SERIOUS SHORTAGE PROTOCOL (SSP)
Reference Number: SSP059

This SSP applies to the following medicine:Name of medicine(including strength andformulation)

Isosorbide mononitrate (Monomil® XL) 60mg modifiedrelease tablet

Legal category

POM

1. Details of medication to be supplied under this SSP

Pharmacies should supply from the medicines in Group 1
Name of medicine(including formulation and in the first instance, supplying from Group 2 where thoseproducts in Group 1 are not available. This is based onstrength) to be supplied
supply volumes and not clinical interchangeability.
Group 1Isosorbide mononitrate (Chemydur® 60XL) 60mg
modified-release tablet
OR
Isosorbide mononitrate (Relosorb® XL) 60mg modifiedrelease tablet
OR
Isosorbide mononitrate (Isotard® 60XL) 60mg modifiedrelease tablet

Group 2Isosorbide mononitrate (Monomax® XL) 60mg modifiedrelease tablet
OR
Isosorbide mononitrate (Monosorb® XL 60) 60mg
modified-release tablet
OR
Isosorbide mononitrate (Tardisc®XL 60) 60mg modifiedrelease tablet
Quantity of thisformulation (if applicable)

Total quantity supplied under this protocol to beequivalent to the number of days supplied on the originalprescription.
For every isosorbide mononitrate (Monomil® XL) 60mg
modified release tablet, the following quantity must be
supplied in accordance with this protocol:
1 x any tablet from the list in the ‘Name of medicine(including formulation and strength) to be supplied’ box
above.

Substitution results in aNochange to whether the use
is licenced

Scope for which this Serious Shortage Protocol (SSP) applies
The SSP applies to thefollowing parts of the UK

UK-wideClinical situation to which this Serious Shortage Protocol (SSP) applies
Scope of SSP

All NHS and private prescriptions.
This protocol does not allow for the quantity supplied tobe less than the number of days prescribed on theoriginal prescription.

Criteria for inclusion•The patient presents with a valid prescription (meetingthe requirements of the Human Medicines Regulations2012) for isosorbide mononitrate (Monomil® XL) 60mg
modified release tablets.

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Criteria for exclusion

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Cautions including any•
relevant action to be taken•

The patient/carer consents to receiving the medicine
supplied under this SSP.
All patients aged 18 years of age or above.
The patient presents with a prescription for a medicine
other than isosorbide mononitrate (Monomil® XL)
60mg modified release tablets.
The patient presents a prescription which is not valid.
The patient/carer does not consent to receiving themedicine(s) supplied under this SSP.
Where the pharmacist, using their professional
judgement, determines that the patient is not suitableto receive alternative medicine under this SSP.
Known previous hypersensitivity or severe adverse
reaction to one of the alternative tablets allowed inaccordance with this protocol, or their excipients.
Patients aged less than 18 years.
Patients should be made aware of the change and bewarned of possible adverse events that they may
experience particularly in the first few days. The mostimportant is hypotension (low blood pressure) as well
as faster heart rate. Also, headache may get worse. Ifthey have concerns, they should contact their doctor.
Ensure that patients considered unsuitable forinclusion are promptly referred to their prescriber for
further advice.

Special considerations for
specific populations ofpatients

Where the pharmacist, using their professional
judgement, determines that the patient is not suitable toreceive the alternative medicine in accordance with thisSSP.

Action to be taken if thepatient is excluded

If a patient does not meet the criteria within this SSP thenthey should be referred back to their prescriber promptly.

Action to be taken if thepatient or carer declines
the supply

If a patient/carer declines to receive medicine under this
SSP then they should be referred back to their prescriber
promptly.

Valid from:26/03/2024

Expiry date:

03/05/2024

Reference number:

SSP059

Version number:

1.0

Any queries regarding the content of this SSP which was issued by the Secretary ofState for Health and Social Care, should be addressed to NHS Prescription Services.
You can get in contact by:
Email: nhsbsa.prescriptionservices@nhsbsa.nhs.uk
Telephone: 0300 330 1349
Textphone: 18001 0300 330 1349
You can also write to us at:
Newcastle

Middlebrook

Wakefield

NHS Prescription Services
NHS Prescription Services
NHS Prescription Services Ridgway House
4th Floor
Bridge House
Northgate Close
Wakefield House
152 Pilgrim Street
Middlebrook
Borough Road
Newcastle upon Tyne
HorwichWakefield
NE1 6SN
BoltonWF1 3UB
BL6 6PQ
Change history

VersionnumberChange details

Date

2. Conditions under which this Serious Shortage Protocol (SSP) will operate•

The decision to supply any medicine under this protocol rests with the individual
registered pharmacist who must abide by the protocol.

•Whilst pharmacy staff may support the dispensing process of the protocol, thismust be carried out under the supervision of the registered pharmacist.

•Pharmacists using this SSP must ensure that it is only used within its authorised
dates and within the criteria set out within the SSP. Pharmacists must check thatthey are using the current version of the SSP, particularly when referring to ahard copy version. Amendments may become necessary prior to the publishedexpiry date. Current versions of SSP templates can be found athttps://www.nhsbsa.nhs.uk/pharmacies-gp-practices-and-appliancecontractors/serious-shortage-protocols-ssps.

•Users must not alter, amend or add to the content of this document; such action
will invalidate the SSP.

Ministerial ratification by:
NamePosition

Andrew

Minister of State for Health

Stephenson

SignatureDate26/03/2024

ADDENDUM
Supporting information on notifying other healthcare professionals• Any items supplied in accordance with an SSP in response to an NHS prescription
also needs to be supplied in accordance with NHS (Pharmaceutical and Local
Pharmaceutical Services) Regulations 2013.
• Those Regulations provide that where a therapeutic equivalent is supplied, apharmacist will need to inform a patient’s GP practice. This would generally beexpected within the next working day, but further guidance would be given in any casewhere this applied.
• Where a different quantity, an alternative pharmaceutical form, an alternative strength
or a generic equivalent is provided, it may not always be necessary that the patient’sprescriber is informed, as the existence of the SSP may be enough for the prescriber
to be aware that these changes in dispensing may take place, unless nationalarrangements agreed with the relevant representative bodies state otherwise.
However, guidance may be issued on particular SSPs to indicate that prescribers
should be informed of any patients that receive supply under it.
• In the absence of any preferred local alternate communication channels, all feedback
to prescribers should be sent by NHSmail. The NHS Service Finder is a way forpharmacies to look up the email address of the patient’s GP.
Northern Ireland• Pharmacists must ensure that the patient’s prescriber and/or GP practice is notified
when supplying a patient in accordance with this SSP as soon as practically possible,
and should aim to forward these details within 3 working days. Please refer to ‘Outlineof Operational Guidance for Dispensers in response to issue of a Serious Shortage
Protocol’ on the BSO website for more information.