protocol (SSP) for Monomax® 60XL tablets (SSP074). SSP074 was due to expire on 18 October 2024 but the end date has been further extended to Friday 15 November 2024.

There are no further changes to SSP075 and SSP076. Please see an updated table below.

Update 27/09/2024 – The Department of Health and Social Care (DHSC) has provided an update on the Serious Shortage Protocol (SSP) for Chemydur® 60XL tablets (SSP073). SSP073 was due to expire on 27 September 2024 but the end date has been further extended to Friday 11 October 2024.

There are no further changes to SSP074, SSP075 and SSP076. Please see updated table below.

In response to a significant ongoing disruption to the supply of some Isosorbide mononitrate 60mg modified-release preparations, four new Serious Shortage Protocols (SSPs) have been issued by the Department of Health and Social Care (DHSC).

Effective today 6 September 2024, SSP073, SSP074, SSP075, and SSP076 provides for the following:

• SSP073 – for every one tablet of Chemydur® 60XL – one tablet of:
  Isotard® 60XL or Medomon® XL or Relosorb XL® or Tardisc® 60XL tablet must be supplied
• SSP074 – for every one tablet of Monomax® XL 60mg, one tablet of:
  Isotard® 60XL or Medomon® XL or Relosorb XL® or Tardisc® 60XL tablet must be supplied
• SSP075 – for every one tablet of Monomil^® XL 60mg, one tablet of:
  Isotard® 60XL or Medomon® XL or Relosorb XL® or Tardisc® 60XL tablet must be supplied
• SSP076 – for every one capsule of Nyzamac^® SR 60mg, one tablet of:
  Isotard® 60XL or Medomon® XL or Relosorb XL® or Tardisc® 60XL tablet must be supplied

SSP073, SSP074, SSP075 and SSP076, authorised by the Secretary of State, has been developed by clinicians and provides pharmacists with procedures to follow in providing a suitable alternative product to help reduce the number of patients having to return to their prescriber for a replacement prescription.

These SSPs may be amended or revoked at any time but currently expire on the specific dates listed in the table above – we will update pharmacy owners on any changes.

Key points relating to Isosorbide mononitrate 60mg modified-release preparations

• • This protocol does not allow for the quantity supplied to be less than the number of days prescribed on original prescription.
  • SSP073 only allows the substitution of Chemydur^® 60XL tablets.
  • SSP074 only allows the substitution of Monomax^® XL 60mg tablets.
  • SSP075 only allows the substitution of Monomil^® XL 60mg tablets.
  • SSP076 only allows the substitution of Nyzamac^® SR 60mg capsules.
  • Ensure that patients considered unsuitable for inclusion are promptly referred to their prescriber for further advice.
  • The supervising pharmacist should ensure that the patient’s prescriber is notified when supplying a patient in accordance with this SSP.
  • The supervising pharmacist, using their professional judgement determines that swapping the patient to a different brand of a Isosorbide mononitrate 60mg modified-release tablets  would not be suitable for the patient.
  • For endorsing requirements please refer to NHSBSA’s supporting guidance for SSP073, SSP074, SSP075 and SSP076.

Pharmacists must exercise their professional judgement to ensure the alternative product is suitable for the patient.

Pharmacy owners will receive an email to their shared NHSmail account informing them of this SSP and pharmacy teams are advised to read the documentation for all SSPs in full and to implement the protocol with immediate effect. Pharmacists are required to read and comply with the requirements outlined within the individual SSP as published on the NHSBSA website.

Reimbursement

Reimbursement is for the medicine supplied in accordance with the SSP and not the originally prescribed medicine i.e. in this instance pharmacy owners will be reimbursed the reimbursement price for the supplied Isosorbide mononitrate 60mg modified-release tablets product dispensed. Supply in accordance with the SSP will result in the following fees being paid to the pharmacy owner and products supplied in accordance with an SSP is to be considered VAT zero-rated:

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

Community Pharmacy England previously reported that the NHS Business Services Authority (NHSBSA) received a number of EPS SSP claims which did not meet the requirements for a valid SSP claim. A large number SSP claims continue to be deemed invalid by the NHSBSA due to incorrect endorsements applied by PMR systems and/or pharmacy staff. We recommend pharmacy owners to regularly reconcile the value of SSP fees on their payment schedules against the number of SSPs declared on the FP34C submission form. Please refer to our new guidance on reconciliation of SSP claims.

If there is a payment discrepancy and it is believed that the correct SSP endorsing guidance was followed, pharmacy owners may consider requesting a re-check of relevant prescriptions and the NHSBSA will be able to explain why the claim was unpaid or rectify the payments.

Pharmacy teams are reminded to follow the SSP-specific guidance to ensure endorsements are applied correctly, and we also have guidance supporting teams raising PMR-specific claiming issues with their suppliers. Click here for more Top Tips on claiming for SSPs. 

Support in implementing the SSP

The following resources have been developed to support pharmacy teams in using these protocols.

Current versions of SSPs

Serious Shortage Protocols Operational Guidance

Serious Shortage Protocols Questions & Answers

Serious Shortage Protocols (SSPs) Endorsing Factsheet

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

Background information on SSPs

Further information on what SSPs are and when they may be used is available via the links below.

Serious Shortage Protocols (SSPs) on-demand webinar

Serious Shortage Protocols (SSPs) webpage