February Horizon Scanning

11th March 2022 - Source: Amanda Chell

Serious Shortages Protocol.

In response to a significant ongoing disruption to the supply of Paracetamol 120mg and 240mg suppositories, a Serious Shortage Protocol (SSP) has been issued by the Department of Health and Social Care (DHSC).

Effective today, 25 January 2022, SSP015 provides that for every Paracetamol 120mg or 240mg suppository originally prescribed, one Paracetamol 125mg or 250mg suppository must be supplied. SSP015, authorised by the Secretary of State, has been developed by clinicians and provides pharmacists with procedures to follow in providing either of these suitable alternative products to help reduce the number of patients having to return to their prescriber for a replacement prescription.

For prescriptions (NHS or private) requesting: Supply permitted under SSP015:
Paracetamol 120mg suppository
Paracetamol 240mg suppository
Paracetamol 125mg suppository
Paracetamol 250mg suppository

The SSP may be amended or revoked at any time but currently expires on 18 February 2022 – PSNC will update contractors on any changes.

Key points relating to SSP015

  • 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 should refer back to the prescriber if their professional judgement determines that the patient is not suitable to receive the marginally stronger medicine in accordance with this SSP.

For endorsing requirements please refer to NHSBSA’s supporting guidance.

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

Contractors will receive an email to their shared NHSmail account informing them of this SSP and pharmacy teams are advised to read the documentation for SSP015 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 SSP015: Paracetamol 120mg and 240mg suppositories.

For further information and guidance please see our news story New SSP issued for Paracetamol 120mg & 240mg suppositories

Reference PSNC

Prescription charge exemption for COVID antivirals

Waiver in force until March 31

DHSC has lifted prescription charges for antiviral medicines supplied to patients who have tested positive for COVID-19 and who are in the eligible cohorts of patients identified by the UK chief medical officers.

This exemption was announced on December 10, and remains in force until 31 March 2022.

This waiver will also apply to therapeutic treatments that are being made available through the NIHR funded HEAL-COVID clinical trial platform.

Reference DDA website

Class 4 Medicines Defect Information: Flamingo Pharma UK Ltd, Ibuprofen 400mg Tablets, EL (22)A/04

Flamingo Pharma UK Ltd have identified an error relating to the embossed batch number on some cartons of Ibuprofen 400mg tablets.

Product description

Ibuprofen 400mg Tablets PL 43461/0005

Batch Number Expiry Date Pack Size First Distributed
1403444 12/2025 24 06 September 2021

Active Pharmaceutical Ingredient: Ibuprofen

Brief description of the problem

Flamingo Pharma UK Ltd have identified an error relating to the embossed batch number on some cartons of Ibuprofen 400mg tablets. The batch number is illegible on some cartons and poses a risk to traceability in the event of a future recall or a medical enquiry. The batch numbers on the blisters within the cartons are clear and present. Additionally, the expiry date is still visible and clearly marked on the carton and blister.

Advice for healthcare professionals

The impacted products are within specification and there is no issue with product quality. Therefore, the affected batches are not being recalled. Healthcare professionals should check the blisters before dispensing the affected batch to ensure the batch number can be read. In the event of a future recall or medical enquiry, the batch number on the blister should be referred to if the number on the carton cannot be read.

A small proportion of these packs have been overlabelled by Mawdsley Brooks & Co Ltd and they have confirmed they will contact customers directly to inform them of this issue.

Further Information

For medical information and stock control queries please contact:

Flamingo Pharma

For medical information safety@flamingopharma.co.uk or general product enquiry sales@flamingopharma.co.uk +44 (0) 7733522465

Reference MHRA

CQC restarts inspections of ‘risk’ services

Some in-person inspections to restart from Tuesday 1 February

Services where there is evidence that people are at risk of harm will be inspected by the CQC from Tuesday 1 February.

In an update to CQC’s regulatory approach, previously postponed inspections to support roll out of booster vaccinations, will now take place where risk of harm is identified.

The update recognises the changing pressures on health and social care services.

Reference DDA website