SSP059 for Monomil® XL 60mg tablets extended

The Department of Health and Social Care (DHSC) has provided an update on the Serious Shortage Protocol (SSP) for Monomil® XL 60mg tablets (SSP059). SSP059 was due to expire on 31 May 2024 but the end date has been further extended to Friday 7 June 2024.


The Department of Health and Social Care (DHSC) has provided an update on the Serious Shortage Protocol (SSP) for Monomil® XL 60mg tablets (SSP059). SSP059 was due to expire on 3 May 2024 but the end date has been further extended to Friday 31 May 2024.


In response to a significant ongoing disruption to the supply of Monomil® XL 60mg tablets, a Serious Shortage Protocol (SSP) has been issued by the Department of Health and Social Care (DHSC).

Effective today 26th March 2024,  SSP059 provides that for every Monomil® XL 60mg tablets originally prescribed one alternative brand of a Isosorbide mononitrate 60mg modified-release tablets from the table below must be supplied. SSP059, authorised by the Secretary of State, has been developed by clinicians and provides pharmacists with procedures to follow in providing this suitable alternative product to help reduce the number of patients having to return to their prescriber for a replacement prescription.

Pharmacies should supply from the medicines in Group 1 in the first instance, supplying from Group 2 where those products in Group 1 are not available. This is based on supply volumes and not clinical interchangeability.

For prescriptions (NHS or private) requesting: Supply permitted under SSP059:
Group 1 (pharmacists should supply from the medicines in Group 1 in the first instance) Monomil® XL 60mg tablets Chemydur® XL tablets

or

Relosorb® XL tablets

or

Isotard® 60XL tablets

Group 2 (pharmacists should supply from the medicines in Group 2 where those products in Group 1 are not available) Monomil® XL 60mg tablets Monomax® XL tablets

or

Monosorb® XL 60 tablets

or

Tardisc®XL 60 tablets

The SSP may be amended or revoked at any time but currently expires on Friday 3 May 2024 – we will update pharmacy owners on any changes.

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 suppliersClick here for more Top Tips on claiming for SSPs. 

Key points relating to SSP059

    • This protocol does not allow for the quantity supplied to be less than the number of days prescribed on original prescription.
    • SSP059 only allows the substitution of Monomil® XL 60mg tablets.
    • 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.
    • The supervising pharmacist should supply from the medicines in Group 1 in the first instance, supplying from Group 2 where those products in Group 1 are not available. This is based on supply volumes and not clinical interchangeability.
    • For endorsing requirements please refer to NHSBSA’s supporting guidance for SSP059.

Pharmacists must exercise their professional judgement to ensure the alternative products are 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 SSP059 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 for SSP059 Monomil® XL 60mg tablets.

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)

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

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