New SSP issued for Combisal®125mcg/25mcg inhalers

In response to a significant ongoing supply disruption affecting Combisal® 125micrograms / 25micrograms inhaler, a Serious Shortage Protocol (SSP) has been issued by the Department of Health and Social Care (DHSC).

Effective 22 July 2022SSP034 authorised by the Secretary of State, has been developed by clinicians and provides pharmacists with procedures to follow in providing a suitable alternative inhaler to help reduce the number of patients having to return to their prescriber for a replacement prescription.

SSP034 provides that for every Combisal® (Fluticasone 125micrograms / Salmeterol 25micrograms) pressurised metered dose inhaler (pMDI) originally prescribed, one Fluticasone 125micrograms / Salmeterol 25micrograms pMDI  must be supplied (specified brands only). Additionally, for patients that use a spacer device with their Combisal® inhaler, SSP034 also provide an option for pharmacists to supply a compatible spacer device if the original spacer that the patient has is not compatible/licensed with the substituted inhaler.

For prescriptions (NHS or private) requesting: Supply permitted under SSP034:
Combisal® (Fluticasone 125microgram / Salmeterol 25microgram) pressurised metered dose inhaler (pMDI)

An alternative brand of Fluticasone 125micrograms / Salmeterol 25micrograms pMDI: 

Alofute® , Sereflo® , Seretide 125 Evohaler®  or Sirdupla® 

AND if required, a compatible spacer device:

AeroChamber Plus® or Volumatic®  (all types listed in Part IXA)

 

The table below shows the alternative brands of Fluticasone 125micrograms / 25micrograms pMDI inhaler CFC free that can be supplied as an alternative to Combisal® in accordance with SSP034. The table also includes information on licensed age restrictions, ethanol content and spacer compatibility for inhalers.

Alternatives to Combisal® 125mcg/25mcg inhaler Licensed age restriction Compatible spacer device Contains ethanol
Aloflute®  18 years and over AeroChamber Plus®*  Yes
Sereflo®  18 years and over Manufacturer
advises spacer
devices are not
compatible with Sereflo 125mcg/25mcg inhaler – if
spacer device
required switch to
alternative fixed-dose combination
preparation which is authorised for use with a spacer device.
No
Seretide 125 Evohaler®  12 years and over Volumatic®*(all types) No
Sirdupla®  18 years and over AeroChamber Plus® * (all types) Yes

The SSP may be amended or revoked at any time but currently expires on 19 August 2022 – PSNC will update contractors on any changes.

Key points relating to SSP034

  • This protocol does not allow for the quantity supplied to be less than the number of days prescribed on original prescription.
  • The SSP can only be used to supply an alternative inhaler (along with a compatible spacer device, if required) to patients aged 12 years or over.
  • The patient/carer must consent to receiving the medicine supplied under this SSP. The patient/carer should only be supplied in accordance with this SSP if the pharmacist is satisfied they understand and are able to accommodate the switch.
  • For children aged between 12-17, only Seretide 125 Evohaler® can be supplied as a licensed alternative.
  • Ensure that patients who meet the SSP ‘Criteria for exclusion‘ are promptly referred to their prescriber for further advice.
  • Both Sereflo® and Seretide 125 Evohaler® are alcohol-free and suitable for patients who are intolerant to alcohol or prefer an alcohol-free alternative.
  • Combisal® inhaler uses the AeroChamber Plus® spacer device. Aloflute® and Sirdupla® inhalers may be suitable alternatives for patients already using the AeroChamber Plus® spacer device.
  • For patients substituted to Seretide 125 Evohaler®, a Volumatic® spacer should be given to patients who require a spacer device.
  • For patients who pay for their prescriptions, they would continue to pay a single charge for the alternative inhaler supplied in accordance with SSP034. Where it is deemed suitable to supply an alternative spacer to the patient, no prescription charge should be taken for the spacer.

Endorsing requirements

  • To claim the correct reimbursement and remuneration for supply in accordance with SSP034, follow the endorsing requirements as outlined in NHSBSA’s supporting guidance. See information on common SSPs endorsing errors identified by the NHSBSA.
  • Contractors should check with their system supplier on the correct method of adding the required SSP endorsements including how to endorse a spacer device, if one is supplied.
  • When a spacer device is supplied in accordance with SSP034, contractors should endorse the brand and type of spacer supplied for example, Volumatic® or Volumatic paediatric® with mask, if appropriate.
  • If your PMR system does not allow endorsement of multiple products (inhaler and spacer) against a single prescribed item, contractors should endorse the alternative inhaler supplied along with the correct SSP endorsement. For the spacer device, the contractor would select the ‘NCSO’ endorsement and enter the brand/type of spacer supplied in the text.
  • If a spacer cannot be added to endorsement this will not be reimbursed. If your PMR system functionality does not support correct endorsement requirements, the patient should be referred back to their prescriber to obtain a new prescription for an alternative inhaler and a compatible spacer.

Pharmacists must exercise their professional judgement to ensure the alternative products are suitable for the patient.

Contractors should have been sent an email to their shared NHSmail account informing them of this SSP. Pharmacists are required to read and comply with the requirements outlined within the individual SSP and supporting guidance as published on the NHSBSA website for SSP034 Combisal® 125mcg/25mcg inhalers.

Remuneration

Supply in accordance with this SSP034 will result in the following fees being paid to the contractor:

  • One Single Activity Fee (£1.27) where only one dispensed item or two Single Activity Fees (2 x £1.27) where it is deemed suitable to supply an alternative spacer to the patient.
  • One SSP fee (£5.35)

Reimbursement

The supplied product in accordance with this SSP034 will be reimbursed as if it was dispensed against a prescription. In this instance, contractors will be reimbursed the NHS list price for the quantity supplied and endorsed for the specified products and strengths listed below:

  • Aloflute® 125microgram / 25microgram
  • Sereflo® 125microgram / 25microgram
  • Seretide® 125 Evohaler
  • Sirdupla® 125microgram / 25microgram

Where deemed appropriate if a spacer is supplied in accordance with this SSP, then pharmacy contractors will be reimbursed the Part IX reimbursement price for the product endorsed. All AeroChamber Plus® and Volumatic® spacer devices types listed in the Tariff can be supplied, as appropriate.

Where the correct endorsement (as per Clause 9 Part II of the Drug Tariff) is not provided, pharmacy contractors will be reimbursed the cheapest spacer/holding chamber device as recommended for the substituted inhaler.

The reimbursement price will account for VAT payment.

Support in implementing the SSPs

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

Current versions of SSPs (NHSBSA website)

Serious Shortage Protocols (SSPs)

PSNC Briefing 011/21: Serious Shortage Protocols (SSPs) updated endorsing guidance

Serious Shortage Protocols Questions & Answers

Background information on SSPs

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

Serious Shortage Protocols (SSPs) on-demand webinar